The independent Data and Safety Monitoring Board (DSMD) completes its third preplanned review of Dynavax's (DVAX +5.6%) ongoing Phase 3 study, called HBV-23,
of its investigational hepatitis B vaccine candidate for adult
patients, HEPLISAV-B. The committee recommends that the study continue
unchanged. This was the same opinion that it had after its second review
in March.
Over 2,200 subjects have completed their final visit
under the study. All visits should be completed by October. Top-line
results are expected in early 2016.
HEPLISAV-B
combines hepatitis B surface antigen with a proprietary Toll-like
Receptor 9 agonist to enhance the immune response. Its value proposition
compared to currently available hep B vaccines is a higher
seroprotection rate with fewer doses. The current U.S. market is ~$270M.
Read more...Labels: HBV-23, HEPLISAV-B, vaccine efficacy