Novavax announces positive results from pre-clinical toxicology study of RSV vaccine candidate

Novavax, Inc. (Nasdaq: NVAX) reported today that results from a pre-clinical toxicology study of its vaccine candidate to prevent respiratory syncytial virus (RSV), showed the vaccine to be safe and well-tolerated at all doses tested.  Novavax's vaccine uses highly purified recombinant particles of RSV-F fusion (RSV-F) protein normally found in the virus. There is currently no approved vaccine to prevent RSV infection.

In previous animal studies, Novavax's vaccine candidate was well tolerated and protected against challenge with live RSV. In this safety study, rabbits were immunized with a placebo or the RSV-F vaccine at a dose of 3 or 30 micrograms with or without an aluminum phosphate adjuvant to boost immunogenicity. A placebo or vaccine was administered to each animal by intramuscular injection on days 1, 15 and 29. There were no vaccine-related adverse effects observed on any key measures of safety other than mild and temporary local reactions at the injection site.

Dr. Rahul Singhvi, President and CEO of Novavax said, "We have now tested our RSV vaccine candidate in well-accepted animal models of toxicity and disease and found sufficient evidence of safety and effectiveness to advance our RSV vaccine candidate toward human clinical trials.  The results of this formal safety study are consistent with our previous findings and provide identification of a safe dose for testing in a Phase I clinical study. We believe that these results, and our overall pre-clinical package, moves us one step closer to filing an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA)."