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Oncolytics Biotech Inc

Oncolytics Biotech Inc (ONCY)

1.01
0.0144
(1.45%)
Closed June 22 4:00PM
1.01
0.00
(0.00%)
After Hours: 7:37PM

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Key stats and details

Current Price
1.01
Bid
0.982
Ask
1.01
Volume
109,143
0.9999 Day's Range 1.01
0.883 52 Week Range 3.3942
Market Cap
Previous Close
0.9956
Open
1.00
Last Trade
3
@
1.01
Last Trade Time
Financial Volume
$ 109,533
VWAP
1.0036
Average Volume (3m)
226,364
Shares Outstanding
75,853,097
Dividend Yield
-
PE Ratio
-2.76
Earnings Per Share (EPS)
-0.37
Revenue
-
Net Profit
-27.75M

About Oncolytics Biotech Inc

Oncolytics Biotech Inc is a development-stage biopharmaceutical company. The company is focused on the discovery and development of pharmaceutical products for the treatment of cancers that have not been treated with therapeutics. Its clinical development plan has the approval of its products as qui... Oncolytics Biotech Inc is a development-stage biopharmaceutical company. The company is focused on the discovery and development of pharmaceutical products for the treatment of cancers that have not been treated with therapeutics. Its clinical development plan has the approval of its products as quickly as possible and expands its products into commercially valuable new treatment areas as objectives. The company's product pipeline includes Bavencio, Keytruda, Retifanlimab, and Tecentriq. Show more

Sector
Biological Pds,ex Diagnstics
Industry
Biological Pds,ex Diagnstics
Headquarters
Calgary, Alberta, Can
Founded
1970
Oncolytics Biotech Inc is listed in the Biological Pds,ex Diagnstics sector of the NASDAQ with ticker ONCY. The last closing price for Oncolytics Biotech was $1. Over the last year, Oncolytics Biotech shares have traded in a share price range of $ 0.883 to $ 3.3942.

Oncolytics Biotech currently has 75,853,097 shares outstanding. The market capitalization of Oncolytics Biotech is $76.61 million. Oncolytics Biotech has a price to earnings ratio (PE ratio) of -2.76.

ONCY Latest News

PeriodChangeChange %OpenHighLowAvg. Daily VolVWAP
1-0.02-1.941747572821.031.04910.982927171.01242614CS
4-0.08-7.339449541281.091.140.981981201.04389559CS
12-0.06-5.607476635511.071.290.982263641.10758696CS
26-0.29-22.30769230771.31.3950.8833284211.11588383CS
52-0.93-47.93814432991.943.39420.8835431861.96157523CS
156-1.93-65.64625850342.943.39420.80213346901.86507734CS
260-0.74-42.28571428571.756.020.3515947702.40964257CS

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ONCY Discussion

View Posts
Paulness Paulness 2 days ago
NEWS -- Oncolytics Biotech® Doses First Patient in Study of Pelareorep/FOLFIRINOX Combination Therapy in Pancreatic Cancer



Demonstrating pelareorep's synergy with modified FOLFIRINOX +/- atezolizumab in pancreatic cancer could expand the number of patients it may benefit

Funding for the study comes from the US$5 million Therapeutic Accelerator Award from PanCAN
SAN DIEGO, and CALGARY, AB, June 20, 2024 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapeutics for oncology, announced the dosing of the first patient in the new GOBLET study cohort evaluating pelareorep and modified FOLFIRINOX (mFOLFIRINOX) with or without atezolizumab (Tecentriq®) in newly diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC) patients. The co-primary endpoints of the cohort are objective response rate (ORR) and safety. It is supported by the US$5M Pancreatic Cancer Action Network (PanCAN) Therapeutic Accelerator Award, an innovative program established to accelerate the development of new treatments for pancreatic cancer patients. It will be conducted in collaboration with AIO-Studien-gGmbH (AIO), a clinical trial group within the German Cancer Society, as part of GOBLET, a Phase 1/2 multiple indication study evaluating pelareorep-based combinations in gastrointestinal cancers.

"Initiation of dosing in the mFOLFIRINOX cohort of the GOBLET study is an important milestone for Oncolytics, and we're excited to begin evaluating another pelareorep combination therapy that could result in a second pancreatic cancer registration program for the company," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. "The combination of pelareorep, atezolizumab, gemcitabine, and nab-paclitaxel in pancreatic cancer patients more than doubled tumor response rates compared to earlier trials of chemotherapy alone. That combination received Fast Track Designation from the FDA and is expected to be evaluated in an adaptive registration-enabling trial through the Global Coalition for Adaptive Research (GCAR). If the combination of pelareorep and mFOLFIRINOX also demonstrates a promising efficacy signal, we could have two pancreatic cancer treatment regimens on the path to registration. I want to highlight PanCAN's important support for this program with gratitude. The US$5M Therapeutic Accelerator Award has made it possible for us to broaden our evaluation of potential therapies that have the potential to improve outcomes for pancreatic cancer patients."

Anna Berkenblit, MD, MMSc, Chief Scientific and Medical Officer at PanCAN said, "Working toward our vision to create a world in which all patients with pancreatic cancer will thrive, PanCAN launched the Therapeutic Accelerator Award to speed the drug development process and bring new options to patients faster. Dosing the first patient in this new cohort of the GOBLET study is an important step toward further evaluation of this investigational immunotherapeutic approach."

Dirk Arnold, M.D., Ph.D., Director of Asklepios Tumorzentrum Hamburg and primary investigator of the GOBLET trial commented, "I have been pleased to observe the strength of the clinical response data for pelareorep in multiple cohorts of the GOBLET gastrointestinal study, especially in pancreatic and anal cancer. mFOLFIRINOX is currently considered the best treatment option for many pancreatic cancer patients. Therefore, the evaluation of pelareorep and mFOLFIRINOX, with or without atezolizumab, presents an important opportunity to identify a novel therapeutic approach that may broaden the population of metastatic pancreatic cancer patients who could benefit from pelareorep-based therapies."

"Oncolytics is in a favorable position as we prepare to advance multiple pelareorep programs toward registration track studies and continue to expand pelareorep's potential as a backbone immunotherapy that can impact various tumor types. The collaboration with GCAR on a registration-enabling study for the combination of pelareorep, atezolizumab, gemcitabine, and nab-paclitaxel in pancreatic cancer, meeting with the FDA to align on next steps for our breast cancer program, expanded enrollment in the GOBLET anal cancer cohort, and now the initiation of dosing in the mFOLFIRINOX cohort of GOBLET, announced today, are all important elements of our corporate plan," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics. "The ability to improve the lives of cancer patients is something that motivates everyone at Oncolytics, and beginning to treat pancreatic cancer patients in the mFOLFIRINOX cohort of GOBLET is hopefully yet another step towards that goal."

About GOBLET cohort 5

The mFOLFIRINOX cohort of the Phase 1/2 GOBLET study is designed to evaluate newly diagnosed PDAC patients treated with pelareorep + mFOLFIRINOX with or without atezolizumab. There will be a three-patient safety run-in to evaluate the tolerability of each treatment arm: pelareorep + mFOLFIRINOX + atezolizumab and pelareorep + mFOLFIRINOX. A total of fifteen evaluable patients will be randomized to each arm in Stage 1 of this Simon two-stage study. The co-primary endpoints are objective response rate and safety. If Stage 1 success criteria are met, one or both treatment arms may be expanded to Stage 2 in which 17 additional evaluable patients per arm will be enrolled. Blood and tumor samples will also be collected for translational evaluations.

About GOBLET

The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 17 centers in Germany and is being managed by AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response rate (ORR) and/or disease control rate assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers. The study comprises five treatment groups:

Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic pancreatic cancer patients;

Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients;

Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients

Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients; and

Pelareorep in combination with mFOLFIRINOX with and without atezolizumab in newly diagnosed metastatic PDAC patients.Any cohort meeting pre-specified efficacy criteria in Stage 1 may be advanced to Stage 2 and enroll additional patients.

About AIO

AIO-Studien-gGmbH (AIO) emerged from the study center of the medical oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally.

About Oncolytics Biotech Inc.

Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: https://www.oncolyticsbiotech.com or follow the company on social media on LinkedIn and on X @oncolytics.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; the design, intent and potential benefits of the mFOLFIRINOX cohort of the GOBLET study; our belief that if the combination of pelareorep and mFOLFIRINOX also demonstrates a promising efficacy signal, the Company could have two pancreatic cancer treatment regimens on the path to registration; our corporate plan; the potential for expansion to Stage 2 if Stage 1 success criteria are met; our plans to advance towards registrational studies in metastatic breast cancer and pancreatic cancer; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

Company Contact
Jon Patton
Director of IR & Communication
mailto://jpatton@oncolytics.ca

Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com

View original content: https://www.prnewswire.com/news-releases/oncolytics-biotech-doses-first-patient-in-study-of-pelareorepfolfirinox-combination-therapy-in-pancreatic-cancer-302177901.html

SOURCE Oncolytics Biotech® Inc.
πŸ‘οΈ0
bwrbad bwrbad 4 weeks ago
Pancreatic cancer the deadliest one - new therapeutic possibility - yes one morning ONCY 10000% ^ not a pipe dream but now a definitive near future. now ONCY selling at fraction of a penny like many giants of today did once in their early days
https://patents.justia.com/assignee/oncolytics-biotech-inc
πŸ‘οΈ0
Paulness Paulness 4 weeks ago
NEWS -- Oncolytics Biotech® ASCO Abstracts Highlight Pelareorep's Potential in Pancreatic Cancer and Immunotherapeutic Mechanism of Action



Trial-in-progress abstract highlights new cohort that could expand the company's pancreatic cancer program

Pelareorep's ability to expand TILs highlights its immunotherapeutic mechanism of action and potential as a backbone immunotherapy for multiple indications

SAN DIEGO and CALGARY, AB, May 24, 2024 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, presented two abstracts at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. One is a trial-in-progress abstract discussing cohort 5 of the GOBLET study, which will evaluate the combination of pelareorep and modified FOLFIRINOX (mFOLFIRINOX) with and without atezolizumab in newly diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC) patients. The second describes pelareorep's ability to induce the expansion of tumor-infiltrating lymphocytes (TILs) across multiple cancers and the correlation between TIL expansion and tumor response. The ASCO annual meeting will take place from May 31 – June 4, 2024, in Chicago, Illinois.

"The two abstracts that we are sharing at ASCO this year are in synch with our mission of advancing pelareorep towards registrational trials. The first abstract outlines the design of a new GOBLET PDAC cohort that could significantly expand the potential of the company's pancreatic cancer program," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics. "The chemotherapy regimens of mFOLFIRINOX and gemcitabine/nab-paclitaxel are the two most common standards of care in metastatic pancreatic cancer. We previously reported that the combination of pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab yielded tumor response rates nearly triple historical results. Should the combination of pelareorep and mFOLFIRINOX produce a similarly positive outcome, an even broader range of metastatic PDAC patients may benefit from pelareorep-based therapy. This cohort is being funded by a US$5 million grant in the form of the Therapeutic Accelerator Award from the Pancreatic Cancer Action Network (PanCAN). We anticipate enrollment in this cohort will begin this quarter."

Thomas Heineman, MD, PhD, Chief Medical Officer of Oncolytics stated, "Pelareorep stimulates a proinflammatory response that primes tumors for immunologic killing and also activates both innate and adaptive immune responses. Our second ASCO abstract provides additional support for pelareorep's immunotherapeutic mechanism of action by describing its ability to stimulate the expansion of pre-existing and new TIL clones in the blood, which correlate with treatment response. These results build upon previously reported data from the AWARE-1 study in breast cancer to expand our understanding of pelareorep's immune-based mechanism of action, and it supports further investigation of TIL expansion as a potential biomarker of clinical activity in patients treated with pelareorep."

Details on the abstracts and poster presentation are shown below.

Title: Phase 1/2 randomized, open-label, multicenter, Simon two-stage study of pelareorep combined with modified FOLFIRINOX +/- atezolizumab in patients with metastatic pancreatic ductal adenocarcinoma.
Presentation Type: Poster
Abstract Number: TPS4203
Session Title: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary
Session Date and Time: June 1, 2024, 1:30 – 4:30 p.m. CT

A copy of the ASCO presentation will be available on the Media page of Oncolytics' website (LINK) following the conclusion of the meeting.

Highlights from the GOBLET cohort 5 abstract and poster include:

The study utilizes a Simon two-stage design to evaluate patients with newly diagnosed metastatic PDAC.

In Stage 1, 15 evaluable patients per arm will be randomized to receive either: 1) pelareorep + mFOLFIRINOX, or 2) pelareorep + mFOLFIRINOX + atezolizumab.

The co-primary endpoints are objective response rate and safety. Secondary and exploratory endpoints include additional efficacy assessments (e.g., progression-free and overall survival), and biomarker evaluations.

If Stage 1 success criteria are met, one or both treatment arms may be expanded to Stage 2, in which 17 additional evaluable patients per arm will be enrolled.

Blood and tumor samples are being collected for translational evaluations.Title: Pelareorep driven blood TIL expansion in patients with pancreatic, breast and colon cancer.
Presentation Type: Online abstract
Abstract Number: e14625

Highlights from the abstract include:

The presence and expansion of TILs are associated with a better prognosis and response to treatment in cancer patients.

Pelareorep treatment increased TIL expansion in the blood in all pancreatic, breast, and colorectal cancer patients evaluated after one cycle of treatment.

Pre-existing TIL clonal expansion in the blood appears to correlate with tumor responses in pancreatic cancer patients.

The addition of the PD-L1 inhibitor avelumab, unlike atezolizumab, eliminated pre-existing TIL expansion in the blood and reduced pelareorep's clinical activity.

These data suggest that pelareorep offers a simple, reliable way to expand TILs to provide clinical benefit.About GOBLET Cohort 5

The mFOLFIRINOX cohort of the Phase 1/2 GOBLET study is designed to evaluate newly diagnosed PDAC patients treated with pelareorep + mFOLFIRINOX with or without atezolizumab. There will be a three-patient safety run-in to evaluate the tolerability of each treatment arm: pelareorep + mFOLFIRINOX + atezolizumab and pelareorep + mFOLFIRINOX. A total of fifteen evaluable patients will be randomized to each arm in Stage 1 of this Simon two-stage study. The co-primary endpoints are objective response rate and safety. If Stage 1 success criteria are met, one or both treatment arms may be expanded to Stage 2, in which 17 additional evaluable patients per arm will be enrolled. Blood and tumor samples will also be collected for translational evaluations.

About GOBLET

The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 12 centers in Germany and is being managed by AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response rate (ORR) and/or disease control rate assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers (T cell clonality and CEACAM6). The study employs a Simon two-stage design with Stage 1 comprising five treatment groups:

Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic pancreatic cancer patients;

Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients;

Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients;

Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients; and

Pelareorep in combination with mFOLFIRINOX with and without atezolizumab in newly diagnosed metastatic PDAC patients.Any cohort meeting pre-specified efficacy criteria in Stage 1 may be advanced to Stage 2 and enroll additional patients.

About AIO

AIO-Studien-gGmbH (AIO) emerged from the study center of the medical oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally.

About Oncolytics Biotech Inc.

Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: https://www.oncolyticsbiotech.com or follow the company on social media on LinkedIn and on X @oncolytics.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; our stated mission of advancing pelareorep towards registrational trials; our belief that should the combination of pelareorep and mFOLFIRINOX produce a similarly positive outcome, an even broader range of metastatic PDAC patients may benefit from pelareorep-based therapy; our plans to advance towards registrational studies in metastatic breast cancer and pancreatic cancer; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. We may incur expenses or delays relating to such events outside of our control, including public health crises such as pandemics and epidemics, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

Company Contact
Jon Patton
Director of IR & Communication
mailto://jpatton@oncolytics.ca

Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com

Logo: https://mma.prnewswire.com/media/1762876/Oncolytics_Biotech_New_Logo.jpg

View original content: https://www.prnewswire.com/news-releases/oncolytics-biotech-asco-abstracts-highlight-pelareoreps-potential-in-pancreatic-cancer-and-immunotherapeutic-mechanism-of-action-302154957.html

SOURCE Oncolytics Biotech® Inc.

