Vical Inc. (VICL)

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Vical's Vaxfectin(R) Demonstrates Potential as "Universal" Adjuvant

Press Release Source: Vical Incorporated On Monday December 13, 2010, 6:30 am EST

SAN DIEGO, Dec. 13, 2010 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL - News) announced today that the company's Vaxfectin(R) adjuvant has significantly boosted the immune response of DNA-based vaccines against a range of pathogens and cancer in preclinical models from rodents to non-human primates. Vaxfectin(R) has demonstrated similar effects with protein- and peptide-based vaccines in preclinical models. Vaxfectin(R)-formulated H5N1 influenza DNA vaccines were well-tolerated and elicited durable immune responses within the predicted protective range in initial human studies.

"Vaxfectin(R) has many of the desired features of a successful adjuvant," said Alain P. Rolland, Pharm.D., Ph.D., Vical's Executive Vice President of Product Development, "including the ability to significantly improve immune responses and favor specific types of immune responses. With a promising safety profile in preclinical and initial clinical studies, ease of formulation, stability and low manufacturing costs, Vaxfectin(R) is well-positioned as a potential 'universal' adjuvant for either immune enhancement or dose sparing applications in a broad range of infectious disease and cancer vaccines. A comprehensive new review of Vaxfectin(R) results published in the journal Expert Opinion on Drug Delivery[1] details Vaxfectin(R)'s development to date and should help us expand our outreach to potential licensees."

Vaxfectin(R) has been shown in multiple animal models to significantly increase the antibody and T-cell immune responses to antigens expressed from plasmid DNA vaccines. Results from two Phase 1 clinical trials of Vaxfectin(R)-formulated H5N1 influenza DNA vaccines demonstrated strong antibody responses and achieved T-cell responses in 75% to 100% of subjects in various dose cohorts. Vaxfectin(R) has demonstrated similar effect with protein-based vaccines, and the formulation can be adjusted to favor specific immune responses. The current publication reviews non-clinical immunological and efficacy studies of Vaxfectin(R) in several infectious disease and cancer models, preclinical safety and toxicology studies, clinical development of Vaxfectin(R)-formulated DNA vaccines, and studies of Vaxfectin(R)'s mechanism of action.

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