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 dynavax.
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
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