BERKELEY, CA--(Marketwire - February 22, 2011) - Dynavax Technologies Corporation (
Data from the Phase 1a and the Phase 1b study, initiated in September 2010, showed:
- N8295 alone or combined with H5N1 vaccine was very safe and generally well tolerated;
- The most common adverse events were mild, self-limited injection site reactions;
- There were no SAEs;
- All N8295 dose groups had an antibody response to M2e, and the placebo group did not;
- All N8295 dose groups had an antibody response to NP, and the placebo group did not;
- All N8295 dose groups had a cellular immune response to NP, and the placebo group did not;
- The addition of N8295 to a non-immunogenic dose of H5N1 vaccine resulted in H1 responses in all N8295 dose groups.(1)
Dr. J. Tyler Martin, M.D., Dynavax President and Chief Medical Officer, said, "The results of these trials demonstrate that N8295 has the attributes we intended: safety, M2e and NP immunogenicity, and the ability to adjuvant the H1 response to a HA based vaccine. These data will allow us to move forward with planning for a Phase 2 proof-of-concept trial."
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™, a Phase 3 investigational adult hepatitis B vaccine designed to enhance protection more rapidly with fewer doses than current licensed vaccines. For more information, visit www.dynavax.com.
[1] The Journal of Infectious Diseases 2008; 198:1309-16 and Vaccine 28 (2010) 840-848
Contact Information:
Contact:
Michael Ostrach
Vice President and Chief Business Officer
510-665-7257