View original content: http://www.newswire.ca/en/releases/archive/May2024/24/c7469.html
πŸ‘οΈ0
Paulness Paulness 1 month ago
NEWS -- Oncolytics Biotech® Announces Voting Results from the Annual General Meeting of Shareholders



SAN DIEGO and CALGARY, AB, May 16, 2024 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced the voting results from its Annual General Meeting (AGM) of Shareholders held on Wednesday, May 15, 2024. A total of 41.34% of the issued and outstanding common shares of the Corporation were represented either in person or by proxy at the meeting.

On a vote by ballot, the eight nominees proposed by the Corporation were elected as Directors of Oncolytics to serve until the Corporation's next Annual Meeting of Shareholders or until their successors are elected or appointed, with shares represented at the meeting voting in favor of individual nominees as follows:



In addition to the election of all nominees listed as directors in the management information circular, dated March 24, 2024, Oncolytics shareholders approved all other resolutions placed before the meeting. These included fixing the number of directors of the Corporation for the ensuing year at eight and appointing the auditors for the Corporation for the ensuing year.

For more details on the matters covered at the annual meeting, please refer to the Corporation's management information circular available on SEDAR at https://www.sedar.com. Final voting results on all matters voted on at the annual meeting will also be filed on SEDAR.

About Oncolytics Biotech Inc.

Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: https://www.oncolyticsbiotech.com or follow the company on social media on LinkedIn and on X @oncolytics.

Company Contact
Jon Patton
Director of IR & Communication
mailto://jpatton@oncolytics.ca

Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com

Logo: https://mma.prnewswire.com/media/1762876/Oncolytics_Biotech_New_Logo.jpg

SOURCE Oncolytics Biotech® Inc.
πŸ‘οΈ0
Paulness Paulness 1 month ago
NEWS -- Oncolytics Biotech® Announces Preliminary Collaboration with GCAR for Inclusion of Pelareorep in Anticipated Pancreatic Cancer Trial



Anticipated evaluation to include combination therapy featuring treatment regimen of checkpoint inhibition and chemotherapy utilized in cohort 1 of the GOBLET study

GCAR is launching a new master protocol for pancreatic cancer with the intent to create a registration-enabling pathway for investigational therapies

Innovative adaptive design could accelerate registrational study timeline and provide substantial cost savings compared to traditional trial designs
SAN DIEGO and CALGARY, AB, May 15, 2024 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced that it has entered into a preliminary collaboration with the Global Coalition for Adaptive Research (GCAR). The purpose of the preliminary collaboration is to commence planning activities for the evaluation of pelareorep in the treatment of first-line metastatic pancreatic ductal adenocarcinoma (PDAC) as part of GCAR's anticipated master protocol for metastatic pancreatic cancer. Activities are currently underway to finalize the seamless Phase 2/3 master protocol design that will evaluate multiple investigational therapies for the treatment of pancreatic cancer. An intent of the study is to produce registration-enabling data.

"We are thrilled to collaborate with GCAR and are honored that pelareorep has been selected as the first therapeutic for evaluation in GCAR's planned adaptive trial in pancreatic cancer patients. We believe this opportunity presents a strategic and efficient pathway forward for the development of pelareorep to address an urgent need for pancreatic cancer patients," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics. "GCAR's anticipated trial design seeks to cut registrational study time and reduce trial costs, speeding up the journey to potentially deliver effective cancer treatment sooner. Through our interactions with GCAR, we have seen the strength of their capabilities and strong engagement with disease experts in pancreatic cancer. These attributes give us great enthusiasm to begin working together right away."

Meredith Buxton, PhD, MPH, Chief Executive Officer and President of GCAR, commented, "Our unwavering mission at GCAR is to accelerate the development of treatments for patients with deadly diseases such as pancreatic cancer. We believe that adaptive platform trials have the potential to achieve that mission and to be game-changing for patients. We are enthusiastic about collaborating with Oncolytics on our planned pancreatic cancer initiative, which was announced earlier this year, and we look forward to working with Oncolytics to advance our program."

Thomas Heineman, MD, PhD, Chief Medical Officer of Oncolytics shared, "The combination of pelareorep's impressive results to date and GCAR's innovative trial design creates a powerful path forward. This strategy, which includes leveraging GCAR's extensive investigator network, enhances our ability to quickly and effectively advance the development of this pelareorep-based combination therapy for PDAC. Updated data from cohort 1 of the GOBLET study, presented at the European Society for Medical Oncology (ESMO) Congress 2023, showed that patients treated with pelareorep combined with a checkpoint inhibitor, gemcitabine, and nab-paclitaxel experienced a 62% objective response rate, nearly triple what has been seen in historical control trials.1-4 We hope to build on these results in GCAR's forthcoming study that will employ GCAR's broad and established network of clinical leaders in pancreatic cancer. I am very optimistic about our program and our collaboration with GCAR and look forward to advancing the evaluation of pelareorep as soon as possible."

About Global Coalition for Adaptive Research

The Global Coalition for Adaptive Research (GCAR) is a 501(c)(3) non-profit corporation uniting physicians, clinical researchers, advocacy and philanthropic organizations, biotech/pharma companies, health authorities, and other key stakeholders in healthcare to expedite the discovery and development of treatments for patients with rare and deadly diseases. As a sponsor of innovative trials, including master protocols and adaptive platform trials, GCAR is dedicated to the advancement of science by modernizing clinical trials that support more efficient, less costly drug development. Adaptive platform trials deliver an unmatched accelerated time from discovery in the lab to implementation in the clinic resulting in better treatments and lives saved. GCAR announced in January 2024 plans to build a platform trial, utilizing a master protocol, for first- and second-line pancreatic cancer in the coming year. To learn more about GCAR and its initiatives, visit https://www.gcaresearch.org/.

References

Von Hoff D et al. N Engl J Med 2013; 369:1691-1703 DOI: 10.1056/NEJMoa1304369O'Reilly et al. Eur J Cancer. 2020 June; 132: 112–121. DOI:10.1016/j.ejca.2020.03.005Karasic et al. JAMA Oncol. 2019 Jul 1; 5(7):993-998. DOI: 10.1001/jamaoncol.2019.0684Tempero et al. Ann Oncol. 2021 May; 32(5):600-608. DOI: 10.1016/j.annonc.2021.01.070About Oncolytics Biotech Inc.

Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: https://www.oncolyticsbiotech.com or follow the company on social media on LinkedIn and on X @oncolytics.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential and benefits of pelareorep as a cancer therapeutic; the design intent and anticipated benefits of the GCAR study; our belief that the GCAR opportunity presents a strategic and efficient pathway forward for the development of pelareorep to address an urgent need for pancreatic cancer patients; our plans to advance towards a registrational study in metastatic pancreatic cancer; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

Company Contact

Jon Patton
Director of IR & Communication
mailto://jpatton@oncolytics.ca

Investor Relations for Oncolytics

Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com

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SOURCE Oncolytics Biotech® Inc.
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accipiterr accipiterr 1 month ago
So I am wondering if anyone here has seen any new updates on the pela virus loaded CAR T cell therapy that resulted in 80% cures in the rodent model. published in april 2022. since then I have seen like no new information about this. Any new update on this would be huge imo
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Paulness Paulness 1 month ago
NEWS -- Oncolytics Biotech® Receives Regulatory Clearance to Evaluate Pelareorep in Combination with Modified FOLFIRINOX +/- an anti-PD-L1 Inhibitor in Pancreatic Cancer



US$5 million PanCAN grant provides important support for the fifth cohort of the GOBLET study

Study of modified FOLFIRINOX/pelareorep/atezolizumab (Tecentriq®) combination expands existing pancreatic cancer program

First patient expected to be enrolled in Q2 2024

SAN DIEGO and CALGARY, AB, May 9, 2024 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, will commence enrollment into a new GOBLET study pancreatic cancer cohort following both German regulatory and ethics approvals. This cohort will evaluate pelareorep in combination with modified FOLFIRINOX (mFOLFIRINOX) with or without the PD-L1 immune checkpoint inhibitor atezolizumab (Tecentriq®) in newly diagnosed patients with pancreatic ductal adenocarcinoma (PDAC). It is supported by a US$5M Therapeutic Accelerator Award from the Pancreatic Cancer Action Network (PanCAN), an innovative program established to accelerate the development of new treatments for pancreatic cancer. The chemotherapy regimens of mFOLFIRINOX or gemcitabine + nab-paclitaxel are the two most common standards of care for pancreatic cancer.1 Oncolytics has already reported data with the combination of gemcitabine and nab-paclitaxel (link to the PR, link to the poster) that surpassed historical outcomes.2-5 Positive results from a combination with mFOLFIRINOX could greatly enhance pelareorep's potential in addressing pancreatic cancer.

"Oncolytics is pleased to announce receipt of regulatory clearance to initiate the mFOLFIRINOX cohort in patients with newly diagnosed metastatic PDAC. We appreciate the opportunity to collaborate with PanCAN, Roche, and AIO on this cohort, which is expected to initiate enrollment in the second quarter," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics. "We believe that working with PanCAN will help to further enrich Oncolytics' clinical relationships with the pancreatic cancer community. We are also grateful for PanCAN's Therapeutic Accelerator Award, which is enabling the evaluation of this combination therapy."

"The Therapeutic Accelerator Award program has been an important part of PanCAN's approach to advancing innovative treatments for pancreatic cancer. We incorporated input from leading scientists and clinicians in the field of pancreatic cancer to select Oncolytics as a recipient of this award," said Anna Berkenblit, MD, MMSc, Chief Scientific and Medical Officer at PanCAN. "Increasing patient access to clinical trials is vital to developing improved treatment options, so we are pleased that Oncolytics has received regulatory clearance for the pelareorep/mFOLFIRINOX combination and is poised to enroll the first patient in this cohort. We hope that the results from this study lead to improved outcomes for patients with pancreatic cancer."

Dirk Arnold, M.D., Ph.D., Director of Asklepios Tumorzentrum Hamburg and primary investigator of the GOBLET trial, commented, "Oncolytics has taken a very strategic approach to the development of pelareorep in pancreatic cancer by focusing its clinical studies on combinations with the most widely used treatment regimens. My experience to date with the GOBLET study, including the positive metastatic PDAC and encouraging anal cancer data reported last year, makes me enthusiastic to initiate enrollment in the mFOLFIRINOX cohort."

"We previously reported very encouraging results in pancreatic cancer patients for the combination of pelareorep, gemcitabine/nab-paclitaxel, and atezolizumab, and we plan to begin a registration-enabling study of this regimen later this year. The new pelareorep/mFOLFIRINOX cohort offers the opportunity to expand pelareorep's role in pancreatic cancer. If the mFOLFIRINOX combination shows a compelling efficacy signal, this therapeutic approach could also be advanced to a registration-enabling study, providing two opportunities for pelareorep-based treatment to benefit pancreatic cancer patients," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. "In addition, translational research studies planned for this cohort will help to further elucidate pelareorep's mechanism of action, including its ability to shape the tumor microenvironment (TME). Notably, we will evaluate the correlation between tumor responses and the expansion of tumor-infiltrating lymphocytes (TILs) in the blood, an effect that was observed in earlier pancreatic cancer studies. We look forward to initiating enrollment into the mFOLFIRINOX/pelareorep study cohort in the second quarter of this year."

References

Botta G, et al. SWI/SNF complex alterations as a biomarker of immunotherapy efficacy in pancreatic cancer. JCI Insight. 2021;6(18):e150453. https://doi.org/10.1172/jci.insight.150453

Von Hoff D et al. N Engl J Med 2013; 369:1691-1703 DOI: 10.1056/NEJMoa1304369

O'Reilly et al. Eur J Cancer. 2020 June; 132: 112–121. DOI:10.1016/j.ejca.2020.03.005

Karasic et al. JAMA Oncol. 2019 Jul 1; 5(7):993-998. DOI: 10.1001/jamaoncol.2019.0684

Tempero et al. Ann Oncol. 2021 May; 32(5):600-608. DOI: 10.1016/j.annonc.2021.01.070About GOBLET Cohort 5

The mFOLFIRINOX cohort of the Phase 1/2 GOBLET study is designed to evaluate newly diagnosed PDAC patients treated with pelareorep + mFOLFIRINOX with or without atezolizumab. There will be a three-patient safety run-in to evaluate the tolerability of each treatment arm: pelareorep + mFOLFIRINOX + atezolizumab and pelareorep + mFOLFIRINOX. A total of fifteen evaluable patients will be randomized to each arm in Stage 1 of this Simon-two stage study. The co-primary endpoints are objective response rate and safety. If Stage 1 success criteria are met, one or both treatment arms may be expanded to Stage 2 in which 17 additional evaluable patients per arm will be enrolled. Blood and tumor samples will also be collected for translational evaluations.

About GOBLET

The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 12 centers in Germany and is being managed by AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response rate (ORR) and/or disease control rate assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers (T cell clonality and CEACAM6). The study employs a Simon two-stage design with Stage 1 comprising five treatment groups:

Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic pancreatic cancer patients;

Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients;

Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients;

Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients; and

Pelareorep in combination with mFOLFIRINOX with and without atezolizumab in newly diagnosed metastatic PDAC patients.Any cohort meeting pre-specified efficacy criteria in Stage 1 may be advanced to Stage 2 and enroll additional patients.

About AIO

AIO-Studien-gGmbH (AIO) emerged from the study center of the medical oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally.

About Oncolytics Biotech Inc.

Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: https://www.oncolyticsbiotech.com or follow the company on social media on LinkedIn and on X @oncolytics.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; our stated goals, objectives and mission; the commencement of enrollment into our new GOBLET study pancreatic cancer cohort and the timing thereof; our belief that positive results from a combination of pelareorep and mFOLFIRINOX could greatly enhance pelareorep's potential in addressing pancreatic cancer, including potentially advancing the approach to a registration-enabling study; our plans to advance towards registrational studies in metastatic breast cancer and pancreatic cancer; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

Company Contact

Jon Patton
Director of IR & Communication
mailto://jpatton@oncolytics.ca

Investor Relations for Oncolytics

Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com

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SOURCE Oncolytics Biotech® Inc.

View original content to download multimedia: http://www.newswire.ca/en/releases/archive/May2024/09/c9118.html
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ShadowVolcano37 ShadowVolcano37 1 month ago
Oncolytics Biotech Inc is such a great company. It's operating in such an interesting field!
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Paulness Paulness 1 month ago
NEWS -- Oncolytics Biotech® to Participate in a Fireside Chat at the 2024 RBC Capital Markets Global Healthcare Conference



SAN DIEGO and CALGARY, AB, May 8, 2024 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced that Dr. Matt Coffey, President and Chief Executive Officer, will participate in a fireside chat at the 2024 RBC Capital Markets Global Healthcare Conference, which is taking place May 14-15, 2024 at the InterContinental New York Barclay in New York, NY. Additional details on the fireside chat can be found below.

Date: Wednesday, May 15, 2024
Time: 10:30 a.m. ET
Location: InterContinental New York Barclay Grand Ballroom I, 2nd Floor
Webcast Link: Available by clicking here

Company management will also be participating in one-on-one investor meetings at the conference. To schedule a meeting, contact your RBC representative or email mailto://jpatton@oncolytics.ca.

A live webcast of the Company's presentation will also be available on the Investor Relations page of Oncolytics' website (LINK) and will be archived until August 13, 2024.

About Oncolytics Biotech Inc.

Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: https://www.oncolyticsbiotech.com or follow the company on social media on LinkedIn and on X @oncolytics.

