Dynavax Technologies Corporation reports that enrollment and the first immunizations of 39 subjects enrolled in its Phase 1 study of the company's universal flu vaccine have been completed. Safety and immunogenicity data from this study are anticipated in the fourth quarter of this year.
The Phase 1 trial began vaccinating subjects in late June to assess the safety and immunogenicity of N8295, the novel component of Dynavax's Universal Flu vaccine candidate. Since that time, 39 subjects were divided into three dose groups. All subjects have received the first of two immunizations of N8295; all subjects will complete their second immunizations one month after the first. 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's 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. Preclinical data have confirmed the expected immunogenicity and mechanistic effects of the vaccine candidate's novel components. The production of cytotoxic T-cells by NP and cytotoxic antibodies by M2e have been demonstrated in preclinical studies, as has an increase in neutralizing antibodies provided by a co-administered inactivated influenza vaccine. A GLP toxicity study demonstrated that this universal flu vaccine candidate is well tolerated.
Novartis Vaccines and Diagnostics, Inc. is committed to supply influenza vaccine for Dynavax's clinical trials under a worldwide supply and option agreement signed in 2008. Novartis has an option to negotiate a joint development and commercialization agreement for Dynavax's Universal Flu vaccine and is obligated to provide commercial supplies of its vaccine once clinical proof-of-concept has been established. A clinical study to demonstrate proof-of-concept data is planned for 2011.