- Bavarian Nordic (OTCPK:BVNKF) (OTCPK:BVNRY) announces the results from two pivotal trials of its Imvamune smallpox vaccine.
- The first of two pivotal Phase 3 studies of the liquid-frozen formulation of Imvamune supporting a Biologics License Application (BLA) to the FDA met its primary endpoint of demonstrating equivalent antibody responses across three lots of product. The 4,000-subject, randomized, placebo-controlled, double-blind study assessed the consistency of antibody responses across three lots in three 1,000-person test arms compared to a 1,000-person control arm. No serious adverse reactions were reported.
- A Phase 2 study comparing the safely and immunogenicity of freeze-dried and liquid-frozen formulations of Imvamune across 650 vaccinia-naive healthy subjects showed equivalent antibody responses, which was the primary endpoint. The results support the stockpiling of the freeze-dried version in the U.S. Strategic National Stockpile. The company is working on increasing its manufacturing capacity of the freeze-dried formulation, supported by $22M in funding by the Biomedical Advanced Research and Development Authority (BARDA). Product deliveries will commence in 2016.