cheynew
2 years ago
VBI Vaccines Receives U.S. FDA Orphan Drug Designation for VBI-1901 for the Treatment of Glioblastoma
June 22 2022 - 08:00AM
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- FDA Orphan Drug Designation reflects urgent need for new therapies for glioblastoma (GBM) patients
- Next steps for development of VBI-1901 :
Q3 2022: Expected initiation of randomized, controlled clinical study in recurrent GBM patients with potential to support accelerated approval application
Q4 2022: Expected initiation of randomized, controlled evaluation in primary GBM patients as part of INSIGhT adaptive platform trial
VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for VBI-1901, a bivalent gB/pp65 immunotherapeutic vaccine candidate for the treatment of glioblastoma (GBM). In June 2021, the FDA also granted Fast Track Designation for VBI-1901 for the treatment of recurrent GBM in patients with first tumor recurrence.
“This orphan drug designation is another significant milestone for our VBI-1901 program, and it underscores the urgency of our effort to develop meaningful new treatment options for patients with this devastating cancer,” said Jeff Baxter, President and CEO of VBI. “As recently presented at ASCO, we continue to see strong tumor response data and improvements in overall survival data compared to historical controls in the Phase 2a study of VBI-1901. With this orphan drug status, we look forward to working closely with the FDA and clinical investigators to build on that data, advancing the potential of this program to be a valuable part of the fight against GBM.”
Though classified as a rare disease, GBM is the most common primary brain cancer with approximately 14,000 new cases diagnosed in the United States each year, and a low median overall survival of 15-18 months after diagnosis of primary GBM.1 Glioblastomas are stage IV brain tumors – they are an exceptionally aggressive form of brain cancer, with high recurrence rates and a five-year survival rate around 10%.2 Standard of care in the frontline setting includes surgical resection, chemotherapy, and radiation therapy. There is no effective standard of care in the recurrent setting – median overall survival in this patient population is approximately eight months.3
About FDA Orphan Drug Designation
The FDA’s Office of Orphan Products Development grants orphan drug designation to investigational drugs and biologics intended to prevent, diagnose, or treat rare medical diseases or conditions that affect fewer than 200,000 people in the United States. Orphan drug status provides benefits to drug developers, including assistance in the drug development process, tax credits for qualified clinical trials, exemptions from certain FDA fees, and the potential for seven years of post-approval marketing exclusivity.
About FDA Fast Track Designation
The Fast Track program facilitates the expedited development and review of new drugs or biologics that are intended to: 1) treat serious or life-threatening conditions, and 2) demonstrate the potential to address unmet medical needs. A therapeutic that receives Fast Track Designation is eligible for some or all of the following: 1) more frequent meetings with FDA to discuss the development plan and data needed to support approval, 2) more frequent written communication from FDA relating to the design of the proposed clinical trials and use of biomarkers, 3) Accelerated Approval and Priority Review, if relevant criteria are met, and 4) Rolling Review, which means the company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, instead of waiting until all sections of the application are completed.
Fast Track Designation was granted to VBI-1901, adjuvanted with granulocyte macrophage colony-stimulating factor (GM-CSF), for the treatment of first-recurrent GBM in June 2021.
About VBI-1901 and GBM
VBI-1901 is a novel cancer vaccine immunotherapeutic candidate developed using VBI’s enveloped virus-like particle (eVLP) technology to target two highly immunogenic cytomegalovirus (CMV) antigens, gB and pp65. Scientific literature suggests CMV infection is prevalent in multiple solid tumors, including glioblastoma (GBM). GBM is among the most common and aggressive malignant primary brain tumors in humans. In the U.S. alone, 14,000 new cases are diagnosed each year. The current standard of care for treating GBM is surgical resection, followed by radiation and chemotherapy. Even with aggressive treatment, GBM progresses rapidly and has a high mortality.
To learn more about VBI’s ongoing Phase 1/2a study and the INSIGhT trial, visit clinicaltrials.gov (Respective Identifiers: NCT03382977 and NCT02977780).
About VBI Vaccines Inc.
VBI Vaccines Inc. (“VBI”) is a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease. Through its innovative approach to virus-like particles (“VLPs”), including a proprietary enveloped VLP (“eVLP”) platform technology, VBI develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system. VBI is committed to targeting and overcoming significant infectious diseases, including hepatitis B, coronaviruses, and cytomegalovirus (CMV), as well as aggressive cancers including glioblastoma (GBM). VBI is headquartered in Cambridge, Massachusetts, with research operations in Ottawa, Canada, and a research and manufacturing site in Rehovot, Israel.
For more information, visit www.vbivaccines.com.
Cautionary Statement on Forward-looking Information
Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are forward-looking information within the meaning of Canadian securities laws (collectively, “forward-looking statements”). The Company cautions that such statements involve risks and uncertainties that may materially affect the Company’s results of operations. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including but not limited to, the impact of general economic, industry or political conditions in the United States or internationally; the impact of the ongoing COVID-19 pandemic on our clinical studies, manufacturing, business plan, and the global economy; the ability to successfully manufacture and commercialize PreHevbrio; the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of pipeline candidates and the commercialization of PreHevbrio; the ability to obtain appropriate or necessary regulatory approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the Company’s ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to the Company’s products. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Company’s filings with the SEC and the Canadian securities authorities, including its Annual Report on Form 10-K filed with the SEC on March 7, 2022, and filed with the Canadian security authorities at sedar.com on March 7, 2022, as may be supplemented or amended by the Company’s Quarterly Reports on Form 10-Q. Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement. All such forward-looking statements made herein are based on our current expectations and we undertake no duty or obligation to update or revise any forward-looking statements for any reason, except as required by law.
References
1. National Cancer Institute. Glioblastoma – Unraveling the Threads: A Q&A with Drs. Mark Gilbert and Terri Armstrong of the NIH Neuro-Oncology Branch. August 2017. https://www.cancer.gov/news-events/cancer-currents-blog/2017/glioblastoma-research-making-progress
2. The University of Texas MD Anderson Cancer Center. Glioblastoma. Accessed June 2022. https://www.mdanderson.org/cancer-types/glioblastoma.html
3. Taal W, Oosterkamp HM, Walenkamp AME, et al. Single-agent bevacizumab or lomustine versus a combination of bevacizumab plus lomustine in patients with recurrent glioblastoma (BELOB trial): a randomized controlled phase 2 trial. Lancet Oncol. 2014; 15: 943-953
View source version on businesswire.com: https://www.businesswire.com/news/home/20220622005240/en/
VBI
Nicole Anderson
Director, Corporate Communications & IR
Phone: (617) 830-3031 x124
Email: IR@vbivaccines.com
cheynew
2 years ago
VBI Vaccines Presents Updated Phase 2a Tumor Response and Overall Survival Data for VBI-1901 in Recurrent GBM at the 2022 ASCO Annual Meeting
June 06 2022 - 08:00AM
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- Median overall survival and 18-month overall survival data continue to show improvements over historical controls1
- One patient remains on protocol progression-free beyond two years, with a sustained 93% tumor reduction relative to baseline
- Next steps :
Recurrent GBM: randomized, controlled evaluation with potential to support accelerated approval application expected to initiate in Q3 2022
Primary GBM: randomized, controlled evaluation in the frontline setting expected to initiate in Q4 2022 as part of INSIGhT adaptive platform trial
VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that new tumor response and overall survival (OS) data from the ongoing Phase 2a study of VBI-1901, the Company’s cancer vaccine immunotherapeutic candidate, in recurrent glioblastoma (GBM) was presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting on June 5. The expanded Phase 2a data were selected for presentation in both a poster session and a poster discussion session.
“We continue to be motivated by the data seen in this Phase 2a study of VBI-1901 as we endeavor to provide new treatment options to patients with very few available to them,” said David E. Anderson, Ph.D., VBI’s Chief Scientific Officer. “Considering the high mortality rate among GBM patients, particularly in the recurrent setting, median overall survival of approximately 13-15 months seen in our two study arms suggests an additional survival benefit of nearly six months in comparison with historical control data in the recurrent population after treatment with a monotherapy.1 Moreover, the correlation of tumor responses and clinical response benefit observed in tandem is very encouraging. We remain in close discussion with our study investigators and scientific advisors as we move toward the next stages of development in both the recurrent and frontline GBM settings, and look forward to advancing this development program as diligently as possible.”
