Dynavax's HEPLISAV(TM) Hepatitis B Vaccine Maintains Full Immunogenicity At 50 Weeks In Phase 3 Trial

Main Category: Liver Disease / Hepatitis
Also Included In: Immune System / Vaccines;  Clinical Trials / Drug Trials
Article Date: 20 Sep 2007 - 0:00 PDT

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Dynavax Technologies Corporation (Nasdaq: DVAX) announced that the seroprotection of HEPLISAV at 50 weeks after the first vaccination remained at 100% while the seroprotection of the comparator, GlaxoSmithKline's Engerix-B(R); vaccine declined.

The data show that after three doses, HEPLISAV provided seroprotection (anti-HBsAg antibodies greater than or equal to 10 mIU/mL) to 100% of subjects versus 68.6% for Engerix-B (p < 0.0001) as measured at 50 weeks.

These data were reported in a poster at the 47th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Chicago, IL. Primary endpoint data from this Phase 3 study in a difficult-to-immunize population of older adults were reported in November, 2006. The primary endpoint is seroprotection four weeks after the third vaccination.

According to Eduardo Martins, M.D., D.Phil., Vice President, Clinical Development, "These results demonstrate HEPLISAV's long-term superior immunogenicity over conventional hepatitis B vaccine as measured at 50 weeks. These data confirm earlier clinical studies showing that HEPLISAV has superior immunogenicity and comparable tolerability to Engerix-B. The overall results suggest that HEPLISAV elicits a faster immune response, higher rates of seroprotection and a more durable immune response than conventional vaccine."

The Phase 3 trial enrolled more than 400 seronegative subjects, 40 to 70 years of age, at study sites in Singapore, Korea and the Philippines. One group of subjects received three doses of Dynavax's HBV vaccine; the other group received three doses of Engerix-B.

Dynavax reported in mid-July 2007, that an international Phase 3 trial in Europe and Canada had completed enrollment. Data from the pivotal Phase 3 trial plus lot-to-lot consistency trials will contribute to a safety database of approximately 4,000 subjects for a planned BLA submission in 2008. Dynavax's HBV vaccine is based on its proprietary immunostimulatory sequence (ISS) that specifically targets Toll-Like Receptor 9 (TLR9) to stimulate an innate immune response. Dynavax's HBV vaccine combines ISS with HBV surface antigen (HBsAg) and is designed to significantly enhance the level, speed and longevity of protection. Dynavax indicates that as a result of its acquisition of Rhein Biotech in April 2006, the company has secured manufacturing capabilities in Dusseldorf, Germany for producing both clinical and initial commercial quantities of the hepatitis B surface antigen component of the vaccine.

About Dynavax

Dynavax Technologies Corporation discovers, develops, and intends to commercialize innovative TLR9 agonist-based products to treat and prevent infectious diseases, allergies, cancer, and chronic inflammatory diseases using versatile, proprietary approaches that alter immune system responses in highly specific ways. Our TLR9 agonists are based on immunostimulatory sequences, or ISS, which are short DNA sequences that enhance the ability of the immune system to fight disease and control chronic inflammation. Our product candidates include: HEPLISAV, a hepatitis B vaccine in Phase 3; TOLAMBA(TM), a ragweed allergy immunotherapy; a therapy for non-Hodgkin's lymphoma (NHL) in Phase 2 and for metastatic colorectal cancer in Phase 1; and a therapy for hepatitis B also in Phase 1. Our preclinical asthma and COPD program is partnered with AstraZeneca. The National Institutes of Health (NIH) partially funds our preclinical work on a vaccine for influenza. Symphony Dynamo, Inc. (SDI) funds our colorectal cancer trials and our preclinical hepatitis C therapeutic program. While the NIH and SDI provide program support, Dynavax has retained rights to seek strategic partners for future development and commercialization. For more information, please visit http://www.dynavax.com.

This press release contains forward-looking statements that are subject to a number of risks and uncertainties, including statements about clinical trials for HEPLISAV, the potential timing of the planned HEPLISAV BLA submission and the superiority of HEPLISAV. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including difficulties or delays in development, initiation and completion of clinical trials, the results of clinical trials and the impact of those results on the initiation and completion of subsequent trials and issues arising in the regulatory process; achieving our collaborative and licensing agreement objectives and obtaining regulatory approval; the scope and validity of patent protection and the possibility of claims against us based on the patent rights of others; our ability to obtain additional financing to support our operations; and other risks detailed in the "Risk Factors" section of our Quarterly Report on Form 10-Q. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.

Dynavax Technologies Corporation
http://www.dynavax.com