Novavax's Pandemic Influenza Vaccine Candidates Trigger Robust Immune Response In Pre-Clinical Models

Main Category: Immune System / Vaccines
Also Included In: Bird Flu / Avian Flu;  Flu / Cold / SARS
Article Date: 09 Nov 2006 - 0:00 PDT

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Novavax, Inc.'s (Nasdaq: NVAX) novel pandemic influenza vaccine candidates triggered a protective immune response in several pre-clinical studies, according to data to be presented for the first time today at the Fifth World Congress on Vaccines, Immunization and Immunotherapy.

Novavax scientists created four vaccine candidates to protect against four different subtypes of human and avian influenza, including H5N1, the strain that global health officials believe could possibly set off a pandemic outbreak. These virus-like particle (VLP) vaccines, which have the three- dimensional structure of the influenza virus but don't contain genetic material, have been tested in three animal models, said Dr. Rick Bright, Novavax Vice President, Global Influenza Programs.

Data show each vaccine candidate triggered an immune response robust enough to protect against infection at very low doses of vaccine. Two of Novavax's vaccine candidates were tested in ferrets, the influenza animal model that is most relevant to humans. These vaccine candidates produced robust immune responses that provided protection against a variety of influenza strains, including strains not included in the vaccines.

Most influenza vaccines are made from proteins. When compared to a single flu protein of a 2002 influenza virus, Novavax's VLP vaccines raised and broadened the ferrets' immune response more than 3.5 times when tested against that virus. In addition, when the immune response was measured against a different influenza strain from 2004, the response generated by Novavax's VLP vaccines was more than eight times higher than that induced by the single flu protein.

"Our data demonstrate the potential for a single vaccine to protect against a range of influenza strains," Dr. Bright said. "This can be a critical factor in a pandemic situation, since a new vaccine would not have to be created every time the virus mutates," Dr. Bright said. "Our goal is to demonstrate in the clinic that our single H5N1 vaccine protects against new mutations of H5N1 viruses." Novavax plans to begin human clinical trials of its pandemic influenza vaccine during the first half of 2007.

While structurally similar to the live influenza virus, Novavax's VLPs do not have the virus's genetic material required for replication or infection. Upon vaccination, these particles attach to cells and trigger a natural immune response that is capable of protecting against influenza. Novavax also has the capability to scale up manufacture of its influenza vaccines rapidly using portable, disposable equipment. This unique manufacturing system does not rely on traditional egg-based methods for vaccine production, which are complex and require cumbersome equipment and many months of preparation.

The data were generated by Novavax and collaborators at the University of Pittsburgh's Center for Vaccine Research, the Southern Research Institute and the U.S. Centers for Disease Control and Prevention.

About Novavax

Novavax Inc. is committed to leading the global fight against infectious disease by creating novel, highly potent vaccines that are safer and more effective than current preventive options. Using the company's proprietary virus-like particle (VLP) and Novasome(R) adjuvant technologies, Novavax is developing vaccines to protect against H5N1 pandemic influenza, seasonal flu and other viral diseases. Novavax's particulate vaccines closely match disease-causing viruses while lacking the genetic material to cause disease, which provides potential for greater immune protection at lower doses than current vaccines. With an exclusive portable manufacturing system that allows for rapid mass-production of vaccines, Novavax is uniquely positioned to meet global public health needs.

Forward Looking Statements

Statements herein relating to future financial or business performance, conditions or strategies and other financial and business matters, including expectations regarding future revenues, operating expenses, and clinical developments are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Novavax cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Factors that may cause actual results to differ materially from the results discussed in the failure by Novavax to secure and maintain relationships with collaborators; risks relating to the early stage of Novavax's product candidates under development; uncertainties relating to clinical trials; risks relating to the commercialization, if any, of Novavax's proposed product candidates; dependence on the efforts of third parties; dependence on intellectual property; competition for clinical resources and patient enrollment from drug candidates in development by other companies with greater resources and visibility, and risks that we may lack the financial resources and access to capital to fund our operations. Further information on the factors and risks that could affect Novavax's business, financial conditions and results of operations, is contained in Novavax's filings with the U.S. Securities and Exchange Commission, which are available at http://www.sec.gov. These forward-looking statements speak only as of the date of this press release, and Novavax assumes no duty to update forward-looking statements.

Novavax, Inc.
http://www.novavax.com/

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