Key results from the ASCO poster presentation:
Data were collected as of May 9, 2022
VBI-1901 + GM-CSF Study Arm – High Dose Part A + Part B (n=16)
Two (2) partial tumor responses and five (5) stable disease seen across Part A and Part B
18-month overall survival (OS) of 25% (n=4/16)
Median OS (mOS) reached at 12.9 months, comparing favorably to 8-month mOS for standard-of-care1
One patient remains on protocol beyond two years, with a 93% tumor reduction relative to initiation of treatment at the beginning of the study – this reduction has been sustained for over 6 months
VBI-1901 + GSK’s AS01B Adjuvant System2 (n=10)
Five (5) stable disease observed
18-month overall survival (OS) of 40% (n=4/10)
Achieved mOS of 14.6 months, comparing favorably to 8-month mOS for standard-of-care1
With few effective treatment options available for recurrent GBM patients, historical control data have demonstrated OS to be ~60% at 6-months and ~30% at 12-months after treatment with a monotherapy.1
This dataset continues to build upon data first shared at ASCO 2021, which resulted in Fast Track Designation granted by the U.S. Food and Drug Administration (FDA) in June 2021, and then updated at the World Vaccine & Immunotherapy Congress in December 2021.
Next Steps for VBI-1901
Based on the data seen to date in the Phase 1/2a study in recurrent GBM patients, VBI expects to assess VBI-1901 in randomized, controlled clinical studies in both primary and recurrent GBM patients in the next phase of development:
Q3 2022: Expected initiation of next phase of development in recurrent GBM setting, aiming to expand the number of patients in the ongoing Phase 1/2a study and adding a control arm, with the potential for accelerated approval based on tumor response rates and improvement in overall survival
Q4 2022: Evaluation of VBI-1901 in the primary GBM setting expected to initiate as part of the Individualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT), a Phase 2 adaptive platform trial
To learn more about VBI’s ongoing Phase 1/2a study and the INSIGhT trial, visit clinicaltrials.gov (Respective Identifiers: NCT03382977 and NCT02977780).
About Fast Track Designation
The Fast Track program facilitates the expedited development and review of new drugs or biologics that are intended to: 1) treat serious or life-threatening conditions, and 2) demonstrate the potential to address unmet medical needs. A therapeutic that receives Fast Track Designation is eligible for some or all of the following: 1) more frequent meetings with FDA to discuss the development plan and data needed to support approval, 2) more frequent written communication from FDA relating to the design of the proposed clinical trials and use of biomarkers, 3) Accelerated Approval and Priority Review, if relevant criteria are met, and 4) Rolling Review, which means the company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, instead of waiting until all sections of the application are completed.
Fast Track Designation was granted to VBI-1901, adjuvanted with granulocyte macrophage colony-stimulating factor (GM-CSF), for the treatment of first-recurrent GBM.
About VBI-1901 and GBM
VBI-1901 is a novel cancer vaccine immunotherapeutic candidate developed using VBI’s enveloped virus-like particle (eVLP) technology to target two highly immunogenic cytomegalovirus (CMV) antigens, gB and pp65. Scientific literature suggests CMV infection is prevalent in multiple solid tumors, including glioblastoma (GBM). GBM is among the most common and aggressive malignant primary brain tumors in humans. In the U.S. alone, 12,000 new cases are diagnosed each year. The current standard of care for treating GBM is surgical resection, followed by radiation and chemotherapy. Even with aggressive treatment, GBM progresses rapidly and has a high mortality.
About VBI Vaccines Inc.
VBI Vaccines Inc. (“VBI”) is a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease. Through its innovative approach to virus-like particles (“VLPs”), including a proprietary enveloped VLP (“eVLP”) platform technology, VBI develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system. VBI is committed to targeting and overcoming significant infectious diseases, including hepatitis B, coronaviruses, and cytomegalovirus (CMV), as well as aggressive cancers including glioblastoma (GBM). VBI is headquartered in Cambridge, Massachusetts, with research operations in Ottawa, Canada, and a research and manufacturing site in Rehovot, Israel.
For more information, visit www.vbivaccines.com.
Cautionary Statement on Forward-looking Information
Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are forward-looking information within the meaning of Canadian securities laws (collectively, “forward-looking statements”). The Company cautions that such statements involve risks and uncertainties that may materially affect the Company’s results of operations. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including but not limited to, the impact of general economic, industry or political conditions in the United States or internationally; the impact of the ongoing COVID-19 pandemic on our clinical studies, manufacturing, business plan, and the global economy; the ability to successfully manufacture and commercialize PreHevbrio/PreHevbri; the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of pipeline candidates and the commercialization of PreHevbrio/PreHevbri; the ability to obtain appropriate or necessary regulatory approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the Company’s ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to the Company’s products. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Company’s filings with the SEC and the Canadian securities authorities, including its Annual Report on Form 10-K filed with the SEC on March 7, 2022, and filed with the Canadian security authorities at sedar.com on March 7, 2022, as may be supplemented or amended by the Company’s Quarterly Reports on Form 10-Q. Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement. All such forward-looking statements made herein are based on our current expectations and we undertake no duty or obligation to update or revise any forward-looking statements for any reason, except as required by law.
References
1. Taal W, Oosterkamp HM, Walenkamp AME, et al. Single-agent bevacizumab or lomustine versus a combination of bevacizumab plus lomustine in patients with recurrent glioblastoma (BELOB trial): a randomized controlled phase 2 trial. Lancet Oncol. 2014; 15: 943-953
2. GlaxoSmithKline Biologicals SA provided AS01B adjuvant used in this study
View source version on businesswire.com: https://www.businesswire.com/news/home/20220606005316/en/
VBI Contact
Nicole Anderson
Director, Corporate Communications & IR
Phone: (617) 830-3031 x124
Email: IR@vbivaccines.com
cheynew
2 years ago
VBI VACCINES ANNOUNCES UK MHRA MARKETING AUTHORISATION FOR PREHEVBRI(TM), A 3-ANTIGEN ADULT HEPATITIS B VACCINE
PreHevbri™ is the only approved 3-antigen hepatitis B vaccine for adults in the United Kingdom
Approval follows the European Commission’s marketing authorisation, granted in April 2022
VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorisation for PreHevbri™ [Hepatitis B vaccine (recombinant, adsorbed)] for active immunisation against infection caused by all known subtypes of the hepatitis B virus (HBV) in adults. It can be expected that hepatitis D will also be prevented by immunisation with PreHevbri as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.
UK marketing authorisation follows the European Commission’s (EC) centralized marketing authorisation received in April 2022, and was conducted as part of the EC Decision Reliance Procedure (ECDRP). VBI expects to make PreHevbri available in the UK in early 2023.
“We are pleased to announce this latest regulatory approval of PreHevbri, our third in the span of six months, and another significant milestone in our efforts to broaden access to our differentiated 3-antigen vaccine,” said Jeff Baxter, VBI’s President and CEO. “Based upon the safety and immunogenicity profiles observed in the PROTECT and CONSTANT pivotal Phase 3 studies, data from which built the foundation of our FDA, EMA, and now UK MHRA approvals, we continue to believe PreHevbri will be a meaningful new intervention in the fight against hepatitis B.”
About Hepatitis B
Hepatitis B is one of the world’s most significant infectious disease threats with more than 290 million people infected globally. HBV infection is the leading cause of liver disease and, with current treatments, it is very difficult to cure, with many patients going on to develop liver cancers. An estimated 900,000 people die each year from complications of chronic HBV such as liver decompensation, cirrhosis, and hepatocellular carcinoma.
About PreHevbri™
VBI’s hepatitis B vaccine is the only 3-antigen hepatitis B vaccine, comprised of the three hepatitis B surface antigens of the hepatitis B virus – S, pre-S1, and pre-S2. It is approved for use in the European Union/European Economic Area, the United Kingdom, the United States, and Israel. The brand names for this vaccine are: PreHevbri™ (EU/EEA/UK), PreHevbrio™ (US), and Sci-B-Vac® (Israel).
Full European Summary of Product Characteristics for PreHevbri are available from the EMA website at www.ema.europa.eu and from the UK MHRA’s website at products.mhra.gov.uk .
Please visit www.PreHevbrio.com for U.S. Important Safety Information for PreHevbrio™ [Hepatitis B Vaccine (Recombinant)], or please see U.S. Full Prescribing Information .
About VBI Vaccines Inc.
VBI Vaccines Inc. (“VBI”) is a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease. Through its innovative approach to virus-like particles (“VLPs”), including a proprietary enveloped VLP (“eVLP”) platform technology, VBI develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system. VBI is committed to targeting and overcoming significant infectious diseases, including hepatitis B, coronaviruses, and cytomegalovirus (CMV), as well as aggressive cancers including glioblastoma (GBM). VBI is headquartered in Cambridge, Massachusetts, with research operations in Ottawa, Canada, and a research and manufacturing site in Rehovot, Israel. For more information, visit www.vbivaccines.com .