Contacts:

Company Contact
Jon Patton
Director of IR & Communication
mailto://jpatton@oncolytics.ca

Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com

Logo: https://mma.prnewswire.com/media/1762876/Oncolytics_Biotech_New_Logo.jpg

View original content: https://www.prnewswire.com/news-releases/oncolytics-biotech-to-participate-in-a-fireside-chat-at-the-2024-rbc-capital-markets-global-healthcare-conference-302139526.html

SOURCE Oncolytics Biotech® Inc.
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bwrbad bwrbad 2 months ago
PFIZER, ROCHE, MERCK already deep on ONCY
soon one or two of these three will bring at least a $billion offer on the table for the ONCY product + the large supporting patents. This could happen before the next p3/4 clinical data become public.
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Paulness Paulness 2 months ago
NEWS -- Oncolytics Biotech® to Host Conference Call to Discuss First Quarter Financial Results and Recent Operational Highlights
CNW Group



Conference call and webcast to take place on Thursday, May 9, 2024, at 4:30 p.m. ET

SAN DIEGO and CALGARY, AB, April 30, 2024 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced that it will host a conference call and webcast on Thursday, May 9, 2024, at 4:30 p.m. ET to discuss a corporate update and financial results for the first quarter 2024.

Conference Call & Webcast

Date: Thursday, May 9, 2024
Time: 4:30 p.m. ET
Dial In – North American Toll-Free: (800) 836-8184
Dial In – International: (289) 819-1350
RapidConnect: to join the conference call without operator assistance, please click here
Conference ID (if needed): 77797
Webcast: please click here

A webcast of the call will also be available on the Investor Relations page of Oncolytics' website, available by clicking here, and will be archived for three months. A dial-in replay will be available for one week and can be accessed by dialing (888) 660-6345 (North America) or (289) 819-1450 (International) and using replay code: 77797#.

About Oncolytics Biotech Inc.

Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: https://www.oncolyticsbiotech.com or follow the company on social media on LinkedIn and on X @oncolytics.

Company Contact
Jon Patton
Director of IR & Communication
mailto://jpatton@oncolytics.ca

Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com

Logo - https://mma.prnewswire.com/media/1762876/Oncolytics_Biotech_New_Logo.jpg

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SOURCE Oncolytics Biotech® Inc.
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Paulness Paulness 2 months ago
NEWS -- Oncolytics Biotech® Announces Upcoming Presentations at the American Society of Clinical Oncology Annual Meeting



SAN DIEGO and CALGARY, AB, April 25, 2024 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced the acceptance of two abstracts at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, which is taking place from May 31 – June 4, 2024, in Chicago, Illinois. Details on the abstracts and poster presentation are shown below.

Title: Phase 1/2 randomized, open-label, multicenter, Simon two-stage study of pelareorep combined with modified FOLFIRINOX +/- atezolizumab in patients with metastatic pancreatic ductal adenocarcinoma.
Presentation Type: Poster
Abstract Number: TPS4203
Session Title: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary
Session Date and Time: June 1, 2024, 1:30 – 4:30 p.m. CT

Title: Pelareorep driven blood TIL expansion in patients with pancreatic, breast and colon cancer.
Presentation Type: Online abstract
Abstract Number: e14625

Abstracts will be published on the ASCO Annual Meeting website at 5:00 p.m. ET on May 23, 2024.

About Oncolytics Biotech Inc.

Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: https://www.oncolyticsbiotech.com or follow the company on social media on LinkedIn and on X @oncolytics.

Company Contact
Jon Patton
Director of IR & Communication
jpatton@oncolytics.ca

Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
tim@lifesciadvisors.com

View original content: https://www.prnewswire.com/news-releases/oncolytics-biotech-announces-upcoming-presentations-at-the-american-society-of-clinical-oncology-annual-meeting-302127249.html

SOURCE Oncolytics Biotech® Inc.
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Paulness Paulness 2 months ago
NEWS -- Oncolytics Biotech® Advances Toward Registration-Enabling Trial for Pelareorep in Breast Cancer with Submission of Type C Meeting Request to FDA



Requested for Q2 2024, the Type C meeting is to focus on planned registration-enabling trial in HR+/HER2- metastatic breast cancerOverall survival results from the randomized HR+/HER2- metastatic breast cancer BRACELET-1 trial expected in H2 2024SAN DIEGO and CALGARY, AB, April 11, 2024 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapeutics for oncology, is pleased to announce the submission of a Type C meeting request to the FDA. This meeting aims to discuss the Company's planned registration-enabling trial for pelareorep in HR+/HER2- metastatic breast cancer (mBC).

"A key focus for Oncolytics in 2024 is defining the regulatory path for pelareorep in breast cancer treatment. We are optimistic that pelareorep, in combination with paclitaxel, could significantly enhance clinical outcomes for patients with HR+/HER2- metastatic breast cancer. Our position is strengthened by encouraging data from two randomized studies (BRACELET-1 and IND-213) and the AWARE-1 study, paving the way for the next phase of pelareorep's development and its registration. Ongoing discussions with our clinical collaborators and partners have helped us to prepare a robust, compelling briefing document," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics. "We eagerly anticipate our discussion with the FDA to align on the design and objectives of the registrational trial for pelareorep in metastatic breast cancer, a critical step towards bringing this innovative treatment to patients. Having a well-defined plan for the registrational track study will also help advance our strategic partnering discussions. We hope to meet with the agency in Q2 2024 and look forward to a productive dialogue. With anticipated overall survival data from the BRACELET-1 study and productive discussions with the FDA, 2024 is poised to be a transformative year for Oncolytics and our stakeholders."

Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics, added, "The data from the randomized BRACELET-1 trial showcased compelling results for the pelareorep/paclitaxel combination therapy in HR+/HER2- metastatic breast cancer patients, with a nearly tripled confirmed response rate, a 50% improvement in median progression-free survival, and a hazard ratio of 0.29 compared to the paclitaxel alone control. Importantly, these data support the statistically significant near doubling of median overall survival in another randomized phase 2 study, IND-213, which also evaluated pelareorep and paclitaxel in HR+/HER2- metastatic breast cancer patients."

Dr. Heineman continued, "Our proposed study plans to evaluate pelareorep in patients with HR+/HER2- mBC who are eligible for chemotherapy after progressing on prior hormonal therapy, including a CDK 4/6 inhibitor. We also intend to evaluate potential biomarkers, including the expansion of tumor-infiltrating lymphocytes, using T cell receptor sequencing. We look forward to the opportunity to discuss our plans with the agency and align on the best approach to advance the development of pelareorep as a potential treatment option to improve outcomes for breast cancer patients."

About Oncolytics Biotech Inc.

Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in Phase 2 studies in breast and pancreatic cancers. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: https://www.oncolyticsbiotech.com or follow the company on social media on LinkedIn and on X @oncolytics.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; our plans for a meeting with the FDA in relation to the Company's planned registration-enabling trial for pelareorep in patients with HR+/HER-2 mBC and the anticipated timing thereof; our focus in 2024; our belief that 2024 is poised to be a transformative year for Oncolytics and its stakeholders; the design and areas of evaluation for our proposed study of pelareorep in patients with HR+/HER-2 mBC; our plans to advance towards registrational studies in metastatic breast cancer and pancreatic cancer; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. We may incur expenses or delays relating to such events outside of our control, including public health crises such as pandemics and epidemics, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

Company Contact

Jon Patton
Director of IR & Communication
mailto://jpatton@oncolytics.ca

Investor Relations for Oncolytics

Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com

View original content: https://www.prnewswire.com/news-releases/oncolytics-biotech-advances-toward-registration-enabling-trial-for-pelareorep-in-breast-cancer-with-submission-of-type-c-meeting-request-to-fda-302113665.html

SOURCE Oncolytics Biotech® Inc.
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bwrbad bwrbad 2 months ago
for the greater good of peoples need everyone should support this company at least with their spare money. Faster their product comes to market faster will be the help to many seriously suffering patients through their platform treatment and off label use in similar high risk cancer patients. explore their pipeline clinical trial data and the quality of their 110+ patent portfolio. help them to speed up their effort.
https://patents.justia.com/assignee/oncolytics-biotech-inc?page=7
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glenn1919 glenn1919 3 months ago
ONCY.................................................https://stockcharts.com/h-sc/ui?s=ONCY&p=W&b=5&g=0&id=p86431144783
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Paulness Paulness 3 months ago
NEWS -- Oncolytics Biotech® to Participate in a Panel Presentation at Canaccord Genuity's Horizons in Oncology Virtual Conference



SAN DIEGO and CALGARY, AB, April 2, 2024 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, today announced that President and Chief Executive Officer Dr. Matt Coffey will participate in the Viral Approaches in Oncology panel at Canaccord Genuity's Horizons in Oncology Virtual Conference, which is taking place on April 15, 2024. Additional details on the panel presentation can be found below.

Date: Monday, April 15, 2024
Time: 9:00 a.m. ET
Panel Title: Viral Approaches in Oncology

A live webcast of the panel presentation will be available to registered attendees of the conference through the conference website. Company management will also be participating in virtual one-on-one investor meetings at the conference. To schedule a meeting, contact your Canaccord representative or email mailto://jpatton@oncolytics.ca.

About Oncolytics Biotech Inc.

Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in Phase 2 studies in breast and pancreatic cancers. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: https://www.oncolyticsbiotech.com or follow the company on social media on LinkedIn and on X @oncolytics.

Company Contact
Jon Patton
Director of IR & Communication
mailto://jpatton@oncolytics.ca

Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com

View original content to download multimedia: https://www.prnewswire.com/news-releases/oncolytics-biotech-to-participate-in-a-panel-presentation-at-canaccord-genuitys-horizons-in-oncology-virtual-conference-302105507.html

SOURCE Oncolytics Biotech® Inc.

View original content to download multimedia: http://www.newswire.ca/en/releases/archive/April2024/02/c3716.html
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bwrbad bwrbad 4 months ago
ONCY earning release tomorrow - Guess it is time for them to talk more on FDA approval, launch time line and the players
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Paulness Paulness 4 months ago
NEWS -- Oncolytics Biotech® Files Amendment to Initiate New Pancreatic Cancer GOBLET Cohort Supported by PanCAN



US$5M grant supports study of pelareorep in combination with modified FOLFIRINOX +/- atezolizumab

Testing with the most common therapies could facilitate broad use of pelareorep in pancreatic cancer patients

SAN DIEGO and CALGARY, AB, March 5, 2024 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, today announced it has submitted an amendment to GOBLET to initiate a new Phase 1/2 cohort evaluating pelareorep in combination with modified FOLFIRINOX (mFOLFIRINOX) with and without atezolizumab (Tecentriq®) in patients with newly diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC). This amendment will be reviewed by the Paul Ehrlich Institute (PEI; Germany's regulatory body) for approval before patient enrollment can begin. The cohort, the fifth of the GOBLET gastrointestinal cancer study, is being supported by the US$5 million Therapeutic Accelerator Award from the Pancreatic Cancer Action Network (PanCAN), an innovative program established to accelerate the development of new treatments for pancreatic cancer. Evaluation of this novel treatment approach will complement Oncolytics' ongoing development of pelareorep, atezolizumab, gemcitabine, and nab-paclitaxel in PDAC, which is expected to advance to a registrational study later this year.

"We are enthusiastic to have the support of PanCAN to expand the evaluation of pelareorep in pancreatic cancer and explore mFOLFIRINOX as another combination that could improve outcomes for patients. Notably, this patient population is newly diagnosed patients who are receiving first-line treatment. Chemotherapies, including either mFOLFIRINOX or gemcitabine and nab-paclitaxel, are the backbone treatment regimens of pancreatic cancer therapy1. Evaluating pelareorep in combination with these widely used regimens is an important step in our broad clinical development program," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics. "Last fall, we reported a 62% objective response rate for the GOBLET PDAC cohort studying pelareorep in combination with the checkpoint inhibitor atezolizumab in addition to gemcitabine and nab-paclitaxel (link to the PR, link to the poster). This response is about three times that of historical controls and forms the basis of the registrational program, expected to begin this year. Therefore, we are enthusiastic about this new mFOLFIRINOX pancreatic cancer cohort and look forward to enrolling the first patient as soon as possible."

Dirk Arnold, M.D., Ph.D., Director of Asklepios Tumorzentrum Hamburg, and primary investigator of the GOBLET trial, commented, "One of the reasons for pancreatic cancer's poor survival rate is that it effectively evades the immune system and can induce an immunosuppressive tumor microenvironment (TME)2. Pelareorep is an attractive combination partner because of its ability to address both issues by activating the innate and adaptive immune systems while driving the remodeling of the tumor microenvironment. Positive results from the Phase 2 study evaluating pelareorep combined with atezolizumab and chemotherapy reported last fall support the potential use of these agents together. I am hopeful that the combination of pelareorep and mFOLFIRINOX (with or without atezolizumab) will yield positive response data and advance the development of new treatment options for patients with pancreatic cancer."

"This study is designed to evaluate whether pelareorep can enhance outcomes in patients receiving mFOLFIRINOX, one of the most commonly used metastatic pancreatic cancer treatments. Combining pelareorep with mFOLFIRINOX represents an expansion of our existing pancreatic cancer program and maximizes the potential of pelareorep-based combination therapies to benefit pancreatic cancer patients," commented Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. "The mFOLFIRINOX cohort utilizes a screened selection design within a Simon two-stage approach that will also allow evaluation of the contribution of atezolizumab to the pelareorep/mFOLFIRINOX combination. In addition, this study is designed to provide valuable translational assessments, such as the expansion of tumor-infiltrating lymphocytes (TILs) in the blood, which has been associated with tumor responses. We look forward to building on PanCAN's strong relationships with the pancreatic cancer community and furthering our collaboration with AIO-Studien-gGmbH (AIO) on the GOBLET study."

References

1. Botta G, et al. SWI/SNF complex alterations as a biomarker of immunotherapy efficacy in pancreatic cancer. JCI Insight. 2021;6(18):e150453. https://doi.org/10.1172/jci.insight.150453.

2. Yoon JH, et al. Immunotherapy for pancreatic cancer. World J Clin Cases. 2021 May 6;9(13):2969-2982. doi: 10.12998/wjcc.v9.i13.2969. PMID: 33969083; PMCID: PMC8080736.

About GOBLET cohort 5

The mFOLFIRINOX cohort of the Phase 1/2 GOBLET study is designed to evaluate newly diagnosed PDAC patients treated with pelareorep + mFOLFIRINOX with or without atezolizumab. There will be a three-patient safety run-in to evaluate the tolerability of each treatment arm - pelareorep + mFOLFIRINOX + atezolizumab and pelareorep + mFOLFIRINOX. A total of fifteen patients may be randomized to each arm in Stage one of the Simon-two stage design. The co-primary endpoints of the cohort are objective response rate and safety. The success criteria for Stage 1 is defined as six or more responses in one or both of the treatment groups. Successful completion of Stage one will support expansion into Stage two, which can include one or both treatment regimens, and would enroll 17 additional evaluable patients. A total of 13 or more responses from Stage 1 and 2 combined are required to achieve the success criteria. Translational data will also be generated.

About GOBLET

The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 12 centers in Germany and is being managed by AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response rate (ORR) and/or disease control rate assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers (T cell clonality and CEACAM6). The study employs a Simon two-stage design with Stage 1 comprising five treatment groups:

1. Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic pancreatic cancer patients;

2. Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients;

3. Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients

4. Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients; and

5. Pelareorep in combination with mFOLFIRINOX with and without atezolizumab in newly diagnosed metastatic PDAC patients.

Any cohort meeting pre-specified efficacy criteria in Stage 1 may be advanced to Stage 2 and enroll additional patients.

About AIO

AIO-Studien-gGmbH (AIO) emerged from the study center of the internal oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally.

About Oncolytics Biotech Inc.

Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in Phase 2 studies in breast and pancreatic cancers. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: https://www.oncolyticsbiotech.com or follow the company on social media on LinkedIn and on X @oncolytics.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; our stated goals, objectives and mission; our belief that pelareorep in combination with mFOLFIRINOX could improve outcomes for pancreatic cancer patients and advance the development of new treatment options for patients with pancreatic cancer; our plans to build on PanCAN's strong relationships with the pancreatic cancer community and further our collaboration with AIO-Studien-gGmbH on our GOBLET study; our plans to advance towards registrational studies in metastatic breast cancer and pancreatic cancer; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

Company Contact
Jon Patton
Director of IR & Communication
+1-858-886-7813
mailto://jpatton@oncolytics.ca

Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com

View original content to download multimedia: https://www.prnewswire.com/news-releases/oncolytics-biotech-files-amendment-to-initiate-new-pancreatic-cancer-goblet-cohort-supported-by-pancan-302079547.html

SOURCE Oncolytics Biotech® Inc.

