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Novavax, Inc. (Nasdaq:NVAX) reported this week that Gregory Glenn, M.D., Senior Vice President and Chief Medical Officer of Novavax, reviewed recent preclinical and clinical findings from the company's respiratory syncytial virus (RSV) vaccine development program at the first Modern Vaccines Adjuvants and Delivery Systems conference in Copenhagen, Denmark. He reported that the findings from the recent Phase I trial were consistent with the preclinical results in relevant animal models, which indicated that the Novavax Fusion (F) protein nanoparticle RSV vaccine candidate was generally well-tolerated, highly immunogenic and produced functional antibodies that neutralized RSV. There is currently no vaccine available to prevent RSV, which is the leading cause of bronchiolitis and pneumonia in infants under one year of age and a leading cause of pneumonia in older adults.
Dr. Glenn stated during his presentation: "The past development of an RSV vaccine has been very challenging to the vaccine industry. In reviewing our clinical and preclinical data, we recently uncovered some important insights about natural infection by RSV that should assist us in the development of an effective vaccine. These insights include:
"In both clinical and preclinical studies, we found that while subjects exposed to RSV infections had anti-F antibodies, there are almost no antibodies to a specific antigenic site (site II) on the highly conserved Fusion (F) protein of RSV.
"In clinical studies, a monoclonal antibody that targets the antigenic site II (i.e., palivizumab) has been shown to be highly effective at preventing RSV disease. In fact, palivizumab (trade name Synagis®) has been approved in multiple countries for years to prevent RSV disease in pre-mature infants.
"Together, these data points suggest a survival advantage for the RSV virus based on keeping the RSV F antigenic site II cryptic during natural infections, and that the antigenic site II specific immunity can be exploited for an effective vaccine."
Dr. Glenn went on to add: "Immunization with the Novavax RSV F nanoparticle vaccine antigen, which contains multiple copies of the antigenic site II epitope, induced robust antigenic site II specific antibodies in both our preclinical and clinical studies. In preclinical studies, immunization of cotton rats with RSV F nanoparticles induced anti-RSV IgG that was neutralizing, competitive for the binding of palivizumab to RSV F, and was completely protective against viral challenge.
"Similarly, in a Phase I placebo-controlled trial, the same vaccine given to healthy adults induced both RSV A and B microneutralizing antibodies that were significantly increased in vaccinees versus placebo and in excess of what has been observed to be protective in other epidemiological studies. Antibodies that both bind to and compete with the F protein antigenic site II were readily induced by the vaccine. Quantitative estimation of palivizumab-like activity found the highest dose group had a mean of 335 µg/ml, exceeding by around 10-fold the trough level used as guidance in palivizumab efficacy evaluations.
"The Novavax RSV F nanoparticle vaccine candidate displays the antigenic site II epitope in its native configuration and was found to induce functional immunity as measured both by microneutralization and palivizumab-like antibodies at levels that exceed those associated with decreased risk of hospitalization. Together, the results suggest that our RSV F nanoparticle vaccine holds great promise as a vaccine candidate for infants, children and the elderly who would benefit from protective immunity against RSV."
Dr. Glenn's plenary presentation, entitled "Recombinant nanoparticle vaccine: Preclinical and clinical evaluation of an Sf9 insect cell-derived respiratory syncytial virus fusion protein," is available in the Our Science/Presentations tab of the company's website, www.novavax.com. Dr. Glenn also served as a scientific advisor to the conference, which was organized to address the urgent need for new adjuvants, delivery systems and technologies to support the development of new vaccines. For more information about the conference, please visit www.meetingsmanagement.co.uk.
About Novavax, Inc.
Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines to address a broad range of infectious diseases worldwide. Using innovative virus-like particle (VLP) and 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 and LG Life Sciences of Korea. Together, these companies have worldwide commercialization capacity and 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 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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