Firm will begin clinical development on vaccine candidate in 2008.

The NIAID has awarded a two-year, $3.25-million grant to Dynavax Technologies for the continued development of a novel universal influenza vaccine for controlling seasonal and emerging pandemic flu strains.

The research at Dynavax, backed by the NIH starting in 2003, focuses on a vaccine that incorporates a second-generation TLR9 agonist and the conserved influenza antigen nucleoprotein (NP). The current funding is directed toward advancing preclinical research into IND-enabling studies and product development.

“We believe that NP represents a unique vaccine component, that when conjugated to our second-generation TLR9 agonist, can address the limitations of seasonal flu vaccines as well as represent an important advance in the development of a universal vaccine to protect against a pandemic flu outbreak,” remarks Gary Van Nest, Ph.D., vp, preclinical research. “With this grant and based on strong preclinical data, we are planning to move into clinical development in 2008.”

Dr. Van Nest says that the vaccine provides strong, cross-strain protective immunity in mice. The vaccine may be used in conjunction with a standard vaccine to enhance immunogenicity and provide dose sparing of traditional flu vaccine components in both mouse and primate models, he adds. Dynavax is also using another conserved influenza antigen, the extracellular domain of matrix protein 2 (M2e) linked to a second-generation TLR9 agonist to generate broadly reactive antibody responses against influenza.

“Immune responses against both NP and M2e conjugates have the ability to kill virus infected cells that evade the protection provided by the standard vaccine,” points out Dr. Van Nest. “This is key when seasonal flu vaccines do not match the flu strains that emerge each year or especially if a completely new pandemic strain emerges.”

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