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 8th 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."
The following poster presentations will occur on Friday, September 28, 2012 at 3:00pm Mountain Time:
Poster Presentation 34: "A Recombinant RSV Fusion (F) Nanoparticle Vaccine Generates Robust F Specific Antibody Responses that are Functionally more Active than in RSV Infected Cotton Rats."
Poster Presentation 30: "Immunogenicity of an Sf9 Insect Cell-Derived Respiratory Syncytial Virus Fusion Protein Nanoparticle Vaccine: Insights into Pathogenicity."
Both posters will be available in the "Our Science/Presentations" tab of the company's website, www.novavax.com. For more information about the conference, please visit http://www.rsv2012.org/
Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines to address a broad range of infectious diseases worldwide. Using innovative recombinant nanoparticle technology, as well as new and efficient manufacturing approaches, the company produces vaccine candidates to combat diseases, with the goal of allowing countries to better prepare for and more effectively respond to rapidly spreading infections. Novavax is committed to using its technology platforms to create geographic-specific vaccine solutions and is therefore involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India, LG Life Sciences of Korea and PATH. Together, these organizations support Novavax's worldwide commercialization strategy and have the global reach to create real and lasting change in the biopharmaceutical field. Additional information about Novavax is available on the company's website, www.novavax.com.
Statements herein relating to the future of Novavax and its ongoing development of its recombinant nanoparticle vaccine candidates are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2011, and filed with the Securities and Exchange Commission. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties
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