VBI Vaccine Announces US FDA Approval for BLA Filing for VBI’s Triantigen Prophylactic Hepatitis B Vaccine | Corporate Finance

“The FDA’s approval of the BLA is an important milestone for VBI, but more importantly for efforts to provide broad access to this vaccine. It is an adult in the fight against hepatitis B. I think it could be a meaningful intervention for us. ” Jeff Baxter, President and Chief Executive Officer. “Progress in the prevention of HBV infection has stagnated, and the 11% increase in acute cases in the United States between 2014 and 2018 highlights the need for new focus, innovation and action in this area. We are committed to working with the FDA throughout this year’s course to address this serious but preventable public health threat. “

In addition, the FDA stated in its submission letter that it has no plans to hold an advisory board to discuss the application.

BLA is supported by data from two important randomized, double-blind, phase 3 trials (PROTECT and CONSTANT), in addition to other relevant data. These studies were designed to evaluate the efficacy and safety of VBI’s three-antigen HBV vaccine compared to Engerix-B® and the consistency of production of VBI vaccines between lots.

Hepatitis B is one of the most serious infectious disease threats in the world, affecting more than 290 million people worldwide. HBV infection is a major cause of liver disease and is very difficult to cure with current treatments, and many patients continue to develop liver cancer. An estimated 780,000 people die each year from complications of chronic HBV such as liver decompensation and hepatocellular carcinoma.

About VBI’s 3-antigen hepatitis B vaccine

The VBI vaccine candidate is the only three-antigen hepatitis B vaccine composed of the hepatitis B virus S, pre-S1 and pre-S2 surface antigens, approved for use and marketed in Israel. I will. In December 2017, VBI administered patients in a global phase 3 clinical program consisting of two simultaneous pivotal studies, PROTECT, a safety and immunogenicity study, and CONSTANT, a lot-to-lot consistency study. have started. Data from both PROTECT and CONSTANT studies, published in June 2019 and January 2020, respectively, form the basis for regulatory submissions in the United States, Europe, and Canada. This vaccine is marketed in Israel under the name Sci-B-Vac®.

VBI Vaccine Co., Ltd. ((( NASDAQ: VBIV ) Is a commercial biopharmacy company developing next-generation vaccines to address unmet needs in infectious diseases and immuno-oncology. VBI is advancing the prevention and treatment of hepatitis B as follows. (1) The only three-antigen hepatitis B vaccine approved for use, marketed in Israel under the name Sci-B-Vac®, and completed the Phase 3 program in the United States, Europe and Canada in 2020. (2) Immunotherapy under development of a functional treatment for chronic hepatitis B. VBI’s Envelope Virus-like Particle (eVLP) platform technology enables the development of eVLP that closely mimics the target virus and elicits a strong immune response. VBI’s leading eVLP programs include vaccine immunotherapy candidates targeting glioblastoma (GBM), prophylactic cytomegalovirus (CMV) vaccine candidates, and prophylactic coronavirus vaccine programs. Headquartered in Cambridge, Massachusetts, VBI has research activities in Ottawa, Canada and research and manufacturing facilities in Rehovot, Israel.

Precautions regarding future prospects

The specific statements in this press release are forward-looking statements, not historical facts, and forward-looking statements in the sense of the Safe Harbor clause of the Private Securities Litigation Reform Act of 1995, and the future in the Canadian sense. Information about the outlook for. Securities Law (collectively, “statement of future prospects”). We note that such statements include risks and uncertainties that may have a significant impact on our performance. These forward-looking statements are based on management’s beliefs, as well as assumptions made by management and information currently available to management. Actual results are not expected in forward-looking statements as a result of certain factors, including but not limited to, the effects of general economic, industrial, or political conditions in the United States or internationally. It can be very different. The impact of the ongoing COVID-19 pandemic on clinical trials, manufacturing, business planning, and the global economy. Ability to prove that a potential product is effective or safe in preclinical or clinical trials. Unexpected delays in both the initiation and completion of planned clinical trials. Ability to establish or maintain partnerships in the development of treatment candidates. Ability to obtain appropriate or necessary government approval to sell potential products. Ability to obtain future funding for development products and working capital, and to obtain such funding on commercially reasonable terms. Our ability to manufacture product candidates on a commercial scale or in collaboration with third parties. Changes in the size and nature of our competitors. Ability to retain key executives and scientists. Ability to secure and enforce legal rights related to our products. A discussion of these and other factors, including risks and uncertainties regarding us, is our filing with the SEC and the Canadian Securities Authority, including the Form 10-K Annual Report filed with the SEC on March 5. It is described in. Submitted to Canadian security authorities in 2020 sedar.com May 5, 2020, supplemented or amended by the company’s quarterly report on Form 10-Q. Considering these risks, uncertainties, and factors, please be careful not to overly rely on such forward-looking statements that are fully qualified by this notice. All such forward-looking statements contained in this document are based on our current expectations and, for whatever reason, forward-looking statements, except as required by law. We have no obligation or obligation to update or revise.

Corporate Communication & IR Director

Phone: (617) 830-3031 x124

Keywords: Massachusetts United States North America Canada

Industry Keywords: Infectious Disease Research FDA Clinical Trials Other Health Biotechnology Pharmaceutical Health Science Oncology

Source: VBI Vaccines Inc.

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PUB: 02/02/2021 08:00 AM / DISC: 02/02/2021 08:02 AM