Dynavax Technologies Corporation began its first human clinical trial in its Universal Flu vaccine programme. The phase-1 trial, which began vaccinating subjects in late June, will assess the safety and immunogenicity of N8295, the novel component of Dynavax's Universal Flu vaccine candidate. Approximately 40 subjects, divided into three dose groups, will receive two immunizations of N8295, one month apart. 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.
Novartis Vaccines and Diagnostics 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.
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.
Standard annual flu vaccines are designed to provide protection against the three strains of the influenza virus that are predicted to be most prevalent in an upcoming flu season. As such, these vaccines do not provide protection against divergent strains that emerge unexpectedly.
Dynavax's novel Universal Flu vaccine is designed to offer protection against divergent strains as well as increase the efficacy and potentially reduce the dose of standard flu vaccine. Dynavax's Universal Flu vaccine includes two conserved antigens, NP and M2e, which are present in all flu strains. Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases.