Novavax Announces New Seasonal Combination Respiratory Vaccine Program - Seite 2

We also demonstrated that we can combine the RSV F and influenza nanoparticle vaccines, bringing together a vaccine approach that induces broadly neutralizing antibodies against both influenza and RSV.  A vaccine with these attributes covering both influenza and RSV, which together are the major cause of serious respiratory infections in older adults and pediatrics, would be a major advance for public health.  Matrix-M adjuvant, which enhances the broadly-neutralizing preclinical antibody response, will be used together with the nanoparticle vaccines in a Phase 1/2 clinical trial early next year."

Advantages of Nanoparticle Influenza Vaccine versus VLP

Using lessons learned from the development of our RSV and Ebola nanoparticle vaccines we have identified several advantages, representing an evolution in vaccinology that have guided our strategic approach:

• Influenza nanoparticles are engineered to display conserved antigenic regions, which elicit broadly neutralizing antibodies;
  
  
• Improved manufacturing yields; and
  
  
• Use of Matrix M adjuvant, shown to be well-tolerated and highly effective at stimulating enhanced immunity.

HHS BARDA Contract Will Complete its Term as Scheduled in September 2016

Since 2011, Novavax has been developing influenza vaccines as part of a project that has been funded under our contract with the U.S. Department of Health and Human Services, Biomedical Advanced Research and Development Authority (HHS BARDA). The scope of the HHS BARDA contract (HHSO100201100012C) has been to develop seasonal and pandemic influenza vaccine candidates, based on our proprietary virus-like particle (VLP) technology.  The advances in our seasonal influenza nanoparticle program have resulted in a natural conclusion of our activities under the HHS BARDA contract, which will continue through the completion of its term in September 2016.

"Although our efforts have progressed beyond the scope of our current HHS BARDA contract and VLP vaccines, we are very excited to develop a differentiated seasonal influenza approach that builds on the proven success of our RSV F Vaccine," said Stanley C. Erck, President and CEO. "We also see enormous value in a combination respiratory vaccine that combines our seasonal influenza nanoparticle vaccine with our RSV F Vaccine. The next step in our program will be to conduct a multi-arm Phase 1/2 clinical trial of our seasonal influenza nanoparticles alone and in combination with our RSV F Vaccine, with and without our potent Matrix-M adjuvant. We expect to initiate this trial in early 2017."