Novavax H7N9 VLP vaccine produced, purified and entered into preclinical immunogenicity and efficacy studies in less than a month
Production of GMP H7N9 clinical trial materials underway
ROCKVILLE, Md., May 10, 2013 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) today announced that it has completed purification of a lot of A/Anhui/1/13 H7N9 virus-like particle (VLP) vaccine and initiated animal immunogenicity and efficacy studies, including studies intended to evaluate protection against wild-type viral challenges. Novavax began work on the strain in early April. Analysis and optimization of the gene sequences for the key viral hemagglutinin (HA) and neuraminidase proteins, synthesis of the genes, construction of a recombinant baculovirus vector, infection of insect cells, purification of the first batches of VLP vaccine, and administration to animals were all completed in 28 days.
In October 2012, the company reported top-line data from its two Phase I clinical trials of A/H5N1 vaccine conducted under the company's $179 million contract with the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA). These trials showed that the VLP avian influenza vaccine was immunogenic at conventional doses without adjuvant and induced strong immunogenicity in all its adjuvanted dose groups including the lowest dose of 3.75µg. In addition to vaccine homologous antibody responses, cross clade immunity was also demonstrated. Such immunity could be important if a pandemic virus undergoes antigenic drift during a vaccine campaign.
"The Novavax team has demonstrated that recombinant vaccine technology can be used to rapidly move from identification of a lethal virus, to production of a vaccine," said Dr. Gregory Glenn, Novavax' Chief Medical Officer. "Based on our recent clinical trials with A/H5N1 vaccine that induced 100% seroprotection using low doses of an otherwise poorly immunogenic vaccine, we are optimistic that our A/H7N9 VLP may induce strong immune responses and perform well in animal efficacy testing."
"While our recent A/H5N1 clinical results help demonstrate the potential efficacy and immunogenicity of our pandemic VLP vaccines, we always believed the true test of our platform would be its ability to respond rapidly to an emerging pandemic threat," added Stanley C. Erck, President and Chief Executive Officer. "We have committed to this A/H7N9 campaign without outside funding."
About VLPs and Novavax' Vaccine Program
VLPs are self-assembling protein structures that resemble the external structure of viruses, elicit broad and strong antibody and cellular immune responses but lack the live genetic material that causes viral replication and infection. VLPs contain three of the major structural virus proteins that are important for fighting influenza: hemagglutinin and neuraminidase, both of which stimulate the body to produce antibodies that neutralize the influenza virus and prevent its spread through the cells in the respiratory tract, and matrix 1, which stimulates cytotoxic T lymphocytes to kill cells that may already be infected. VLPs can be designed quickly to match individual viral strains and be produced efficiently using portable recombinant cell-culture technology. Novavax' VLP-based vaccine candidates are produced more rapidly than egg-based vaccines because of our cell-culture technology platform combined with single-use bioprocessing technology employed strategically throughout the manufacturing process.
Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biopharmaceutical company creating 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 platform 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' 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 vaccine products 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, 2012, and filed with the Securities and Exchange Commission (SEC). 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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