Vical Incorporated Expands Portfolio of CMV Vaccine Technologies Through License Agreement With The Wistar Institute

SAN DIEGO, Jan. 22 /PRNewswire-FirstCall/ -- Vical Incorporated today announced a license agreement with The Wistar Institute granting Vical exclusive, worldwide rights to Wistar’s Towne strain of cytomegalovirus (CMV) and related technologies. Financial terms of the license agreement were not disclosed.

The Towne strain is an attenuated, or weakened, form of human CMV which was developed for potential vaccine applications by renowned vaccinologist Stanley Plotkin, M.D., a member of Wistar’s research faculty from 1960 to 1991 and co-author of the definitive medical text Vaccines. Dr. Plotkin currently is executive advisor to sanofi pasteur, the vaccine division of sanofi aventis, professor emeritus of virology at The Wistar Institute, and professor emeritus of pediatrics at the University of Pennsylvania. Among his many contributions to vaccine research while at Wistar, Dr. Plotkin developed the Rubella vaccine now in common use worldwide. He also developed experimental vaccines against polio and varicella and collaborated on vaccines against rabies and rotavirus.

“In a number of vaccine studies over the years, the Towne strain has demonstrated the ability to elicit targeted immune responses against CMV,” said Dr. Plotkin, “and it was recently used in a prime-boost combination to demonstrate the memory immune response elicited by DNA vaccination. Continued advances in the fields of vaccines and immunology may create new opportunities for commercialization. I am pleased to see the Towne strain advance in the hands of a capable vaccine development company such as Vical.”

Russel E. Kaufman, M.D., president and CEO of the Wistar Institute, added, “We are delighted to have Vical as a corporate partner who has the expertise and resources to pursue the application of this Wistar technology.”

Vical’s President and Chief Executive Officer, Vijay Samant, said, “CMV is an important target for Vical, and the Wistar technology adds to our already-strong intellectual property in this field. As we approach the completion of enrollment in our CMV vaccine trial for hematopoietic cell transplant recipients, we view the Towne strain as an excellent opportunity to expand our options to address the congenital CMV market segment, which may include our Vaxfectin(TM) adjuvant, vaccine delivery devices, and prime-boost vaccination.”

Stuart Adler, M.D., Professor of Pediatrics at Virginia Commonwealth University, is currently conducting a Phase 2 / 3 clinical trial of a Towne strain vaccine in up to 180 CMV-seronegative women with children in daycare to evaluate its safety and effectiveness in preventing CMV infection. The trial is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). Vical is separately conducting a Phase 2 trial of a DNA-based CMV vaccine in up to 80 donors and recipients undergoing hematopoietic cell transplant (HCT) procedures, and up to 80 additional HCT recipients, to evaluate its safety and effectiveness in reducing the occurrence rate of clinically significant CMV levels.

About CMV

CMV is a herpes virus that infects more than half of all adults in the United States by age 40, and is even more widespread in developing countries. While a healthy immune system typically protects an infected person against CMV disease, it rarely succeeds in completely eliminating the infection, and those whose immune systems are not fully functional are at high risk of CMV proliferation, potentially leading to severe illness or death. Those at heightened risk include transplant patients who take immunosuppressive drugs, and fetuses and newborns of mothers who first become infected during pregnancy.

CMV infection affects 30 to 60 percent of the patients undergoing various transplant procedures, causing transplant rejection, serious illness and even death if untreated. Expensive antiviral drug therapy is used to control the disease, but does not eliminate the infection. Congenital CMV infection affects one out of every hundred infants, and causes severe consequences in about 3,600 infants and death in about 400 each year in the United States. CMV is the most common intrauterine infection of fetuses and the most frequent infectious cause of congenital deafness and mental retardation. The Institute of Medicine of the National Academy of Science considers a vaccine against CMV to have the highest priority.

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 http://www.vical.com.

About The Wistar Institute

The Wistar Institute is an international leader in biomedical research with special expertise in cancer research and vaccine development. Founded in 1892 as the first independent nonprofit biomedical research institute in the country, Wistar has long held the prestigious Cancer Center designation from the National Cancer Institute. Discoveries at Wistar led to the creation of the rubella vaccine that eradicated the disease in the United States, human rabies vaccines used worldwide in humans and animals, and a new rotavirus vaccine approved in 2006. Today, Wistar is home to preeminent research programs such as the Wistar Institute Vaccine Center, launched in 2007. Vaccine Center scientists are creating new vaccines against pandemic influenza, HIV, and other diseases threatening global health. Wistar works actively to transfer its inventions to the commercial sector to ensure that research advances move from the laboratory to the clinic as quickly as possible. The Wistar Institute: Today’s Discoveries -- Tomorrow’s Cures. On the web at http://www.wistar.org.

This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected, including: whether the company will successfully enroll 80 matched, related stem cell transplant donor/recipient pairs or 80 additional recipients in a timely manner, if at all; whether the CMV vaccine will achieve the safety and efficacy endpoints in the Phase 2 trial for stem cell transplant donors and/or recipients, including whether the favorable interim safety data are predictive of safety data for the full trial; whether the company will expand development of a CMV vaccine to address prevention of congenital disease; whether the vaccine will induce both antibody and cellular immune responses; whether the vaccine will prevent clinically significant CMV levels; 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.

http://www.vical.comaporter@wistar.orghttp://www.wistar.org

CONTACT: Alan R. Engbring of Vical Incorporated, +1-858-646-1127; or Abbey
J. Porter of The Wistar Institute, +1-215-898-3943, aporter@wistar.org

Web site: http://www.vical.com/
http://www.wistar.org/

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