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Vical Expands Testing Of Vaxfectin(TM) Adjuvant To U.S. Navy Malaria Vaccine Program

July 08, 2017

Vical Incorporated (Nasdaq: VICL) announced today that the company has signed a Cooperative Research and Development Agreement (CRADA) with the Naval Medical Research Center (NMRC), a biomedical research organization within the U.S. Navy, to explore the use of Vical's novel Vaxfectin(TM) adjuvant with experimental DNA vaccines against malaria. Vaxfectin(TM) 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(TM) and their use with DNA vaccines, as well as patents in the United States covering the use of Vaxfectin(TM) 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(TM) 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(TM)-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(TM) adjuvant."

Vaxfectin(TM) 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(R) 2005-2006 Formula commercial product) formulated with Vaxfectin(TM) 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(TM) 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(TM)-formulated vaccine will be designed to elicit both T-cell and antibody immune responses.

About Vical

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. The company is developing certain infectious disease vaccines and cancer therapeutics internally. In addition, the company collaborates with major pharmaceutical companies and biotechnology companies that give it access to complementary technologies or greater resources. These strategic partnerships provide the company with mutually beneficial opportunities to expand its product pipeline and address significant unmet medical needs. Additional information on Vical is available at vical.

This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements about Vical's technology and its current and potential applications, the scope of coverage of and potential applications for the company's issued and future patents and the potential uses and benefits of Vaxfectin(TM), as well as the company's focus, collaborative partners, and product candidates. Risks and uncertainties include whether the company's technology will be successfully applied by the NMRC or others; whether the company's issued patents will be challenged and whether such challenges will have an adverse effect on the scope of the patents; whether the company will enforce its issued patents or will be successful in any enforcement efforts; whether the company will successfully prosecute additional patent applications and whether such applications will lead to the issuance of additional patents; whether we will begin human testing of a Vaxfectin-formulated vaccine as anticipated in the second half of 2007, or at all; whether Vaxfectin(TM), if used as an adjuvant in any vaccine in human clinical trials, will be safe and effective at enhancing the immune response; whether the company or any of its collaborative partners will incorporate Vaxfectin(TM) into any of their products; whether Vical or others will continue evaluation of Vaxfectin(TM) as an adjuvant for conventional vaccines against seasonal or pandemic influenza; whether Vaxfectin(TM) will be used as a dose-sparing agent with conventional influenza vaccines against seasonal or pandemic influenza strains; whether Vical or others will continue development of the pandemic influenza DNA vaccine candidate; whether any strains of influenza will emerge as pandemic threats; whether the company's DNA vaccine candidate will be effective in protecting humans against emerging strains of influenza; whether the influenza vaccine or any other product candidates will be shown to be safe and effective; the timing, nature and cost of clinical trials; whether Vical or its collaborative partners will seek or gain approval to market any product candidates; whether Vical or its collaborative partners will succeed in marketing any product candidates; and additional risks set forth in the company's filings with the Securities and Exchange Commission. These forward-looking statements represent the company's judgment as of the date of this release. The company disclaims, however, any intent or obligation to update these forward-looking statements.

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