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Poseida Therapeutics Inc

Poseida Therapeutics Inc (PSTX)

3.23
-0.11
(-3.29%)
Closed July 18 4:00PM
3.23
0.00
( 0.00% )
Pre Market: 7:00AM

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Key stats and details

Current Price
3.23
Bid
3.12
Ask
3.72
Volume
-
0.00 Day's Range 0.00
1.60 52 Week Range 4.27
Market Cap
Previous Close
3.23
Open
-
Last Trade
Last Trade Time
-
Financial Volume
-
VWAP
-
Average Volume (3m)
469,021
Shares Outstanding
96,957,650
Dividend Yield
-
PE Ratio
-2.54
Earnings Per Share (EPS)
-1.27
Revenue
64.7M
Net Profit
-123.43M

About Poseida Therapeutics Inc

Poseida Therapeutics Inc is a clinical-stage biopharmaceutical company focused on leveraging non-viral gene engineering technologies to create life-saving therapeutics for patients with a high unmet delivery technology. It has built a pipeline of autologous and allogeneic chimeric antigen receptor T... Poseida Therapeutics Inc is a clinical-stage biopharmaceutical company focused on leveraging non-viral gene engineering technologies to create life-saving therapeutics for patients with a high unmet delivery technology. It has built a pipeline of autologous and allogeneic chimeric antigen receptor T cell, or CAR-T, product candidates, initially focused on the treatment of hematological malignancies and solid tumours. Show more

Sector
Biological Pds,ex Diagnstics
Industry
Biological Pds,ex Diagnstics
Website
Headquarters
Wilmington, Delaware, USA
Founded
1970
Poseida Therapeutics Inc is listed in the Biological Pds,ex Diagnstics sector of the NASDAQ with ticker PSTX. The last closing price for Poseida Therapeutics was $3.23. Over the last year, Poseida Therapeutics shares have traded in a share price range of $ 1.60 to $ 4.27.

Poseida Therapeutics currently has 96,957,650 shares outstanding. The market capitalization of Poseida Therapeutics is $313.17 million. Poseida Therapeutics has a price to earnings ratio (PE ratio) of -2.54.

PSTX Latest News

Poseida Therapeutics Announces Participation in Stifel's 2024 Virtual Cell Therapy Forum

Poseida Therapeutics Announces Participation in Stifel's 2024 Virtual Cell Therapy Forum PR Newswire SAN DIEGO, July 1, 2024 SAN DIEGO, July 1, 2024 /PRNewswire/ -- Poseida Therapeutics, Inc...

Poseida Therapeutics Announces Virtual 2024 Annual Meeting of Stockholders

Poseida Therapeutics Announces Virtual 2024 Annual Meeting of Stockholders PR Newswire SAN DIEGO, June 3, 2024 SAN DIEGO, June 3, 2024 /PRNewswire/ --ย Poseida Therapeutics, Inc. (Nasdaq: PSTX), a...

Poseida Therapeutics Provides Updates and Financial Results for the First Quarter of 2024

Poseida Therapeutics Provides Updates and Financial Results for the First Quarter of 2024 PR Newswire SAN DIEGO, May 14, 2024 Expanded strategic relationship withย Astellas with new research...

PeriodChangeChange %OpenHighLowAvg. Daily VolVWAP
1-0.15-4.437869822493.383.623.174600413.37204599CS
40.5319.62962962962.73.622.414214663.02078413CS
121.259.11330049262.033.622.034690212.90419114CS
260.3512.15277777782.884.271.876124133.1222131CS
521.2764.79591836731.964.271.67220372.76872532CS
156-5.28-62.0446533498.5111.11.546003353.64935897CS
260-13.77-811717.621.545293654.74202114CS

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PSTX Discussion

View Posts
Monksdream Monksdream 2 months ago
PSTX under $3
๐Ÿ‘๏ธ0
Monksdream Monksdream 7 months ago
Early Barchart 100
https://www.barchart.com/stocks/performance/percent-change/advances?timeFrame=today&viewName=main&screener=overall&orderBy=percentChange&orderDir=desc
๐Ÿ‘๏ธ0
subslover subslover 7 months ago
Poseida Therapeutics Presents Positive Early Results from its Phase 1 Trial of Allogeneic CAR-T P-BCMA-ALLO1 in Relapsed-Refractory Multiple Myeloma at the 65th American Society of Hematology (ASH) Annual Meeting
82% ORR and deep clinical responses from off-the-shelf, allogeneic BCMA-targeted CAR-T in heavily pretreated patients receiving adequate lymphodepletion

100% ORR in these patients who were not previously treated with a BCMA-targeted bispecific T cell-engaging antibody

Favorable emerging safety and reliability profile, with all (100%) intent-to-treat (ITT) patients receiving therapy, no GvHD or dose-limiting toxicities and low incidences of CRS and neurotoxicity observed (all ≤ Grade 2)

Preliminary data show allogeneic TSCM-rich CAR-T cells trafficking to bone marrow, differentiating to cell-killing effector T cells and persisting at least 6 weeks

Two additional poster presentations highlight advancements across the Company's cell and gene therapy programs and platforms

Company to host webcast and conference call today at 11:00 AM PST

SAN DIEGO, Dec. 10, 2023 /PRNewswire/ -- Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage cell and gene therapy company advancing a new class of treatments for patients with cancer and rare diseases, today announced early efficacy and safety results from its Phase 1 study of P-BCMA-ALLO1, its BCMA-targeted allogeneic, T stem cell memory (TSCM)-rich chimeric antigen receptor (CAR)-T therapy candidate. The Company is investigating P-BCMA-ALLO1 in partnership with Roche for the treatment of relapsed/refractory multiple myeloma (RRMM). Detailed study findings, along with two additional Company poster presentations in cell and gene therapy, are being featured at the 65th ASH Annual Meeting and Exposition being held in San Diego on December 9-12, 2023.