View original content to download multimedia: http://www.newswire.ca/en/releases/archive/March2024/05/c7756.html
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Paulness Paulness 4 months ago
NEWS -- Oncolytics Biotech® to Host Conference Call to Discuss Fourth Quarter and Full Year Financial Results and Recent Operational Highlights



Conference call and webcast to take place on Thursday, March 7, 2024, at 4:30 p.m. ET

SAN DIEGO and CALGARY, AB, March 4, 2024 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, today announced that it will host a conference call and webcast on Thursday, March 7, 2024, at 4:30 p.m. ET to discuss a corporate update and financial results for the fourth quarter and full year 2023.

Conference Call & Webcast

Date: Thursday, March 7, 2024
Time: 4:30 p.m. ET
Dial In – North American Toll-Free: (888) 664-6383
Dial In – International: (416) 764-8650
RapidConnect: to join the conference call without operator assistance, please click here
Conference ID (if needed): 6244-5815
Webcast: please click here

A webcast of the call will also be available on the Investor Relations page of Oncolytics' website, available by clicking here, and will be archived for three months. A dial-in replay will be available for one week and can be accessed by dialing (888) 390-0541 (North America) or (416) 764-8677 (International) and using replay code: 445-815#.

About Oncolytics Biotech Inc.

Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in Phase 2 studies in breast and pancreatic cancers. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: https://www.oncolyticsbiotech.com or follow the company on social media on LinkedIn and on X @oncolytics.

Company Contact
Jon Patton
Director of IR & Communication
+1-858-886-7813
mailto://jpatton@oncolytics.ca

Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com

View original content: https://www.prnewswire.com/news-releases/oncolytics-biotech-to-host-conference-call-to-discuss-fourth-quarter-and-full-year-financial-results-and-recent-operational-highlights-302078051.html

SOURCE Oncolytics Biotech® Inc.

View original content: http://www.newswire.ca/en/releases/archive/March2024/04/c8901.html
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bwrbad bwrbad 4 months ago
Patents Assigned to Oncolytics Biotech, Inc. till 2020, 2021-24 newly filed list not yet public
https://patents.justia.com/assignee/oncolytics-biotech-inc
2024 Outlook: Dr. Coffey: Looking ahead to 2024, we expect to initiate the first Phase 3 study for pelareorep in pancreatic cancer. The transition to a late-stage biopharmaceutical company will mark an important inflection point for investors, clinical collaborators and potential partners by providing a line of sight towards the path to regulatory approval and achieving our mission of developing pelareorep as an immunotherapeutic agent for cancer. We are excited to launch a new Phase 1/2 pancreatic cancer study investigating, for the first time, pelareorep in combination with modified FOLFIRINOX (mFOLFIRINOX). Finally, our discussions with regulators on a pivotal Phase 3 trial have been productive to date, and we expect to provide guidance on the registration path for metastatic breast cancer in the first half of 2024. We look forward to updating our stakeholders on our progress as the year unfolds."
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Paulness Paulness 4 months ago
NEWS -- Oncolytics Biotech® Announces Presentation at the Cancer Advocacy Group of Louisiana's 3rd Annual NeauxCancer Conference
PR Newswire



SAN DIEGO and CALGARY, AB, Feb. 28, 2024 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, today announced that Chief Executive Officer Dr. Matt Coffey will present a corporate overview at the Cancer Advocacy Group of Louisiana's 3rd Annual NeauxCancer Conference. The conference is taking place from February 29 - March 2, 2024, at the Ritz Carlton Hotel in New Orleans, LA. Additional details on the presentation can be found below.

Date: Friday, March 1, 2024
Time: 11:30 a.m. ET
Location: Ritz Carlton Hotel New Orleans, Acadia Room 2nd Floor
Webcast Link: Available by clicking here

Company management will also be participating in one-on-one investor meetings at the conference. To schedule a meeting, please submit a request to the conference organizers or email mailto://jpatton@oncolytics.ca

A live webcast of the Company's presentation will also be available on the Investor Relations page of Oncolytics' website (LINK).

Additional information about the event can be found on the official website by clicking here.

About Oncolytics Biotech Inc.

Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in phase 2 studies in breast and pancreatic cancers. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: https://www.oncolyticsbiotech.com or follow the company on social media on LinkedIn and on X @oncolytics.

Company Contact

Jon Patton
Director of IR & Communication
+1-858-886-7813
mailto://jpatton@oncolytics.ca

Investor Relations for Oncolytics

Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com

View original content to download multimedia: https://www.prnewswire.com/news-releases/oncolytics-biotech-announces-presentation-at-the-cancer-advocacy-group-of-louisianas-3rd-annual-neauxcancer-conference-302074097.html

SOURCE Oncolytics Biotech® Inc.
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Paulness Paulness 4 months ago
NEWS -- Oncolytics Biotech® Initiates Enrollment Expansion of GOBLET Anal Cancer Cohort



Successful Stage 1 data showed a near tripling of Objective Response Rate compared to checkpoint inhibitor monotherapy, including a Complete Response, and supports expansion

SAN DIEGO and CALGARY, Alberta, Feb. 14, 2024 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, today announced the expansion of enrollment for the anal cancer cohort of the GOBLET study evaluating pelareorep in combination with atezolizumab (Tecentriq®) in patients with second-line or later unresectable squamous cell carcinoma of the anal canal (SCCA). The study was expanded based on positive data from Stage 1 of the study, presented at the 2nd International Multidisciplinary Anal Cancer Conference (IMACC) in November 2023 (link to the PR, link to the poster).

"These exciting clinical data, which exceed the Simon two-stage success criteria, provide strong support to expand the evaluation of pelareorep in patients with advanced anal cancer. The results reported at IMACC 2023 showed that the combination of pelareorep and atezolizumab provided a 37.5% objective response rate, including one patient with a long-lasting complete response, and good overall tolerability. These data represent a meaningful contrast to recent clinical trial results which show that patients with second-line or later anal carcinoma treated with checkpoint inhibitor therapy experienced response rates of 10-14%1-3," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics."

"We begin the Stage 2 expansion with substantial optimism for patients and the potential of pelareorep, especially considering the initial efficacy signal observed for pelareorep-based therapy in pancreatic cancer. There is currently no established standard therapy for patients with anal carcinoma who have failed first-line treatment. Continued positive results could potentially expand the opportunity for pelareorep beyond the lead indications of breast cancer and pancreatic cancer and open the door to a rapid regulatory pathway in this rare and significantly under-served patient population," continued Dr. Coffey.

Dirk Arnold, M.D., Ph.D., Director of Asklepios Tumorzentrum Hamburg, and primary investigator of the GOBLET trial, commented, "One of the most difficult challenges in my practice is the limited number of treatment options that are available for patients with advanced anal cancer who have progressed on first-line therapy. I am enthusiastic about the expansion of this cohort because it will enable the continued evaluation of the pelareorep/atezolizumab combination and could provide important confirmatory data that may lead to better treatment options for patients with this late-stage disease."

"We look forward to building on the oncology community's enthusiastic reception of the IMACC 2023 data by expanding enrollment in the anal carcinoma cohort and incorporating additional sites into the study," commented Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. "Careful consideration of recently published clinical trial results indicates that a modest expansion of fewer than 20 patients will be sufficient to solidify the efficacy signal we have observed to date and lay the groundwork for a potential future registrational study in this population. We look forward to continuing our excellent collaboration with the clinical sites and investigators at AIO and hope to report additional results in 2025."

References

1. Rao S, et al. Phase II study of retifanlimab in patients (pts) with squamous carcinoma of the anal canal (SCAC) who progressed following platinum-based chemotherapy. Annals of Oncology. 2020 September. doi: https://doi.org/10.1016/j.annonc.2020.08.2272.

2. Marabelle A, et al. Pembrolizumab for previously treated advanced anal squamous cell carcinoma: results from the non-randomised, multicohort, multicentre, phase 2 KEYNOTE-158 study. Lancet Gastroenterol Hepatol. 2022 May;7(5):446-454. doi: 10.1016/S2468-1253(21)00382-4.

3. Lonardi S, et al. Randomized phase II trial of avelumab alone or in combination with cetuximab for patients with previously treated, locally advanced, or metastatic squamous cell anal carcinoma: the CARACAS study. J Immunother Cancer. 2021 November;9(11):e002996. doi: 10.1136/jitc-2021-002996. PMID: 34815354; PMCID: PMC8611452.

About GOBLET

The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 12 centers in Germany and is being managed by AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response rate (ORR) assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers (T cell clonality and CEACAM6). The study employs a Simon two-stage design with Stage 1 comprising four treatment groups:

1. Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic pancreatic cancer patients;

2. Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients;

3. Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients; and

4. Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients.

Any cohort meeting pre-specified efficacy criteria in Stage 1 may be advanced to Stage 2 and enroll additional patients.

About AIO

AIO-Studien-gGmbH (AIO) emerged from the study center of the internal oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally.

About Oncolytics Biotech Inc.

Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in Phase 2 studies in breast and pancreatic cancers. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer. For further information, please visit: https://www.oncolyticsbiotech.com.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; our plan to expand the evaluation of pelareorep in patients with advanced anal cancer; our belief that continued positive results could potentially expand the opportunity for pelareorep beyond the lead indications of breast cancer and pancreatic cancer and open the door to a rapid regulatory pathway; our belief that the expansion of the anal cancer cohort will enable the continued evaluation of the pelareorep/atezolizumab combination and could provide important confirmatory data that may lead to better treatment options for patients with this late-stage disease; our belief in the potential for a future registrational study in anal cancer; our plans to continue our collaboration with the clinical sites and investigators at AIO-Studien-gGmbH and hope to report additional results in 2025; our plans to advance towards registrational studies in metastatic breast cancer and pancreatic cancer; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

Company Contact

Jon Patton
Director of IR & Communication
+1-858-886-7813
mailto://jpatton@oncolytics.ca

Investor Relations for Oncolytics

Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com

View original content: https://www.prnewswire.com/news-releases/oncolytics-biotech-initiates-enrollment-expansion-of-goblet-anal-cancer-cohort-302061219.html

SOURCE Oncolytics Biotech® Inc.

View original content: http://www.newswire.ca/en/releases/archive/February2024/14/c7011.html
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Market Hacker Market Hacker 4 months ago
Good hire of Patricia S. Andrews. Bad cash position. They need something big to happen, or they need to raise cash or sell…..Too much risk at $1 for me. It is a swing for the fences, but a swing they have. Hope I eat crow. Good luck all!
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ZRock ZRock 4 months ago
gonna be little while, imo. still play time for the shorts.
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bwrbad bwrbad 4 months ago
this could be $20 to $80 in a single day
there drug showing game changing result in pancreatic cancer in clinical trials - that is why so many big company now lined up behind
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Paulness Paulness 5 months ago
NEWS -- Oncolytics Biotech® Appoints Patricia S. Andrews to its Board of Directors



SAN DIEGO and CALGARY, AB, Jan. 9, 2024 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, today announced the appointment of Patricia S. Andrews to its Board of Directors (the "Board").

"I am pleased to welcome Pat Andrews to our Board of Directors," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics. "Pat's extensive board and executive leadership experience navigating first registrational trials in oncology and completing transformational business development agreements with global pharmaceutical companies makes her a natural fit for Oncolytics. As we begin preparations to initiate pivotal studies with pelareorep in breast and pancreatic cancers and progress partnering discussions, we look forward to benefitting from her insights and strategic and operational experience."

"I am honored to join the Oncolytics board at this exciting time for the organization as it advances pelareorep toward registrational studies," said Ms. Andrews. "Promising recent results from the BRACELET-1 and GOBLET studies suggest that pelareorep has the potential to make an important contribution to cancer care, and I look forward to working with my fellow board members in addition to Dr. Coffey and the Executive Team to execute Oncolytics' clinical and corporate development plans."

Ms. Andrews is an accomplished biopharmaceutical executive and public company board member with a track record of success in corporate strategy, first-in-class and first-for-the-company new product commercializations, and business development. Ms. Andrews currently serves as a Director and Member of the Audit Committee at GlycoMimetics. During her tenure, the company planned and initiated its first Phase 3 study and is preparing for commercialization.

Ms. Andrews previously served as Chief Executive Officer for Sumitomo Pharma Oncology, Inc. (SMP Oncology), where she led the organization through the integration of its multiple predecessor companies. Under her leadership, the organization completed three Phase 3 trials and expanded the clinical pipeline from two programs to eight. Prior to SMP Oncology, Ms. Andrews served as Chief Commercial Officer for Incyte and led the organization through the launch preparations and introduction of Jakafi®, the company's first commercial product, a novel, first-in-class, first-in-disease agent for the treatment of myelofibrosis. While with Incyte, she also steered landmark licensing arrangements with Novartis and Eli Lilly that were critically important to fund the company's long-term trajectory.

Prior to Incyte, Ms. Andrews spent 17 years with Pfizer, ultimately serving as Vice President and General Manager of the U.S. Oncology Business Unit, a $900 million portfolio at the time. Under her leadership, Sutent® was launched, becoming the market leader in renal cell carcinoma, and a refreshed positioning of Camptosar® led to robust revenue growth after years of declining sales in colorectal cancer. Ms. Andrews is a member of the Boston chapter of the Board of Advisors for Life Science Cares, a collective impact organization dedicated to fighting poverty in local communities. She earned an MBA from the University of Michigan and her BA from Brown University.

About Oncolytics Biotech Inc.

Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in Phase 2 studies in breast and pancreatic cancers. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer. For further information, please visit: https://www.oncolyticsbiotech.com.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; our plans to advance towards registrational studies in metastatic breast cancer and pancreatic cancer; our plans to progress partnering discussions; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

Company Contact
Jon Patton
Director of IR & Communication
+1-858-886-7813
mailto://jpatton@oncolytics.ca

Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com

View original content: https://www.prnewswire.com/news-releases/oncolytics-biotech-appoints-patricia-s-andrews-to-its-board-of-directors-302029215.html

SOURCE Oncolytics Biotech® Inc.

View original content: http://www.newswire.ca/en/releases/archive/January2024/09/c2494.html
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Paulness Paulness 6 months ago
NEWS -- Oncolytics Biotech® Recaps 2023 Accomplishments, Provides Outlook for 2024



SAN DIEGO, CA and CALGARY, AB, Jan. 4, 2024 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, reported on significant 2023 accomplishments and announced corporate priorities and anticipated clinical development milestones for 2024.

Overview: "2023 was an outstanding year for Oncolytics and the development of pelareorep as a potential cancer therapy. To date, we have studied pelareorep in more than 1,100 patients, and it has been shown to be well-tolerated with mild side effects. Promising clinical and translational results from our Phase 2 programs and mechanism of action learnings from a wide range of tumor types, as detailed below, provided consistent data and efficacy signals with durable responses that support the use of pelareorep as an immunotherapeutic agent, either as a monotherapy or in combination with other agents. These data readouts from multiple clinical studies at numerous sites and from diverse cancer indications that are clinically important make a compelling argument for pelareorep as a true backbone immunotherapy with the potential to help countless patients across a range of tumors," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics. "We believe our cash balance and strong data, supported by our active business development program, position us well for 2024."

Positive Clinical and Translational Data: "Positive, early results from the Phase 1/2 GOBLET study in three gastrointestinal cancers - pancreatic, anal, and colorectal - showed that the combination of pelareorep and atezolizumab produced clinically meaningful improvements in response rates and survival timelines that are notably improved compared to historical results with no toxicity concerns. Translational data from studies in solid tumors, breast, pancreatic, and colorectal cancers showed that treatment with pelareorep remodels the tumor microenvironment and stimulates tumor-directed immune responses, affirming its mechanism of action as an immunotherapeutic agent. Together, these data provide a strong foundation to support advancing pelareorep into registrational-track studies, starting in 2024," continued Dr Coffey.

