BERKELEY, Calif. — Dynavax Technologies Corp. announced Feb. 25 that it has selected a clinical vaccine candidate for its novel Universal Flu program and completed key preclinical studies.
The company is reviewing clinical plans with the Food and Drug Administration in anticipation of initiating a Phase I study by mid-year.
Dynavax also said the trial will be conducted at centers that are members of the Vaccine Testing and Evaluation Units of the National Institute for Allergy and Infectious Disease.
Specifically, Dynavax will collaborate with principal investigators Dr. Robert B. Belshe of the VTEU at St. Louis University and with Dr. Wendy A. Keitel of the VTEU at Baylor University in Houston. Dynavax made its comments Feb. 25 in connection with a workshop on influenza vaccinology sponsored by the President's Council of Advisors on Science and Technology in Washington, D.C.
According to Dino Dina, president and CEO, "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."
Dynavax indicated that a 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 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.