July AdCom will give Dynavax a new shot to prove vaccine safety
- The Food and Drug administration has scheduled a Vaccines and Related Biological Products Advisory Committee (VRBPAC) advisory meeting for July 28 to review Dynavax Technologies' Heplisav-B hepatitis B vaccine.
- The new advisory committee meeting date is ten months after a similar meeting was canceled and an FDA rejection in November. The meeting will take place a month before the user fee action date of August 10.
- Dynavax stock briefly shot up 19% on high volume, but closed back at $5.85 on Monday. The stock opened lower Tuesday morning, and is well off its high of $23.62.
Getting Heplisav-B to this point has been a bit more complicated than Dynavax Technologies perhaps hoped. In September 2016, the Food and Drug Administration canceled the scheduled November advisory committee meeting in order to review a number of outstanding issues, and Dynavax's stock tumbled by over 30%.
This cancelation led to a turndown of its submission for approval on safety grounds, as predicted by analysts, with the complete response letter noting "adverse events of special interest" and a "numerical imbalance" in cardiac events seen in the HBV-23 study. Dynavax has been working to resolve the issues and will have to prove the drug is safe to the committee if it is going to reverse the FDA's previous decision.
"The notification of a VRBPAC [Vaccines and Related Biological Products Advisory Committee] meeting comes as no surprise and thus we are prepared for it," said Eddie Gray, CEO of Dynavax. "The company looks forward to continuing to work with the FDA through the review process and discussing Heplisav-B with the advisory committee."
Heplisav-B's advantage is its dosing schedule of just two doses over one month, rather than three over six months, and its effectiveness in people with type 2 diabetes. This group is particularly vulnerable to hepatitis B infections, but doesn't always have an adequate immune response to vaccination. In a Phase 3 study, Heplisav-B was seroprotective in 90% of people with diabetes, compared with 65% with GlaxoSmithKline's Engerix-B.
Dynavax has now restructured to focus resources away from the hepatitis B drug, cutting 38% of stuff to conserve cash and focus resources on its immunotherapy pipeline. It has kept aside money to complete the Heplisav-B development, and is seeking a partner for the vaccine.
- Dynavax Technologies Statement
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