In addition to the demonstrated ability of Dynavax’s vaccine to generate cytotoxic T-cells and cytotoxic antibodies, the data showed that the universal components of Dynavax’s vaccine enhanced the efficacy of a standard flu vaccine by increasing antibody production directed at virus neutralisation.
Dynavax said that these data are key indicators of immunogenicity and the potential for dose-sparing in the event of a pandemic. Dynavax’s Universal Flu vaccine is designed to combine a TLR9 agonist and two conserved antigens, NP and M2e, with a standard trivalent flu vaccine.
Dynavax plans to initiate Phase 1 clinical development of Universal Flu vaccine by mid-year 2010 at centers that are members of the Vaccine Testing and Evaluation Units (VTEUs) of the National Institute for Allergy and Infectious Disease (NIAID/NIH).
Reportedly, a GLP toxicity study has demonstrated that this Universal Flu vaccine candidate is well-tolerated, and clinical material for the upcoming trial has been manufactured.
Dynavax’s research and development program has been partially funded by grants from the National Institutes of Health (NIH). Dynavax has a supply and option agreement with Novartis Vaccines and Diagnostics, for the Universal Flu vaccine program.
Dino Dina, president and CEO of Dynavax, said: “The vaccine candidate presented at the Vaccine Research conference represents the final formulation that we intend to take into the clinic. We have now confirmed the key biological effects of this molecule, and are on-track to begin clinical development imminently.”