Dynavax Phase 3 Data in Chronic Kidney Disease Demonstrates Superiority of HEPLISAV vs Engerix-B

Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that the company has unblinded its Phase 3 primary endpoint immunogenicity data in subjects with chronic kidney disease and that the data achieved statistical significance demonstrating both the superiority and non-inferiority of HEPLISAV as compared to Engerix-B. A partial safety analysis also showed a similar safety profile for the two vaccines, with the incidence of post-injection reactions and adverse events similar in both groups.

This Phase 3 multi-center trial evaluated 507 subjects with chronic kidney disease, as defined by a modified intent-to-treat analysis, and compared three doses of HEPLISAV given at months 0, 1 and 6 with eight doses of Engerix-B given as double-doses at months 0, 1, 2 and 6. Detailed results of the trial will be presented in November at the American Society of Nephrology Kidney Week meeting in Philadelphia.