Cautionary Statement on Forward-looking Information
Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are forward-looking information within the meaning of Canadian securities laws (collectively, “forward-looking statements”). The Company cautions that such statements involve risks and uncertainties that may materially affect the Company’s results of operations. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including but not limited to, the impact of general economic, industry or political conditions in the United States or internationally; the impact of the ongoing COVID-19 pandemic on our clinical studies, manufacturing, business plan, and the global economy; the ability to successfully manufacture and commercialize PreHevbrio/PreHevbri; the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of pipeline candidates and the commercialization of PreHevbrio/PreHevbri; the ability to obtain appropriate or necessary regulatory approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the Company’s ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to the Company’s products. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Company’s filings with the SEC and the Canadian securities authorities, including its Annual Report on Form 10-K filed with the SEC on March 7, 2022, and filed with the Canadian security authorities at sedar.com on March 7, 2022, as may be supplemented or amended by the Company’s Quarterly Reports on Form 10-Q. Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement. All such forward-looking statements made herein are based on our current expectations and we undertake no duty or obligation to update or revise any forward-looking statements for any reason, except as required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220601005331/en/
VBI Contact
Nicole Anderson
Director, Corporate Communications & IR
Phone: (617) 830-3031 x124
Email: IR@vbivaccines.com
cheynew
2 years ago
VBI Vaccines Offers Updated Clinical, Preclinical Data From Its Coronavirus Program, VBI-2900
Mentioned: VBIV
- New Phase 1b clinical data of VBI-2905 (monovalent, Beta) demonstrated a well-tolerated safety profile and an encouraging ability to boost and broaden the immune response against the Beta variant- New preclinical data demonstrated VBI-2901 (trivalent, pan-coronavirus) induced antibody titers that were even higher than VBI-2902 (monovalent, ancestral) against a broad panel of variants, including Omicron and a bat coronavirus which has not yet made the jump to humans- New data continues to strengthen potential of the eVLP platform against coronaviruses- First clinical study of VBI-2901 expected to initiate summer 2022
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- VBI Vaccines Inc. (NASDAQ:VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced updated clinical and preclinical data from its coronavirus program, VBI-2900.
VBI-2900 consists of three candidates derived from the Company's proprietary enveloped virus-like particle (eVLP) technology platform, including:
VBI-2902: A monovalent candidate directed against the ancestral/Wuhan SARS-CoV-2 strain
VBI-2905: A monovalent candidate directed against the Beta SARS-CoV-2 variant
VBI-2901: A trivalent, pan-coronavirus candidate targeting SARS-CoV-2 (COVID-19), SARS-CoV (SARS), and MERS-CoV (MERS)
Jeff Baxter, President and CEO of VBI, said: 'These new data continue to strengthen the potential of eVLP candidates against coronaviruses. The magnitude of antibody boosting against the Beta variant in the Phase 1b study of VBI-2905 was greater than expected. After one dose, this candidate was able to broaden robust immunity to the Beta variant, in addition to the ancestral strain (against which participants were previously vaccinated), thus overcoming the potential for â??original antigenic sin.' Moreover, we are excited by the preclinical data we have continued to generate with VBI-2901. We have long believed that in order to ensure long-term protection against known and unknown coronavirus variants, we must cease chasing variants and instead develop vaccines that can provide a broader foundation of immunity. We believe VBI-2901 has enormous potential and we look forward to initiating our first-in-human clinical study of VBI-2901 expected this summer.'
Dr. Melanie Saville, Executive Director of Vaccine R&D, CEPI, said: 'Over the last two years, we have seen the persistent evolution of SARS-CoV-2. To stay one-step ahead of SARS-CoV-2 variants and other deadly coronaviruses, the world must invest in multivalent, broadly protective coronavirus vaccine technologiesâ??like the eVLP technology being advanced by VBI. These data represent an important first step in the evaluation of this technology and toward developing an effective vaccine platform against variants of concern and other coronavirus threats.'
The new clinical and preclinical data for all three candidates have continued to support the robust potential of the eVLP platform, with candidates that have been able to elicit broad immune responses against coronaviruses. These new data demonstrate:
Safety:
In clinical studies, VBI-2902 and VBI-2905 were well-tolerated with no safety signals observed.
VBI-2902 and VBI-2905 were evaluated at a low dose of 5µg and both are adjuvanted with aluminum phosphate, a well-known adjuvant with decades of safety data from multiple FDA-approved vaccines.
Breadth of Immunogenicity:
In the Phase 1b study (n=53), a single-dose booster of VBI-2905 increased the geometric mean titer (GMT) of neutralizing antibodies directed against the Beta variant 3.8-fold, at day 28, in participants who had previously received two-doses of an mRNA vaccine (ancestral strain) â?? approximately 2-fold increases were also seen at day 28 in antibody GMTs against both the ancestral and delta variant.
Against a panel of coronavirus variants in mice, reactivity was seen with VBI-2902 against all variants including the ancestral strain, Delta, Beta, Omicron, Lambda, and RaTG13 (a bat coronavirus that is distant to circulating human strains).
In this same panel, VBI-2901 was able to elicit an even stronger response against all variants tested â?? as the strains became more divergent from the ancestral strain, VBI-2901 elicited a greater difference in GMT from VBI-2902, ranging from 2.5-fold higher against the ancestral strain to 9.0-fold higher against the bat coronavirus.
A validated pseudoparticle neutralization assay (PNA) benchmarked against the WHO reference standard demonstrated that VBI-2902 elicited neutralizing antibody responses of 176 IU50/mL in its Phase 1a study â?? this international standard measure would predict a greater than 90% efficacy, with two internationally approved vaccines estimated to have 90% efficacy at 83 and 140 IU50/mL (Gilbert, PB, 2021).
The VBI-2900 program is supported by:
A partnership with CEPI, with a contribution of up to $33 million
A partnership with the Government of Canada through its Strategic Innovation Fund, with an award of up to CAD $56 million, which was recently extended through the end of 2023
Contribution of up to CAD $1 million from a collaboration with the National Research Council of Canada (NRC)
© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserved
cheynew
2 years ago
Item 1.01 Entry into a Material Definitive Agreement.
As previously disclosed, on September 16, 2020, VBI Vaccines Inc. (the “Company”), as guarantor, and Variation Biotechnologies Inc., a Canadian federal corporation and a wholly-owned subsidiary of the Company (“Variation”), as the recipient, entered into a Contribution Agreement (the “Agreement”) with Her Majesty The Queen in Right of Canada, as represented by the Minister of Industry (the “Minister”), pursuant to which Variation is obligated to develop a novel, broadly reactive coronavirus vaccine against SARS-COV2 (“COVID-19”), Middle East Respiratory Syndrome and Severe Acute Respiratory Syndrome, and/or a monovalent vaccine targeting only COVID-19 through Phase 2 studies (such undertaking, the “Project”). Pursuant to the Agreement, the Company agreed to complete the Project in or before the first quarter of 2022 (the “Project Completion Date”), which will be conducted exclusively in Canada, except as permitted otherwise under certain circumstances.
On March 28, 2022, the Company and the Minister signed an amendment (the “Amendment”) to the Agreement, the main purpose of which was to extend the collaboration and move the Project Completion Date from March 31, 2022 to December 31, 2023.
cheynew
2 years ago
14a ET 3/29/2022 - Benzinga
VBI Vaccines Announces PreHevbrio Is Now Available In The United States For The Prevention Of Hepatitis B In Adults
Mentioned: VBIV
- PreHevbrioâ?¢ [Hepatitis B Vaccine (Recombinant)] is the only approved 3-antigen hepatitis B vaccine for adults in the U.S.
- FDA approval of PreHevbrio received in November 2021
- PreHevbrio added to ACIP list of recommended adult HBV vaccines in February 2022
- Wholesale Acquisition Cost (WAC) set at $64.75/dose
VBI Vaccines Inc. (NASDAQ:VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that PreHevbrioâ?¢ [Hepatitis B Vaccine (Recombinant)] is now available in the United States for the prevention of infection caused by all known subtypes of hepatitis B virus (HBV) in adults age 18 years and older. PreHevbrio was approved by the U.S. Food and Drug Administration (FDA) on November 30, 2021, and is the only approved 3-antigen HBV vaccine for adults.
"We are proud to announce the U.S. availability of PreHevbrio, a significant milestone in our effort to be part of the fight against hepatitis B," said Jeff Baxter, VBI's President and CEO. "This launch coincides with the swell of momentum following the ACIP's November 2021 unanimous vote to move to a universal HBV vaccination recommendation for all adults age 19-59, and its February 2022 decision to include PreHevbrio in its list of recommended adult HBV vaccines. With new guidelines and new tools, U.S. healthcare providers have more support than ever to increase vaccination rates and protect more of their adult patients against HBV."
