Dynavax Technologies
Corporation (Nasdaq: DVAX) announced today positive results from a Phase 2
trial comparing two different vaccination schedules of HEPLISAV, its
hepatitis B virus (HBV) vaccine. The primary endpoint is comparative
seroprotection after the second dose. The data was reported today in a
poster at the Canadian Immunization Conference in Winnipeg, Manitoba,
Canada by Dr. Scott A. Halperin, Professor of Pediatrics and Microbiology
and Immunology at Dalhousie University and Head of Pediatric Infectious
Disease at the Halifax-based IWK Health Center.
The data show that 100% seroprotection is achieved whether the second
dose is administered one or two months after the first.
According to Melissa Malhame, project leader for hepatitis B vaccines,
"The data presented in Canada are the first reported that support our
decision to study a two-dose, 0 and 1-month vaccination schedule for
HEPLISAV in our upcoming Phase 3 trials. By vaccinating at 0 and 1 month,
we once again see that HEPLISAV has a rapid onset of immunogenicity that
can effectively be translated to an even shorter, more convenient
vaccination schedule without compromising effectiveness."
Dr. Halperin indicated that 100% of all subjects were seroprotected at
month three (3) and that all subjects sustained seroprotection at month
eight (8). HEPLISAV was found to be safe and well tolerated.
The Phase 2 trial enrolled more than 40 seronegative subjects, 18 - 39
years of age, at one study site in Canada. One group of subjects received
HEPLISAV at 0 and 1 month; the other group received HEPLISAV at 0 and 2
months.
Dynavax plans to pursue approval of a two-dose regimen administered at
0 and 1 month, and expects to initiate multi-center, international Phase 3
trials in Europe, Canada and the United States before the year-end,
comparing the two-dose regimen against Engerix-B in patients from 11 to 55
years of age. The first dosing is expected in Canada, followed in early
2007 by dosing in the U.S. and in Europe. These trials are expected to be
completed 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. 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 commercial quantities of the vaccine.
About Dynavax
Dynavax Technologies Corporation discovers, develops, and intends to
commercialize innovative TLR9 agonist-based products to treat and prevent
allergies, infectious diseases, 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
pipeline includes: TOLAMBA(TM), a ragweed allergy immunotherapeutic, for
which a major safety and efficacy trial (DARTT) is currently underway, and
that is in a supportive clinical trial in ragweed allergic children;
HEPLISAV(TM), a hepatitis B vaccine in Phase 3; and a therapy for
non-Hodgkin's lymphoma in Phase 2. Our pre-clinical asthma and COPD
programs are partnered with AstraZeneca. Funding for our preclinical
programs in cancer, therapies for hepatitis B and hepatitis C; and for an
influenza vaccine has been provided by Symphony Dynamo, Inc. and the NIH,
and these programs represent future partnering opportunities. For more
information, please visit dynavax.
Dynavax Technologies Corporation
This press release contains forward-looking statements that are subject
to a number of risks and uncertainties, including statements about the
potential safety and efficacy of HEPLISAV, whether successful results may
be shown in additional clinical studies, the timing of and whether HEPLISAV
may show similar or supportive results in the planned Phase 3 clinical
studies and the potential for HEPLISAV to achieve clinical and commercial
success. 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, achieving the objectives
of our collaborative and licensing agreements and obtaining regulatory
approval for our products; the scope and validity of patent protection for
our products; possible claims against us on the patent rights of others;
competition from other companies; our ability to obtain additional
financing to support our operations; and other risks detailed in the "Risk
Factors" section of our Annual Report on Form 10-K and 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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