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.
But Dynavax believed it could address the agency's concerns, and it had positive data from PHAST showing that Heplisav provided greater seroprotection than one of two adult HBV vaccines available in the U.S. - Engerix-B from GlaxoSmithKline plc.
According to CEO Dino Dina, it was a combination of data and expert advice to FDA that resulted in the clinical hold being lifted.
Since then, additional Phase III data have shown two doses of Heplisav are superior to the standard