VBI Vaccines Inc (VBIV)

[cheynew]

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.

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