2024 Outlook: Dr. Coffey concluded by saying, "Looking ahead to 2024, we expect to initiate the first Phase 3 study for pelareorep in pancreatic cancer. The transition to a late-stage biopharmaceutical company will mark an important inflection point for investors, clinical collaborators and potential partners by providing a line of sight towards the path to regulatory approval and achieving our mission of developing pelareorep as an immunotherapeutic agent for cancer. We are excited to launch a new Phase 1/2 pancreatic cancer study investigating, for the first time, pelareorep in combination with modified FOLFIRINOX (mFOLFIRINOX). Finally, our discussions with regulators on a pivotal Phase 3 trial have been productive to date, and we expect to provide guidance on the registration path for metastatic breast cancer in the first half of 2024. We look forward to updating our stakeholders on our progress as the year unfolds."

Immunotherapeutic Mechanism of Action: Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics, said, "Translational data from multiple studies in 2023 have helped define pelareorep's role in shaping the tumor microenvironment and have provided a better understanding of its ability to induce the expansion of T cell populations. Notably, the positive association between tumor response and TIL clone expansion could become a useful marker of clinical outcomes in future studies and during patient care. Moreover, these findings further distinguish pelareorep's mechanism of action from that of other immunotherapeutic agents and provide support for its immunologic effects, which are largely driven by the introduction of its double-stranded RNA genome into cancer cells."

Financial Strength and Partnering Outlook: Kirk Look, Oncolytics' Chief Financial Officer, commented, "Our $40 million cash balance as of September 30, 2023, and the grant funding from The Pancreatic Cancer Action Network (PanCAN) provides us with over 12 months of runway to support our operations, including the initiation of our first Phase 3 study and the BRACELET-1 survival data. We continue to have active conversations with potential partners and work diligently with clinical collaborators, including Roche and Pfizer. We believe the positive, extended dataset, including continued and durable responses, survival results, and translational observations, will provide potential partners with a well-defined and unique target product profile that will add to our discussions."

Anticipated Milestones are expected to include:

H1 2024: Guidance on the registration path for HR+/HER2- mBC (metastatic breast cancer)H1 2024: Initiation of the PanCAN-supported Phase 2 Pancreatic Ductal Adenocarcinoma (PDAC) trial incorporating mFOLFIRINOX +/- atezolizumab and pelareorepMid-2024: Initiation of the adaptive Phase 3 trial for pelareorep in PDACOverall survival results from the BRACELET-1 studyExpand enrollment following achievement of success criteria from the GOBLET Phase 1/2 study anal cancer cohort
Highlights of Oncolytics Biotech's 2023 Achievements:

HR+/HER2- Metastatic Breast Cancer Program and the BRACELET-1 study

Promising Randomized Phase 2 Data Readout Supports Previous Near Doubling of Median Overall Survival: Data presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting showed that pelareorep in combination with paclitaxel (cohort 2) resulted in a near tripling of confirmed overall response rate, a 50% increase in median progression-free survival, and a hazard ratio of 0.29 (link to the PR) compared to paclitaxel monotherapy (cohort 1).
Overall survival (OS) data continues to mature since multiple patients continue to be followed for survival in the pelareorep + paclitaxel cohort. Positive results would provide Oncolytics with two successful randomized Phase 2 studies showing a meaningful OS benefit for pelareorep. The data reported so far supports the initiation of a pivotal study in mBC and makes the case for an overall survival and progression-free survival dual endpoint in a registrational trial, which could substantially reduce the time to potential approval.

Gastrointestinal Cancers and the GOBLET study cohorts

Pancreatic Cancer Survival Data Reported at ESMO Supports Decision to Move to Phase 3: Updated data presented at the European Society for Medical Oncology (ESMO) Congress 2023 showed a 62% objective response rate, nearly triple what has been seen in historical control trials. In addition, interim survival data, including median progression-free survival and median overall survival timelines, exceed historical control trials by 25% or more (link to the PR, link to the poster). Patients in this single-arm, open-label study with advanced PDAC were treated with pelareorep, atezolizumab, gemcitabine, and nab-paclitaxel.
We continue to follow the survival of several patients in this cohort as well as patients from the GOBLET study with third-line colorectal cancer, which also met the pre-defined success criteria (link to the PR, link to the poster). Having received Fast Track designation from the FDA for the treatment regimen of pelareorep, atezolizumab, gemcitabine, and nab-paclitaxel in metastatic PDAC patients last year, we were very pleased to report additional promising data for this combination, paving the way to initiate our adaptive Phase 3 trial which will now be conducted by Oncolytics, building on the positive feedback from our work with PanCAN.

Also, thanks to a US$5 million grant from PanCAN, we will examine the potential of pelareorep in combination with mFOLFIRINOX +/- atezolizumab. With these data plus the results from the adaptive Phase 3 PDAC study (pelareorep + gemcitabine + nab-paclitaxel + atezolizumab), we hope to show efficacy data for pelareorep in combination with the two most commonly used treatment regimens for pancreatic cancer patients, which could help pave the way for future broad adoption by physicians and impact a substantial number of patients.

Anal Cancer Data - Positive Early Results in an Underserved Patient Population: Data presented at the 2nd International Multidisciplinary Anal Cancer Conference (IMACC 2023) achieved the pre-defined Simon-two-step success criteria and showed a near tripling of objective response rates compared to historical control trials in addition to a complete response (link to the PR, link to the poster). Patients in this single-arm, open-label study with second-line, unresectable squamous cell carcinoma of the anal canal (SCCA) were treated with pelareorep and atezolizumab, marking an exciting signal of efficacy in an indication where checkpoint inhibitors have had limited impact historically, and there are few treatment options.
Having met the success criteria for efficacy for this cohort, we will work closely with AIO-Studien-gGmbH (AIO), which is managing the GOBLET study, to expand the number of patients who can be treated and, hopefully, accelerate the enrollment process. With continued positive data, this could become another high-priority indication for the company.

Other Opportunities: Preclinical data published in Science Translational Medicine (link to the PR) from studies in murine tumor models showed that combining CAR T cells with pelareorep improved CAR T cell persistence and efficacy in solid tumors. An intravenous boost of pelareorep enhanced this effect and led to tumor cures in >80% of cases. We believe there is a significant opportunity here as CAR T cell therapy is currently only effective in hematological cancers, and solid tumors are the vast majority of cancers diagnosed each year. While we do not have an active program underway, we continue to have discussions on the best way to advance this effort.

I would like to take this moment to wish everyone a Happy New Year and thank our shareholders for their support. We look forward to providing additional positive updates in 2024.

Dr. Matt Coffey
President & CEO
Oncolytics Biotech

About Oncolytics Biotech Inc.

Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in Phase 2 studies in breast and pancreatic cancers. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer. For further information, please visit: https://www.oncolyticsbiotech.com.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; our belief that we have a strong foundation to support advancing pelareorep into registrational-track studies, starting in 2024; our stated goals, objectives and mission; our plans to launch a Phase 1/2 pancreatic cancer study; our plan to provide guidance on the registration path for metastatic breast cancer in the first half of 2024; our belief that our cash on hand provides us with over 12 months of runway to support our operations, including the initiation of our first Phase 3 study and the BRACELET-1 survival data; our anticipated milestones and the timing thereof, including: guidance on the registration path for HR+/HER2- mBC (metastatic breast cancer); initiation of the PanCAN-supported Phase 2 Pancreatic Ductal Adenocarcinoma (PDAC) trial incorporating modified FOLFIRINOX (mFOLFIRINOX) +/- atezolizumab and pelareorep; initiation of the adaptive Phase 3 trial for pelareorep in PDAC; overall survival results from the BRACELET-1 study; expand enrollment following achievement of success criteria from the GOBLET Phase 1/2 study anal cancer cohort; our plans to examine the potential of pelareorep in combination with mFOLFIRINOX +/- atezolizumab; our plans to work closely with AIO-Studien-gGmbH to expand the number of patients who can be treated and, hopefully, accelerate the enrolment process; our plans to advance towards registrational studies in metastatic breast cancer and pancreatic cancer; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

Company Contact
Jon Patton
Director of IR & Communication
+1-858-886-7813
mailto://jpatton@oncolytics.ca

Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com

View original content: https://www.prnewswire.com/news-releases/oncolytics-biotech-recaps-2023-accomplishments-provides-outlook-for-2024-302025887.html

SOURCE Oncolytics Biotech® Inc.

View original content: http://www.newswire.ca/en/releases/archive/January2024/04/c2936.html
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Paulness Paulness 7 months ago
NEWS -- Oncolytics Biotech® and SOLTI Present Positive Translational Data at SABCS



Pelareorep induced prominent expansion of pre-existing Tumor Infiltrating Lymphocytes (TILs) in the blood and new TILs in the tumorData highlights the association between the expansion of existing TILs in the blood and decreased tumor sizeResults affirm pelareorep's role as an immunotherapySAN DIEGO and CALGARY, AB, Dec. 7, 2023 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, today announced the presentation of additional translational data from the AWARE-1 breast cancer window-of-opportunity study conducted in combination with SOLTI-Innovative Cancer Research at The San Antonio Breast Cancer Symposium (SABCS).

"Translational data presented from the AWARE-1 study at SABCS showed that pelareorep induced the expansion of tumor-infiltrating lymphocytes, or TILs, in matched tumor biopsy and peripheral blood samples of newly diagnosed breast cancer patients. In addition, sequencing of the T cell receptors (TCRs) showed a more prominent expansion of existing TIL clones in the blood. We consider these results to be positive and important because they build on additional translational results reported this fall at two other medical meetings, The Society for Immunotherapy of Cancer (SITC) and The European Society for Medical Oncology (ESMO), from the AWARE-1 and GOBLET studies respectively, and provide further support for pelareorep's unique immunologic mechanism of action," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics. "Taken together, these translational data affirm pelareorep's ability to enhance T cell infiltration into tumors and expand TILs in the peripheral blood, which have been correlated with tumor response. We intend to incorporate these learnings into the designs of our registrational studies in metastatic breast cancer and pancreatic cancer."

Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics, commented, "A review of the AWARE-1 study translational data presented at this year's SABCS and previous scientific conferences demonstrates that pelareorep treatment, especially in combination with atezolizumab, results in:

an increase in CelTIL score, which correlates with improved clinical outcomes in breast cancerincreased CD8+ T cell infiltration into tumorsthe generation and expansion of T cell clones, especially TILsthe upregulation of tumor PD-L1 expressionThese findings confirm that pelareorep remodels the tumor microenvironment and stimulates tumor-directed immune responses, effects we believe are driven by the introduction of pelareorep's double-stranded RNA into cancer cells."

Dr. Heineman concluded, "Results from multiple prior studies lead us to believe that pelareorep has the potential to fill very important treatment gaps for both breast and pancreatic cancer patients. The translational data reported this fall emphasize the importance of TIL clone expansion in pelareorep-treated patients and represents an important area for further exploration. We believe that analysis of TIL clone expansion could become a helpful precision tool to provide an early indication of treatment response and serve as a potential guide to patient care with pelareorep. We remain dedicated to expeditiously advancing the clinical development of pelareorep in support of our goal to provide cancer patients with improved treatment options."

Summary of Data and Findings for TIL-TCR-Seq from the AWARE-1 Study:

Samples: From the AWARE-1 window-of-opportunity study of patients with early-stage HR+/HER2- breast cancer:

Collected from two patient cohorts, treated with pelareorep plus letrozole (cohort 1) or pelareorep plus letrozole and atezolizumab (cohort 2)Matched tumor and peripheral blood samples collected at two time points:#1 at the beginning of the study on Day 1 and#2: Day 21 -- when tumors were surgically removedEvaluation:

Composite T cell scores, a tool to evaluate cellularity, previously analyzed according to the CelTIL scale; data provided in the poster for referenceT cell fractions, to assess the TIL-fraction of T cellsT cell Receptor Analysis, using T cell receptor sequencing (TCR Seq) as a proxy to analyze the number of TIL-specific clones and assess their origin, from pre-existing or new clonesT cell data was analyzed to assess T cell clonal expansion according to origin (existing or new) at both time points (baseline and Day 21) and tissue samples (tumor biopsy or peripheral blood), using Adaptive Biotechnology's Immunoseq's protocolResults: Pelareorep induced the expansion of existing TIL clones as well as new clones. These data are consistent with results from posters recently presented at SITC and ESMO and affirm that pelareorep functions as an immunotherapeutic agent.

CelTIL showed a composite increase in T cells: as previously reported, the majority of patients in both cohorts achieved an increase in CelTIL scores, with 60% of patients in Cohort 2 achieving a 30% increase in CelTIL scores, the primary endpoint of the studyT cell fractions showed that TILs increased in both study cohorts (1.27 fold in Cohort 1, 2.74 fold in Cohort 2), with a greater increase in Cohort 2Clonal expansion results showed that pelareorep induced an expansion of TILs in tumor and peripheral blood with:In tumors, new clones were more prominentIn peripheral blood, existing clones were more prominentIn cohort 2, there was greater overall expansion (qualified by the small numbers)About AWARE-1

AWARE-1 was an open-label window-of-opportunity study in early-stage breast cancer. The study combined pelareorep, without or with atezolizumab, and standard of care therapy according to breast cancer subtype. Tumor tissue was collected from patients as part of their initial breast cancer diagnosis, again on day three following initial treatment, and finally at three weeks following treatment, on the day their tumor is surgically resected. Key objectives of the study were to confirm that pelareorep is acting as a novel immunotherapy, to evaluate potential synergy between pelareorep and checkpoint blockade, and to collect biomarker data. The primary endpoint of the translational study was overall CelTIL score (a measurement of cellularity and tumor-infiltrating lymphocytes). Secondary endpoints for the study included safety and tumor and blood-based biomarkers. AWARE-1 met its primary endpoint of overall CelTIL score in 2021 (link to the PR, link to the poster). Additional biomarker data announced in 2022 showed pelareorep's potential to improve the prognosis of breast cancer patients (link to the PR, link to the poster).

Poster Information
Poster Title T Cell Receptor Sequencing to Monitor Pelareorep-Induced Expansion of Tumor Infiltrating Lymphocytes
Presentation ID PO1-02-01
Session Poster Session 1
Poster Date & Time Wednesday, December 6, 2023 from 12 p.m. – 2 p.m. Central Time

A copy of the poster is available on the Oncolytics website and can be found by clicking here.

About Oncolytics Biotech Inc.

Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in Phase 2 studies in breast and pancreatic cancers. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer. For further information, please visit: https://www.oncolyticsbiotech.com.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding the timing and anticipated content of upcoming poster presentations involving pelareorep; Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; our plans to advance towards registrational studies in metastatic breast cancer and pancreatic cancer; our plans to expeditiously advance the clinical development of pelareorep in support of our goals; our stated goals and objectives; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

Logo: https://mma.prnewswire.com/media/1762876/Oncolytics_Biotech_New_Logo.jpg

Company contact:
Jon Patton
Director of IR & Communication
+1-858-886-7813
mailto://jpatton@oncolytics.ca

Investor relations for Oncolytics:
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com

View original content:https://www.prnewswire.com/news-releases/oncolytics-biotech-and-solti-present-positive-translational-data-at-sabcs-302008693.html

SOURCE Oncolytics Biotech Inc.

View original content: http://www.newswire.ca/en/releases/archive/December2023/07/c1074.html
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Paulness Paulness 7 months ago
NEWS -- Oncolytics Provides Update on Pancreatic Cancer Program for Pelareorep



Updated plan follows PanCAN's strategic re-evaluation of the Precision PromiseSM Program

PanCAN US$5 million grant provides support for new GOBLET mFOLFIRINOX arm to proceed as planned

New Phase 3 strategy provides significant value-creation opportunities

SAN DIEGO, CA and CALGARY, AB, Nov. 9, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (Oncolytics) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, provided an update on the planned program for pelareorep in pancreatic ductal adenocarcinoma (PDAC).