VBI is working with a network of wholesalers, distributors, group purchasing organizations, and federal accounts to enable broad access to PreHevbrio, and the Company expects to further build out this network in the coming weeks. The Wholesale Acquisition Cost (WAC) for PreHevbrio has been set at $64.75 per dose. For information on the list of current distributors, please request to speak with a VBI Vaccine Specialist (at www.prehevbrio.com) or email distribution-us@vbivaccines.com.
In July 2021, the American Medical Association established a unique Current Procedural Terminology (CPT) code for a 3-antigen (S, Pre-S1, Pre-S2) Hepatitis B (HBV) vaccine. This is the code PreHevbrio will be reported under and it differentiates PreHevbrio from other approved single-antigen HBV vaccines. Many insurance plans and institutions also require recommendation from the Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) in order to provide reimbursement coverage. Following the February 2022 ACIP meeting, PreHevbrio was added to the list of ACIP-recommended products for prophylactic adult vaccination against HBV infection without the need for a formal vote. Additionally, VBI, in partnership with Syneos Health, has now deployed a field team of nearly 80 individuals devoted to PreHevbrio, including more than 50 vaccine sales specialists.
© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserved
cheynew
2 years ago
VBI Vaccines Receives Positive CHMP Opinion for 3-Antigen Hepatitis B Vaccine for Immunization Against Hepatitis B Infection in Adults in the European Union
February 25 2022 - 08:30AM
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- Following positive CHMP recommendation, final EMA regulatory decision expected in coming months
- European Union (EU) brand name to be PreHevbri™
- If approved, PreHevbri will be the only approved 3-antigen hepatitis B vaccine for adults in the E.U.
VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human use (CHMP) has adopted a positive opinion for VBI’s 3-antigen hepatitis B (HBV) vaccine, under the brand name PreHevbri™ [Hepatitis B vaccine (recombinant, adsorbed)]. The CHMP recommends PreHevbri for active immunization against infection caused by all known subtypes of the hepatitis B virus in adults.
“The positive CHMP opinion for PreHevbri underscores its potential to be a meaningful option for healthcare providers as they help protect their patients against hepatitis B,” said Jeff Baxter, VBI’s President & CEO. “Hepatitis B remains a persistent public health problem in Europe and this milestone is a meaningful advancement in our efforts to be part of the solution.”
The European Commission (EC) will review the CHMP recommendation and a final decision on the Marketing Authorization Application (MAA) for PreHevbri in the EU is expected in the coming months. At this time, PreHevbri has not been approved for commercial use in the EU. If approved by the EC, the centralized marketing authorization would be valid in all EU Member States as well as in the European Economic Area (EEA) countries – Iceland, Liechtenstein, and Norway. In the United Kingdom (UK), the MAA for VBI’s 3-antigen HBV vaccine is expected to be reviewed as part of the EC Decision Reliance Procedure (ECDRP), the process for which is now being initiated upon receipt of positive CHMP opinion.
The CHMP’s positive opinion was supported by data from the two pivotal, randomized, double-blind, controlled Phase 3 studies – PROTECT and CONSTANT – as well as other relevant data.
About Hepatitis B
Hepatitis B is one of the world’s most significant infectious disease threats with more than 290 million people infected globally. HBV infection is the leading cause of liver disease and, with current treatments, it is very difficult to cure, with many patients going on to develop liver cancers. An estimated 900,000 people die each year from complications of chronic HBV such as liver decompensation, cirrhosis, and hepatocellular carcinoma.
About PreHevbri™
VBI’s hepatitis B vaccine is the only 3-antigen hepatitis B vaccine, comprised of the S, pre-S1, and pre-S2 surface antigens of the hepatitis B virus. It is approved for use in the United States and in Israel, and regulatory submissions are still under review in Europe and in Canada. The brand names for this vaccine are: PreHevbrio™ (U.S.), PreHevbri™ (European Union), and Sci-B-Vac® (Israel).
U.S. Indication and Use
PreHevbrio is indicated for prevention of infection caused by all known subtypes of hepatitis B virus. PreHevbrio is approved for use in adults 18 years of age and older.
U.S. Important Safety Information (ISI)
Do not administer PreHevbrio to individuals with a history of severe allergic reaction (e.g. anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of PreHevbrio.
Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of PreHevbrio.
Immunocompromised persons, including those on immunosuppressant therapy, may have a diminished immune response to PreHevbrio.
PreHevbrio may not prevent hepatitis B infection, which has a long incubation period, in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration.
The most common side effects (> 10%) in adults age 18-44, adults age 45-64, and adults age 65+ were pain and tenderness at the injection site, myalgia, fatigue, and headache.
There is a pregnancy exposure registry that monitors pregnancy outcomes in women who received PreHevbrio during pregnancy. Women who receive PreHevbrio during pregnancy are encouraged to contact 1-888-421-8808 (toll-free).
To report SUSPECTED ADVERSE REACTIONS, contact VBI Vaccines at 1-888-421-8808 (toll-free) or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.
Please see Full Prescribing Information.
About VBI Vaccines Inc.
VBI Vaccines Inc. (“VBI”) is a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease. Through its innovative approach to virus-like particles (“VLPs”), including a proprietary enveloped VLP (“eVLP”) platform technology, VBI develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system. VBI is committed to targeting and overcoming significant infectious diseases, including hepatitis B, coronaviruses, and cytomegalovirus (CMV), as well as aggressive cancers including glioblastoma (GBM). VBI is headquartered in Cambridge, Massachusetts, with research operations in Ottawa, Canada, and a research and manufacturing site in Rehovot, Israel.
Website Home: http://www.vbivaccines.com/
News and Resources: http://www.vbivaccines.com/news-and-resources/
Investors: http://www.vbivaccines.com/investors/
Cautionary Statement on Forward-looking Information
Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are forward-looking information within the meaning of Canadian securities laws (collectively, “forward-looking statements”). The Company cautions that such statements involve risks and uncertainties that may materially affect the Company’s results of operations. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including but not limited to, the impact of general economic, industry or political conditions in the United States or internationally; the impact of the ongoing COVID-19 pandemic on our clinical studies, manufacturing, business plan, and the global economy; the ability to successfully manufacture and commercialize PreHevbrio; the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of pipeline candidates and the commercialization of PreHevbrio; the ability to obtain appropriate or necessary regulatory approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the Company’s ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to the Company’s products. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Company’s filings with the SEC and the Canadian securities authorities, including its Annual Report on Form 10-K filed with the SEC on March 2, 2021, and filed with the Canadian security authorities at sedar.com on March 2, 2021, as may be supplemented or amended by the Company’s Quarterly Reports on Form 10-Q. Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement. All such forward-looking statements made herein are based on our current expectations and we undertake no duty or obligation to update or revise any forward-looking statements for any reason, except as required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220225005262/en/
VBI Contact
Nicole Anderson
Director, Corporate Communications & IR
Phone: (617) 830-3031 x124
Email: IR@vbivaccines.com
cheynew
2 years ago
VBI Vaccines Announces Dosing of First Patient in Second Phase 2 Study in Chronic Hepatitis B Patients as Part of Expansion of Clinical Collaboration With Brii Bio
January 05 2022 - 08:00AM
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- A second, two-part Phase 2a/2b study will assess the safety and efficacy of VBI-2601 (BRII-179) as an add-on therapy to standard-of-care treatment in chronic hepatitis B patients
- Partner, Brii Biosciences, recently initiated dosing in the newly announced trial, expected to enroll 600 patients in China
- Initial data from this new study expected in H1 2023
- Initial data from ongoing Phase 2 combination study of VBI-2601 (BRII-179) and BRII-835 (VIR-2218), initiated April 2021, expected H2 2022
VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that the first patient has been dosed in a second Phase 2a/2b clinical study evaluating VBI-2601 (BRII-179), an immunotherapeutic candidate targeting chronic hepatitis B virus (HBV). This newly announced Phase 2 study will assess VBI-2601 as an add-on therapy to the standard-of-care, nucleos(t)ide reverse transcriptase inhibitor (Nrtl) and pegylated interferon (PEG-IFN-a) therapy, which currently has a functional cure rate of approximately 9%1. A functional cure for chronic HBV infection is defined as achievement of undetectable HBV surface antigen (HBsAg) levels and sustained suppression of HBV DNA. As previously announced in April 2021, VBI-2601 is also being assessed in an additional Phase 2 study as part of a combination regimen with BRII-835 (VIR-2218), an investigational small interfering ribonucleic acid (siRNA) targeting HBV.
“Our commitment to the fight against hepatitis B includes a focus on both prevention and treatment of the disease,” said Jeff Baxter, VBI’s President and CEO. “More than 290 million people are chronically infected with HBV worldwide and, together with our partners, we are working hard to provide more patients with improved therapeutic options. This effort includes the assessment of new investigational treatment regimens, as in the ongoing combination study of VBI-2601 and an siRNA candidate, as well as ways to potentially improve upon functional cure rates achieved with the current standard of care, as with this newly announced Phase 2 study. We believe a multi-pronged approach is critical for driving innovation in the treatment of chronic HBV, and we look forward to sharing data from these two Phase 2 studies in the second half of 2022 and the first half of 2023, respectively.”