"Today, far too many patients are unable to benefit from autologous CAR-T therapy due to its limited supply, lengthy timelines, complex logistics, and cost," said Kristin Yarema, Ph.D., President, Cell Therapy at Poseida. "We have long believed that readily produced, off-the-shelf allogeneic, TSCM-rich CAR-T products have the potential to offer a compelling efficacy and safety profile while also supporting patient access. TSCM-rich CAR-T products can be difficult to produce with older virus-based technology, but we are able to create a portfolio of such products using Poseida's unique, non-viral set of technologies. We see these early P-BCMA-ALLO1 results in multiple myeloma, in which all enrolled patients received CAR-T therapy and most patients receiving adequate lymphodepletion achieved a stringent complete response (sCR) or very good partial response (VGPR), as validating our vision and eagerly await additional data yet to come from this study. This is also the first known publicly presented data set that provides clear clinical evidence supporting the hypothesis that TSCM cells are the ideal cell type for allogeneic CAR-T, extending our previous findings with autologous TSCM cells to the allogeneic setting. We hope that TSCM-rich allogeneic CAR-T therapies may potentially offer the optimal combination of clinical results, on-demand availability and high-volume production, while supporting broader access to CAR-T therapies. We are excited to have taken this first step with our early P-BCMA-ALLO1 clinical results. They inspire us to further develop P-BCMA-ALLO1 in partnership with Roche, and to continue advancing our entire allogeneic TSCM cell-based CAR-T portfolio."

P-BCMA-ALLO1 program data presentations

At the time of the October 23, 2023 data cut off, 39 patients were enrolled as an intent-to-treat (ITT) population in the ongoing Phase 1 multicenter, open-label dose-escalation study (NCT04960579). Enrolled patients had previously failed protease inhibitor, immunomodulatory drug (IMiD), and anti-CD38 antibody treatments or were otherwise triple-refractory. Previous treatment with B cell maturation antigen (BCMA)-targeted therapy was allowed including autologous BCMA CAR-T and bispecific T cell-engaging (TCE) antibodies. All enrolled patients completed lymphodepletion and went on to receive P-BCMA-ALLO1 a median of 7 days after enrollment for a 100% ITT treatment rate with no use of bridging therapy. Six patient cohorts varying in size (n=1 to n=6) received one of three fludarabine/cyclophosphamide (flu/cy) lymphodepleting conditioning regimens including 3 days of fludarabine at 30 mg/m2/day for all patients and, depending upon the patient cohort, 3 days of cyclophosphamide at 300, 500, or 1,000 mg/m2/day followed by infusion of P-BCMA-ALLO1 cells at cell doses varying by cohort up to 6x106 cells/kg to date.

Evaluable patients with at least 4 weeks of follow up (n=33) were heavily pretreated with a median of 7 prior lines of therapy. Additionally, 30% of these patients had high risk disease by cytogenetics and nearly 2 in 5 (39%) had received previous BCMA-targeted therapy. 11 of the 33 evaluable patients were in the two cohorts receiving 2x106 cells/kg of P-BCMA-ALLO1 and higher cyclophosphamide preconditioning doses at either 500 mg/m2 ('P1 arm'; n=5) or 1,000 mg/m2 ('P2 arm'; n=6).

An overall objective response rate (ORR) of 82% (9/11 total patients) was reached among patients in the pooled P1 and P2 arms. ORR in the P2 arm was 83% (5/6) with 100% (5/5) of the responding P2 patients achieving a VGPR or better and 40% (2/5) achieving sCR. 80% ORR was obtained in the P1 arm (4/5) with 50% of responding patients achieving VGPR. Both nonresponding patients, one in each of the P1 and P2 arms, had received and not achieved clinical response with the BCMAxCD3 bispecific TCE antibody therapy teclistamab prior to receiving P-BCMA-ALLO1.

A 100% ORR (9/9) was achieved among patients in P1 and P2 arms who had not received a prior BCMA-targeting bispecific TCE antibody as well as 100% ORR (2/2) in patients who had received prior autologous CAR-T BCMA targeted therapy.

P-BCMA-ALLO1 was very well tolerated, with no graft-vs-host disease (GvHD) at any dose and low rates of cytokine release syndrome (CRS) and neurotoxicity, all Grade 2 or less, found among all evaluable patients.

Expansion and persistence of the CAR-T cells in patients after infusion was found to be highly dependent upon the conditioning dose of cyclophosphamide, with P-BCMA-ALLO1 levels measured in the blood much higher in patient cohorts in the P1 and P2 arms receiving the 500 mg/m2 and 1,000 mg/m2 conditioning doses than in any of the 300 mg/m2 (arm 'S', n=20) cohorts. Clinical responses in patients receiving arm S conditioning treatment were inferior to those achieved by patients in P1 or P2.

Analysis of P-BCMA-ALLO1 cellular kinetics in two patients with high CAR-T expansion showed CAR-T cells persisted and were measurable in the peripheral blood of one patient for at least 4 weeks and engrafted and persisted at a high level in the bone marrow of the other for at least 6 weeks. Moreover, in both cases cells in the TSCM-rich CAR-T infused drug product underwent differentiation after infusion to generate a much more effector T cell-rich population, particularly among the important CD8+ 'killer T cell' subpopulation. These findings are the first known direct clinical evidence supporting the theory that allogeneic TSCM-based CAR-T cells can act as effective prodrugs because they can expand, traffic to the relevant tissues, differentiate into effector cells and persist, all of which may contribute to driving deep clinical responses in patients while also being well-tolerated.

