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12:00 AM
Oct 24, 2011
 |  BioCentury  |  Product Development

Heplisav's salvation

Superiority to GSK's Engerix-B, CDC vote could boost Dynavax's Heplisav for HBV

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 three doses of Engerix-B.

While Dynavax focuses on submitting its BLA and talking with potential new partners, it could gain momentum from the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP), which this week was expected to recommend that all diabetics be vaccinated against HBV.

On hold

Heplisav is a hepatitis B surface antigen (HBsAg) given with immunostimulatory DNA sequences (ISS) that target toll-like receptor 9 (TLR9). According to President and CMO J. Tyler Martin, TLR9 stimulation acts as an adjuvant that allows Heplisav to achieve a faster and more durable seroprotective response with two doses over one month vs. Engerix-B, which is given in three doses over six months.

While adjuvanted vaccines are not new, FDA had yet to approve an adjuvanted vaccine when it placed the clinical hold on Heplisav in March 2008. The agency has since approved GSK's Cervarix HPV vaccine, a bivalent vaccine against HPV types 16 and 18 that is formulated with the...

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