Dynavax Technologies Corporation reported completing the first immunizations of over 2,000 subjects enrolled in its large-scale phase-3 study of Heplisav. This starts a 12-month follow-up on these subjects and sets the study's completion for May 2011. Dynavax said this event supports its goal of a BLA submission for Heplisav in the second half of 2011.
Heplisav is an investigational adult hepatitis B vaccine. The vaccine candidate is being evaluated in two phase-3 studies that are directed toward fulfilling licensure requirements in US, Canada and Europe.
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases.