Therapy Areas: Vaccines
VBI Vaccines Submits Marketing Authorization Application for 3-Antigen Prophylactic Hepatitis B Vaccine to the European Medicines Agency
24 November 2020 - - US-based biopharmaceutical company VBI Vaccines Inc. (NASDAQ: VBIV) has submitted a Marketing Authorization Application to the European Medicines Agency for the company's 3-antigen prophylactic hepatitis B vaccine candidate, seeking approval for the prevention of infection caused by all known subtypes of the hepatitis B virus in adults, the company said.

Hepatitis B is one of the world's most significant infectious disease threats with more than 290 m 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 780,000 people die each year from complications of chronic HBV such as liver decompensation and hepatocellular carcinoma.

This 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, 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 US, Europe, and Canada. This vaccine is sold under the name Sci-B-Vac in Israel.

VBI Vaccines Inc. (NASDAQ: VBIV) is a commercial-stage biopharmaceutical company developing a next generation of vaccines to address unmet needs in infectious disease and immuno-oncology.

VBI is advancing the prevention and treatment of hepatitis B, with: the only 3-antigen hepatitis B vaccine, which is approved for use and commercially available in Israel and recently completed its Phase 3 program in the US, Europe, and Canada; and an immunotherapeutic in development for a functional cure for chronic hepatitis B.

VBI's enveloped virus-like particle platform technology enables development of eVLPs that closely mimic the target virus to elicit a potent immune response.

VBI's lead eVLP programs include a vaccine immunotherapeutic candidate targeting glioblastoma, a prophylactic cytomegalovirus vaccine candidate, and a prophylactic coronavirus vaccine program.

VBI is headquartered in Cambridge, MA, with research operations in Ottawa, Canada, and research and manufacturing facilities in Rehovot, Israel.