Pre-Clinical Study of Novavax's Seasonal Influenza VaccinePublished in Journal 'Vaccine'Data Demonstrate Broad, Robust Immune Response to VLP Vaccine
ROCKVILLE, Md., February 21, 2007 /PRNewswire-FirstCall/ -- Novavax, Inc. seasonal influenza vaccine produced robust and broad immune responses compared to other influenza vaccine types, according to a pre- clinical study published in the journal "Vaccine."
In the study, which appears in the online edition of the peer-reviewed journal "Vaccine," mice and ferrets were inoculated with Novavax's virus-like particle (VLP) vaccine. The VLP vaccine produced antibody responses that were between 1.8 and 7.4 times greater than antibody responses triggered by the comparator vaccines.
There remains an unmet medical need for more effective influenza vaccines. Traditional vaccines, which produce antibodies to the viral protein hemagglutinin, are effective in healthy adults but provide only limited protection among high-risk populations such as the elderly and patients with compromised immune systems. According to the study, Novavax's influenza vaccine triggered neutralizing antibodies against hemagglutinin. Novavax's VLP vaccine also produced antibodies against neuraminidase, which could lead to broader protection against viruses that mutate from season to season.
In both mice and ferrets, Novavax's H3N2 VLP vaccine raised antibodies against the 2002 Fujian strain of influenza as well as a broad group of seasonal flu viruses that had mutated over a five-year period. It is because of these annual mutations that traditional flu vaccines must be reformulated each year.
"The ability to elicit a broadly reactive immune response by a single vaccine against viruses from different flu seasons is an important advance," said Dr. Ted Ross, co-author and Assistant Professor of Medicine and Principal Investigator in the Center for Vaccine Research at the University of Pittsburgh School of Medicine. "These results have implications not only for seasonal influenza, but also for emerging influenza strains with pandemic potential."
Virus-like particles mimic the three-dimensional structure of a virus but do not contain genetic material, so they cannot replicate or cause infection. As VLPs maintain functional properties of both influenza surface proteins (hemagglutinin and neuraminidase), they likely trigger multiple arms of the immune system to generate a broadly protective immune response.
"Our VLP can mimic a live virus without infecting the host," said Dr. Rick Bright, lead author of the study and Novavax's vice president of global influenza programs. "These data are important because they show that the immune responses triggered by VLP vaccines may be broader than those from traditional vaccines."
The breadth of protection provided by Novavax's VLP vaccine "could mean that the vaccine will remain effective throughout an entire flu season and potentially could be effective the following year," Dr. Bright said.
"These data represent the first of three influenza strains that will ultimately comprise the seasonal vaccine we will take into human clinical trials," Dr. Bright said. As previously stated, Novavax plans to begin human clinical trials with its VLP vaccine for pandemic influenza later this year. Clinical trials using its seasonal flu strain could follow as soon as 2008.
Traditional influenza vaccines are made from viruses grown in chicken eggs that are then chemically inactivated, a process that can take up to six months. Novavax's vaccines are produced in insect cells using cell-culture technology in about 60 days.
The Novavax study is available at http://www.sciencedirect.com/science/journal/0264410X. The print edition of "Vaccine" will be published shortly.
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.
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 forward-looking statements or historical experience include risks and uncertainties, including 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.
Posted: February 2007