BiondVax pairs with NIAID to test universal flu vaccine in U.S. PhII

Last week saw two developments by players large and small in a universal flu vaccine race that's heating up. Now, Israel-based BiondVax ($BVXV) is following up with some news of its own: It's partnering with the National Institute of Allergy and Infectious Diseases to test its candidate in the U.S.

BiondVax CEO Ron Babecoff

BiondVax said on Wednesday that the NIAID will launch a Phase II study of its Multimeric-001 (M-001) universal flu vaccine as a primer to be administered several weeks before a pandemic vaccine to the H7N9 avian strain. Unlike traditional, strain-specific flu vaccines that take up to 6 months to produce, BiondVax's candidate, if stockpiled, could enable vaccinations to begin immediately during a pandemic. NIAID's study will test M-001's potential as a stockpiled flu vaccine and will look at its capacity to prime for other strains, BiondVax said in a statement.

"The scenario is that immediately following a flu pandemic outbreak of any strain, our vaccine could be used from day zero, saving multiple lives and limiting the wild spread of a flu pandemic," Ron Babecoff, BiondVax CEO, said in a statement. "This collaboration with NIAID brings us a significant step closer to our Phase 3 clinical trial."

The study, which will take place during the "2015-2016 timeframe," according to the release, will complement an upcoming European trial of the candidate as a primer to the H5N1 avian pandemic vaccine, the company's CSO, Tamar Ben-Yedidia, said in the statement.

BiondVax's shares jumped about 36% on the news Wednesday.

Last month, in releasing Phase II results from a 2012 trial, the company said its candidate provided patients with increased immunogenicity against influenza strains that didn't exist at the time of the study. The FDA accepted BiondVax's Investigational New Drug Application for M-001 in June, one month after the biotech raised $9.5 million through a Nasdaq IPO to fund the candidate's development.

The news closely follows two separate developments in the universal flu vaccine contest: On Aug. 25, Wisconsin-based FluGen said it raised $12 million to fund an early stage trial of its candidate, Redee Flu; that was just one day after Johnson & Johnson ($JNJ) and The Scripps Research Institute said their most advanced candidate fully protected mice in a lethal challenge.

- here's the release

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