"Despite the emergence of autologous BCMA-targeted therapies, multiple myeloma remains an incurable malignancy. Autologous CAR-T therapies may be associated with numerous challenges for patients and physicians, including prolonged manufacturing times, inconsistent drug quality and serious safety issues," said Bhagirathbhai Dholaria, M.D., Associate Professor of Medicine (Hematology/Oncology) at the Vanderbilt-Ingram Cancer Center. "Allogeneic CAR-T therapies have the potential to overcome many of these challenges. Today's data demonstrate that P-BCMA-ALLO1 is a well-tolerated off-the-shelf therapy with a favorable emerging safety profile and encouraging evidence of early clinical activity. In addition, the data show that P-BCMA-ALLO1 can achieve deep clinical responses in patients with high-risk disease and those who have previously received BCMA targeting therapies. Importantly, P-BCMA-ALLO1 was delivered to all patients in the ITT population with all drug product meeting all quality specifications. We look forward to continuing to enroll patients in this study."

Enrollment is ongoing including additional exploration of dose regimens and lymphodepleting conditioning regimens. While still early to assess durability, at the time of the data cut off 8 of the 9 responding patients in P1 and P2 arms remained in response. The Company, together with Roche, plans to present additional clinical data updates for P-BCMA-ALLO1 at scientific meetings in 2024, subject to coordination with Roche.

A second Poseida-sponsored poster highlights the development of an in vivo bioassay for assessing BCMA CAR-T final product potency and presents data suggesting P-BCMA-ALLO1 drug product may have greater potency than drug products produced in the Company's earlier, autologous P-BCMA-101 CAR-T program.

P-FVIII-101 program data presentation

The Company has also presented a third poster describing P-FVIII-101, a fully non-viral liver-directed gene therapy combining Poseida's proprietary piggyBac® DNA Delivery System with nanoparticle delivery for the treatment of Hemophilia A. This poster demonstrates the capabilities of the piggyBac DNA insertion system and non-viral approach in providing stable Factor VIII (FVIII) transgene expression through genomic integration, along with the potential for redosing. The poster highlights 52-week durability in an adult Hemophilia A model along with a favorable tolerability profile of Poseida's liver-targeted non-viral delivery platform providing further proof-of-principle toward developing an effective and durable treatment for Hemophilia A.

Company-Hosted Webcast and Conference Call Information:

Poseida will host a webcast and conference call today, December 10th at 11:00 AM PST / 2:00 PM EST. The conference call can be accessed by dialing 800-225-9448 (United States) or 203-518-9708 (International) with the conference ID PSTX23. A live webcast may be accessed using the link here, or by visiting the Events and Presentations section of the Poseida website at investors.poseida.com. After the live webcast, the event will remain archived on the Poseida site for 90 days.

Poster Presentation Details:

Title: Early Safety Results of P-BCMA-ALLO1, a Fully Allogeneic Chimeric Antigen Receptor T-Cell (CAR-T), in Patients with Relapsed/Refractory Multiple Myeloma (RRMM)

Presenting Author: Bhagirathbhai Dholaria, M.D., Associate Professor of Medicine (Hematology/Oncology) at the Vanderbilt-Ingram Cancer Center
Session Date & Time: Sunday, December 10, 2023, at 6:00 โ€“ 8:00 PM PT
Publication Number: 3479
Session Title: 704. Cellular Immunotherapies: Early Phase and Investigational Therapies: Poster II
Location: Halls G-H
Title: A Tumor-Bearing Murine Xenograft Model as a Bioassay for Assessing CAR-T Product Potency Shows Positive Predictive Value for Clinical Performance

Presenting Author: Stacey Cranert, Ph.D., Poseida Therapeutics
Session Date & Time: Saturday, December 9, 2023, at 5:30 โ€“ 7:30 PM PT
Publication Number: 2293
Session Title: 803. Emerging Tools, Techniques and Artificial Intelligence in Hematology: Poster I
Location: Halls G-H
Title: Effective Gene Therapy for Hemophilia A: Novel Re-Dosable Non-Viral Formulation That Provides Stable, and Durable FVIII Expression with Improved Tolerability

Presenting Author: Brian Truong, Ph.D., Poseida Therapeutics
Session Date & Time: Saturday, December 9, 2023, at 5:30 โ€“ 7:30 PM PT
Publication Number: 1232
Session Title: 321. Coagulation and Fibrinolysis: Basic and Translational: Poster I
Location: Halls G-H
About P-BCMA-ALLO1

P-BCMA-ALLO1 is an allogeneic CAR-T product candidate licensed to Roche targeting B-cell maturation antigen (BCMA) for the treatment of relapsed/refractory multiple myeloma in Phase 1 development. This allogeneic program includes a VH-based binder that targets BCMA and has shown early evidence of encouraging safety and efficacy. Additional information about the Phase 1 study is available at www.clinicaltrials.gov using identifier: NCT04960579.

About P-FVIII-101

P-FVIII-101 is a liver-directed gene therapy combining Poseida's non-viral piggyBac platform and nanoparticle delivery technologies for the in vivo treatment of Hemophilia A. Hemophilia A is a bleeding disorder caused by a deficiency in Factor VIII production with a high unmet need. P-FVIII-101 utilizes the piggyBac gene integration system delivered via lipid nanoparticle, which has demonstrated stable and sustained Factor VIII expression in juvenile and adult animal models.

About Poseida Therapeutics, Inc.

Poseida Therapeutics is a clinical-stage biopharmaceutical company advancing differentiated cell and gene therapies with the capacity to cure certain cancers and rare diseases. The Company's pipeline includes allogeneic CAR-T cell therapy product candidates for both solid and liquid tumors as well as in vivo gene therapy product candidates that address patient populations with high unmet medical need. The Company's approach to cell and gene therapies is based on its proprietary genetic editing platforms, including its non-viral piggyBac® DNA Delivery System, Cas-CLOVER™ Site-Specific Gene Editing System, and nanoparticle and hybrid gene delivery technologies as well as in-house GMP cell therapy manufacturing. The Company has formed a global strategic collaboration with Roche to unlock the promise of cell therapies for patients with hematological malignancies. Learn more at www.poseida.com and connect with us on X and LinkedIn.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, expected plans with respect to clinical trials, including timing of regulatory submissions and approvals and clinical data updates; anticipated timelines and milestones with respect to the Company's development programs and manufacturing activities and capabilities; the potential capabilities and benefits of the Company's technology platforms and product candidates, including the efficacy and safety profile of such product candidates; the quotes from Dr. Yarema and Dr. Dholaria; and the Company's plans and strategy with respect to developing its technologies and product candidates. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon the Company's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the Company's reliance on third parties for various aspects of its business; risks and uncertainties associated with development and regulatory approval of novel product candidates in the biopharmaceutical industry; the Company's ability to retain key scientific or management personnel; and the other risks described in the Company's filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