Brii Biosciences (Brii Bio) is the sponsor of this newly announced Phase 2a/2b study and, with the support of VBI, has led the design and implementation of this study as well as the ongoing Phase 2 combination study.
About the Phase 2a/2b Study
The Phase 2a/2b trial of VBI-2601 (BRII-179) is a double-blind, randomized, placebo-controlled, parallel-group study to evaluate the clinical effect of adding VBI-2601 (BRII-179) to existing PEG-IFN-a and Nrtl standard-of-care therapy in non-cirrhotic chronic HBV patients. Patients participating in the study have had partial responses to ongoing PEG-IFN-a and NrtI treatment.
Phase 2a:
Expected enrollment of 120 patients
Primary endpoint : The percentage of patients with HBsAg loss at completion of treatment
Phase 2b:
Expanded enrollment of 480 patients
Primary endpoint : The percentage of patients achieving a functional cure, defined as undetectable HBsAg and sustained suppression of HBV DNA
An independent Data and Safety Monitoring Board will monitor patient safety and efficacy data for this study.
About Hepatitis B
Hepatitis B is one of the world’s most significant infectious disease threats, with more than 290 million people infected globally. HBV infection is the leading cause of liver disease, and, with current treatments, it is very difficult to cure, and many patients go on to develop liver cancers. An estimated 780,000 people die each year from complications of chronic HBV, such as liver decompensation and hepatocellular carcinoma.
About VBI-2601 (BRII-179)
VBI-2601 (BRII-179) is a novel recombinant, protein-based HBV immunotherapeutic candidate designed to induce enhanced B-cell and T-cell immunity. VBI-2601 (BRII-179) builds upon the 3-antigen conformation of VBI Vaccines’ prophylactic HBV vaccine, which is approved in the U.S. under the name PreHevbrio™ [Hepatitis B Vaccine (Recombinant)]. Brii Bio licensed commercial rights to VBI-2601 (BRII-179) in China, Hong Kong, Macau, and Taiwan from VBI Vaccines in December of 2018.
In addition to the Phase 2a/2b trial, VBI-2601 (BRII-179) is currently being investigated in a Phase 2 combination study with BRII-835 (VIR-2218) as part of a potential functional cure regimen for the treatment of chronic HBV infection.
About VBI Vaccines Inc.
VBI Vaccines Inc. (“VBI”) is a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease. Through its innovative approach to virus-like particles (“VLPs”), including a proprietary enveloped VLP (“eVLP”) platform technology, VBI develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system. VBI is committed to targeting and overcoming significant infectious diseases, including hepatitis B, coronaviruses, and cytomegalovirus (CMV), as well as aggressive cancers including glioblastoma (GBM). VBI is headquartered in Cambridge, Massachusetts, with research operations in Ottawa, Canada, and a research and manufacturing site in Rehovot, Israel. For more information, visit www.vbivaccines.com.
1. Qiu K, Liu B, Li S-Y, et. al. Systematic review with meta-analysis: combination treatment of regimens based on pegylated interferon for chronic hepatitis B focusing on hepatitis B surface antigen clearance. Alimentary Pharmacology & Therapeutics 2018;47:1340-1348.
Cautionary Statement on Forward-looking Information
Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are forward-looking information within the meaning of Canadian securities laws (collectively, “forward-looking statements”). The Company cautions that such statements involve risks and uncertainties that may materially affect the Company’s results of operations. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including but not limited to, the impact of general economic, industry or political conditions in the United States or internationally; the impact of the ongoing COVID-19 pandemic on our clinical studies, manufacturing, business plan, and the global economy; the ability to successfully manufacture and commercialize PreHevbrio; the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of pipeline candidates and the commercialization of PreHevbrio; the ability to obtain appropriate or necessary regulatory approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the Company’s ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to the Company’s products. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Company’s filings with the SEC and the Canadian securities authorities, including its Annual Report on Form 10-K filed with the SEC on March 2, 2021, and filed with the Canadian security authorities at sedar.com on March 2, 2021, as may be supplemented or amended by the Company’s Quarterly Reports on Form 10-Q. Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement. All such forward-looking statements made herein are based on our current expectations and we undertake no duty or obligation to update or revise any forward-looking statements for any reason, except as required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220105005324/en/
VBI
Nicole Anderson
Director, Corporate Communications & IR
Phone: (617) 830-3031 x124
Email: IR@vbivaccines.com
Brii Bio
media@briibio.com
Summer Li (China)
+86-135-2191-1607
Ben Shannon (U.S.)
+1-919-360-3039
ir@briibio.com
Chris Fang
+86-139-1692-8049
cheynew
2 years ago
VBI Vaccines Announces Filing of New Drug Submission for 3-Antigen Hepatitis B Vaccine to Health Canada
CAMBRIDGE, Mass. (December 9, 2021) – VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced the filing of a New Drug Submission (NDS) to Health Canada for the Company’s 3-antigen prophylactic hepatitis B vaccine candidate, seeking approval in Canada for the prevention of infection caused by all known subtypes of the hepatitis B virus in adults.
“This regulatory filing for approval in Canada is another milestone in our effort to expand access to our 3-antigen HBV vaccine candidate in more countries,” said Jeff Baxter, VBI’s President & CEO. “We are committed to working collaboratively with Health Canada throughout their review of this submission, as we believe our vaccine candidate has the potential to be a meaningful new tool for healthcare providers in the fight against adult hepatitis B.”
About Hepatitis B
Hepatitis B is one of the world’s most significant infectious disease threats with more than 290 million people infected globally. HBV infection is the leading cause of liver disease and, with current treatments, it is very difficult to cure, with many patients going on to develop liver cancers. An estimated 900,000 people die each year from complications of chronic HBV such as liver decompensation, cirrhosis, and hepatocellular carcinoma.
About VBI’s 3-Antigen Hepatitis B Vaccine
VBI’s vaccine candidate is the only 3-antigen hepatitis B vaccine, comprised of the S, pre-S1, and pre-S2 surface antigens of the hepatitis B virus, and is approved for use in the United States under the name PreHevbrio™ [Hepatitis B Vaccine (Recombinant)], and in Israel under the name Sci-B-Vac®. This vaccine candidate is not yet approved in Canada or Europe, where the regulatory submissions are still under review. In December 2017, VBI initiated patient dosing in a global Phase 3 clinical program that consisted of two concurrent pivotal studies: PROTECT, a safety and immunogenicity study, and CONSTANT, a lot-to-lot consistency study. Data from both the PROTECT study and the CONSTANT study, which were announced in June 2019 and January 2020, respectively, comprised the basis for the regulatory submissions in the U.S., Europe, and Canada.
To learn more about VBI’s 3-Antigen Hepatitis B vaccine candidate visit: https://www.vbivaccines.com
About VBI Vaccines Inc.
VBI Vaccines Inc. (“VBI”) is a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease. Through its innovative approach to virus-like particles (“VLPs”), including a proprietary enveloped VLP (“eVLP”) platform technology, VBI develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system. VBI is committed to targeting and overcoming significant infectious diseases, including hepatitis B, coronaviruses, and cytomegalovirus (CMV), as well as aggressive cancers including glioblastoma (GBM). VBI is headquartered in Cambridge, Massachusetts, with research operations in Ottawa, Canada, and a research and manufacturing site in Rehovot, Israel.
Website Home: http://www.vbivaccines.com/
News and Resources: http://www.vbivaccines.com/news-and-resources/
Investors: http://www.vbivaccines.com/investors/
cheynew
2 years ago
Chief business officer bought some shares
https://ih.advfn.com/stock-market/NASDAQ/vbi-vaccines-VBIV/stock-news/86735641/statement-of-changes-in-beneficial-ownership-4
Statement of Changes in Beneficial Ownership (4)
December 06 2021 - 10:06AM
Edgar (US Regulatory)
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FORM 4 [ ] Check this box if no longer subject to Section 16. Form 4 or Form 5 obligations may continue. See Instruction 1(b).
