Data Reinforce Previous Clinical and Preclinical Studies
Successfully Induced F-Protein Specific Neutralizing Antibody Response
Phase 2 Studies to Begin in the Fourth Quarter of 2012
ROCKVILLE, Md., Sept. 27, 2012 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) today announced that Gregory Glenn, M.D., Senior Vice President and Chief Medical Officer, and Ramadevi Raghunandan, Ph.D., Manager, Preclinical Immunology & Discovery, are presenting recent findings from the company's respiratory syncytial virus (RSV) vaccine development program at the 8 th Annual International Respiratory Virus Symposium (RSV 2012) meeting in Santa Fe, New Mexico. In its first poster, Novavax reported that recent data from a preclinical study in cotton rats showed that the nanoparticles that comprise its RSV vaccine retain a native structure, a feature considered important for the induction of functional immunity. Neutralizing antibody responses were observed specific to, and with high binding affinities to, multiple neutralizing sites on the fusion (F) protein. The company's RSV vaccine was found to induce >10 fold higher palivizumab-like antibodies, as well as 14-50 fold higher antibodies against an array of neutralizing sites defined by a known panel of monoclonal antibodies versus a formalin inactivated whole virus RSV (FI-RSV). Novavax is also presenting a second poster at RSV 2012 related to the immunogenicity of its RSV vaccine candidate and reviewing its previously reported Phase 1 data, which suggests that its vaccine is potentially more protective than live-viral, naturally-induced immunity. "Our clinical and preclinical data suggest that for RSV, immunization with our nanoparticle vaccine may be superior to live viral infection, as it focuses the immune response on key portions of the virus. Unlike natural infections or immunization with the FI-RSV vaccine, our vaccine candidate demonstrated induction of functional, neutralizing antibodies to multiple sites on the F protein that have a high binding affinity," said Dr. Glenn. "These findings further support our rationale for additional clinical development, as we plan to begin Phase 2 evaluations in Q4 of this year."