Dynavax Reports Phase 1a Safety and Immunogenicity Results for Universal Flu
Vaccine
Detailed Phase 1a and 1b Results to Be Reported at WHO Meeting in February 2011
BERKELEY, CA, Dec 07, 2010 (MARKETWIRE via COMTEX) -- Dynavax Technologies
Corporation (DVAX) today reported safety and immunogenicity data from its Phase
1a clinical trial of N8295, one of two key components of its Universal Flu
Vaccine candidate. N8295 is a fusion protein comprised of NP and M2e, two highly
conserved influenza antigens covalently linked to Dynavax's proprietary
second-generation TLR9 agonist. The trial assessed three dose levels of N8295 in
a total study population of 39 subjects. The Phase 1a data showed:
--All doses were very safe and generally well tolerated;
--No dose limiting toxicities;
--Positive antibody responses to M2e; and
--Positive T-cell mediated responses to NP.
Based on preliminary safety data, Dynavax initiated a Phase 1b study in September
2010 to evaluate the safety of the combination of N8295, the novel component of
Dynavax's Universal Flu vaccine candidate, and an investigational H5N1 avian
influenza vaccine. Detailed results of the Phase 1a and 1b studies will be
reported at the World Health Organization 7th Meeting on Evaluation of Pandemic
Influenza Prototype Vaccines in Clinical Trials in Geneva, Switzerland in
February 2011.
Dr. J. Tyler Martin, M.D., Dynavax President and Chief Medical Officer, said,
"Now that we have completed the safety assessment of the novel component, N8295,
we are eager to assess the combination of N8295 with an avian flu vaccine. Those
data are expected to improve our understanding of the immunologic properties of
our universal flu vaccine candidate in the absence of pre-existing immunity to
the H5N1 flu strain in human subjects. These are key achievements in the
continued development of Dynavax's Universal Flu Vaccine as they should allow us
to design a proof-of-concept study."
Dynavax's Universal Flu Vaccine is designed to offer protection against divergent
influenza strains as well as to increase the efficacy of a conventional influenza
vaccine. Preclinical data have confirmed the expected immunogenicity and
mechanistic effects of the vaccine candidate's novel components. The production
of cytotoxic T-cells by NP and cytotoxic antibodies by M2e have been demonstrated
in preclinical studies, as has an increase in neutralizing antibodies provided by
a co-administered conventional influenza vaccine. A GLP toxicity study
demonstrated that this Universal Flu vaccine candidate is well-tolerated.
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(TM), 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.com.
Forward-looking Statements
This press release contains "forward-looking statements" that are subject to a
number of risks and uncertainties, including statements related to the
anticipated timing and nature of data from clinical trials of our universal flu
vaccine candidate and the features of the vaccine. Actual results may differ
materially from those set forth in this press release due to the risks and
uncertainties inherent in our business, including whether results of completed
studies can be replicated in human studies with greater numbers of subjects,
difficulties or delays in initiation and completion of preclinical or clinical
studies, the results of those studies and the impact of those results on the
initiation and completion of subsequent studies and issues arising in the
regulatory process; achieving the objectives under our collaborative agreement;
our ability to obtain additional financing to support our operations; and other
risks detailed in the "Risk Factors" section of our current periodic reports
filed with the SEC. We undertake no obligation to revise or update information
herein to reflect events or circumstances in the future, even if new information
becomes available.
Contact:
Michael Ostrach
Vice President and Chief Business Officer
510-665-7257
Email Contact
SOURCE: Dynavax Technologies |
