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Hepatitis B Therapeutic Vaccine Appears Safe and Stimulates Immune Response

SUMMARY: In late December, Dynavax Technologies reported findings from a small early clinical trial showing that its investigational hepatitis B virus (HBV) therapeutic vaccine DV-601 -- intended to help control the virus in people already infected, rather than prevent infection -- was well tolerated and produced immunological and virological responses at all dose levels. Larger studies are needed, however, to show whether the vaccine is clinically effective.

Below is an excerpt from a press release issued by Dynavax describing the study findings.

Dynavax Reports Phase 1B Safety and Immunogenicity Results for Hepatitis B Therapy Candidate

Berkeley, CA -- December 23, 2010 -- Dynavax Technologies Corporation (NASDAQ: DVAX) today reported safety and immunogenicity data from its Phase 1b clinical trial of DV-601, its proprietary hepatitis B therapeutic vaccine. The dose escalation study assessed safety and the immunologic and virologic responses in 14 subjects with chronic hepatitis B infection. The Phase 1b data showed:

All doses were generally safe and well tolerated; and
Individual immunologic and virologic responses were observed across cohorts at all dose levels.

No conclusions regarding the potential clinical impact of the therapy could be reached in this small study. Dynavax's treatment approach combines both the surface and core hepatitis B virus (HBV) antigens with Iscomatrix adjuvant originally entered into development by Rhein Biotech prior to its acquisition by Dynavax in 2006. The candidate vaccine, DV-601, is designed to induce an immune response against HBV-infected cells and if proven to be safe and effective, may offer an alternative therapeutic option for patients chronically infected with HBV.

About Dynavax

Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The company's lead product candidate is Heplisav, a Phase 3 investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines. For more information, visit


Dynavax Technologies. Dynavax Reports Phase 1B Safety and Immunogenicity Results for Hepatitis B Therapy Candidate. Press release. December 23, 2010.























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