Dynavax Presents New Efficacy Data on Hepatitis B Vaccine, HEPLISAV-B(TM), in Adults With Type 2 Diabetes at ADA Scientific Sessions

BERKELEY, CA--(Marketwired - June 11, 2016) - Dynavax Technologies Corporation (NASDAQ: DVAX) today announced preliminary results from a pivotal Phase 3 trial demonstrating that HEPLISAV-B [Hepatitis B Vaccine, Recombinant (Adjuvanted)] provided a significantly higher rate of seroprotection than Engerix-B®, an approved hepatitis B vaccine, in adults with type 2 diabetes mellitus. The data are being presented at the 76th Annual Scientific Sessions of the American Diabetes Association (ADA) in New Orleans.

Adults with diabetes are particularly vulnerable to infection with hepatitis B. According to the Centers for Disease Control and Prevention (CDC), people ages 23 to 59 with diabetes are about twice as likely to develop acute hepatitis B as individuals without diabetes. The CDC recommends that all adults age 19 to 59 should be vaccinated against hepatitis B as soon as possible after their diagnosis of diabetes, and those who are age 60 and older may be vaccinated at their physician's discretion after assessing their risk and the likelihood of an adequate immune response. Approximately 20 million U.S. adults have diabetes, and 1.5 million new cases of diabetes are diagnosed each year.

The Phase 3 trial, HBV-23, was a randomized, observer-blinded, active-controlled, multi-center study that compared two doses of HEPLISAV-B with three doses of Engerix-B in adults age 18 to70. Among the over 8,000 randomized participants, there were 1,144 adults with type 2 diabetes of whom two-thirds had diabetes for five years or more. Demographics consisting of age, sex and race were generally similar between the two treatment arms.

Results showed that HEPLISAV-B provided seroprotection in 90.0 percent of participants with diabetes compared with 65.1 percent for Engerix-B - a statistically significant difference of 24.9 percent. Larger differences were observed in participants age 60 to 70, with HEPLISAV-B demonstrating an 85.8 percent rate of seroprotection compared with 58.5 percent for Engerix-B. For participants with a body mass index greater than or equal to 30, HEPLISAV-B demonstrated an 89.5 percent rate of seroprotection compared to 61.4 percent for Engerix-B.