Dynavax Technologies said that this starts a 12-month follow-up on these subjects and sets the study’s completion for May 2011. The 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 said that in a completed pivotal Phase 3 trial, Heplisav demonstrated increased, rapid protection with fewer doses than current licensed vaccines.
Dynavax has worldwide commercial rights to Heplisav and is developing the vaccine for large, high-value populations that are less responsive to current licensed vaccines, including individuals with chronic kidney disease. Heplisav combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist known as ISS to enhance the immune response.