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news.Dynavax has selected a clinical vaccine candidate for its novel Universal Flu program, completed key preclinical studies and is reviewing clinical plans with the FDA in anticipation of initiating a Phase I study by mid-year.
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Dynavax also said that the trial will be conducted at centers that are members of the Vaccine Testing and Evaluation Units (VTEUs) of the National Institute for Allergy and Infectious Disease (NIAID/NIH). Specifically, Dynavax will collaborate with Dr Robert Belshe, principal investigator of the VTEU at St Louis University in St Louis, MO and with Dr Wendy Keitel, principal investigator of the VTEU at Baylor University in Houston, TX.
Dynavax indicated that a GLP toxicity study demonstrated that its Universal Flu vaccine candidate is well-tolerated and clinical material for the upcoming trial has been manufactured. Through the addition of two highly conserved antigens, known as NP and M2e, linked to a proprietary TLR9 agonist, Dynavax’s Universal Flu vaccine is designed to offer protection against divergent influenza strains, increase the efficacy of standard vaccines, and potentially reduce the dose of vaccine to extend the quantity available during a pandemic.
Dynavax presented data on its Universal Flu vaccine at two medical conferences in 2009: Third International Conference on Influenza Vaccines for the World in Cannes, France April 27 – 30, 2009 and the Twelfth Annual Conference on Vaccine Research in Baltimore, Maryland April 27 – 29, 2009.
Dynavax’s research and development program has been partially funded by grants from the National Institutes of Health (NIH). Dynavax has a worldwide supply and option agreement with Novartis Vaccines and Diagnostics for the Universal Flu vaccine program and is exploring grants and other sources of funding for the Phase 1 clinical trial program.
Dino Dina, president and CEO, said: “As new pandemic threats such as the H1N1 epidemic of the 2009 flu season emerge, it is becoming increasingly clear that our Universal Flu approach represents an important intervention with the potential to provide broad protection against new strains of the influenza virus. We expect the initial data, including evidence of the biological activity of the vaccine’s proprietary components, to be available this year.”