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news.Dynavax Technologies has initiated first Phase 1 human trial in its universal flu vaccine program to evaluate the safety and immunogenicity of N8295. In the trial, the patients are expected to receive two immunizations of N8295, one month apart.
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N8295 is the novel component of Dynavax’s Universal Flu vaccine candidate. N8295 is a fusion protein comprised of NP and M2e, two highly conserved influenza antigens covalently linked to Dynavax’s proprietary second-generation TLR9 agonist. Dynavax expects to report data by year-end 2010.
Dynavax claimed that its Universal Flu Vaccine is designed to offer protection against divergent influenza strains as well as to increase the efficacy of a standard trivalent inactivated influenza vaccine.
The preclinical data have confirmed the expected immunogenicity and mechanistic effects of the vaccine candidate’s novel components.
Dynavax said that the Novartis Vaccines and Diagnostics will supply influenza vaccine for Dynavax’s clinical trials under a worldwide supply and option agreement signed in 2008.