Dynavax Technologies Corporation announced an agreement with Novartis Vaccines and Diagnostics, Inc. for the supply and development, and possible commercialization, of Dynavax's novel Universal Influenza Vaccine in collaboration with Novartis.
Under the agreement Novartis will provide Dynavax a supply of trivalent influenza vaccine, an essential component of Dynavax's Universal Influenza Vaccine, for both clinical trial use and vaccine sales. Novartis receives an exclusive option to negotiate a Joint Development and Commercialization Agreement with Dynavax.
"This agreement with one of the world's leading manufacturers and innovators in influenza vaccines is a fundamental step for the successful development of our universal flu vaccine," said Dino Dina, chief executive officer and president of Dynavax. "With this agreement in place we can proceed toward the clinic and to licensure through a known regulatory pathway."
Under the agreement Dynavax will conduct early-stage development through a defined proof-of-concept. If Novartis exercises the right to negotiate a further agreement for development and commercialization, Dynavax would retain co-commercialization rights in the U.S. and receive product royalties outside of the U.S. Should the option not be exercised, Novartis remains committed to providing commercial supply of trivalent influenza vaccine with pre-agreed commercial terms and Dynavax retains the right to independently continue with late-stage development and commercialization.
The Dynavax Universal Influenza Vaccine combines a proprietary second-generation TLR9 agonist with two conserved influenza antigens, nucleoprotein (NP) and the extracellular domain of matrix protein 2 (M2e), and a trivalent influenza vaccine. The Dynavax vaccine is designed to be differentiated from other influenza vaccines by providing both an adjuvant effect to enhance the immunogenicity of the seasonal vaccine and cross-strain protection via conserved influenza antigens.
Gary Van Nest, vice president of vaccines stated, "We have demonstrated that our novel vaccine can provide cross-strain protective immunity in pre-clinical challenge models and that NP-ISS induces strong type-1 helper T cell (Th1) and cytotoxic T cell responses (CTL) that kill virus infected cells. M2e-ISS induces cytotoxic antibody responses that also kill infected cells, limiting disease severity. In effect, even if a standard flu vaccine does not match the virus that circulates in the season, our universal flu vaccine can potentially protect against viral disease caused by strains not included in the standard vaccine."
Dynavax Technologies Corporation discovers, develops, and intends to commercialize innovative TLR9 agonist-based products to treat and prevent infectious diseases, allergy, cancer, and chronic inflammatory diseases using versatile, proprietary approaches that alter immune system responses in highly specific ways.