Dynavax
Technologies Corp. could soon reap the rewards of persevering with its
Heplisav HBV program. It has Phase III data in hand showing superiority to standard
of care, a BLA submission planned for year end and a CDC vote this month that
would expand the vaccine's market opportunity.
Three years ago, FDA put the Heplisav program on clinical hold
after a single case of Wegner's granulomatosis, a disease in which the blood
vessels are inflamed, was reported in the Phase III PHAST trial. Later that
year, partner Merck
& Co. Inc. returned rights.