BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) ’s pivotal Phase 3 trial in Europe was completed in June 2020 and the analysis of the results are expected in the fall. The trial, which is assessing M-001’s ability to provide clinical protection from circulating influenza strains, was conducted in more than 12,400 volunteers aged 50+ (with half aged 65+) over two flu seasons in seven countries.
So far, seven human studies have been completed in Israel, Europe, and, most recently (2020), in the United States sponsored and conducted by NAIAD/NIH. All of them met their goals, having successfully demonstrated that M-001 is safe, well tolerated, and immunogenic. In a clear indication of a primary advantage of M-001 over seasonal quadrivalent influenza vaccines, participants were followed up four years after one study had begun and it was found that the group administered M-001 showed a significant level of immunity to a strain of influenza that did not even exist when they were originally vaccinated.
Successful completion of the phase 3 study would likely result in acceptance for market by the European Medicines Agency, but not for the United States. However, with such a very large study showing safety, tolerability, and immunogenicity, it can be expected that the US FDA regulatory process will be accelerated given that so many American lives could be saved.
An universal influenza vaccine is of vital importance due to the double threat of the Coronavirus and the flu threatening to overload hospitals during the winter seasonal outbreaks. While approximately 300 companies are developing vaccines for the Coronavirus, Biondvax is the sole company which will be introducing universal influenza vaccines into use in the near future.
M-001 is considered a modern vaccine, not composed of a “weakened” version of the actual influenza virus itself but, rather, consists of specific antigen-presenting proteins. In this way, immune cells become able to identify, and remember, particular viruses. M-001‘s focus is on nine different “conserved” (do not mutate) sites on the stem of the virus. It is not grown in eggs, eliminating concern for allergies and genetic drift that occurs as viruses adapt to their egg environment during the process of bringing sufficient quantities of the vaccine to meet demand. Unlike traditional viruses, it can also be stored up to three years before use. Despite its obvious advantages over traditional, egg incubated vaccines, M-001 is far less labor intensive and less expensive to manufacture. Further, it can be manufactured year round, evening out the flow of production, further diminishing cost.
BiondVax (NASDAQ: BVXV) is a Phase 3 clinical stage biopharmaceutical company developing a universal flu vaccine. The vaccine candidate, called M-001, is designed to provide multi-strain and multi-season protection against current and future, seasonal and pandemic influenza. BiondVax’s proprietary technology utilizes a unique combination of conserved and common influenza virus peptides intended to stimulate both arms of the immune system for a cross-protecting and long-lasting effect. In a total of seven completed Phase 1/2 and Phase 2 clinical trials enrolling 818 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic. The ongoing pivotal Phase 3 clinical trial aims to assess safety and effectiveness of M-001 in reducing flu illness and severity. For more information, visit www.biondvax.com.
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