Dynavax Technologies Corporation (NASDAQ: DVAX) today announced completion of planned enrollment in the ongoing phase 3 clinical trial of HEPLISAV-B, its investigational adult hepatitis B vaccine. More than 8,250 adults, including over 1,100 diabetic subjects, have been enrolled at 40 sites in the U.S.
This large safety and immunogenicity study (known as HBV-23) is intended to provide an adequately-sized database of vaccinated subjects to enable the U.S. Food and Drug Administration to complete its review of the pending HEPLISAV-B Biologics License Application. The study is also designed to assess the immunogenicity of HEPLISAV-B in adults for whom approved hepatitis B vaccines are less effective, including those with type-2 diabetes mellitus.
“Concluding enrollment of HBV-23 is a major milestone in the path to potential approval of HEPLISAV-B. I am pleased with the team’s efforts to complete this key phase of the trial three months ahead of schedule” said Eddie Gray, Chief Executive Officer of Dynavax. “HEPLISAV-B is the most advanced demonstration of our leadership in TLR biology and validates our targeted approach to modulating the immune system to prevent and treat disease.”
HBV-23 is an observer-blinded, randomized, active-controlled trial. Adult subjects between the ages of 18 and 70 have been randomized in a 2:1 ratio to receive a 2-dose series of HEPLISAV-B or a 3-dose series of the control vaccine, Engerix-B®. Safety follow up will continue for 12 months following each subject’s second vaccination. All study visits will be completed by October, 2015.
Additional details regarding HBV-23 are available at www.clinicaltrials.gov.
HEPLISAV-B is an investigational adult hepatitis B vaccine that combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist to enhance the immune response. Dynavax has worldwide commercial rights to HEPLISAV-B.
Dynavax, a clinical-stage biopharmaceutical company, discovers and develops novel vaccines and therapeutics in the areas of infectious and inflammatory diseases and oncology. Dynavax’s lead product candidate is HEPLISAV-B, a Phase 3 investigational adult hepatitis B vaccine. For more information visit www.dynavax.com.