Novavax Reports positive data from Phase 2 Trial of Quadrivalent Seasonal Influenza VLP Print E-mail
By Marilyn Mullen   
Thursday, 30 July 2015 14:50

Clinical stage vaccine firm Novavax, Inc. (NASDAQ:NVAX) has confirmed positive top-line data from Phase 2clinical trial of the recombinant quadrivalent seasonal influenza virus-like particle (VLP) vaccine candidate.

The project has been given financial assistance by the Federal funds from Office of Assistant Secretary for Preparedness and Response, Department of Health and Human Services and Biomedical Advanced Research and Development Authority under the firm’s contract with HHS-BARDA.


The trial showed that Seasonal Influenza VLP vaccine candidate had good response with no adverse events. The trial achieved its immunogenicity targets as well as showed potential of meeting Center for Biological Evaluation and Research (CBER) criteria for accelerated approval.


Novavax’ technology platform allows creation of recombinant as well as strain-specific VLPs. The firm’s Seasonal Influenza VLP comprises of ones representing four different strains of influenza virus.


The dose was made for assessing the safety of the Seasonal Influenza VLP in 400 healthy adults. The initial results of trial evaluated safety as well as tolerability of Seasonal Influenza VLP along with quantifying immune responses to each of four influenza strains based on hemagglutination-inhibiting antibody titers.


Louis F. Fries III, M.D., Chief Medical Officer, Novavax, opined that Titers of antibodies which stop hemagglutination by influenza virus remaining best-accepted correlates of protection given by influenza vaccines.


Fries was glad on witnessing the Seasonal Influenza vaccine candidate showing surge in HAI titers for all four viral strains which would permit the vaccine to fulfill CBER’s criteria for accelerated approval.


Novavax President and CEO, Stanley C. Erck opined that the positive topline data from Phase 2 trial of the Seasonal Influenza vaccine candidate demonstrate vital achievement in the program.


Erck feels that the review of the data with the partner BARDA would provide details on next steps in development of this product.


He further stated that BARDA also has development of novel H7N9 Influenza vaccine candidate in combination with Matrix-M

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