https://c212.net/c/img/favicon.png?sn=LA89296&sd=2023-12-10 View original content to download multimedia:https://www.prnewswire.com/news-releases/poseida-therapeutics-presents-positive-early-results-from-its-phase-1-trial-of-allogeneic-car-t-p-bcma-allo1-in-relapsed-refractory-multiple-myeloma-at-the-65th-american-society-of-hematology-ash-annual-meeting-302010725.html
๐Ÿ‘๏ธ0
subslover subslover 7 months ago
Poseida Therapeutics Presents Positive Early Results from its Phase 1 Trial of Allogeneic CAR-T P-BCMA-ALLO1 in Relapsed-Refractory Multiple Myeloma at the 65th American Society of Hematology (ASH) Annual Meeting
82% ORR and deep clinical responses from off-the-shelf, allogeneic BCMA-targeted CAR-T in heavily pretreated patients receiving adequate lymphodepletion

100% ORR in these patients who were not previously treated with a BCMA-targeted bispecific T cell-engaging antibody

Favorable emerging safety and reliability profile, with all (100%) intent-to-treat (ITT) patients receiving therapy, no GvHD or dose-limiting toxicities and low incidences of CRS and neurotoxicity observed (all ≤ Grade 2)

Preliminary data show allogeneic TSCM-rich CAR-T cells trafficking to bone marrow, differentiating to cell-killing effector T cells and persisting at least 6 weeks

Two additional poster presentations highlight advancements across the Company's cell and gene therapy programs and platforms

Company to host webcast and conference call today at 11:00 AM PST

SAN DIEGO, Dec. 10, 2023 /PRNewswire/ -- Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage cell and gene therapy company advancing a new class of treatments for patients with cancer and rare diseases, today announced early efficacy and safety results from its Phase 1 study of P-BCMA-ALLO1, its BCMA-targeted allogeneic, T stem cell memory (TSCM)-rich chimeric antigen receptor (CAR)-T therapy candidate. The Company is investigating P-BCMA-ALLO1 in partnership with Roche for the treatment of relapsed/refractory multiple myeloma (RRMM). Detailed study findings, along with two additional Company poster presentations in cell and gene therapy, are being featured at the 65th ASH Annual Meeting and Exposition being held in San Diego on December 9-12, 2023.


"Today, far too many patients are unable to benefit from autologous CAR-T therapy due to its limited supply, lengthy timelines, complex logistics, and cost," said Kristin Yarema, Ph.D., President, Cell Therapy at Poseida. "We have long believed that readily produced, off-the-shelf allogeneic, TSCM-rich CAR-T products have the potential to offer a compelling efficacy and safety profile while also supporting patient access. TSCM-rich CAR-T products can be difficult to produce with older virus-based technology, but we are able to create a portfolio of such products using Poseida's unique, non-viral set of technologies. We see these early P-BCMA-ALLO1 results in multiple myeloma, in which all enrolled patients received CAR-T therapy and most patients receiving adequate lymphodepletion achieved a stringent complete response (sCR) or very good partial response (VGPR), as validating our vision and eagerly await additional data yet to come from this study. This is also the first known publicly presented data set that provides clear clinical evidence supporting the hypothesis that TSCM cells are the ideal cell type for allogeneic CAR-T, extending our previous findings with autologous TSCM cells to the allogeneic setting. We hope that TSCM-rich allogeneic CAR-T therapies may potentially offer the optimal combination of clinical results, on-demand availability and high-volume production, while supporting broader access to CAR-T therapies. We are excited to have taken this first step with our early P-BCMA-ALLO1 clinical results. They inspire us to further develop P-BCMA-ALLO1 in partnership with Roche, and to continue advancing our entire allogeneic TSCM cell-based CAR-T portfolio."

P-BCMA-ALLO1 program data presentations

At the time of the October 23, 2023 data cut off, 39 patients were enrolled as an intent-to-treat (ITT) population in the ongoing Phase 1 multicenter, open-label dose-escalation study (NCT04960579). Enrolled patients had previously failed protease inhibitor, immunomodulatory drug (IMiD), and anti-CD38 antibody treatments or were otherwise triple-refractory. Previous treatment with B cell maturation antigen (BCMA)-targeted therapy was allowed including autologous BCMA CAR-T and bispecific T cell-engaging (TCE) antibodies. All enrolled patients completed lymphodepletion and went on to receive P-BCMA-ALLO1 a median of 7 days after enrollment for a 100% ITT treatment rate with no use of bridging therapy. Six patient cohorts varying in size (n=1 to n=6) received one of three fludarabine/cyclophosphamide (flu/cy) lymphodepleting conditioning regimens including 3 days of fludarabine at 30 mg/m2/day for all patients and, depending upon the patient cohort, 3 days of cyclophosphamide at 300, 500, or 1,000 mg/m2/day followed by infusion of P-BCMA-ALLO1 cells at cell doses varying by cohort up to 6x106 cells/kg to date.

Evaluable patients with at least 4 weeks of follow up (n=33) were heavily pretreated with a median of 7 prior lines of therapy. Additionally, 30% of these patients had high risk disease by cytogenetics and nearly 2 in 5 (39%) had received previous BCMA-targeted therapy. 11 of the 33 evaluable patients were in the two cohorts receiving 2x106 cells/kg of P-BCMA-ALLO1 and higher cyclophosphamide preconditioning doses at either 500 mg/m2 ('P1 arm'; n=5) or 1,000 mg/m2 ('P2 arm'; n=6).