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP OF SECURITIES
OMB APPROVAL
OMB Number: 3235-0287
Estimated average burden
hours per response... 0.5
Filed pursuant to Section 16(a) of the Securities Exchange Act of 1934 or Section 30(h) of the Investment Company Act of 1940
1. Name and Address of Reporting Person * Beattie Nell 2. Issuer Name and Ticker or Trading Symbol VBI Vaccines Inc/BC [ VBIV ] 5. Relationship of Reporting Person(s) to Issuer (Check all applicable)_____ Director _____ 10% Owner
__X__ Officer (give title below) _____ Other (specify below)
Chief Business Officer
(Last) (First) (Middle)
C/O VBI VACCINES INC.,, 160 SECOND STREET 3. Date of Earliest Transaction (MM/DD/YYYY)
12/3/2021
(Street)
CAMBRIDGE, MA 02142
(City) (State) (Zip)
4. If Amendment, Date Original Filed (MM/DD/YYYY)
6. Individual or Joint/Group Filing (Check Applicable Line) _X _ Form filed by One Reporting Person
___ Form filed by More than One Reporting Person
Table I - Non-Derivative Securities Acquired, Disposed of, or Beneficially Owned
1.Title of Security
(Instr. 3) 2. Trans. Date 2A. Deemed Execution Date, if any 3. Trans. Code
(Instr. 8) 4. Securities Acquired (A) or Disposed of (D)
(Instr. 3, 4 and 5) 5. Amount of Securities Beneficially Owned Following Reported Transaction(s)
(Instr. 3 and 4) 6. Ownership Form: Direct (D) or Indirect (I) (Instr. 4) 7. Nature of Indirect Beneficial Ownership (Instr. 4)
Code V Amount (A) or (D) Price
Common Shares, no par value per share 12/3/2021 P 8200 A $2.4492 (1) 68200 D
Table II - Derivative Securities Beneficially Owned (e.g., puts, calls, warrants, options, convertible securities)
1. Title of Derivate Security
(Instr. 3) 2. Conversion or Exercise Price of Derivative Security 3. Trans. Date 3A. Deemed Execution Date, if any 4. Trans. Code
(Instr. 8) 5. Number of Derivative Securities Acquired (A) or Disposed of (D)
(Instr. 3, 4 and 5) 6. Date Exercisable and Expiration Date 7. Title and Amount of Securities Underlying Derivative Security
(Instr. 3 and 4) 8. Price of Derivative Security
(Instr. 5) 9. Number of derivative Securities Beneficially Owned Following Reported Transaction(s) (Instr. 4) 10. Ownership Form of Derivative Security: Direct (D) or Indirect (I) (Instr. 4) 11. Nature of Indirect Beneficial Ownership (Instr. 4)
Code V (A) (D) Date Exercisable Expiration Date Title Amount or Number of Shares
Explanation of Responses:
(1) The price reported in Column 4 is a weighted average price. These shares were purchased in multiple transactions at prices ranging from $2.4492 to $2.455, inclusive. The reporting person undertakes to provide to VBI Vaccines Inc., any security holder of VBI Vaccines Inc., or the staff of the Securities and Exchange Commission, upon request, full information regarding the number of shares sold at each separate price within the ranges set forth in footnote (1) to this Form 4.
Reporting Owners
Reporting Owner Name / Address
Relationships
Director 10% Owner Officer Other
Beattie Nell
C/O VBI VACCINES INC.,
160 SECOND STREET
CAMBRIDGE, MA 02142
Chief Business Officer
Signatures
/s/ Nell Beattie 12/6/2021
**Signature of Reporting Person Date
cheynew
2 years ago
VBI Vaccines Announces FDA Approval of PreHevbrio™ for the Prevention of Hepatitis B in Adults
December 01 2021 - 07:30AM
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- PreHevbrio™ is the only approved 3-antigen hepatitis B vaccine for adults in the U.S.
- Shareholder conference call to be held today, December 1, at 8:30 AM ET
VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that the U.S. Food and Drug Administration (FDA) has approved PreHevbrio™ [Hepatitis B Vaccine (Recombinant)] for the prevention of infection caused by all known subtypes of hepatitis B virus (HBV) in adults age 18 years and older. PreHevbrio contains the S, pre-S2, and pre-S1 HBV surface antigens, and is the only approved 3-antigen HBV vaccine for adults in the U.S.
“As we work to implement the ACIP’s new universal hepatitis B vaccine recommendation for all adults ages 19-59, as voted on in November, we benefit from having more tools, including this newly approved 3-antigen hepatitis B vaccine,” said Chari Cohen, DrPH, MPH, Senior Vice President of the Hepatitis B Foundation. “Having more vaccine options will help us effectively expand vaccine uptake, ensure more people are protected from hepatitis B infection, and reach the 2030 goal of eliminating hepatitis B in the U.S.”
Jeff Baxter, VBI’s President and CEO, commented: “We are proud to announce the approval of PreHevbrio, VBI’s first FDA-approved vaccine. This is a substantial achievement that demonstrates the VBI team’s ability to progress vaccine candidates from the clinic through to approval. This approval, however, is just the first step in our mission to provide broad access to our vaccine and to help strengthen the public health effort to put an end to adult HBV infections. We would like to thank the study participants, clinical site investigators, our employees, and all who contributed to this achievement, and we look forward to working with public health and advocacy organizations as we join the fight against hepatitis B.”
The approval of PreHevbrio was based on the results from two Phase 3 clinical studies, PROTECT and CONSTANT, data from which were published, respectively, in The Lancet Infectious Diseases in May 2021 and The Journal of the American Medical Association Network Open in October 2021. The pivotal studies compared PreHevbrio to Engerix-B, a single-antigen HBV vaccine. Data from the PROTECT study showed that PreHevbrio elicited higher rates of seroprotection in all subjects age 18+ (91.4% vs. 76.5%), including in adults age 45+ (89.4% vs. 73.1%). The integrated safety analysis of both studies demonstrated good tolerability with no unexpected reactogenicity. The most common adverse events in all age groups were injection site pain and tenderness, myalgia, and fatigue, all which generally resolved without intervention in 1-2 days.
VBI expects to make PreHevbrio available in the U.S. in the first quarter of 2022, and has partnered with Syneos Health for the past two years to ensure commercial readiness.
Outside of the U.S., VBI continues to support the European Medicines Agency’s (EMA) ongoing review of the marketing authorization application for VBI’s 3-antigen HBV vaccine. VBI expects to complete regulatory submissions to the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) and to Health Canada in 2022.
Conference Call Details
VBI Vaccines will host a conference call on Wednesday, December 1 at 8:30 AM ET. The live call can be accessed via the Events/Presentations page in the Investors section of the Company’s website, or by clicking this link: https://viavid.webcasts.com/starthere.jsp?ei=1517423&tp_key=00a076a769.
A replay of the conference call will be archived on the Company’s website following the live call.
To listen to the live conference call, please dial:
- Toll-free U.S. & Canada Dial-In: 877-705-6003
- International Dial-In: 201-493-6725
- Conference ID: 13725342
Indication and Use
PreHevbrio is indicated for prevention of infection caused by all known subtypes of hepatitis B virus. PreHevbrio is approved for use in adults 18 years of age and older.
Important Safety Information (ISI)
Do not administer PreHevbrio to individuals with a history of severe allergic reaction (e.g. anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of PreHevbrio.
Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of PreHevbrio.
Immunocompromised persons, including those on immunosuppressant therapy, may have a diminished immune response to PreHevbrio.
PreHevbrio may not prevent hepatitis B infection, which has a long incubation period, in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration.
The most common side effects (> 10%) in adults age 18-44, adults age 45-64, and adults age 65+ were pain and tenderness at the injection site, myalgia, fatigue, and headache.
There is a pregnancy exposure registry that monitors pregnancy outcomes in women who received PreHevbrio during pregnancy. Women who receive PreHevbrio during pregnancy are encouraged to contact 1-888-421-8808 (toll-free).
To report SUSPECTED ADVERSE REACTIONS, contact VBI Vaccines at 1-888-421-8808 (toll-free) or VAERS at 1-800-822-7967 or www.vaers.hhs.gov
Please see full Prescribing Information.
About Hepatitis B
Hepatitis B is one of the world’s most significant infectious disease threats with more than 290 million people infected globally. HBV infection is the leading cause of liver disease and, with current treatments, it is very difficult to cure, with many patients going on to develop liver cancers. An estimated 900,000 people die each year from complications of chronic HBV such as liver decompensation, cirrhosis, and hepatocellular carcinoma.
Earlier in November 2021, the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) unanimously voted to recommend universal HBV vaccination for adults age 18 to 59, and for adults age 60+ with risk factors for infection, expanding the addressable adult population that should be vaccinated.
About PreHevbrio™
PreHevbrio is an adult hepatitis B vaccine that contains the three hepatitis B surface antigens of the hepatitis B virus – S, pre-S1, and pre-S2. PreHevbrio is also approved for use and commercially available in Israel under the brand name Sci-B-Vac®.
About VBI Vaccines Inc.
