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Company Description

Contact Info

10390 Pacific Center Court

San Diego, CA 92121

United States

Phone: 858-646-1100

Fax: 858-646-1150

Vical Incorporated engages in the research and development of biopharmaceutical products based on patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases. The company has three active independent clinical and preclinical development programs in the areas of infectious disease and cancer, including an enrolled ongoing Phase 3 clinical trial using its Allovectin immunotherapeutic in patients with metastatic melanoma which has been funded, up to certain limits, by AnGes MG, Inc. (AnGes) through cash payments and equity investments under a research and development agreement; a preclinical program, with an allowed investigational new drug application using its CyMVectin prophylactic vaccine formulated with its proprietary Vaxfectin adjuvant to prevent cytomegalovirus (CMV) infection before and during pregnancy; and a preclinical program with therapeutic and prophylactic vaccines for herpes simplex virus type 2 (HSV-2) formulated with its proprietary Vaxfectin adjuvant. The company has licensing arrangements with biopharmaceutical companies, such as Astellas Pharma Inc. (Astellas); Merck & Co., Inc. (Merck); Sanofi; AnGes; Aqua Health Ltd. of Canada (Aqua Health), an affiliate of Novartis Animal Health; and Merial Limited (Merial), a subsidiary of Sanofi. In addition, the company has licensed complementary technologies from research institutions and biopharmaceutical companies. It also has granted non-exclusive, academic licenses to its DNA delivery technology patent estate to 11 research institutions, including Stanford, Harvard, Yale, and the Massachusetts Institute of Technology. The non-exclusive academic licenses allow university researchers to use its technology free of charge for educational and internal, non-commercial research purposes. Product Development Independent Programs Targeting Infectious Diseases CMV Vaccines: The company and its collaborator are developing two CMV vaccines, TransVax and CyMVectin. TransVax is designed to serve the first patient population by preventing CMV reactivation or infection in transplant recipients. In 2011, the company licensed the right to develop and commercialize TransVax to Astellas. CyMVectin is designed to serve the second, much larger patient population by preventing primary CMV infection during pregnancy and thereby precluding maternal-fetal CMV transmission, congenital CMV infection, and related birth defects. CyMVectin consists of pDNA that encodes the human CMV gB antigen with pDNA that encodes the human CMV pp65 antigen. Other Infectious Disease Programs Influenza Programs: The company has applied its DNA delivery technology to the development of a pandemic influenza vaccine formulated with its proprietary adjuvant Vaxfectin. In 2011, the company completed a Phase 1 clinical trial of its Vaxfectin-formulated DNA vaccine against A/H1N1 pandemic influenza. Government Collaborations Two ongoing infectious disease programs are being conducted by the U.S. government using its technology. The National Institutes of Health (NIH) has clinical-stage vaccine programs based on its technology for HIV and is conducting a Phase 2b DNA-prime, adenovirus-boost study. The Naval Medical Research Center has initiated a Phase 1 study of a tetravalent (serotypes 1, 2, 3, and 4) dengue DNA vaccine formulated with Vaxfectin. In addition to these programs, the company has developed various vaccines targeted at emerging diseases, including malaria, anthrax, severe acute respiratory syndrome (SARS), West Nile Virus (WNV), and Ebola. The company has performed preclinical work and completed a Phase 1 clinical trial targeting anthrax. The NIH has completed Phase 1 clinical trials using its vaccines targeting SARS, WNV, and Ebola. Independent Program Targeting Cancer Allovectin: Allovectin is a plasmid/lipid formulation containing the DNA sequences encoding HLA-B7 and ß2 microglobulin, which together form a Major Histocompatibility Complex Class I complex. The company has completed a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (the FDA) for a Phase 3 trial of high-dose, 2 mg, Allov

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