Pipeline :: Flu Vaccine

Our novel Universal Flu vaccine entered clinical development in June 2010. The Phase 1 trial is assessing the safety and immunogenicity of N8295, the novel component of Dynavax's Universal Flu vaccine candidate. A total of 39 subjects, divided into three dose groups, will receive two immunizations of N8295, one month apart. By late July 2010, all 39 had received their first immunizations. 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.

Our candidate 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 approach is based on combining two highly conserved antigens and our proprietary second-generation Toll-like Receptor 9 (TLR9) agonist with standard flu vaccines:

Two highly conserved antigens NP and M2e offer protection against divergent strains - Our Universal Flu vaccine includes two conserved antigens, NP and M2e, which are present in all flu strains. NP, or nucleoprotein, is highly conserved across human and animal strains, while M2e, the extracellular domain of the matrix 2 protein, is conserved but with some variations among species. NP provides cytotoxic T-cell protection and M2e offers protective antibodies for protection against divergent strains.
Our proprietary second-generation TLR9 agonist to enhance efficacy and enable dose-sparing - NP and M2e are linked to our proprietary second-generation TLR9 agonist, which has demonstrated the potential to boost the immune response and enable dose sparing, which could extend the quantity of standard flu vaccine available.
Standard flu vaccine - Our proprietary component, NP and M2e linked to our TLR9 agonist, is combined with the standard flu vaccine, to produce neutralizing antibodies. Our proprietary component could be combined with any standard flu vaccine, including standard trivalent influenza vaccine (TIV) and emerging strains such as H5N1 or H1N1.

Our research and development program has been partially funded by grants from the National Institutes of Health (NIH). Dynavax has established a worldwide supply and option agreement with Novartis Vaccines and Diagnostics, Inc. for our Universal Flu vaccine program.

Commercial Opportunity

Human viral influenza is an acute respiratory disease with high morbidity and mortality that occurs in annual epidemics worldwide. There are an estimated 30,000 to 40,000 viral influenza-associated deaths per year in the United States, primarily in those over 65 years of age. Influenza pandemics occur infrequently, on average every 30 to 40 years, but the next pandemic could result in millions of deaths worldwide. Analysts estimate the current worldwide market opportunity for seasonal influenza vaccines to be approximately $3 billion annually.

Standard flu vaccines can provide protection against the influenza strains predicted to be prevalent during a season. The efficacy of these vaccines is often decreased by unpredictable changes in the actual strains causing influenza. Current vaccines are also least effective in those who need prevention the most, the elderly and others with weaker immune systems. Pandemic vaccination is further complicated by the need to produce large quantities of vaccine in a short time period.

Our Universal Flu vaccine is designed to offer protection against divergent influenza strains, increase the efficacy of standard vaccines, and potentially reduce the dose of vaccine to extend the quantity available during a pandemic.