Oncolytics' collaborator, The Pancreatic Cancer Action Network (PanCAN), a pancreatic cancer patient advocacy organization, advised the company that it is implementing a strategic re-evaluation of the Precision PromiseSM program and will not be adding any new investigational therapies to the platform until the re-evaluation is complete. Oncolytics and PanCAN had previously planned to initiate a Phase 3 trial using the Precision PromiseSM platform in H1 2024. Oncolytics now plans to conduct an adaptive Phase 3 program of pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab, similar to the Precision Promise study and manage it directly within our Clinical Group and a contract research organization (CRO) with the goal of enrolling the first patient in mid-2024.

Additionally, Oncolytics and PanCAN confirmed that PanCAN will continue with its plans to grant US$5 million to Oncolytics as part of the Therapeutic Accelerator Award for the new Phase 2 GOBLET study arm evaluating the combination of pelareorep and modified FOLFIRINOX (mFOLFIRINOX) in pancreatic cancer patients.

Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics, said, "Oncolytics remains steadfast in its commitment to initiate the Phase 3 program for pelareorep, starting in PDAC, in 2024. Having a compelling Phase 2 dataset in hand and strong connections with the pancreatic cancer community, Oncolytics is well positioned to effectively conduct the Phase 3 pancreatic cancer program. Trial preparations are actively underway, and we expect to initiate the enrollment of the first patient in mid-2024. The company plans to provide a further update on the design of the Phase 3 trial in H1 2024."

Dr. Coffey continued, "The opportunity to work with the strong scientific, regulatory and clinical leadership teams at PanCAN continues to be valuable for Oncolytics. We are grateful for our ongoing collaboration through the US$5 million Therapeutic Accelerator Award grant program in support of the new arm of the GOBLET study of pelareorep and mFOLFIRINOX, slated to begin in H1 2024."

"While we are undertaking a strategic re-evaluation of the program and are not adding any new therapies until the evaluation is complete, we remain committed to Oncolytics' efforts to accelerate therapies for pancreatic cancer patients through the US$5 million Therapeutic Accelerator Award Grant," said Julie Fleshman, President and CEO of PanCAN."

Dr. Coffey concluded by saying, "Looking ahead, we believe our updated plan to conduct the pelareorep Phase 3 pancreatic cancer program will enable us to be much closer to the conduct of the trial and the data. We believe this will be strategically valuable as we advance our partnering discussions and explore regulatory strategies to accelerate the development of pelareorep in order to bring this potentially important immunotherapeutic agent to people with cancer."

About Oncolytics Biotech Inc.

Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in Phase 2 studies in breast and pancreatic cancers. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer. For further information, please visit: https://www.oncolyticsbiotech.com.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential and benefits of pelareorep as a cancer therapeutic; our planned program for pelareorep in PDAC, including our plan to conduct an adaptive Phase 3 program managed directly within our clinical group and the anticipated benefits and timing thereof; our goals regarding the timing of enrollment in the study; our expectations regarding the US$5 million Therapeutic Accelerator Award from PanCAN and our planned usage thereof; our belief that we are well-positioned to effectively conduct the Phase 3 pancreatic cancer program; our plans for providing a further update on the design of the Phase 3 trial; our plans to advance partnering discussions and explore regulatory strategies to accelerate the development of pelareorep; our plans to advance towards a registration study in metastatic breast cancer and pancreatic cancer; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

Company Contact

Jon Patton
Director of IR & Communication
+1-858-886-7813
mailto://jpatton@oncolytics.ca

Investor Relations for Oncolytics

Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com

View original content: https://www.prnewswire.com/news-releases/oncolytics-provides-update-on-pancreatic-cancer-program-for-pelareorep-301983006.html

SOURCE Oncolytics Biotech® Inc.
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ZRock ZRock 7 months ago
ONCY news.
Oncolytics Provides Update on Pancreatic Cancer Program for Pelareorep

https://finance.yahoo.com/news/oncolytics-provides-pancreatic-cancer-program-113000246.html
πŸ‘οΈ0
ZRock ZRock 8 months ago
ONCY, reports Q3 financials.

https://finance.yahoo.com/news/oncolytics-biotech-reports-third-quarter-110000259.html
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Paulness Paulness 8 months ago
NEWS -- Oncolytics Presents Positive Updated Pancreatic Cancer Data from GOBLET Phase 1/2 Study at ESMO

7.2 months mPFS and 10.6 months interim median OS surpass historical outcomes by = 25%

T-cell expansion data correlate with tumor response, providing important proof-of-concept

SAN DIEGO and CALGARY, AB, Oct. 23, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY),( Oncolytics) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, today announced the poster presentation of positive, updated results from the Phase 1/2 GOBLET study evaluating pelareorep-based combination therapy in patients with pancreatic ductal adenocarcinoma (PDAC) at the European Society for Medical Oncology meeting (ESMO 2023), taking place in Madrid, Spain.



"We are very pleased to share such positive and consistent data on pelareorep from the PDAC arm of the GOBLET study, including an impressive overall response rate, 7.2 months of median progression-free survival, interim median overall survival of 10.6 months, and expansion of both pre-existing and new T-cell clones. These data build upon results from previous studies showing the clinical benefit of pelareorep combination therapy in PDAC and support the decision to move to a licensure-enabling study in pancreatic cancer," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics. "Everything we do at Oncolytics is focused on advancing the development of our immunotherapy candidate, pelareorep, with a goal of providing improved care and longer survival for patients with pancreatic cancer and other tumor types. The data we are presenting at ESMO provide a solid foundation as we advance our pancreatic cancer program through the Precision PromiseSM Phase 3 trial in this indication."

Summary of Data and Findings from the PDAC Arm of the Phase 1/2 GOBLET Study:

Tumor Responses: Consistent with the abstract, data from the study outlined patient responses, including:
Objective Response Rate (ORR) of 62% (54% confirmed by two or more scans)A Disease Control Rate (DCR) of 85%Survival data: Evaluated based on 4 parameters including:
Median duration of response was 5.7 monthsMedian progression-free survival (PFS) was 7.2 monthsInterim 12-month survival rate was 46%Interim median overall survival (OS) was 10.6 monthsT-Cell Populations: Analysis of changes of T-cell clones and tumor-infiltrating lymphocytes (TILs) showed:Mean baseline TIL cell levels of 22%Expansion of pre-existing and new T cell clones, including the expansion of TIL-specific clonesA correlation between the expansion in the blood of TIL-specific clones and tumor responseSafety: The treatment combination has been well tolerated with no safety concerns
Most common grade 3 and 4 treatment-related adverse events were related to red and white blood cell counts (anemia, neutropenia and decreased neutrophil counts)"The data from this study show a correlation between the expansion of TIL-specific clones and tumor response, which provides compelling support for the use of pelareorep-based therapies in immunologically "cold" tumors. In particular, these data, along with the impressive clinical results, support the ability of pelareorep-checkpoint inhibitor combination therapies to meaningfully improve treatment responses in diseases like pancreatic cancer that have resisted immune-based therapeutic approaches," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. "Given the urgent need for better treatment options for patients with pancreatic cancer, we are especially gratified to observe that results from the combination regimen we are evaluating surpassed published historical results1-4. We look forward to beginning the Precision PromiseSM Pivotal Phase 3 platform trial as soon as possible, and we wish to express our sincere gratitude to all the patients, caregivers, and study site personnel associated with the GOBLET trial."

GOBLET Study PDAC Patient Overview:

Patients in the PDAC cohort, presented at ESMO 2023, are undergoing first-line treatment with a combination of pelareorep, atezolizumab, gemcitabine and nab-paclitaxel. The 13 evaluable patients enrolled in the first stage of the study have been evaluated based on a September 18, 2023 data cut-off date. The enrolled patient population included 93% of patients with metastatic disease (69% with liver metastases) and baseline ECOG scores of 0 (31%) and 1 (69%), with an average age of 61.2 years.

References

1. Von Hoff D et al. N Engl J Med 2013; 369:1691-1703 DOI: 10.1056/NEJMoa1304369

2. O'Reilly et al. Eur J Cancer. 2020 June; 132: 112–121. DOI:10.1016/j.ejca.2020.03.005

3. Karasic et al. JAMA Oncol. 2019 Jul 1; 5(7):993-998. DOI: 10.1001/jamaoncol.2019.0684

4. Tempero et al. Ann Oncol. 2021 May; 32(5):600-608. DOI: 10.1016/j.annonc.2021.01.070



Poster Information

Poster Title: Pelareorep (pela) + atezolizumab (atezo) and chemotherapy in first-line (1L) advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) patients – Results from the GOBLET study

Final Publication Number (FPN): 1623P

Poster Date: October 23, 2023

About GOBLET

The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 12 centers in Germany and is being managed by AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response rate (ORR) assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers (T cell clonality and CEACAM6). The study employs a Simon two-stage design with Stage 1 comprising four treatment groups expected to enroll a total of approximately 55 patients:Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic pancreatic cancer patients (n=12);Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients (n=19);Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients (n=14); andPelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients (n=10).Any cohort showing an ORR above a pre-specified threshold in Stage 1 may be advanced to Stage 2 and enroll additional patients.

About AIO

AIO-Studien-gGmbH (AIO) emerged from the study center of the internal oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally.

About Oncolytics Biotech Inc.

Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in Phase 2 studies in breast and pancreatic cancers. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer. For further information, please visit: https://www.oncolyticsbiotech.com.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential, mechanism of action, and benefits of pelareorep as a cancer therapeutic; our stated goals and objectives; and our plans to advance towards a registrational study in metastatic breast cancer and pancreatic cancer. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

Company Contact
Jon Patton
Director of IR & Communication
+1-858-886-7813
mailto://jpatton@oncolytics.ca

Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com

View original content: https://www.prnewswire.com/news-releases/oncolytics-presents-positive-updated-pancreatic-cancer-data-from-goblet-phase-12-study-at-esmo-301964264.html

SOURCE Oncolytics Biotech® Inc.
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Paulness Paulness 8 months ago
NEWS -- Oncolytics Achieves Success Criteria for Efficacy in the Third-Line Colorectal Cancer Cohort of the GOBLET Study

Results met efficacy criteria for enrollment expansion and provide support for pelareorep's mechanism of action

SAN DIEGO and CALGARY, AB, Oct. 23, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY), (Oncolytics) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, today announced the poster presentation of interim results from the Phase 1/2 GOBLET study evaluating a combination treatment of pelareorep in patients with third-line (3L) metastatic colorectal cancer (CRC) regardless of microsatellite instability status at the European Society for Medical Oncology meeting (ESMO 2023), taking place in Madrid, Spain.



"The results presented at ESMO met the criteria to advance the study to the next stage, with 4 of 14 enrolled patients demonstrating stable disease at week 16. These data demonstrated a 40% overall disease control rate and provided further encouraging data for pelareorep," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics. "In a patient population that had failed multiple rounds of treatment, we continue to see pelareorep's ability to synergize with atezolizumab by generating an immune response, including the expansion of T cell clones. The translational data from this cohort are consistent with the observed clinical response, providing further support for pelareorep's mechanism of action as a potential backbone immunotherapy for patients with gastrointestinal and other forms of cancer."

"We designed the GOBLET study to evaluate pelareorep's ability to improve clinical outcomes in different gastrointestinal cancers, including at different disease stages, and to better understand pelareorep's mechanism of action by generating strong translational data. The data from this arm of the study demonstrate that pelareorep is taken up by tumor cells and stimulates T cell expansion even in heavily pre-treated colorectal cancer patients," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. "These patients demonstrated a 40% disease control rate, a progression-free survival of 2.8 months, a median overall survival of 8.0 months, and a 12-month survival rate of 33%, exceeding historical results1-3. These findings are encouraging given that exhaustion of tumor-infiltrating lymphocytes, resulting from late stage of disease and extensive prior chemotherapy, may have limited their ability to expand in response to treatment. Notably, this is the second GOBLET study cohort in a row that has met its success criteria, further supporting pelareorep's ability to synergize with atezolizumab. These data also support pelareorep's immunologic mechanism of action and will inform our plans for further development."

GOBLET Study 3L Metastatic CRC Patient Overview:

Patients in the CRC cohort, presented at ESMO 2023, are undergoing third-line treatment with a combination of pelareorep, atezolizumab, and trifluridine/tipiracil. The 15 evaluable patients enrolled in the first stage of the study have been evaluated based on a September 18, 2023 data cut-off date. The enrolled patient population included patients with an ECOG score of =1 and confirmed colorectal cancer, regardless of microsatellite instability status.

References

1. Mayer et al. N Engl J Med 2015; 372:1909-1919. DOI: 10.1056/NEJMoa1414325

2. Moriwaki et al. The Oncologist 2018; 23(1):7-15. DOI: 10.1634/theoncologist.2017-0275

3. Bachet et al. ESMO Open. 2020 Jun;5(3):e000698. doi: 10.1136/esmoopen-2020-000698

Poster Information

Poster Title: Pelareorep + atezolizumab and chemotherapy in third-line (3L) metastatic colorectal cancer (mCRC) patients – Interim results from the GOBLET study

Final Publication Number (FPN): 619P

Poster Date: October 22, 2023

About GOBLET

The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 12 centers in Germany and is being managed by AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response rate (ORR) assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers (T cell clonality and CEACAM6). The study employs a Simon two-stage design with Stage 1 comprising four treatment groups expected to enroll a total of approximately 55 patients:

1. Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic pancreatic cancer patients (n=12);

2. Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients (n=19);

3. Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients (n=14); and

4. Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients (n=10).

Any cohort showing an ORR above a pre-specified threshold in Stage 1 may be advanced to Stage 2 and enroll additional patients.

About AIO

AIO-Studien-gGmbH (AIO) emerged from the study center of the internal oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally.

About Oncolytics Biotech Inc.

Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in Phase 2 studies in breast and pancreatic cancers. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer. For further information, please visit: https://www.oncolyticsbiotech.com.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential, mechanism of action, and benefits of pelareorep as a cancer therapeutic; our stated goals and objectives; and our plans to advance towards a registrational study in metastatic breast cancer and pancreatic cancer. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

Company Contact
Jon Patton
Director of IR & Communication
+1-858-886-7813
mailto://jpatton@oncolytics.ca

Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com

View original content: https://www.prnewswire.com/news-releases/oncolytics-achieves-success-criteria-for-efficacy-in-the-third-line-colorectal-cancer-cohort-of-the-goblet-study-301964255.html

SOURCE Oncolytics Biotech® Inc.
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Paulness Paulness 8 months ago
NEWS -- Oncolytics Biotech® to Host Conference Call to Discuss Third Quarter Financial Results and Recent Operational Highlights

Conference call and webcast to take place on Friday, November 3, 2023, at 8:30 a.m. ET

SAN DIEGO and CALGARY, AB, Oct. 20, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, today announced that it will host a conference call and webcast on Friday, November 3, 2023, at 8:30 a.m. ET to discuss a corporate update and financial results for the third quarter of 2023.



Conference Call & Webcast

Date: Friday, November 3, 2023

Time: 8:30 a.m. ET

Dial-In – North American Toll-Free: (888) 664-6383

Dial-In – International: (416) 764-8650

RapidConnect: to join the conference call without operator assistance, please click here

Conference ID (if needed): 6026-0546

Webcast: please click here

A webcast of the call will also be available on the Investor Relations page of Oncolytics' website, available by clicking here, and archived for three months. A dial-in replay will be available for one week and can be accessed by dialing (888) 390-0541 (North America) or (416) 764-8677 (International) and using replay code: 260-546#.

About Oncolytics Biotech Inc.

Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in Phase 2 studies in breast and pancreatic cancers. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer. For further information, please visit: https://www.oncolyticsbiotech.com.

