Israeli universal flu vaccine developer BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) saw its share price fall 86% on Wall Street after the company announced the negative results of its pivotal, phase III clinical trial of M-001 as a standalone universal flu vaccine candidate.
The Jerusalem-based company said that the results did not demonstrate a statistically significant difference between the vaccinated and placebo groups in reduction of flu illness and severity, and therefore failed to meet both the primary and secondary efficacy endpoints. The study's primary safety endpoint was met.
Biondvax founder, president and CEO Dr. Ron Babecoff said, "We are disappointed with these results, and I wish to thank the BiondVax team for their efforts, dedication, and passion over the past 15 years. Together we have endeavored to develop an innovative approach to a persistent global problem. I am especially grateful to each of the clinical trial participants, as well as the investigators in all our trials for their efforts, and to our stakeholders for their support."
He added, "The significant need for better, more proactive flu protection is well-understood by clinicians and public health experts around the world, and we have devoted many years in pursuit of this worthy goal. Unfortunately, this study did not have the efficacy outcomes that we anticipated for M-001 on a standalone basis. We have observed in seven previous studies that M-001 safely provoked an immune response to a broad range of flu strains, but ultimately this was not sufficient on a standalone basis to show protection."
Dr. Babecoff continued, "We have developed expertise and IP in pursuit of our goals, and we retain a state-of-the-art manufacturing facility. Going forward, we will examine options to maximize the value of these assets."
BiondVax's main shareholders include Yossi Ben Yosef's Kadima high tech fund, Yorkville and Marius Nacht both from his personal funds and through his first aMoon fund.
Biondvax's flu vaccine was based on development by Prof. Ruth Arnon of the Weizmann Institute of Science, who also co-developed Teva's blockbuster multiple sclerosis treatment Copaxone.
Full disclosure: Marius Nacht is the former partner of Anat Agmon, part of the controlling shareholders of "Globes." The former couple is involved in a personal and economic dispute.
Published by Globes, Israel business news - en.globes.co.il - on October 25, 2020
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