Dynavax Technologies Corporation announced that the National Institutes of Allergy and Infectious Disease (NIAID), a division of the National Institutes of Health (NIH), has awarded a two-year $3.25 million grant to continue development of a novel universal influenza vaccine for controlling seasonal and emerging pandemic flu strains.

The research at Dynavax, funded by the NIH starting in 2003, focuses on a new vaccine that incorporates a second- generation TLR9 agonist and the conserved influenza antigen nucleoprotein (NP). The new grant, U01AI074578, is directed toward advancing preclinical research into IND-enabling studies and product development.

According to Dr. Gary Van Nest, vice president, preclinical research, "The grant is another important endorsement of our approach. 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. With this grant, and based on strong preclinical data, we are planning to move into clinical development in 2008."

Dr. Van Nest said that Dynavax has shown in mice that its novel vaccine can provide strong, cross-strain protective immunity. He also indicated that mouse and primate models had shown that the novel vaccine may be used in conjunction with standard vaccine to enhance immunogenicity and provide dose sparing of traditional flu vaccine components. Dynavax is also using another conserved influenza antigen, the extra-cellular domain of matrix protein 2 (M2e) linked to a second-generation TLR9 agonist to generate broadly reactive antibody responses against influenza.

Dr. Van Nest continued, "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. 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."

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.