Company Contact

Jon Patton
Director of IR & Communication
+1-858-886-7813
mailto://jpatton@oncolytics.ca

Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com

Logo: https://mma.prnewswire.com/media/1808285/4295352/Oncolytics_Biotech_Grey.jpg

View original content: https://www.prnewswire.com/news-releases/oncolytics-biotech-to-host-conference-call-to-discuss-third-quarter-financial-results-and-recent-operational-highlights-301962804.html

SOURCE Oncolytics Biotech® Inc.
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Paulness Paulness 8 months ago
NEWS -- Oncolytics Biotech® To Present Two Posters on the Pelareorep-Based GOBLET Study at ESMO 2023


Abstracts Overview

Preliminary updated PDAC data show 6-month overall survival rate of 82%

Results from pelareorep combination in mCRC met the Stage 1 success criteria

SAN DIEGO and CALGARY, AB, Oct. 16, 2023 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, today announced the publication of two abstracts for posters to be presented during the upcoming European Society for Medical Oncology (ESMO) Congress 2023, taking place from October 20th to 24th at the IFEMA Madrid Conference Center in Madrid, Spain.

Abstracts Overview



Abstracts Summaries

Abstract 1623P

The GOBLET Phase 1/2 Simon two-stage basket study was designed to evaluate pelareorep in combination with the PD-L1 inhibitor atezolizumab (atezo) and chemotherapy in patients with different solid tumors. In the first stage of the pancreatic ductal adenocarcinoma (PDAC) cohort, 13 evaluable patients were enrolled (including 92% with metastatic disease, 69% in the liver). Primary objectives were safety and efficacy, measured by Stage 1 success criterion of >3 confirmed responses (PDAC segment). T cell receptor sequencing (TCR-seq) was also performed during the course of treatment.Updated data from the study showed that 8 of 13 evaluable patients had a partial response (PR) and 3 had stable disease (SD) for an objective response rate (ORR) of 62% (53% confirmed with two scans) and a clinical benefit rate (CBR) of 85%. As of the data cut-off (January 19, 2023), the median duration of response was 6.0 months, the 6-month progression-free survival (PFS) rate was 72.9%, and the 6-month overall survival (OS) rate was 82.1%. T cell receptor sequencing (TCR-seq) showed an expansion of new and pre-existing T-cell clones. No safety signals were observed. Updated efficacy and TCR-seq results will be presented at ESMO; final PFS and OS are pending.The authors concluded from these data that the combination of pelareorep, atezo and chemotherapy was well-tolerated and that the ORR exceeded the pre-specified success criterion. The authors also noted that these data compare favorably with ORRs from prior first-line PDAC trials.Abstract 619P

This abstract evaluated pelareorep combination therapy (pelareorep plus atezo plus chemotherapy, trifluridine/tipiracil) in third-line metastatic colorectal cancer patients with microsatellite stable (MSS) disease. In the first stage of this segment, 15 evaluable patients were enrolled, and the primary objectives were safety and efficacy, measured by Stage 1 success criterion of >4 patients with SD at week 16. TCR-seq was also performed during the course of the treatment cycle to assess the treatment effect on the T cell repertoire.Interim data from the study showed that 5 of 15 patients had SD as their best response, including 4 with SD at week 16, and 10 patients had progressive disease (PD). The CBR, defined as stable disease or better, was 33%. Translational research, including TCR-seq, showed an expansion of new and pre-existing T-cell clones. No safety signals were observed. Updated efficacy (PFS and OS) and TCR-seq results will be presented at ESMO.The authors concluded from these data that the pelareorep combination was well-tolerated and the primary efficacy success criterion was met. The authors believe that protective immune responses were initiated in these patients but that they may have been too immunocompromised or have insufficient time before disease progression to fully benefit from the pelareorep-based immunotherapy.About GOBLET

The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 12 centers in Germany and is being managed by AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response rate (ORR) assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers (T cell clonality and CEACAM6). The study employs a Simon two-stage design with Stage 1 comprising four treatment groups expected to enroll a total of approximately 55 patients:

Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic pancreatic cancer patients (n=12);Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients (n=19);Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients (n=14); andPelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients (n=10).
Any cohort showing an ORR above a pre-specified threshold in Stage 1 may be advanced to Stage 2 and enroll additional patients.

About AIO

AIO-Studien-gGmbH (AIO) emerged from the study center of the internal oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally.

About Oncolytics Biotech Inc.

Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in Phase 2 studies in breast and pancreatic cancers. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer. For further information, please visit: https://www.oncolyticsbiotech.com.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential and benefits of pelareorep as a cancer therapeutic; our expectations regarding the results to be presented at ESMO; and our plans to advance towards a registrational study in metastatic breast cancer and pancreatic cancer. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

Company Contact

Jon Patton
Director of IR & Communication
+1-858-886-7813
mailto://jpatton@oncolytics.ca

Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com

Logo: https://mma.prnewswire.com/media/1808285/4295352/Oncolytics_Biotech_Grey.jpg

View original content: https://www.prnewswire.com/news-releases/oncolytics-biotech-to-present-two-posters-on-the-pelareorep-based-goblet-study-at-esmo-2023-301956805.html

SOURCE Oncolytics Biotech® Inc.

View original content: http://www.newswire.ca/en/releases/archive/October2023/16/c1484.html
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ZRock ZRock 8 months ago
ONCY news, Oncolytics Biotech® To Present Two Posters on the Pelareorep-Based GOBLET Study at ESMO 2023

https://finance.yahoo.com/news/oncolytics-biotech-present-two-posters-110000707.html
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ZRock ZRock 9 months ago
hit the ask and mm fill ya half way between bid n ask. course only they can do that seeing as ONCY trades in 1 cent increments..
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Paulness Paulness 9 months ago
NEWS -- THE PANCREATIC CANCER ACTION NETWORK SELECTS ONCOLYTICS BIOTECH® INC. TO RECEIVE $5 MILLION THERAPEUTIC ACCELERATOR AWARD TO DEVELOP LEADING-EDGE TREATMENTS



Innovative Multimillion-Dollar Grant Was Created in 2022 to Drive Biopharma Industry to Speed Development of Pancreatic Cancer Therapies

BOSTON and SAN DIEGO and CALGARY, AB, Sept. 26, 2023 /PRNewswire/ -- In an effort to continue accelerating new treatment options for people with pancreatic cancer, the Pancreatic Cancer Action Network (PanCAN) today announced Oncolytics Biotech, Inc. (NASDAQ: ONCY) (TSX: ONC) as the recipient of its second annual PanCAN Therapeutic Accelerator Award. Oncolytics received this award in recognition of its promising work on pelareorep, an investigational immunotherapy treatment that introduces double-stranded RNA into cancer cells, which stimulates anticancer inflammatory effects, including innate and adaptive immune responses and the activation and recruitment of T cells into the tumor. This $5 million grant will enable Oncolytics to continue the next stage of its research focused on a clinical trial with Oncolytics' proprietary reovirus pelareorep in combination with modified FOLFIRINOX chemotherapy with or without an immune checkpoint inhibitor. If results are encouraging, the treatment combination may be advanced to late-stage clinical development through the PanCAN Precision PromiseSM adaptive clinical trial platform.



The Pancreatic Cancer Action Network (PanCAN) is dedicated to fighting the world’s toughest cancer. In our urgent mission to save lives, we attack pancreatic cancer on all fronts: research, clinical initiatives, patient services and advocacy. Our effort is amplified by a nationwide network of grassroots support. We are determined to improve outcomes for today’s patients and those diagnosed in the future. (PRNewsfoto/Pancreatic Cancer Action Network)

The combination of pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab was granted Fast Track designation by the FDA last year and has already been selected for inclusion in the Precision Promise clinical trial platform, which is anticipated to open in early 2024. Testing pelareorep in combination with FOLFIRINOX expands the approach so all patients with advanced pancreatic cancer could have the opportunity to benefit from this innovative immunotherapeutic approach.

The announcement of the Therapeutic Accelerator Award is being made in advance of PanCAN's annual Scientific Summit in Boston, which brings together PanCAN's Community for Progress, including research grant recipients, Scientific and Medical Advisors, industry partners and special guests to share ideas and build collaboration. Oncolytics was selected to receive the 2023 PanCAN Therapeutic Accelerator Award for $5 million through a rigorous, competitive process involving scientific, business and programmatic review from leading experts in the field.

Pancreatic cancer is notoriously aggressive and hard to treat. Current estimates suggest that the disease will be the second leading cause of cancer-related deaths in the United States before 2030. Most people with pancreatic cancer are diagnosed at a late stage when their tumor is inoperable, leaving these patients with few treatment options. And because the disease is significantly more resistant to chemotherapy than other cancers, it can even be difficult to treat in its earliest stages. Despite the fact that there is an urgent need for better outcomes for pancreatic cancer, research is often not prioritized because pancreatic cancer affects a relatively small population compared to other cancers, and clinical research can be risky and expensive.

"Today's five-year survival rate of 12% is too low and we need new treatment options now," said PanCAN Chief Science Officer Lynn Matrisian, PhD, MBA. "PanCAN launched our own clinical program to de-risk companies' investment through both the Therapeutic Accelerator Award and the Precision Promise platform to facilitate rapid advances in this disease."

PanCAN continues to take bold actions to improve the lives of everyone impacted by pancreatic cancer, including the investment of more than $208 million since 2003 to advance scientific research. PanCAN created the multimillion-dollar Therapeutic Accelerator Award in 2022 as a research investment focused on supporting companies working on new pancreatic cancer therapies that plan to conduct early-stage (Phase 1 and 2) clinical trials for these therapies.

"Oncolytics is so pleased to receive this innovative award and have the opportunity to work with PanCAN," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc. "This generous grant will enable early and late-stage patients with pancreatic cancer to potentially benefit from another commonly employed chemotherapy backbone, as FOLFIRINOX and gemcitabine + nab-paclitaxel are the most frequently used chemotherapy standards of care in both the first and second-line setting. By teaming up with PanCAN, we believe we may be able to expedite development and provide pancreatic cancer patients with a bespoke immunotherapeutic treatment option."

Oncolytics plans to utilize the grant funding to study pelareorep in combination with modified FOLFIRINOX chemotherapy in patients with metastatic pancreatic cancer who have not received prior cancer treatment. In addition, a separate group of patients will receive this combination along with a checkpoint inhibitor to verify synergies previously observed in this patient population. The goal of this research is to evaluate the safety and efficacy of these combination therapies. Efficacy will be assessed by measuring the effect of the treatments on tumor size, progression-free survival, and overall survival. In addition, immune responses to treatment will be assessed.

The funding offered through the PanCAN Therapeutic Accelerator Award represents an innovative and groundbreaking way for a non-profit to accelerate drug development. If the result of the clinical trial is positive, the hope is that the selected investigational treatment combination will be incorporated into the PanCAN Precision Promise adaptive clinical trial. While Precision Promise provides an effective approach for late-stage research on new pancreatic cancer therapies, many companies are not investing in the early-stage research necessary for late-stage studies and potential drug approval in this disease.

To learn more about PanCAN's research investments, visit https://pancan.org.

About the Pancreatic Cancer Action Network

The Pancreatic Cancer Action Network (PanCAN) leads the way in accelerating critical progress for pancreatic cancer patients. PanCAN takes bold action by funding life-saving research, providing personalized patient services and creating a community of supporters and volunteers who will stop at nothing to create a world in which all pancreatic cancer patients will thrive. For 18 years in a row, PanCAN has earned a Four-Star Rating from Charity Navigator – the highest rating an organization can receive. This rating designates PanCAN as an official "Give with Confidence" charity, indicating strong financial health, ongoing accountability and transparency.

About Oncolytics Biotech Inc.

Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in phase 2 studies in breast and pancreatic cancers. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer. For further information, please visit: https://www.oncolyticsbiotech.com.

Media Contacts:

Charaighn Sesock
Public Relations
Pancreatic Cancer Action Network
Direct: 559-972-4877
mailto://charaighn@gmail.com

Jillian Scholten
Senior Manager, Public Relations
Pancreatic Cancer Action Network
Direct: 310-706-3360
Email: mailto://jscholten@pancan.org

Jon Patton
Director of IR & Communication
Oncolytics Biotech, Inc.
858-886-7813
mailto://jpatton@oncolytics.ca

View original content to download multimedia: https://www.prnewswire.com/news-releases/the-pancreatic-cancer-action-network-selects-oncolytics-biotech-inc-to-receive-5-million-therapeutic-accelerator-award-to-develop-leading-edge-treatments-301938335.html

SOURCE Pancreatic Cancer Action Network
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Paulness Paulness 9 months ago
NEWS -- Oncolytics Biotech® Announces Fireside Chat at the Cantor Global Healthcare Conference



SAN DIEGO and CALGARY, AB, Sept. 19, 2023 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, today announced its participation in an analyst-led fireside chat at the Cantor Global Healthcare Conference 2023 with Chief Executive Officer Dr. Matt Coffey. The conference is taking place September 26-28, 2023 at the InterContinental Barclay Hotel in New York, NY. Additional details on the fireside chat can be found below.

Date: Wednesday, September 27, 2023
Time: 8:35 a.m. ET
Location: InterContinental Barclay Hotel New York, Track 1
Webcast Link: Available by clicking here

Company management will also be participating in one-on-one investor meetings at the conference. To schedule a meeting, please submit a request on the conference website, contact your Cantor Fitzgerald representative, or email mailto://jpatton@oncolytics.ca.

A live webcast of the Company's presentation will also be available on the Investor Relations page of Oncolytics' website (LINK) and will be archived for three months.

About Oncolytics Biotech Inc.

Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in phase 2 studies in breast and pancreatic cancers. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer. For further information, please visit: https://www.oncolyticsbiotech.com

Company Contact

Jon Patton
Director of IR & Communication
+1-858-886-7813
mailto://jpatton@oncolytics.ca

Investor Relations for Oncolytics

Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com
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Paulness Paulness 9 months ago
NEWS -- Oncolytics Biotech® Announces Full Exercise of Over-Allotment Option from Public Offering

CALGARY, AB, Sept. 7, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. ("Oncolytics" or the "Company") (NASDAQ: ONCY) (TSX: ONC) today announced that in connection with the previously announced underwritten public offering of US$15,000,750 (the "Offering") and the underwriting agreement dated August 1, 2023 (the "Underwriting Agreement"), Leede Jones Gable Inc. (the "Underwriter") has exercised their option (the "Over-Allotment Option"), in full, to purchase 1,000,050 units (the "Optioned Units") at US$2.25 for aggregate gross proceeds of US$2,250,112. The Company intends to use the proceeds from the Offering to continue the advancement of its pelareorep clinical programs in metastatic breast and pancreatic cancers, as well as general corporate and working capital purposes.



Each Optioned Unit consists of one common share of the Company (each a "Common Share") and one Common Share purchase warrant (each a "Warrant"). Each Warrant entitles the holder thereof to purchase one Common Share at an exercise price of US$2.81 at any time up to 60 months following the Closing, subject to acceleration in certain circumstances. Pursuant to the Underwriting Agreement, in consideration for the services rendered by the Underwriter in connection with the Offering, the Company paid to the Underwriter a cash commission equal to 7.0% of the aggregate gross proceeds raised from the Offering and issued to the Underwriter such number of compensation warrants (the "Compensation Warrants") as is equal to 7.0% of the aggregate number of Optioned Units sold in the Offering. Each Compensation Warrant is exercisable into one Common Share (an "Underwriter's Warrant Share") at an exercise price of US$2.25 per Underwriter's Warrant Share at any time up to 60 months following the Closing.

The Offering is being made by way of a prospectus supplement to the Company's short form base shelf prospectus filed on August 1, 2023 in each of the provinces and territories of Canada, except Quebec, pursuant to National Instrument 44-101 – Short Form Prospectus Distributions and National Instrument 44-102 - Shelf Distributions.

The securities referred to in this news release have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, and may not be offered or sold within the United States or to, or for the account or benefit of, U.S. persons absent U.S. registration or an applicable exemption from the U.S. registration requirements. This press release does not constitute an offer for sale of securities, nor a solicitation for offers to buy any securities in the United States, nor in any other jurisdiction in which such offer, solicitation or sale would be unlawful. Any public offering of securities in the United States must be made by means of a prospectus containing detailed information about the company and management, as well as financial statements.

About Oncolytics Biotech Inc.

