Development Programs > Clinical Development Programs > Hepatitis B Prevention

Hepatitis B Prevention

Our lead product candidate is HEPLISAV™, a hepatitis B vaccine that met its primary endpoint in a Phase 3 trial and demonstrated the potential to provide more rapid and increased protection against hepatitis B viral infection and with fewer doses than the licensed vaccine. Our 9 clinical trials conducted over the past 10 years have included approximately 2,500 individuals.

HEPLISAV is aimed at unmet medical needs in the vaccination of adults and end-stage renal disease (ESRD) patients by providing rapid and increased protection with fewer doses. This vaccine is based on our proprietary immunostimulatory sequences (ISS) that specifically target Toll-like Receptor 9 (TLR9) to stimulate an innate immune response. HEPLISAV combines our first generation 1018 ISS with hepatitis B surface antigen (HBsAg) manufactured in our Dynavax Europe facility in Düsseldorf, Germany.

The two Investigational New Drug (IND) Applications for HEPLISAV have been and remain on U.S. FDA clinical hold. We are in active discussions with regulatory agencies to resolve the FDA’s clinical hold on HEPLISAV and identify an appropriate path for its approval in the United States, Europe, and the rest of the world

Clinical Results

HEPLISAV met its primary endpoint in a large, multi-center Phase 3 trial evaluating more than 2,400 subjects. The seroprotection rate at the primary endpoint was 95% in subjects receiving 2 doses of HEPLISAV at 0 and 1 month, compared to 81% in subjects receiving 3 doses of licensed vaccine Engerix-B at 0, 1, and 6 months. At each time point, there was a statistically significant (p < 0.0001) difference in the seroprotection rate for subjects receiving HEPLISAV or Engerix-B.

Commercial Opportunity

We estimate the hepatitis B vaccine market for healthy adults and ESRD patients worldwide to be approximately $500 million annually. HEPLISAV is designed to address the limitations of current vaccines by delivering complete vaccination in fewer doses and 5 months earlier than current vaccines.

Hepatitis B is a chronic disease which can lead to cirrhosis of the liver and hepatocellular carcinoma. There is no cure for hepatitis B and disease prevention through effective vaccines is critical to reducing the spread of the disease. Current hepatitis B vaccines for adults usually require 3 doses given over 6 months to provide seroprotection of approximately 30%, 75%, and 90% after the first, second, and third doses respectively. The effectiveness of current vaccines is further compromised because only 30% of people receive all 3 doses.

Engerix-B® is a registered trademark of GlaxoSmithKline.