Bavarian Nordic A/S said the phase 3 trial of its nonreplicating smallpox vaccine Imvamune met its main goals, showing the drug's effectiveness compared to a current U.S.-licensed replicating smallpox vaccine.
The study, conducted in 440 volunteers, demonstrated Imvamune's efficacy and statistically superior immune response in comparison to Acam2000. Based on the results, Imvamune stimulated peak neutralizing antibodies twofold higher than Acam2000.
The company plans to submit a biologics license application for the vaccine in the second half of 2018.
Bavarian Nordic funded the study in whole or in part using federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority.