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer. For further information, please visit: https://www.oncolyticsbiotech.com.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential and benefits of pelareorep as a cancer therapeutic; the Company's anticipated use of proceeds from the Offering: the terms of the Warrants, the Compensation Warrants; the Company's plans to advance towards a registrational study in metastatic pancreatic cancer; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, the Company may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. The Company may incur expenses or delays relating to such events outside of its control, which could have a material adverse impact on the Company's business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

Company Contact
Jon Patton
Director of IR & Communication
+1-858-886-7813
mailto://jpatton@oncolytics.ca

Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com

View original content: https://www.prnewswire.com/news-releases/oncolytics-biotech-announces-full-exercise-of-over-allotment-option-from-public-offering-301920771.html

SOURCE Oncolytics Biotech® Inc.
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Paulness Paulness 10 months ago
NEWS -- Oncolytics Biotech® to Participate in a Fireside Chat at the H.C. Wainwright 25th Annual Global Investment Conference



Oncolytics Biotech® Inc. Logo (PRNewsfoto/Oncolytics Biotech® Inc.)

SAN DIEGO and CALGARY, AB, Sept. 6, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that Chief Executive Officer Dr. Matt Coffey will participate in a fireside chat at the H.C. Wainwright 25th Annual Global Investment Conference, which is taking place September 11-13, 2023 at the Lotte New York Palace Hotel in New York, NY. Additional details on the fireside chat can be found below.

Date: Tuesday, September 12, 2023
Time: 9:30 a.m. ET
Location: Lotte New York Palace Hotel, Adams Room 4th Floor
Webcast Link: Available by clicking here

Company management will also be participating in one-on-one investor meetings at the conference. To schedule a meeting, please submit a request on the conference website, contact your H.C. Wainwright representative, or email mailto://jpatton@oncolytics.ca.

A live webcast of the Company's presentation will also be available on the Investor Relations page of Oncolytics' website (LINK) and will be archived for three months.

About Oncolytics Biotech Inc.

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer. For further information, please visit: https://www.oncolyticsbiotech.com.

Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com

Company Contact
Jon Patton
Director of IR & Communication
+1-858-886-7813
mailto://jpatton@oncolytics.ca

View original content to download multimedia: https://www.prnewswire.com/news-releases/oncolytics-biotech-to-participate-in-a-fireside-chat-at-the-hc-wainwright-25th-annual-global-investment-conference-301918192.html

SOURCE Oncolytics Biotech® Inc.
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Paulness Paulness 10 months ago
NEWS -- Oncolytics Biotech® Reports Second Quarter 2023 Financial Results and Operational Highlights



Phase 2 data from randomized BRACELET-1 trial in HR+/HER2- metastatic breast cancer showed a near tripling of confirmed ORR, >50% improvement in PFS, and 71% reduction in risk of disease progressionPelareorep selected for inclusion in the Precision PromiseSM phase 3 platform trial in pancreatic cancer, designed to accelerate registration path and reduce by ~50% phase 3 costs compared to traditional trial$24.4 million in cash, cash equivalents and marketable securities as of June 30, 2023 provides projected runway into H2 2024Strengthened financial position with a successful US$15 million public offering on August 8, 2023Management hosting conference call and webcast today at 8:30 a.m. ETSAN DIEGO and CALGARY, AB, Aug. 14, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced recent operational highlights and financial results for the second quarter ended June 30, 2023. All dollar amounts are expressed in Canadian currency unless otherwise noted.

"Our core programs in pancreatic and breast cancer are both progressing rapidly towards registrational studies on the back of the impressive clinical data showing the potential of pelareorep as a backbone immunotherapy," said Dr. Matt Coffey, President and Chief Executive Officer. "Data reported at the American Society of Clinical Oncology (ASCO) Annual Meeting from our BRACELET-1 randomized phase 2 trial demonstrated robust improvements in objective response rate (ORR) and progression-free survival (PFS) with a hazard ratio of 0.29 (95% CI: 0.09, 0.98). This has unlocked the potential for including PFS as a dual endpoint in our registrational trial, which could considerably reduce the time to a pivotal readout. At the same time, pelareorep was selected for inclusion in the ongoing Precision Promise pancreatic cancer platform trial. Precision Promise, created by the Pancreatic Cancer Action Network, provides us with the opportunity to reduce the time and costs needed for a potential approval, and we are honored to have been selected for participation in this novel and exclusive trial."

To view rest of Oncolytics' Press Release including Financial Charts, follow link below:

https://www.prnewswire.com/news-releases/oncolytics-biotech-reports-second-quarter-2023-financial-results-and-operational-highlights-301899635.html
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Paulness Paulness 10 months ago
NEWS -- Oncolytics Biotech® Successfully Raises US$15 Million to Advance Breast and Pancreatic Cancer Clinical Programs



CALGARY, Alberta, Aug. 8, 2023 /CNW/ -- Oncolytics Biotech® Inc. ("Oncolytics" or the "Company") (NASDAQ: ONCY) (TSX: ONC) today announced the closing (the "Closing") of the previously announced underwritten public offering of US$15,000,750 (the "Offering"). An institutional investor was a significant participant in the Offering. The Company intends to use the proceeds from the Offering to continue the advancement of its pelareorep clinical programs in metastatic breast and pancreatic cancers, as well as general corporate and working capital purposes.

Leede Jones Gable Inc. acted as underwriter and bookrunner (the "Underwriter") in accordance with the terms of an underwriting agreement between the Company and the Underwriter dated as of August 1, 2023 (the "Underwriting Agreement"), pursuant to which Oncolytics issued 6,667,000 units (the "Equity Units") for gross proceeds to the Company of US$15,000,750 at a price of US$2.25 per Equity Unit. Each Equity Unit consists of one common share of the Company (each a "Common Share") and one Common Share purchase warrant (each a "Warrant"). Each Warrant entitles the holder thereof to purchase one Common Share at an exercise price of US$2.81 at any time up to 60 months following the Closing, subject to acceleration in certain circumstances.

In addition, pursuant to the Underwriting Agreement, the Company granted the Underwriter an option (the "Over-Allotment Option"), exercisable in part or in whole at the Underwriter's sole discretion, at any time beginning on the Closing until 30 days following the Closing, to purchase up to that number of additional Equity Units, Common Shares or Warrants, or any combination thereof, as is equal to 15% of the aggregate number of Equity Units sold in the Offering to cover the Underwriter's over-allotment position, if any, and for market stabilization purposes.

Pursuant to the Underwriting Agreement, in consideration for the services rendered by the Underwriter in connection with the Offering, at the Closing, the Company paid to the Underwriter a cash commission equal to 7.0% of the aggregate gross proceeds raised from the Offering and issued to the Underwriter such number of compensation warrants (the "Compensation Warrants") as is equal to 7.0% of the aggregate number of Equity Units sold in the Offering. Each Compensation Warrant is exercisable into one Common Share (an "Underwriter's Warrant Share") at an exercise price of US$2.25 per Underwriter's Warrant Share at any time up to 60 months following the Closing.

The Offering is being made by way of a prospectus supplement to the Company's short form base shelf prospectus filed on August 1, 2023 in each of the provinces and territories of Canada, except Quebec, pursuant to National Instrument 44-101 – Short Form Prospectus Distributions and National Instrument 44-102 - Shelf Distributions.

The securities referred to in this news release have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, and may not be offered or sold within the United States or to, or for the account or benefit of, U.S. persons absent U.S. registration or an applicable exemption from the U.S. registration requirements. This press release does not constitute an offer for sale of securities, nor a solicitation for offers to buy any securities in the United States, nor in any other jurisdiction in which such offer, solicitation or sale would be unlawful. Any public offering of securities in the United States must be made by means of a prospectus containing detailed information about the company and management, as well as financial statements.

About Oncolytics Biotech Inc.

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer. For further information, please visit: https://www.oncolyticsbiotech.com.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential and benefits of pelareorep as a cancer therapeutic; the Company's anticipated use of proceeds from the Offering: the terms of the Warrants, the Compensation Warrants and the Over-Allotment Option; the Company's plans to advance towards a registrational study in metastatic pancreatic cancer; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, the Company may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. The Company may incur expenses or delays relating to such events outside of its control, which could have a material adverse impact on the Company's business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

Company Contact
Jon Patton
Director of IR & Communication
+1-858-886-7813
mailto://jpatton@oncolytics.ca

Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com

View original content: https://www.prnewswire.com/news-releases/oncolytics-biotech-successfully-raises-us15-million-to-advance-breast-and-pancreatic-cancer-clinical-programs-301895716.html

SOURCE Oncolytics Biotech® Inc.

View original content: http://www.newswire.ca/en/releases/archive/August2023/08/c2445.html
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Paulness Paulness 11 months ago
NEWS -- Oncolytics Biotech® to Participate in a Fireside Chat at Canaccord Genuity's 43rd Annual Growth Conference

SAN DIEGO and CALGARY, AB, Aug. 4, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that Chief Executive Officer Dr. Matt Coffey will participate in a fireside chat at Canaccord Genuity's 43rd Annual Growth Conference, which is taking place August 7-10, 2023 at the InterContinental Boston in Boston, MA. Additional details on the fireside chat can be found below.

Date: Thursday, August 10, 2023
Time: 12:00 p.m. ET
Location: InterContinental Boston, Abigail Adams C Room
Webcast Link: Available by clicking here

Company management will also be participating in one-on-one investor meetings at the conference. To schedule a meeting, please submit a request on the conference website, contact your Canaccord representative, or email jpatton@oncolytics.ca.

A live webcast of the Company's presentation will also be available on the Investor Relations page of Oncolytics' website (LINK) and will be archived for three months.

About Oncolytics Biotech Inc.

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer. For further information, please visit: https://www.oncolyticsbiotech.com.

Company Contact

Jon Patton
Director of IR & Communication
+1-858-886-7813
mailto://jpatton@oncolytics.ca

Investor Relations for Oncolytics

Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com

View original content to download multimedia: https://www.prnewswire.com/news-releases/oncolytics-biotech-to-participate-in-a-fireside-chat-at-canaccord-genuitys-43rd-annual-growth-conference-301893276.html

SOURCE Oncolytics Biotech® Inc.
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Paulness Paulness 11 months ago
NEWS -- Oncolytics Biotech® to Host Conference Call to Discuss Second Quarter Financial Results and Recent Operational Highlights

Conference call and webcast to take place on Monday, August 14, 2023, at 8:30 a.m. ET

SAN DIEGO and CALGARY, AB, Aug. 4, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that it will host a conference call and webcast on Monday, August 14, 2023, at 8:30 a.m. ET to discuss a corporate update and financial results for the second quarter of 2023.

Conference Call & Webcast

Date: Monday, August 14, 2023
Time: 8:30 a.m. ET
Dial-In – North American Toll-Free: (888) 664-6383
Dial-In – International: (416) 764-8650
RapidConnect: to join the conference call without operator assistance, please click here
Conference ID (if needed): 5411-4798
Webcast: please click here

A webcast of the call will also be available on the Investor Relations page of Oncolytics' website, available by clicking here, and will be archived for three months. A dial-in replay will be available for one week and can be accessed by dialing (888) 390-0541 (North America) or (416) 764-8677 (International) and using replay code: 114-798#.

About Oncolytics Biotech Inc.

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer. For further information, please visit: https://www.oncolyticsbiotech.com.

Company Contact
Jon Patton
Director of IR & Communication
+1-858-886-7813
mailto://jpatton@oncolytics.ca

Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com

View original content: https://www.prnewswire.com/news-releases/oncolytics-biotech-to-host-conference-call-to-discuss-second-quarter-financial-results-and-recent-operational-highlights-301893245.html

SOURCE Oncolytics Biotech® Inc.
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Cobra Stock Sleuth Cobra Stock Sleuth 11 months ago
Intresting to see if they reveal who bought deal is by? Will it be oversubscribed?

Not great, but maybe best deal to add stability for now and move forward.

Lots of catalysts still between now and year end.
👍️ 1
Paulness Paulness 11 months ago
NEWS -- Oncolytics Biotech® Announces US$15 Million Bought Deal Offering of Units



Not for distribution to U.S. Newswire Services or Dissemination in the United States

CALGARY, AB, July 31, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. ("Oncolytics" or the "Company") (NASDAQ: ONCY) (TSX: ONC) today announced that it has entered into an agreement with Leede Jones Gable Inc. as underwriter and bookrunner (the "Underwriter"), pursuant to which the Underwriter has agreed to purchase, on a bought-deal basis, 6,667,000 units (the "Equity Units") for gross proceeds to the Company of US$15,000,750 (the "Offering") at a price of US$2.25 per Equity Unit.

Each Equity Unit will consist of one common share of the Company (a "Common Share") and one Common Share purchase warrant (each whole purchase warrant, a "Warrant"). Each Warrant will entitle the holder thereof to purchase one Common Share at an exercise price of US$2.81 (the "Exercise Price") at any time up to 60 months following the Closing (as defined below).

The Company has granted the Underwriter an option (the "Over-Allotment Option"), exercisable in part or in whole at the Underwriter's sole discretion, at any time beginning on the Closing until 30 days following the Closing, to purchase up to that number of additional Equity Units, Common Shares or Warrants, or any combination thereof, as is equal to 15% of the aggregate number of Equity Units sold in the Offering to cover over-allotments, if any.

The Equity Units will be offered by way of a prospectus supplement to the Company's short form base shelf prospectus to be filed in all provinces of Canada except Quebec pursuant to National Instrument 44-101 – Short Form Prospectus Distributions and National Instrument 44-102 - Shelf Distributions.

The Company intends to use the net proceeds from the Offering to continue its pelareorep clinical programs in metastatic breast cancer and pancreatic cancer and general corporate and working capital purposes.

The closing of the Offering is expected to occur on or about August 4, 2023 (the "Closing") and is subject to the Company receiving all necessary regulatory approvals, including the approval of the Exchange.

The securities referred to in this news release have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, and may not be offered or sold within the United States or to, or for the account or benefit of, U.S. persons absent U.S. registration or an applicable exemption from the U.S. registration requirements. This press release does not constitute an offer for sale of securities, nor a solicitation for offers to buy any securities in the United States, nor in any other jurisdiction in which such offer, solicitation or sale would be unlawful. Any public offering of securities in the United States must be made by means of a prospectus containing detailed information about the company and management, as well as financial statements.

About Oncolytics Biotech Inc.

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer. For further information, please visit: https://www.oncolyticsbiotech.com.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential and benefits of pelareorep as a cancer therapeutic; the Offering and the timing thereof and anticipated use of proceeds therefrom; our plans to advance towards a registrational study in metastatic pancreatic cancer; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

Company Contact
Jon Patton
Director of IR & Communication
+1-858-886-7813
mailto://jpatton@oncolytics.ca

Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com

Logo: https://mma.prnewswire.com/media/1762876/Oncolytics_Biotech_New_Logo.jpg

View original content:https://www.prnewswire.com/news-releases/oncolytics-biotech-announces-us15-million-bought-deal-offering-of-units-301889041.html

SOURCE Oncolytics Biotech® Inc.
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JFXL2 JFXL2 11 months ago
Let's hope these guys don't go the way of PMCB - they too focused on pancreatic cancer "targeting method". So far IMO ONCY seems better positioned then PMCB ever was... didn't get burned by PMCB but it was close - didn't make any $$ either. LOL Cheers FX
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Cobra Stock Sleuth Cobra Stock Sleuth 12 months ago
10 to 40$ a share possible if buyout.
Breast Cancer, Pancreatic Cancer P3 announcement around September 20th, CAR-T BD possible announcement, Colorectal, Pancreatic and Anal Cancer Data in October. Asian Deal with Adlai Nortye P3 in Breast cancer triggers 80 million dollar payment.

Depending on which ones are good news/ vs bad news or don't work.

But lots of catalysts to move forward.
Announcement could come at anytime. BE READY. Good luck everyone. I'm already up a lot here so don't care reallly it's all free money for me. $$$$$$$$$$$$$$$$$$
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ALLEYCATINHEET ALLEYCATINHEET 12 months ago
What’s going on with the stock any predictions.

Cheers
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