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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 researches and develops 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 or partnered, development programs in the area of infectious disease consisted of an ongoing Phase 3 clinical trial of ASP0113 for prevention of cytomegalovirus (CMV) reactivation in stem cell transplant recipients and an ongoing Phase 2 clinical trial of ASP0113 for prevention of CMV infection in kidney transplant recipients, both in collaboration with Astellas Pharma Inc. (Astellas); an ongoing Phase 1/2 clinical trial using its Vaxfectin-formulated therapeutic vaccine for herpes simplex virus type 2 (HSV-2), a cause of recurrent genital herpes; and a completed preclinical program, with an allowed investigational new drug application using the company’s CyMVectin prophylactic vaccine formulated with its proprietary Vaxfectin adjuvant to prevent CMV infection during pregnancy. In addition, the company has licensed complementary technologies from major research institutions and biopharmaceutical companies. Product Development The company, together with its licensees and collaborators, is developing various DNA-based vaccines and therapeutics for the prevention or treatment of infectious diseases. Independent Programs Targeting Infectious Diseases HSV–2 HSV-2 is a member of the herpes virus family and is the major cause of recurrent genital herpes worldwide. In 2013, the company initiated a Phase 1/2 trial of its Vaxfectin-formulated therapeutic vaccine for HSV-2. A total of 165 HSV-2-infected patients were enrolled in the trial. In 2014, the company completed enrollment of the Phase 1/2 trial and expects to release topline efficacy data by the middle of 2015. CMV Vaccines The company is developing two CMV vaccines to address the unmet needs in each of these two populations, such as ASP0113 (TransVax, in collaboration with Astellas) and CyMVectin. ASP0113 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 ASP0113 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 CyMVectin consists of pDNA (closed loops of DNA called plasmids) that encodes the human CMV glycoprotein B antigen and pDNA that encodes the human CMV phosphoprotein 65 antigen. The product is formulated with the company’s proprietary lipid-based adjuvant Vaxfectin. Vaxfectin has been shown in clinical and/or nonclinical studies by the company and others to improve immune responses, particularly antibody responses, to expressed immunogens. Other Infectious Disease Programs Influenza Programs: The company 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. Ebola: In January 2015, the company and AnGes MG, Inc. announced a collaboration to develop and commercialize an equine polyclonal antibody therapy for patients afflicted with Ebola virus disease. The company would develop and provide to AnGes a DNA vaccine encoding the glycoprotein antigen of the 2014 Zaire strain of Ebola virus, formulated with its proprietary Vaxfectin adjuvant. Government Collaborations: The company has developed various vaccines targeting other diseases, including malaria, anthrax, severe acute respiratory syndrome (SARS), West Nile virus (WNV), and Ebola. The company has performed nonclinical work and completed a Phase 1 clinical trial targeting anthrax. The National Institutes of Health has completed Phase 1 clinical trials using the company’s vaccines targeting SARS, WNV, and Ebola. Adjuvant Development DNA Vaccines with Vaxfectin: Vaxfectin is the company’s prop


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