Good news for Dynavax Pipeline

Recently, Dynavax Technologies Corp. (DVAX - Snapshot Report) received a boost when its lead candidate, Heplisav, a vaccine under development for treating patients suffering from the hepatitis B virus (HBV) proved to be superior to GlaxoSmithKline plc’s (GSK - Analyst Report) HBV vaccine, Engerix-B (the current standard of care).

These results were published on the website of the 61st annual meeting of the American Association for the Study of Liver Diseases (AASLD). The Dynavax vaccine (two doses over 4 weeks) displayed superior seroprotection in patients suffering from diabetes compared to Engerix-B (three doses over 24 weeks).

The data on 62 adult diabetics from the company’s previously reported multicenter late-stage study called PHAST (phase III Heplisav short-regimen trial) revealed that at 12 weeks 84% patients treated with Heplisav achieved seroprotection. However, none of the patients treated with Glaxo’s vaccine achieved similar results. The data revealed that at 28 weeks, 93% patients in the Heplisav arm achieved seroprotection as against 35% in the Engerix-B arm. The higher rate of seroprotection was displayed by Heplisav, despite patients in the Heplisav arm not being immunized beyond four weeks. However, patients in the Engerix-B arm received a third immunisation at 24 weeks.

Dynavax’s HBV vaccine is being evaluated in two late-stage studies. The continuity of studies was recently approved by the Data Safety Monitoring Board. One of them is a large-scale late-stage lot-to-lot consistency study. The large-scale study, which completed enrollment in May 2010, intends to show that Dynavax’s HBV vaccine is just as effective as Engerix-B eight weeks after the last active dose. The other study, whose enrollment is expected to be completed shortly, will evaluate Heplisav in patients with chronic kidney disease.

These two studies are aimed at fulfilling licensing requirements in the US, Canada and Europe. Heplisav aims to provide increased and rapid protection, utilizing fewer doses than currently available vaccines.

We currently have a Neutral recommendation on Dynavax, which is supported by a Zacks #3 Rank (short-term Hold rating).

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