Dynavax launches first human trial of universal flu vax

Dynavax (NASDAQ: DVAX) has been busy over the last few days. The Berkeley, CA-based vaccine developer says it has begun dosing its first patients in a Phase I trial of its experimental universal flu vaccine. And the biotech company says that it won a $600,000 federal grant to fund research work on a new universal vaccine to guard against HPV, which can trigger cervical cancer.

Roughly 40 volunteers will be assessed in the trial to test the safety and immunogenicity of N8295. The subjects have been divided into three dose groups and are scheduled to be vaccinated twice, with a month between jabs. N8295 is a fusion protein, which is comprised of two influenza antigens covalently linked to Dynavax's second-generation TLR9 agonist. A proof-of-concept trial for the flu vaccine is slated to run next year.

Dynavax's lead program is Heplisav, a hepatitis B vaccine that grabbed headlines back in April after researchers turned in promising mid-stage data. Soon after that milestone, Dynavax released positive preclinical data for its flu program.

There are already two vaccines approved to prevent infections from HPV; both target strains responsible for most cancer cases. Dynavax will use a $600,000 grant from the NIH to develop a vaccine that provides immunity to "nearly all cancer-causing strains of HPV." Each year, 470,000 cervical cancers are diagnosed worldwide, and 250,000 deaths are due to cervical cancers.

- here's the release on the Phase I flu trial
- get the release on the NIH grant
- here's the story from the San Francisco Business Times