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The data show that after three doses, HEPLISAV provided seroprotection(anti-HBsAg antibodies greater than or equal to 10 mIU/mL) to 100% of subjectsversus 68.6% for Engerix-B (p < 0.0001) as measured at 50 weeks.
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These data were reported in a poster at the 47th Annual InterscienceConference on Antimicrobial Agents and Chemotherapy (ICAAC) in Chicago, IL.Primary endpoint data from this Phase 3 study in a difficult-to-immunizepopulation of older adults were reported in November, 2006. The primaryendpoint is seroprotection four weeks after the third vaccination.
According to Eduardo Martins, M.D., D.Phil., Vice President, ClinicalDevelopment, "These results demonstrate HEPLISAV's long-term superiorimmunogenicity over conventional hepatitis B vaccine as measured at 50 weeks.These data confirm earlier clinical studies showing that HEPLISAV has superiorimmunogenicity and comparable tolerability to Engerix-B. The overall resultssuggest that HEPLISAV elicits a faster immune response, higher rates ofseroprotection and a more durable immune response than conventional vaccine."
The Phase 3 trial enrolled more than 400 seronegative subjects, 40 to 70years of age, at study sites in Singapore, Korea and the Philippines. Onegroup of subjects received three doses of Dynavax's HBV vaccine; the othergroup received three doses of Engerix-B.
Dynavax reported in mid-July 2007, that an international Phase 3 trial inEurope and Canada had completed enrollment. Data from the pivotal Phase 3trial plus lot-to-lot consistency trials will contribute to a safety databaseof 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 aninnate immune response. Dynavax's HBV vaccine combines ISS with HBV surfaceantigen (HBsAg) and is designed to significantly enhance the level, speed andlongevity of protection. Dynavax indicates that as a result of its acquisitionof Rhein Biotech in April 2006, the company has secured manufacturingcapabilities in Dusseldorf, Germany for producing both clinical and initialcommercial quantities of the hepatitis B surface antigen component of thevaccine.
About Dynavax
Dynavax Technologies Corporation discovers, develops, and intends tocommercialize innovative TLR9 agonist-based products to treat and preventinfectious diseases, allergies, cancer, and chronic inflammatory diseasesusing versatile, proprietary approaches that alter immune system responses inhighly specific ways. Our TLR9 agonists are based on immunostimulatorysequences, or ISS, which are short DNA sequences that enhance the ability ofthe immune system to fight disease and control chronic inflammation. Ourproduct candidates include: HEPLISAV, a hepatitis B vaccine in Phase 3;TOLAMBA(TM), a ragweed allergy immunotherapy; a therapy for non-Hodgkin'slymphoma (NHL) in Phase 2 and for metastatic colorectal cancer in Phase 1; anda therapy for hepatitis B also in Phase 1. Our preclinical asthma and COPDprogram is partnered with AstraZeneca. The National Institutes of Health (NIH)partially funds our preclinical work on a vaccine for influenza. SymphonyDynamo, Inc. (SDI) funds our colorectal cancer trials and our preclinicalhepatitis C therapeutic program. While the NIH and SDI provide programsupport, Dynavax has retained rights to seek strategic partners for futuredevelopment and commercialization. For more information, please visithttp://www.dynavax.com.
This press release contains forward-looking statements that are subject to