An overall objective response rate (ORR) of 82% (9/11 total patients) was reached among patients in the pooled P1 and P2 arms. ORR in the P2 arm was 83% (5/6) with 100% (5/5) of the responding P2 patients achieving a VGPR or better and 40% (2/5) achieving sCR. 80% ORR was obtained in the P1 arm (4/5) with 50% of responding patients achieving VGPR. Both nonresponding patients, one in each of the P1 and P2 arms, had received and not achieved clinical response with the BCMAxCD3 bispecific TCE antibody therapy teclistamab prior to receiving P-BCMA-ALLO1.

A 100% ORR (9/9) was achieved among patients in P1 and P2 arms who had not received a prior BCMA-targeting bispecific TCE antibody as well as 100% ORR (2/2) in patients who had received prior autologous CAR-T BCMA targeted therapy.

P-BCMA-ALLO1 was very well tolerated, with no graft-vs-host disease (GvHD) at any dose and low rates of cytokine release syndrome (CRS) and neurotoxicity, all Grade 2 or less, found among all evaluable patients.

Expansion and persistence of the CAR-T cells in patients after infusion was found to be highly dependent upon the conditioning dose of cyclophosphamide, with P-BCMA-ALLO1 levels measured in the blood much higher in patient cohorts in the P1 and P2 arms receiving the 500 mg/m2 and 1,000 mg/m2 conditioning doses than in any of the 300 mg/m2 (arm 'S', n=20) cohorts. Clinical responses in patients receiving arm S conditioning treatment were inferior to those achieved by patients in P1 or P2.

Analysis of P-BCMA-ALLO1 cellular kinetics in two patients with high CAR-T expansion showed CAR-T cells persisted and were measurable in the peripheral blood of one patient for at least 4 weeks and engrafted and persisted at a high level in the bone marrow of the other for at least 6 weeks. Moreover, in both cases cells in the TSCM-rich CAR-T infused drug product underwent differentiation after infusion to generate a much more effector T cell-rich population, particularly among the important CD8+ 'killer T cell' subpopulation. These findings are the first known direct clinical evidence supporting the theory that allogeneic TSCM-based CAR-T cells can act as effective prodrugs because they can expand, traffic to the relevant tissues, differentiate into effector cells and persist, all of which may contribute to driving deep clinical responses in patients while also being well-tolerated.

"Despite the emergence of autologous BCMA-targeted therapies, multiple myeloma remains an incurable malignancy. Autologous CAR-T therapies may be associated with numerous challenges for patients and physicians, including prolonged manufacturing times, inconsistent drug quality and serious safety issues," said Bhagirathbhai Dholaria, M.D., Associate Professor of Medicine (Hematology/Oncology) at the Vanderbilt-Ingram Cancer Center. "Allogeneic CAR-T therapies have the potential to overcome many of these challenges. Today's data demonstrate that P-BCMA-ALLO1 is a well-tolerated off-the-shelf therapy with a favorable emerging safety profile and encouraging evidence of early clinical activity. In addition, the data show that P-BCMA-ALLO1 can achieve deep clinical responses in patients with high-risk disease and those who have previously received BCMA targeting therapies. Importantly, P-BCMA-ALLO1 was delivered to all patients in the ITT population with all drug product meeting all quality specifications. We look forward to continuing to enroll patients in this study."

Enrollment is ongoing including additional exploration of dose regimens and lymphodepleting conditioning regimens. While still early to assess durability, at the time of the data cut off 8 of the 9 responding patients in P1 and P2 arms remained in response. The Company, together with Roche, plans to present additional clinical data updates for P-BCMA-ALLO1 at scientific meetings in 2024, subject to coordination with Roche.

A second Poseida-sponsored poster highlights the development of an in vivo bioassay for assessing BCMA CAR-T final product potency and presents data suggesting P-BCMA-ALLO1 drug product may have greater potency than drug products produced in the Company's earlier, autologous P-BCMA-101 CAR-T program.

P-FVIII-101 program data presentation

The Company has also presented a third poster describing P-FVIII-101, a fully non-viral liver-directed gene therapy combining Poseida's proprietary piggyBac® DNA Delivery System with nanoparticle delivery for the treatment of Hemophilia A. This poster demonstrates the capabilities of the piggyBac DNA insertion system and non-viral approach in providing stable Factor VIII (FVIII) transgene expression through genomic integration, along with the potential for redosing. The poster highlights 52-week durability in an adult Hemophilia A model along with a favorable tolerability profile of Poseida's liver-targeted non-viral delivery platform providing further proof-of-principle toward developing an effective and durable treatment for Hemophilia A.

Company-Hosted Webcast and Conference Call Information:

Poseida will host a webcast and conference call today, December 10th at 11:00 AM PST / 2:00 PM EST. The conference call can be accessed by dialing 800-225-9448 (United States) or 203-518-9708 (International) with the conference ID PSTX23. A live webcast may be accessed using the link here, or by visiting the Events and Presentations section of the Poseida website at investors.poseida.com. After the live webcast, the event will remain archived on the Poseida site for 90 days.

