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VBI vaccines: Press release of October 13, 2021 (provided in accordance with section 7.01) – Form 8-K


Room 99.1

VBI Vaccines announces the publication of the results of the pivotal phase 3 study,

CONSTANT, of the VBI hepatitis B prophylactic 3-antigen vaccine candidate in The

Journal of the American Medical Association Network Open

Title of publication: “Immunogenicity and safety of a 3-antigen hepatitis B vaccine compared to a single-antigen hepatitis B vaccine; A phase 3 randomized clinical trial ”

The phase 3 study, conducted in 2,838 adults aged 18 to 45 years, evaluated the immunogenicity, safety and batch-to-batch manufacturing equivalence of the candidate 3-antigen hepatitis VBI vaccine. B versus Engerix-B.®

VBI vaccine candidate demonstrated robust and consistent immune responses in all three batches after two and three doses, with higher seroprotection rates and geometric mean antibody concentration (GMC) compared to Engerix-B®

No safety signal was observed

CAMBRIDGE, Massachusetts (October 13, 2021) – VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company focused on immunology in pursuit of potent disease prevention and treatment, today announced the results of the pivotal study phase 3, CONSTANT, of the prophylactic antigen 3 of VBI hepatitis B vaccine candidate (HBV) in adults aged 18 to 45 years has been published in The Journal of the American Medical Association Network Open. The study was designed to demonstrate the manufacturing equivalence of three lots of the candidate VBI HBV vaccine, as well as to assess the immunogenicity of the 3-antigen HBV candidate VBI vaccine compared to a HBV vaccine at single antigen, Engerix-B.®, after two and three doses, and safety and reactogenicity. Together with the results of the first pivotal phase 3 study, PROTECT, these results formed the basis for regulatory submissions of the 3-antigen HBV vaccine candidate VBI in the United States, Europe and Canada.

Dr Timo Vesikari, MD, Ph.D., Emeritus Professor and Director of the Nordic Vaccine Research Network in Finland, Principal Investigator of the CONSTANT Study and author of the manuscript commented: “In North America and Europe, older adults 25 to 49 years old have the highest rates of HBV infection. Unfortunately, it is also this population that has the lowest rates of adherence to the full cycle of immunization. The data from this pivotal phase 3 study are of significant public health importance, demonstrating the ability of the anti-HBV 3-vaccine candidate to achieve high levels of seroprotection and increased antibody titers after two and three doses in this vaccine. population compared to the conventional single-antigen HBV vaccine. In addition, these data add to the well-established safety profile of this vaccine. ”

Dr Francisco Diaz-Mitoma, MD, Ph.D., Medical Director of VBI, commented: “We are delighted to have the results of the CONSTANT study published in The Journal of the American Medical Association Network Open. We continue to work with regulators in North America and Europe to support their review of our marketing authorization applications, as we believe this vaccine candidate has the potential to enhance provider efforts. health care to prevent the spread of HBV infection. ”

The results of this Phase 3 study include:

The seroprotection rate (SPR) is defined as the percentage of participants who achieved antibody titers (anti-HBs) above the protective threshold of 10 mIU / mL

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The main endpoint of the consistency of manufacture from one batch to another, measured by GMC of the concentration of anti-HBs on day 196 on three consecutively manufactured batches of the candidate VBI vaccine with 3 antigens against HBV, was reached.

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The SPR after two doses, on day 168, was 90.4% for the candidate vaccines with 3 VBI antigens compared to 51.6% for Engerix-B®, increasing to 99.3% and 94.8%, respectively, after the third dose.

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The mean GMC of anti-HBs titers was more than 7.5 times higher after two doses, on day 168, and 3.5 times higher after three doses, on day 196 (5442.4 mIU / mL VBI versus 1567.2 mIU / mL Engerix-B)

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The VBI 3-antigen vaccine candidate also elicited a higher percentage of participants with anti-HBs titers ≥ 100 mIU / mL, a tighter titer cut-off, of 95.8% vs. 86.3% for Engerix -B on day 196.

