Pipeline :: Hepatitis B Vaccine

HEPLISAV™ Hepatitis B vaccine

Our lead product candidate is HEPLISAV™, a Phase 3 investigational adult hepatitis B vaccine that is designed to elicit enhanced protection more rapidly and with fewer doses than current licensed vaccines. Our global strategy is to develop HEPLISAV for populations that are less responsive to current licensed vaccines, including adults over 40 years of age, individuals with chronic kidney disease, and others.

We have initiated a Phase 3 trial in chronic kidney disease patients and a Phase 3 lot-to-lot consistency trial in adults over 40 years of age. The lot-to-lot trial is a large-scale trial designed to demonstrate the lot-to-lot consistency of commercial vaccine and to complete the safety database for HEPLISAV. Both studies are directed toward fulfilling licensure requirements in the U.S., Canada and Europe. In the U.S., patient enrollment and immunization is ongoing; at the Canadian sites, immunizations are expected to begin shortly. Dynavax has worldwide commercial rights to HEPLISAV, which combines hepatitis B surface antigen (HBsAg) with a proprietary Toll-like Receptor 9 (TLR9) agonist to enhance the immune response.

Clinical Results

Over 2,500 individuals have been vaccinated with HEPLISAV to date. Phase 3 data from our PHAST clinical trial demonstrate subjects over 40 years of age receiving two doses of HEPLISAV over one month achieved a seroprotection rate of 92%, compared to 75% of subjects receiving 3 doses of a licensed vaccine over six months.

Commercial Opportunity

The total worldwide market for adult hepatitis B vaccines is estimated at over $500 million annually. Current vaccines leave unmet needs for more rapid and increased protection, particularly for less responsive, underserved populations.

Chronic Kidney Disease Market – A high-value segment, the chronic kidney disease market is large, growing rapidly, and is widely recommended for vaccination. In 2006, there were approximately 750,000 end-stage renal disease (ESRD) patients in the United States and the 5 major European markets and approximately 150,000 new patients are added annually. Approximately 35% of these immunocompromised ESRD patients do not respond to vaccination and 20% require boosters. As vaccination for these patients occurs regularly at dialysis centers, this is a highly concentrated, renewable market that can be served by cost-effective, targeted sales distribution networks.

HEPLISAV is a trademark of Dynavax Technologies Corporation