BiondVax stock implodes after a big PhIII gamble for its universal flu vaccine fails
After flying high on Wall Street for the last few months of a pandemic, BiondVax’s stock and dreams of getting approval for its universal flu vaccine hit the windshield.
The Jerusalem-based biotech announced on Friday that its only clinical candidate, M-001, failed both primary and secondary endpoints in a Phase III study. There was no statistically significant difference in reduction of flu illness and severity between the vaccine and placebo groups, according to the company. The vaccine did prove safe, if ineffective, BiondVax said.
The news sent BiondVax’s stock plummeting 85%, closing at $5.20 per share. The day before, shares closed at $37.88 apiece. For the last few years, the biotech’s share value lingered around $5 to $7 per share. Prices began to rise in January, then surged from April to July, likely due to the pandemic. On July 14, they peaked at $48.25 apiece. Evercore ISI analyst Josh Schimmer predicted back in March that all vaccine developers — not just those focused on Covid-19 — would profit from the health crisis, listing $BVXV among the potential winners.
BiondVax’s Phase III trial included 12,463 adults ages 50 and up: “the group most urgently in need of improved protection from the flu,” CSO Tamar Ben-Yedidia said in a statement. The candidate, designed as a common denominator to influenza A and B viruses, was studied over the course of two flu seasons, beginning in 2018. Each participant was monitored for just one flu season.
There was no sugar-coating the findings. “We are disappointed with these results …” founder, president and CEO Ron Babecoff said before he went on to thank the team for 15 years of “dedication and passion.”
“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,” Babecoff said in the statement.
It’s not looking good for the biotech, which said it’s “examining options to maximize the value” of its assets, including IP and a state-of-the-art manufacturing facility.
Back in June, BiondVax met both primary endpoints in a Phase II trial supported by the NIAID. The company had announced that the candidate “induced significant polyfunctional T cell responses” — but it wasn’t enough to clear Phase III.
Other players in search of the Holy Grail include Vaccitech, which began dosing participants in a Phase IIb study last June, and the NIH, which unveiled a candidate headed for the clinic last April.