Novavax, Inc. (NVAX) announced positive top-line data from a dose-ranging, randomized, observer-blinded, placebo-controlled phase I/II study on its H7N9 avian influenza virus-like particle (VLP) vaccine candidate, H7N9 VLP.

The study was conducted under Novavax’s contract with the Biomedical Advanced Research and Development Authority (:BARDA) of the U.S. Department of Health and Human Services (HHS) for the development of VLP vaccines for influenza with pandemic potential.

The study evaluated the safety and immunogenicity of H7N9 VLP plus adjuvant Matrix-M in 610 healthy participants. H7N9 VLP and Matrix-M were well tolerated among the patients.

The study showed that addition of Matrix-M led to a clear immunogenicity benefit compared to unadjuvanted H7N9 VLP, thereby showing the effect of Matrix-M on antigen dose-sparing regimens. Participants receiving 3.75μg of H7N9 VLP in combination with Matrix-M showed statistically significantly greater immune responses than those receiving 15μg of H7N9 VLP without Matrix-M.

Additionally, participants receiving H7N9 VLP plus Matrix-M showed strong neuraminidase inhibiting antibody response.

This was the first study evaluating H7N9 VLP in combination with Matrix-M for influenza with pandemic potential.

We remind investors that in Feb 2011, Novavax was awarded a contract with BARDA worth up to $179 million for the advanced development and manufacturing of recombinant influenza vaccines for pandemic preparedness. In Sep 2014, Novavax modified the contract to exercise an option period, which extended the contract until Sep 2016.

Milestones to be achieved during the option period include development of the H7N9/Matrix-M adjuvant pandemic influenza vaccine and completion of a phase II study (expected to be initiated in 4Q14) on a quadrivalent seasonal influenza vaccine candidate.

Novavax carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector include Gilead Sciences Inc. (GILD), Medivation, Inc. (MDVN) and Regado Biosciences, Inc. (RGDO). All these stocks carry a Zacks Rank #1 (Strong Buy).

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