VBI Vaccines Inc. (“VBI”) is a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease. Through its innovative approach to virus-like particles (“VLPs”), including a proprietary enveloped VLP (“eVLP”) platform technology, VBI develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system. VBI is committed to targeting and overcoming significant infectious diseases, including hepatitis B, coronaviruses, and cytomegalovirus (CMV), as well as aggressive cancers including glioblastoma (GBM). VBI is headquartered in Cambridge, Massachusetts, with research operations in Ottawa, Canada, and a research and manufacturing site in Rehovot, Israel.
Website Home: http://www.vbivaccines.com/
News and Resources: http://www.vbivaccines.com/news-and-resources/
Investors: http://www.vbivaccines.com/investors/
Cautionary Statement on Forward-looking Information
Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are forward-looking information within the meaning of Canadian securities laws (collectively, “forward-looking statements”). The Company cautions that such statements involve risks and uncertainties that may materially affect the Company’s results of operations. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including but not limited to, the impact of general economic, industry or political conditions in the United States or internationally; the impact of the ongoing COVID-19 pandemic on our clinical studies, manufacturing, business plan, and the global economy; the ability to successfully manufacture and commercialize PreHevbrio; the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of pipeline candidates and the commercialization of PreHevbrio; the ability to obtain appropriate or necessary regulatory approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the Company’s ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to the Company’s products. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Company’s filings with the SEC and the Canadian securities authorities, including its Annual Report on Form 10-K filed with the SEC on March 2, 2021, and filed with the Canadian security authorities at sedar.com on March 2, 2021, as may be supplemented or amended by the Company’s Quarterly Reports on Form 10-Q. Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement. All such forward-looking statements made herein are based on our current expectations and we undertake no duty or obligation to update or revise any forward-looking statements for any reason, except as required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20211201005387/en/
VBI
Nicole Anderson
Director, Corporate Communications & IR
Phone: (617) 830-3031 x124
Email: IR@vbivaccines.com
cheynew
2 years ago
VBI VACCINES ANNOUNCES E-POSTER PRESENTATION OF 3-ANTIGEN PROPHYLACTIC HEPATITIS B VACCINE DATA AT THE LIVER MEETING® 2021
VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that its abstract highlighting data from PROTECT, the pivotal Phase 3 immunogenicity and safety study of its 3-antigen prophylactic hepatitis B (HBV) vaccine, was accepted for e-poster presentation at the American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting®, to be held November 12-15, 2021.
Presentation Details
Poster #: 706
Title: Cell-mediated and humoral immune responses after vaccination with a 3-antigen HBV vaccine containing pre-S1, pre-S2, and S antigens, compared to a single-antigen HBV vaccine: Results from a pivotal phase III, randomized clinical trial (PROTECT)
Session: Hepatitis B: Diagnostics and Biomarkers
Presenter: Francisco Diaz-Mitoma, M.D., Ph.D., VBI’s Chief Medical Officer
The e-poster will be available for the duration of The Liver Meeting®.
About Hepatitis B
Hepatitis B is one of the world’s most significant infectious disease threats with more than 290 million people infected globally. HBV infection is the leading cause of liver disease and, with current treatments, it is very difficult to cure, with many patients going on to develop liver cancers. An estimated 900,000 people die each year from complications of chronic HBV such as liver decompensation, cirrhosis, and hepatocellular carcinoma.
About VBI’s 3-Antigen Hepatitis B Vaccine
VBI’s vaccine candidate is the only 3-antigen hepatitis B vaccine, comprised of the S, pre-S1, and pre-S2 surface antigens of the hepatitis B virus, and is approved for use and commercially available in Israel. In December 2017, VBI initiated patient dosing in a global Phase 3 clinical program that consisted of two concurrent pivotal studies: PROTECT, a safety and immunogenicity study, and CONSTANT, a lot-to-lot consistency study. Data from both the PROTECT study and the CONSTANT study, which were announced in June 2019 and January 2020, respectively, comprise the basis for the regulatory submissions in the U.S., Europe, and Canada. This vaccine is sold under the name Sci-B-Vac ® in Israel.
To learn more about VBI’s 3-Antigen Hepatitis B vaccine visit: https://www.vbivaccines.com/sci-b-vac/
About VBI Vaccines Inc.
VBI Vaccines Inc. (“VBI”) is a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease. Through its innovative approach to virus-like particles (“VLPs”), including a proprietary enveloped VLP (“eVLP”) platform technology, VBI develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system. VBI is committed to targeting and overcoming significant infectious diseases, including hepatitis B, coronaviruses, and cytomegalovirus (CMV), as well as aggressive cancers including glioblastoma (GBM). VBI is headquartered in Cambridge, Massachusetts, with research operations in Ottawa, Canada, and a research and manufacturing site in Rehovot, Israel.
Website Home: http://www.vbivaccines.com/
News and Resources: http://www.vbivaccines.com/news-and-resources/
Investors: http://www.vbivaccines.com/investors/
Cautionary Statement on Forward-looking Information
Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are forward-looking information within the meaning of Canadian securities laws (collectively, “forward-looking statements”). The Company cautions that such statements involve risks and uncertainties that may materially affect the Company’s results of operations. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including but not limited to, the impact of general economic, industry or political conditions in the United States or internationally; the impact of the ongoing COVID-19 pandemic on our clinical studies, manufacturing, business plan, and the global economy; the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of therapeutic candidates; the ability to obtain appropriate or necessary governmental approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the Company’s ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to the Company’s products. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Company’s filings with the SEC and the Canadian securities authorities, including its Annual Report on Form 10-K filed with the SEC on March 2, 2021, and filed with the Canadian security authorities at sedar.com on March 2, 2021, as may be supplemented or amended by the Company’s Quarterly Reports on Form 10-Q. Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement. All such forward-looking statements made herein are based on our current expectations and we undertake no duty or obligation to update or revise any forward-looking statements for any reason, except as required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20211101005293/en/
VBI Contact
Nicole Anderson
Director, Corporate Communications & IR
Phone: (617) 830-3031 x124
Email: IR@vbivaccines.com
cheynew
3 years ago
VBI Vaccines Reports New CPT Code Issued for a 3-Antigen Prophylactic Hepatitis B Vaccine
July 01 2021 - 04:05PM
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VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today reported that the American Medical Association (AMA) Current Procedural Terminology (CPT®) Panel has established a unique CPT code for a 3-antigen (S, Pre-S1, Pre-S2) Hepatitis B (HBV) vaccine. If approved, VBI’s 3-antigen HBV vaccine candidate will be reported using the new code, differentiating it from other single-antigen HBV vaccines.
VBI’s 3-antigen HBV vaccine candidate is currently under regulatory review for marketing approval in the U.S. and Europe. The U.S. Food and Drug Administration (FDA) has set the Prescription Drug User Fee Act (PDUFA) target action date of November 30, 2021.
“The AMA’s issuance of a unique CPT code for a 3-antigen HBV vaccine enables a streamlined reimbursement process for our vaccine candidate that is distinct from the process for the other approved, single-antigen HBV vaccines,” said Jeff Baxter, President and CEO. “This is a significant milestone and one of many steps being taken to prepare for the potential approval and launch of our 3-antigen HBV vaccine for adults in the U.S., and we continue to support the FDA in their review of our application.”
About CPT® Codes
CPT codes offer doctors and health care professionals a uniform language for coding medical services and procedures to streamline reporting, increase accuracy and efficiency. CPT Codes are also used for administrative management purposes such as claims processing and developing guidelines for medical care review. The CPT terminology is the most widely accepted medical nomenclature used across the U.S. to report medical, surgical, and diagnostic services and procedures to public and private health insurance programs for the purpose of reimbursement. CPT® is a registered trademark of the American Medical Association, which develops and maintains CPT codes.
About Hepatitis B
Hepatitis B is one of the world’s most significant infectious disease threats with more than 290 million people infected globally. HBV infection is the leading cause of liver disease and, with current treatments, it is very difficult to cure, with many patients going on to develop liver cancers. An estimated 900,000 people die each year from complications of chronic HBV such as liver decompensation, cirrhosis, and hepatocellular carcinoma.
About VBI’s 3-Antigen Hepatitis B Vaccine
VBI’s vaccine candidate is the only 3-antigen hepatitis B vaccine, comprised of the S, pre-S1, and pre-S2 surface antigens of the hepatitis B virus, and is approved for use and commercially-available in Israel. In December 2017, VBI initiated patient dosing in a global Phase 3 clinical program that consisted of two concurrent pivotal studies: PROTECT, a safety and immunogenicity study, and CONSTANT, a lot-to-lot consistency study. Data from both the PROTECT study and the CONSTANT study, which were announced in June 2019 and January 2020, respectively, comprise the basis for the regulatory submissions in the U.S., Europe, and Canada. This vaccine is sold under the name Sci-B-Vac® in Israel.
To learn more about VBI’s 3-Antigen Hepatitis B vaccine candidate visit: https://www.vbivaccines.com/sci-b-vac/
About VBI Vaccines Inc.