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The safety and tolerability observed in this study supports the safety profile of the 3-antigen VBI vaccine candidate – with no safety signals observed in both arms of the study, and no new safety risks identified.

The CONSTANT study reported the first results in January 2020 and was a randomized, controlled, double-blind trial conducted at 37 research centers in the United States, United Kingdom, Finland, Belgium and Canada. The study recruited 2,838 healthy adults between the ages of 18 and 45. Study participants were randomized 1: 1: 1: 1 to receive a 3-dose regimen of 10 µg of 3-antigen VBI vaccine from batch A, batch B, or batch C, or 20 µg Engerix-B®, given on days 0, 28 and 168.

The full manuscript is available online here:

http://jamanetwork.com/journals/jamanetworkopen/fullarticle/10.1001/jamanetworkopen.2021.28652?utm_source=For_The_Media&utm_medium=referral&utm_campaign=ftm_links&utm_term=101221

About hepatitis B

Hepatitis B is one of the world’s biggest infectious disease threats with more than 290 million people infected worldwide. HBV infection is the leading cause of liver disease and with current treatments it is very difficult to cure, with many patients developing liver cancer. It is estimated that 900,000 people die each year from complications of chronic HBV such as liver decompensation, cirrhosis and hepatocellular carcinoma.

About the VBI 3-Antigen Hepatitis B Vaccine

The VBI vaccine candidate is the only 3-antigen hepatitis B vaccine, composed of the S, pre-S1 and pre-S2 surface antigens of hepatitis B virus, and is approved for use and available in the trade in Israel. In December 2017, VBI initiated patient testing 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 the PROTECT study and the CONSTANT study, which were announced in June 2019 and January 2020, respectively, form the basis for regulatory submissions in the United States, Europe and Canada. This vaccine is sold under the name Sci-B-Vac® in Israel.

To learn more about the VBI 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 focused on immunology in pursuit of potent disease prevention and treatment. Using its innovative approach to viral-like particles (“VLP”), including proprietary enveloped VLP (“eVLP”) platform technology, VBI is developing candidate vaccines that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system. system. VBI is committed to targeting and defeating important 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.

Home page: http://www.vbivaccines.com/

News and Resources: http://www.vbivaccines.com/news-and-resources/

Investors: http://www.vbivaccines.com/investors/

Caution regarding 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 law. securities (collectively, “forward-looking statements”). The Company cautions that such statements involve risks and uncertainties which may significantly affect the results of operations of the Company. These forward-looking statements are based on the beliefs of management as well as on the assumptions made by management and on the information currently available to it. Actual results could differ materially from those contemplated by forward-looking statements due to certain factors, including, but not limited to, the impact of economic, industrial or general 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 effective 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 government approvals to market potential products; the ability to obtain future financing for development products and working capital and to obtain such financing on commercially reasonable terms; the Company’s ability to manufacture product candidates on a commercial scale or in collaboration with third parties; changes in the size and nature of competitors; the ability to retain key leaders and scientists; and the ability to secure and enforce legal rights relating to the Company’s products. A discussion of these and other factors, including the risks and uncertainties regarding the Company, is set out in the Company’s filings with the SEC and Canadian securities regulators, including its annual report on Form 10- K filed with the SEC on March 2. , 2021, and filed with Canadian safety authorities on sedar.com on March 2, 2021, as may be completed or amended by the Company’s quarterly reports on Form 10-Q. In view of these risks, uncertainties and factors, you are cautioned not to place undue reliance on these forward-looking statements, which are qualified in their entirety by this cautionary statement. All of these forward-looking statements made here are based on our current expectations and we assume no obligation or obligation to update or revise any forward-looking statements for any reason, except as required by law.

Contact VBI

Nicole anderson

Director, Corporate Communications and RI

Telephone: (617) 830-3031 ext. 124

Email: [email protected]

Disclaimer

VBI Vaccines Inc. published this content on October 13, 2021 and is solely responsible for the information it contains. Distributed by Public, unedited and unmodified, on October 13, 2021 12:11:09 PM UTC.


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