Poster Presentation Details:

Title: Early Safety Results of P-BCMA-ALLO1, a Fully Allogeneic Chimeric Antigen Receptor T-Cell (CAR-T), in Patients with Relapsed/Refractory Multiple Myeloma (RRMM)

Presenting Author: Bhagirathbhai Dholaria, M.D., Associate Professor of Medicine (Hematology/Oncology) at the Vanderbilt-Ingram Cancer Center
Session Date & Time: Sunday, December 10, 2023, at 6:00 โ€“ 8:00 PM PT
Publication Number: 3479
Session Title: 704. Cellular Immunotherapies: Early Phase and Investigational Therapies: Poster II
Location: Halls G-H
Title: A Tumor-Bearing Murine Xenograft Model as a Bioassay for Assessing CAR-T Product Potency Shows Positive Predictive Value for Clinical Performance

Presenting Author: Stacey Cranert, Ph.D., Poseida Therapeutics
Session Date & Time: Saturday, December 9, 2023, at 5:30 โ€“ 7:30 PM PT
Publication Number: 2293
Session Title: 803. Emerging Tools, Techniques and Artificial Intelligence in Hematology: Poster I
Location: Halls G-H
Title: Effective Gene Therapy for Hemophilia A: Novel Re-Dosable Non-Viral Formulation That Provides Stable, and Durable FVIII Expression with Improved Tolerability

Presenting Author: Brian Truong, Ph.D., Poseida Therapeutics
Session Date & Time: Saturday, December 9, 2023, at 5:30 โ€“ 7:30 PM PT
Publication Number: 1232
Session Title: 321. Coagulation and Fibrinolysis: Basic and Translational: Poster I
Location: Halls G-H
About P-BCMA-ALLO1

P-BCMA-ALLO1 is an allogeneic CAR-T product candidate licensed to Roche targeting B-cell maturation antigen (BCMA) for the treatment of relapsed/refractory multiple myeloma in Phase 1 development. This allogeneic program includes a VH-based binder that targets BCMA and has shown early evidence of encouraging safety and efficacy. Additional information about the Phase 1 study is available at www.clinicaltrials.gov using identifier: NCT04960579.

About P-FVIII-101

P-FVIII-101 is a liver-directed gene therapy combining Poseida's non-viral piggyBac platform and nanoparticle delivery technologies for the in vivo treatment of Hemophilia A. Hemophilia A is a bleeding disorder caused by a deficiency in Factor VIII production with a high unmet need. P-FVIII-101 utilizes the piggyBac gene integration system delivered via lipid nanoparticle, which has demonstrated stable and sustained Factor VIII expression in juvenile and adult animal models.

About Poseida Therapeutics, Inc.

Poseida Therapeutics is a clinical-stage biopharmaceutical company advancing differentiated cell and gene therapies with the capacity to cure certain cancers and rare diseases. The Company's pipeline includes allogeneic CAR-T cell therapy product candidates for both solid and liquid tumors as well as in vivo gene therapy product candidates that address patient populations with high unmet medical need. The Company's approach to cell and gene therapies is based on its proprietary genetic editing platforms, including its non-viral piggyBac® DNA Delivery System, Cas-CLOVER™ Site-Specific Gene Editing System, and nanoparticle and hybrid gene delivery technologies as well as in-house GMP cell therapy manufacturing. The Company has formed a global strategic collaboration with Roche to unlock the promise of cell therapies for patients with hematological malignancies. Learn more at www.poseida.com and connect with us on X and LinkedIn.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, expected plans with respect to clinical trials, including timing of regulatory submissions and approvals and clinical data updates; anticipated timelines and milestones with respect to the Company's development programs and manufacturing activities and capabilities; the potential capabilities and benefits of the Company's technology platforms and product candidates, including the efficacy and safety profile of such product candidates; the quotes from Dr. Yarema and Dr. Dholaria; and the Company's plans and strategy with respect to developing its technologies and product candidates. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon the Company's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the Company's reliance on third parties for various aspects of its business; risks and uncertainties associated with development and regulatory approval of novel product candidates in the biopharmaceutical industry; the Company's ability to retain key scientific or management personnel; and the other risks described in the Company's filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

https://c212.net/c/img/favicon.png?sn=LA89296&sd=2023-12-10 View original content to download multimedia:https://www.prnewswire.com/news-releases/poseida-therapeutics-presents-positive-early-results-from-its-phase-1-trial-of-allogeneic-car-t-p-bcma-allo1-in-relapsed-refractory-multiple-myeloma-at-the-65th-american-society-of-hematology-ash-annual-meeting-302010725.html
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jondoeuk jondoeuk 1 year ago
Link to webcast https://wsw.com/webcast/cc/pstx5/1465560

Slides https://investors.poseida.com/static-files/00aa2f74-8058-4a80-982f-b441664c9db1
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jondoeuk jondoeuk 1 year ago
R&D Day PR https://www.prnewswire.com/news-releases/poseida-therapeutics-hosts-third-annual-virtual-rd-day-highlighting-novel-pipeline-assets-and-latest-technology-innovations-301752568.html
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beambe beambe 2 years ago
good NEWS
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beambe beambe 2 years ago
https://poseida.com/science/pipeline/
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beambe beambe 2 years ago
Volume: 544,284
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beambe beambe 2 years ago
Volume
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beambe beambe 2 years ago
good News
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trendzone trendzone 2 years ago
The usual greedy bigs.
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retireat40 retireat40 2 years ago
Dropped an offering at 4:01pm. Greedy schmucks.
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beambe beambe 2 years ago
https://www.nasdaq.com/market-activity/stocks/pstx/institutional-holdings
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jondoeuk jondoeuk 2 years ago
Link to webcast https://event.on24.com/wcc/r/3876127/0CBE308BDD621EB200051542826DCC8C

Slides https://investors.poseida.com/static-files/472c5468-0ae7-4bdb-9cf9-f6050ddf58eb
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jondoeuk jondoeuk 2 years ago
They have announced a partnership with RHHBY to jointly develop allo CAR-T therapies. Per the terms, the Swiss pharma giant will receive either exclusive rights or options from Poseida to develop and sell multiple CARs globally against targets in multiple myeloma, B-cell lymphomas, and other hematologic malignancies. In return, Poseida will receive $110M of upfront payment in addition to $110M in near-term milestones and other payments within the next several years. Notably, the company is entitled to receive up to $6B worth of milestones and other payments based on research, development, launch, and net sales. The completion of the agreement is subject to clearance under the HSR Act.
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KOmani KOmani 2 years ago
This would be so easy without the $6 billion tossed in casually at the end.
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KOmani KOmani 2 years ago
Damn.

