BiondVax Pharmaceuticals Ltd (BVXV)

[midastouch017]

Last of 12,400 Participants Completes Final Visit in BiondVax's M-001 Universal Flu Vaccine Pivotal Phase 3 Clinical Trial

PR Newswire PR Newswire•July 1, 2020

JERUSALEM, July 1, 2020 /PRNewswire/ -- BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) today announced that all participants in the placebo-controlled, blinded, pivotal, clinical efficacy, Phase 3 trial of BiondVax's M–001 universal influenza vaccine candidate have now completed their site visits. In total, over 12,400 volunteers aged 50+ (with half aged 65+) were enrolled in the trial over the past two flu seasons in 83 sites across seven European countries. The purpose of the study is to assess M-001's ability as a standalone non-adjuvanted vaccine to provide clinical protection from circulating influenza strains as measured by reduction of influenza illness rate (as a primary endpoint) and severity (as a secondary endpoint), as well as to assess M-001's safety.

Seasonal influenza annually infects approximately 10-20% of the world's population[1] resulting in up to about five million cases of severe illness and 650,000 deaths[2]. In addition, pandemic influenza, such as the H1N1 Swine Flu pandemic of 2009, is a constant global threat. However, current influenza vaccines, which target frequently mutating parts of the flu virus and therefore must be updated annually in the hope they will match the next flu season's circulating strains, achieve on average only about 40% vaccine effectiveness in the general population[3] and as low as 12% in older adults[4].

BiondVax's M-001 is a single recombinant protein of highly conserved influenza epitopes. Consequently:

M-001 does not need to be updated and therefore can be manufactured and distributed year-round.
M-001 is designed to provide protection to both existing and future seasonal A and B strains, as well as emerging pandemic strains.
Dr. Tamar Ben-Yedida, BiondVax's Chief Scientist, commented, "We are pleased that despite the ongoing COVID-19 pandemic, and the challenge of conducting the trial across 83 sites and seven countries, thanks to all the people involved – including the CRO, investigators, and thousands of participants – we have maintained the planned timelines of our pivotal Phase 3 trial. In light of the ongoing COVID-19 pandemic, the need for improved influenza vaccines has arguably never been clearer. To better protect lives and economies, influenza vaccines must be more effective in reducing illness rates and severity. Needless to say, we are eagerly anticipating results of our trial by the end of this year."

Participants in the trial's second cohort were enrolled prior to the 2019/20 flu season and monitored for influenza-like illness (ILI) symptoms throughout the flu season. Swabs samples were collected from those participants with ILI, and influenza confirmation is currently being conducted by a qualified laboratory. Analysis will continue in the coming months, and results are expected by the end of 2020.

As part of this Phase 3 study, cell-mediated immunogenicity markers of M-001 will be evaluated in a subset of participants. The recently completed clinical study report (CSR) of a U.S. National Institute of Allergy and Infectious Diseases (NIAID) supported Phase 2 clinical trial of M-001 concluded that, "M-001 induced significant polyfunctional T cell responses."

In addition to the ongoing pivotal, clinical efficacy, Phase 3 trial, equipment installation and manufacturing process scale-up in BiondVax's pilot facility in Jerusalem are in progress. The facility has planned annual capacity of up to between 10 and 20 million doses in bulk.

https://finance.yahoo.com/news/last-12-400-participants-completes-100000695.html