Pipeline :: Hepatitis B Vaccine

HEPLISAV™ Hepatitis B vaccine

Our lead product candidate is HEPLISAV™, a Phase 3 investigational adult hepatitis B vaccine that has demonstrated, in several Phase 3 trials, more rapid and superior protection with fewer doses than currently licensed vaccines. Our global strategy is to develop HEPLISAV for populations that are less responsive to currently licensed vaccines, including adults over 40 years of age, individuals with chronic kidney disease, and others.

We reported in July 2011 the results of our Phase 3 trial directed toward fulfilling licensure requirements in the U.S., Canada and Europe and expanding our safety database. We have an ongoing Phase 3 trial in chronic kidney disease patients, also directed at licensure.

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 4,800 individuals have been vaccinated with HEPLISAV to date.

The most recently reported topline results from our Phase 3 trial comparing HEPLISAV, an investigational hepatitis B virus (HBV) vaccine, to a currently marketed HBV vaccine, Engerix-B, demonstrated non-inferiority, superiority and the safety of HEPLISAV. The study evaluated a two-dose regimen of HEPLISAV administered at 0 and 1 month compared to a three-dose regimen of Engerix-B administered at 0, 1 and 6 months. The trial studied 2,449 healthy adults 40 to 70 years of age, randomized to HEPLISAV or Engerix-B in a 4:1 ratio. On July 28, 2011, the Food and Drug Administration (FDA) notified Dynavax that CBER agreed that clinical consistency of three consecutively manufactured lots of HEPLISAV have been demonstrated.

In an earlier completed pivotal Phase 3 trial, called PHAST, HEPLISAV demonstrated increased, rapid protection with fewer doses than currently licensed vaccines. 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 monovalent hepatitis B vaccines is estimated to exceed $400 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 2008, there were approximately 750,000 end-stage renal disease (ESRD) patients in the United States and 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 approximately 27-43% require boosters. As vaccination for these patients occurs regularly at dialysis centers, this is a concentrated, renewable market that can be served by cost-effective, targeted sales distribution networks.

HEPLISAV is a trademark of Dynavax Technologies Corporation