Pipeline :: Flu Vaccine

Our Universal Flu vaccine candidate is designed to offer protection against divergent influenza strains as well as to increase the efficacy and potentially reduce the antigen content of standard flu vaccines. This unique approach is based on our proprietary component N8295, which is a fusion protein comprised of two highly conserved influenza antigens, nucleoprotein (NP) and matrix protein 2 (M2e), covalently linked to our proprietary second-generation immunostimulatory sequence (ISS).

The antigens NP and M2e are present in all flu strains and are expected to confer protection against divergent strains of the virus. NP induces cytotoxic T-cell protection, and M2e induces antibodies that may provide protection against divergent strains. Our proprietary ISS may enhance vaccine efficacy and enable antigen-sparing. These three components form N8295, which is then combined with a conventional flu vaccine.

Standard flu vaccines can provide protection against the flu 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 proprietary component, N8295, could be combined with any flu vaccine, including standard trivalent influenza vaccine (TIV) and vaccines for emerging strains such as H5N1 or H1N1. We have established a worldwide supply and option agreement with Novartis Vaccines and Diagnostics, Inc., under which Novartis is supplying TIV.

Clinical Results

In mid-February, 2011, in Geneva, Switzerland, at the World Health Organization’s 7th Meeting on the Evaluation of Pandemic Influenza Prototype Vaccines in Clinical Trials, we reported new Phase 1a and Phase 1b safety and immunogenicity data for our universal flu candidate vaccine. The study evaluated 54 subjects, including 39 from the Phase 1a dose escalation study of N8295 and 15 from the Phase 1b dose escalation study of N8295 in combination with H5N1.

The data from the studies showed that N8295 alone or combined with H5N1 vaccine was safe and generally well tolerated. There were no serious adverse events (SAEs). Furthermore, the addition of N8295 to a non-immunogenic dose of H5N1 vaccine resulted in hemagglutination inhibition (HI) responses in all N8295 dose groups.

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.