It also said it is eligible to receive up to $6 billion in research, development, launch and other payments, along with royalties on product sales.
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subslover subslover 2 years ago
Poseida Therapeutics Inks Collaboration With Roche
August 03 2022 - 08:18AM
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By Colin Kellaher


Poseida Therapeutics Inc. on Wednesday said it signed a collaboration and license agreement potentially worth billions of dollars with Swiss pharmaceutical company Roche Holding AG.

San Diego-based Poseida, a clinical-stage biopharmaceutical company, said the deal covers the research and development of multiple existing and novel "off-the-shelf" cell therapies against targets in multiple myeloma, B-cell lymphomas and other hematologic indications.

Poseida said it would receive an upfront payment of $110 million, and that it could receive up to $110 million in near-term milestones and other payments over the next several years.

It also said it is eligible to receive up to $6 billion in research, development, launch and other payments, along with royalties on product sales.

Trading in shares of Poseida, which closed Tuesday at $2.43, was halted premarket on Wednesday.
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jondoeuk jondoeuk 2 years ago
https://www.prnewswire.com/news-releases/poseida-therapeutics-to-present-interim-results-from-phase-1-trial-of-p-psma-101-at-asco-genitourinary-cancers-symposium-301484390.html

Video https://poseida.com/wp-content/uploads/2022/02/Audio-P-PSMA-101-ASCO2022.mp4

Slides https://poseida.com/wp-content/uploads/2022/02/P-PSMA-101-ASCO-GU2022-Speaker-Slides-27Jan22-FINAL.pdf

Poster https://poseida.com/wp-content/uploads/2022/02/P-PSMA-101-ASCO-GU2022-Poster-27Jan22-FINAL.pdf
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jondoeuk jondoeuk 2 years ago
R&D Day
Wed, Feb 23 (10:00am - 1:30pm ET / 7:00am - 10:30am PT)
https://wsw.com/webcast/cc/pstx4/1464498
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jondoeuk jondoeuk 3 years ago
SITC posters

Memory Phenotype in Allogeneic Anti-BCMA CAR-T Cell Therapy (P-BCMA-ALLO1) Correlates with In Vivo Tumor Control https://poseida.com/wp-content/uploads/2021/11/16344-YanZhang-Poster.pdf

P-MUC1C-ALLO1: A Fully Allogeneic Stem Cell Memory T Cell (TSCM) CAR-T Therapy with Broad Potential in Solid Tumor https://poseida.com/wp-content/uploads/2021/11/Final-SITC-Poster-BCMA-ALLO-Memory.pdf
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jondoeuk jondoeuk 3 years ago
ASH PR https://www.prnewswire.com/news-releases/poseida-therapeutics-provides-update-on-bcma-targeted-car-t-clinical-trials-at-the-2021-american-society-of-hematology-ash-annual-meeting-301442793.html
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jondoeuk jondoeuk 3 years ago
The company has entered into a research collaboration and exclusive license agreement with Takeda Pharma. Under the terms of the agreement, the parties will collaborate to initially develop up to six in vivo gene therapy programs utilising Poseida's tech platforms, including piggyBac, Cas-CLOVER and biodegradable nanoparticles, as well as certain emerging technologies. Takeda also has an option to add two additional programs and is obligated to provide funding for all R&D costs. Poseida will receive an upfront payment of $45M and preclinical milestones, potentially exceeding $125M. They are also eligible to receive future milestone payments of up to $2.7B for all six programs, and up to $3.6B related to additional two optional programs.
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jondoeuk jondoeuk 3 years ago
SITC:

Title: Memory Phenotype in Allogeneic Anti-BCMA CAR-T Cell Therapy (P-BCMA-ALLO1) Correlates with In Vivo Tumor Control
Presenter: Hubert Tseng, Ph.D., Poseida Therapeutics
Session Date/Time: ePoster Hall opens November 12, 2021, at 7:00am ET
Abstract Number: 147

Title: P-MUC1C-ALLO1: A Fully Allogeneic Stem Cell Memory T Cell (TSCM) CAR-T Therapy with Broad Potential in Solid Tumor
Presenter: Yan Zhang, Ph.D., Poseida Therapeutics
Session Date/Time: ePoster Hall opens November 12, 2021, at 7:00am ET
Abstract Number: 123
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jondoeuk jondoeuk 3 years ago
Slide decks from the CAR-TCR Summit

Developing CAR-T Cells for Multiple Myeloma: From Autologous to Allogeneic https://poseida.com/wp-content/uploads/2021/08/Matt-Spear_BCMA-CAR-TCR21-final-210831.pdf

Advancing Nonviral Manufacturing for Multi-Product Allogeneic T-Cell Therapies https://poseida.com/wp-content/uploads/2021/09/210901-Shedlock-CAR-TCR-Summit-2.pdf

Developing piggyBac Systems โ€œOff-the-Shelfโ€ CAR-T Cells for Bone Marrow Transplant Conditioning https://poseida.com/wp-content/uploads/2021/08/Nina-Timberlake_20210902-CAR-TCR-Beyond-Oncology.pdf
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jondoeuk jondoeuk 3 years ago
As of the cutoff date, the trial had enrolled a total of nine patients with mCRPC. Five were treated with Dose A (an average of about 20M cells), and four with Dose B (an average of about 60M cells). Patients were heavily pre-treated, having received an average of six prior lines of therapy. Five showed measurable declines in PSA levels, with three showed a greater than 50% decline. One demonstrated evidence of complete tumour elimination and remains in a durable response of greater than five months at the time of this presentation https://poseida.com/wp-content/uploads/2021/08/CAR-TCR-Summit-2021_P-PSMA-101-Update_08312021.pdf
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jondoeuk jondoeuk 3 years ago
The company plans to provide an update from the PhI P-PSMA-101 trial to be presented by CEO, Eric Ostertag, at the 6th Annual CAR-TCR Summit virtual meeting at 10:00 am ET on August 31, entitled, "P-PSMA-101 is a High-Tscm Autologous CAR-T Targeting PSMA Producing Exceptionally Deep and Durable Responses in Castration-Resistant Metastatic Prostate Cancer.''
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jondoeuk jondoeuk 3 years ago
Presentations at the American Society of Gene and Cell Therapy Annual Meeting;

