Vical Incorporated has signed a Cooperative Research and Development Agreement (CRADA) with the Naval Medical Research Center (NMRC), a biomedical research organization within the US Navy, to explore the use of Vical's novel Vaxfectin adjuvant with experimental DNA vaccines against malaria.
Vaxfectin is a cationic lipid/co-lipid formulation designed to increase the immune response to vaccines.
The company holds patents in the United States and Europe covering a new class of adjuvants including Vaxfectin and their use with DNA vaccines, as well as patents in the United States covering the use of Vaxfectin with conventional vaccines based on proteins, polypeptides, and polysaccharides, including those containing all or part of a bacterial or viral pathogen. Vical has provided Vaxfectin to academic researchers for several years, and data have been published showing evidence of increased immunogenicity and/or protective efficacy of DNA vaccines against diseases including anthrax (Vical), tuberculosis (Pasteur Institute of Brussels), HIV (UC-San Francisco), Japanese Encephalitis Virus (Kobe U School of Medicine), influenza (Vical), and malaria (NMRC) in animal models ranging from mice to non-human primates.
"We expect initial human testing of a Vaxfectin-formulated DNA vaccine to begin in the second half of 2007 in our pandemic influenza program," said Vijay B. Samant, Vical's President and Chief Executive Officer, "potentially paving the way for other applications to advance into clinical-stage development. We believe the potential of this new class of adjuvants is quite broad, including DNA vaccines and conventional vaccines against infectious diseases or cancer. We are especially pleased to expand our collaboration with the U.S. Navy on the malaria vaccine development program with the Vaxfectin adjuvant."
Vaxfectin was developed to boost the immune response to DNA vaccines, but also has been shown to boost the immune response to a conventional seasonal influenza vaccine. In mouse studies, conventional influenza vaccines (Sanofi-Pasteur Fluzone 2005-2006 Formula commercial product) formulated with Vaxfectin yielded significantly higher hemagglutination inhibition titers, the accepted standard correlate of protection, than unformulated vaccines at even an approximately 10-fold higher dose. Results from the study suggest that Vaxfectin has the potential to be used as a dose-sparing agent with conventional influenza vaccines against seasonal or possibly pandemic influenza strains.
The NMRC plans to conduct a series of antigen screening tests and further development in several animal models of malaria to optimize the design of a vaccine potentially leading to initial testing in humans. The Vaxfectin-formulated vaccine will be designed to elicit both T-cell and antibody immune responses.
Vical researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases. Potential applications of the company's DNA delivery technology include DNA vaccines for infectious diseases or cancer, in which the expressed protein is an immunogen; cancer immunotherapeutics, in which the expressed protein is an immune system stimulant; and cardiovascular therapies, in which the expressed protein is an angiogenic growth factor.