Researchers for Dynavax and Merck say that a late-stage trial of their hepatitis B vaccine Heplisav hit the endpoint they were aiming at: non-inferior antibody response compared to GlaxoSmithKline's Engerix-B. The vaccine is being studied as a treatment for end stage renal disease. Altogether 95 percent of the Heplisav group developed HBV antibodies compared to 81 percent of the Engerix-B group. Dynavax shares surged about 11 percent on the news.
The FDA had placed a clinical hold on the Heplisav work earlier in the year after a patient developed symptoms of an autoimmune disease. And BioWorld notes that the hold--which is ongoing--has interrupted research needed to support the companies' BLA. Pressed by analysts, Dynavax CEO Dino Dina declined to lay out a timeline for responding to the FDA or when he expects the hold to be lifted.
- here's the release
- read the report on Heplisav