Preclinical Evaluation of Combined Adeno-Associated Virus and Nanoparticle Delivery of piggyBac Transposon System for Durable Transgene Expression in the Growing Neonatal Murine Liver https://poseida.com/wp-content/uploads/2021/05/ASGCT-2021-In-vivo-gene-therapy-JJ_FINAL.pdf

In a preclinical study, Poseida evaluated concomitant delivery of recombinant adeno-associated virus (rAAV) vectors and novel nanoparticle (NP) vectors using its piggyBac and "Super" piggyBac (SPB) technologies in order to deliver transposon and transposase in a growing neonatal mouse model. Data demonstrated that the piggyBac DNA Delivery System was effective in using both rAAV and NP vectors to introduce edited genes into targeted hepatocyte genomes. Poseida also found that SPB, a hyperactive form of the transposase, produced stable vector integration into the hepatocyte genome for more than three months, compared to transpose alone. Similarly, delivery of a novel NP formulation using SPB produced efficient delivery of mRNA to the liver hepatocytes, with similarly high levels of durability in the transgene expression. Taken together, these preclinical findings suggest the potential of piggyBac and SPB technology for gene therapies that treat congenital liver disease in infants and young children.

P-BCMA-ALL01: A Fully Allogeneic Stem Cell Memory T Cell (TSCM) CAR-T Therapy Targeting BCMA for the Treatment of Multiple Myeloma Shows Potent Anti-Tumor Activity https://poseida.com/wp-content/uploads/2021/05/ASGCT-2021-P-BCMA-ALLO1-Poster-Max-Richter.pdf

P-BCMA-ALLO1 is Poseida's first fully allogenic product candidate targeting B-cell maturation antigen (BCMA) for the treatment of relapsed/refractory multiple myeloma. In in vitro and in vivo preclinical studies, P-BCMA-ALL01 showed effective, targeted cancer cell killing and cytokine secretion, with similar or superior performance in anti-tumor efficacy compared to an autologous CAR-T therapy. Inclusion of a proprietary "booster molecule" in the allogeneic manufacturing process further improved expansion of gene-edited cells and enabled production of hundreds of patient doses from a single manufacturing run, thereby reducing the manufacturing cost per dose into the same range as that of a monoclonal antibody.

Anti-c-kit CAR-T Cells Afford Effective Eradication of Human AML and Normal Hematopoietic Cells in a Preclinical Model of Safer Non-Genotoxic Stem Cell Transplant Conditioning https://poseida.com/wp-content/uploads/2021/05/ASGCT-2021-Poster-Deck-cKit-Nina-Timberlake.pdf

Poseida is investigating its anti-c-kit CAR-T program, which leverages its proprietary piggyBac DNA Delivery System in preclinical studies as a potentially safer precursor conditioning therapy to the transplantation of hematopoietic stem cells (HSC) for patients suffering from AML. The piggyBac delivery vectors under investigation include a transposon that generates pure CAR+ product as well as a safety switch that allows rapid clearance of the reactive CAR-T cells prior to donor transplant of hematopoietic stem cells. Preclinical data to be presented in the poster showed that the lead CAR-T cells that express the anti-c-kit binder (CAR 1) deplete up to 92% of human CD34+ stem and progenitor cells in bone marrow within 48 hours. Additionally, an enhanced anti-c-kit CAR-T product, CAR 2, killed an estimated >99% of leukemia cells, exceeding the killing ability of a single dose of 30 mg/kg dose of busulfan. These encouraging data suggest that stem cell-directed CAR-T cells may be a safer preconditioning regimen compared to the current standard of care and may expand access to treatment for acute myeloid leukemia patients needing HSC transplant.
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jondoeuk jondoeuk 3 years ago
Slides https://investors.poseida.com/static-files/49ba1622-3013-4ac5-90dd-58119c2ed2cd
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jondoeuk jondoeuk 3 years ago
R&D Day https://wsw.com/webcast/cc/pstx/1409274
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jondoeuk jondoeuk 4 years ago
ASH slides https://poseida.gcs-web.com/static-files/cfd40f97-eac8-4226-8a2c-f4ea58207ab9
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jondoeuk jondoeuk 4 years ago
ASH abstract https://ash.confex.com/ash/2020/webprogram/Paper142695.html
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jondoeuk jondoeuk 4 years ago
Data from TScan https://www.cell.com/immunity/fulltext/S1074-7613(20)30447-7
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jondoeuk jondoeuk 4 years ago
The company and TScan Therapeutics have entered into a research collaboration and license agreement to explore development of TCR-T cell therapies for the treatment of COVID-19.

The allo T-cell platform will be used in combination with TScan's immunodominant epitopes and TCR sequences for the development and commercialisation of TCR-T cell therapies.
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jondoeuk jondoeuk 4 years ago
SITC

Just one entitled: P-MUC1C-ALLO1: An Allogeneic CAR-T for Multiple Solid Tumor Indications
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jondoeuk jondoeuk 4 years ago
Yes, I am. My position was reduced after the FDA hold on PSMA-101, but I will wait for the updated data at ASH from BCMA-101. This could inform the potentially registrational PhII trial (including a possible outpatient cohort). Also, work on a number of improvements is ongoing (see my second post).
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Mr Krabs Mr Krabs 4 years ago
Hey are you still there I would like to know what you think about this company now
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jondoeuk jondoeuk 4 years ago
Slides https://investors.poseida.com/static-files/7bb33fc4-5c79-4c96-a849-8df23f70f4ce
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jondoeuk jondoeuk 4 years ago
The company will provide an initial presentation of certain manufacturing improvements and related clinical data for the expanded PhI P-BCMA-101 trial with a late breaking abstract by the CEO to be presented at the CAR-TCR Digital Week virtual meeting on Sept 16.
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