DYNAVAX INITIATES PIVOTAL PHASE III TRIAL VACCINE

Dynavax Technologies has announced the initiation of a pivotal Phase III clinical trial of its hepatitis B (HBV) vaccine.

The pivotal Phase III trial is designed to compare the effectiveness of Dynavax's HBV vaccine to GlaxoSmithKline's Engerix-B HBV vaccine in an older adult population that is more difficult to immunize with conventional vaccine. A second pivotal Phase III trial in a younger adult population to be conducted in Europe and Canada is anticipated to begin in early 2006.

Assuming positive data from these trials, Dynavax could potentially file a Biologic License Application for its HBV vaccine in 2007.

Dynavax's HBV vaccine is based on its proprietary immunostimulatory sequence (ISS) that specifically targets Toll-Like Receptor 9 (TLR-9) to stimulate an innate immune response. Dynavax's HBV vaccine combines ISS with HBV surface antigen (HBsAg) and is designed to significantly enhance the level, speed and longevity of protection.