Novavax Initiates Phase 2 Clinical Trial Of Quadrivalent Seasonal Influenza VLP

Novavax, Inc.

, a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced that enrollment has begun in a Phase 2 clinical trial of its recombinant quadrivalent seasonal influenza virus-like particle (VLP) vaccine candidate (Seasonal Influenza VLP). This trial is being conducted under the company's contract with the U.S. Department of Health and Human Services, Biomedical Advanced Research and Development Authority (BARDA) (Contract No. HHSO 100201100012C) for the development of Novavax' recombinant vaccines to address seasonal influenza and influenza strains with pandemic potential. Novavax' technology platform enables the creation of recombinant, strain-specific VLPs. Novavax' Seasonal Influenza VLP consists of VLPs representing four different strains of influenza virus, each expressing strain-specific hemagglutinin and neuraminidase antigens. Antibodies to both hemagglutinin and neuraminidase have been shown to contribute to resistance to influenza illness. Because these VLP constructs elicit immune responses to both hemagglutinin and neuraminidase molecules in the four strains of seasonal influenza, it is expected that immunized subjects will be protected from influenza infection and disease-related symptoms. The trial is a randomized, observer-blinded, dose-ranging trial designed to evaluate the safety and immunogenicity of the Seasonal Influenza VLP in 400 healthy adult subjects. The primary outcomes of the trial will assess safety and tolerability of the Seasonal Influenza VLP and quantify immune responses to each of the four influenza strains based on hemagglutination-inhibiting antibody titers. In addition, secondary outcomes will evaluate neuraminidase-inhibition antibody titers for all four influenza strains. "We are delighted to announce the initiation of this Phase 2 clinical trial of our Seasonal Influenza VLP. We believe this vaccine has the potential to provide a differentiated immune response through the presentation of both hemagglutinin and the intact neuraminidase antigen," said Stanley C. Erck, President and CEO of Novavax. "That differentiated immune response has the potential to deliver more robust protection against infection. We are committed to moving this product from this current trial into clinical efficacy trials."