VBI Vaccines Inc. (“VBI”) is a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease. Through its innovative approach to virus-like particles (“VLPs”), including a proprietary enveloped VLP (“eVLP”) platform technology, VBI develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system. VBI is committed to targeting and overcoming significant infectious diseases, including hepatitis B, coronaviruses, and cytomegalovirus (CMV), as well as aggressive cancers including glioblastoma (GBM). VBI is headquartered in Cambridge, Massachusetts, with research operations in Ottawa, Canada, and a research and manufacturing site in Rehovot, Israel.
Website Home: http://www.vbivaccines.com/
News and Resources: http://www.vbivaccines.com/news-and-resources/
Investors: http://www.vbivaccines.com/investors/
Cautionary Statement on Forward-looking Information
Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are forward-looking information within the meaning of Canadian securities laws (collectively, “forward-looking statements”). The Company cautions that such statements involve risks and uncertainties that may materially affect the Company’s results of operations. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including but not limited to, the impact of general economic, industry or political conditions in the United States or internationally; the impact of the ongoing COVID-19 pandemic on our clinical studies, manufacturing, business plan, and the global economy; the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of therapeutic candidates; the ability to obtain appropriate or necessary governmental approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the Company’s ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to the Company’s products. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Company’s filings with the SEC and the Canadian securities authorities, including its Annual Report on Form 10-K filed with the SEC on March 2, 2021, and filed with the Canadian security authorities at sedar.com on March 2, 2021, as may be supplemented or amended by the Company’s Quarterly Reports on Form 10-Q. Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement. All such forward-looking statements made herein are based on our current expectations and we undertake no duty or obligation to update or revise any forward-looking statements for any reason, except as required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210701005848/en/
VBI Contact
Nicole Anderson
Director, Corporate Communications & IR
Phone: (617) 830-3031 x124
Email: IR@vbivaccines.com
cheynew
3 years ago
VBI Vaccines Announces Initial Positive Phase 1 Data for Its eVLP Vaccine Candidate Against COVID-19
Mentioned: VBIV
VBI Vaccines Inc. (Nasdaq:VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced positive Phase 1 data from its Phase 1/2 trial of the first of its enveloped virus-like particle (eVLP) COVID-19 vaccine candidates, VBI-2902a, in healthy adults age 18-54 years of age. The 5ug dose of VBI-2902a, which expresses an optimized SARS-CoV-2 spike antigen and is adjuvanted with aluminum phosphate, was generally well-tolerated and elicited potent immune responses significantly higher than those seen in human convalescent sera. The data establish a robust human proof-of-concept, at a low dose without the use of a next-generation adjuvant, demonstrating the potency of the eVLP particulate delivery platform against COVID-19.
"We are encouraged by the validating data seen to-date from VBI-2902a, one of several eVLP candidates we are developing to target known and emerging variants of COVID-19, with the partnership and support of the Government of Canada, CEPI, and the National Research Council of Canada," said Jeff Baxter, President and CEO of VBI. "Building on our objective to add meaningfully to those vaccines already approved, and following positive discussions with our partners and Health Canada, we plan to assess VBI-2905a, our eVLP candidate that expresses the spike protein of the Beta (B.1.351) COVID-19 variant, in the next phase of the ongoing adaptive Phase 1/2 study, initiation of which is expected in the third quarter of 2021. Additionally, we are working hard to develop multivalent eVLP candidates, designed to increase the breadth of protection against COVID-19, and we expect to initiate the first clinical study of one of these candidates in the first half of 2022. We look forward to sharing further data as we continue to focus on the development of long-term, effective solutions against COVID-19 and other coronaviruses."
The ongoing adaptive Phase 1/2 clinical study is a randomized, observer-blind, placebo-controlled trial. The Phase 1 portion of the study assessed a 5ug dose of VBI-2902a, adjuvanted with aluminum phosphate, in both one- and two-dose vaccination regimens, with the second immunization given 28 days after the first. 61 healthy, previously unvaccinated adults, age 18-54, were enrolled in the Phase 1 portion of the study.
Phase 1 Study Data Highlights:
VBI-2902a was well-tolerated with no safety signals observed, with a safety profile consistent with that seen in prior eVLP clinical studiesVBI-2902a induced neutralization titers in 100% of participants, with a GMT of 329, 4.3x the GMT of the convalescent serum panel, after two dosesAfter two doses, VBI-2902a also induced antibody binding titers in 100% of participants, with a GMT of 4,047 units/mL, 5.0x the GMT of the convalescent serum panelData from this study also support the assessment of a one-dose booster regimen in seropositive individualsData was compared to a panel of 25 sera of convalescent patients who had contracted COVID-19, with mild-to-moderate illness
Next Steps for VBI's eVLP Platform Targeting COVID-19:
Q3 2021 : Expected initiation of the next phase of the ongoing adaptive Phase 1/2 study, assessing one and two doses (for seropositive and seronegative individuals, respectively) of VBI-2905a, VBI's eVLP candidate expressing the spike protein of the Beta COVID-19 variant (also known as B.1.351)H1 2022 : Expected initiation of the first clinical study of VBI's multivalent candidate, designed to increase breadth of protection against COVID-19
Conference Call and Webcast Details
VBI Vaccines will host a conference call and webcast with accompanying slides on Tuesday, June 29 at 8:30 AM ET. The live webcast and slide presentation can be accessed via the Events/Presentations page in the Investors section of the company's website, or by clicking this link:
https://lifescipartners.zoom.us/webinar/register/WN_AqSgdjnGTBSVGf3Qq9KKQg
A replay of the webcast will be archived on the Company's website following the live conference call.
About VBI's Coronavirus Vaccine Program: VBI-2900
VBI-2900 consists of three enveloped virus-like particle (eVLP) vaccine candidates: (1) VBI-2901, a trivalent pan-coronavirus vaccine expressing the SARS-CoV-2, SARS-CoV, and MERS-CoV spike proteins, (2) VBI-2902, a monovalent COVID-19-specific vaccine expressing the native SARS-CoV-2 spike protein, and (3) VBI-2905, a monovalent COVID-19-specific vaccine expressing the spike protein from the Beta variant (also known as B.1.351). The vaccine program has been developed through collaborations with the National Research Council of Canada (NRC), the Coalition for Epidemic Preparedness Innovations (CEPI), and the Government of Canada, through their Strategic Innovation Fund.
About Coronaviruses
Coronaviruses are a large family of enveloped viruses that usually cause respiratory illnesses of varying severity, including the common cold and pneumonia. Only seven coronaviruses are known to cause disease in humans, four of which most frequently cause symptoms of the common cold. Three of the seven coronaviruses, however, have more serious outcomes in people: (1) SARS-CoV-2, a novel coronavirus identified as the cause of coronavirus disease 2019 (COVID-19); (2) MERS-CoV, identified in 2012 as the cause of Middle East respiratory syndrome (MERS); and (3) SARS-CoV, identified in 2002 as the cause of an outbreak of severe acute respiratory syndrome (SARS).(1,2)
About VBI Vaccines Inc.
VBI Vaccines Inc. ("VBI") is a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease. Through its innovative approach to virus-like particles ("VLPs"), including a proprietary enveloped VLP ("eVLP") platform technology, VBI develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system. VBI is committed to targeting and overcoming significant infectious diseases, including hepatitis B, coronaviruses, and cytomegalovirus (CMV), as well as aggressive cancers including glioblastoma (GBM). VBI is headquartered in Cambridge, Massachusetts, with research operations in Ottawa, Canada, and a research and manufacturing site in Rehovot, Israel.
Website Home: http://www.vbivaccines.com/ News and Resources: http://www.vbivaccines.com/news-and-resources/ Investors: http://www.vbivaccines.com/investors/
Cautionary Statement on Forward-looking Information
Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are forward-looking information within the meaning of Canadian securities laws (collectively, "forward-looking statements"). The Company cautions that such statements involve risks and uncertainties that may materially affect the Company's results of operations. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including but not limited to, the impact of general economic, industry or political conditions in the United States or internationally; the impact of the ongoing COVID-19 pandemic on our clinical studies, manufacturing, business plan, and the global economy; the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of therapeutic candidates; the ability to obtain appropriate or necessary governmental approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the Company's ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to the Company's products. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Company's filings with the SEC and the Canadian securities authorities, including its Annual Report on Form 10-K filed with the SEC on March 2, 2021, and filed with the Canadian security authorities at sedar.com on March 2, 2021, as may be supplemented or amended by the Company's Quarterly Reports on Form 10-Q. Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement. All such forward-looking statements made herein are based on our current expectations and we undertake no duty or obligation to update or revise any forward-looking statements for any reason, except as required by law.
References
"Coronavirus." World Health Organization,
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