Today, Novavax announced it has completed purification of one lot of A/Anhui/1/13 H7N9 virus-like particle (NYSE:VLP) vaccine and has commenced animal immunogenicity and efficacy studies, including studies that are intended to evaluate protection against wild-type viral challenges. The company began work on the strain in early April 2013, completing within 28 days analysis and optimization of the gene sequences for the key viral hemagglutinin (NASDAQ:HA) and neuraminidase proteins synthesis of the genes, construction of a recombinant baculoviris vector, infection of insect cells, purification of the first batches of VLP vaccine, and administration to animals.
In October of last year, Novavax reported topline data from its two Phase I clinical trials of A/H5N1 vaccine, which were 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). The trials demonstrated that the VLP avian influenza vaccine was immunogenic at conventional doses without adjuvant and induced strong immunogenicity in all its adjuvanted does groups, including the lowest dose of 3.75ug. Vaccine homologous antibody responses were demonstrated as well as cross clade immunity - an immunity which could be important if a pandemic virus experiences 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 Novavax Chief Medical Officer Dr. Gregory Glenn. "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 the company's recent clinical results for A/H5N1 help demonstrate the potential efficacy and immunogenicity of its pandemic VLP vaccines, Novavax has always believed the real test of its platform would be the ability to quickly respond to an emerging pandemic threat. The company has committed to its A/H7N9 campaign without the aid of outside funding.
For more information, visit the Novavax Web site at novavax.com
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