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 four active, independent or partnered, development programs in the area of infectious disease. An ongoing Phase 3 clinical trial of ASP0113 for prevention of cytomegalovirus (CMV), reactivation in hematopoietic 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). Astellas expects enrollment in the Phase 3 clinical trial to be completed during the third quarter of 2016. In June 2015, the company announced results from an ongoing randomized, double-blind, placebo controlled Phase 1/2 clinical study of its therapeutic genital herpes vaccine, designed to reduce viral shedding and genital herpes lesions in herpes simplex virus type 2 (HSV-2), infected patients. An ongoing Phase 1 program of VL-2397 for invasive fungal infections, including invasive Aspergillus, which are major causes of morbidity and mortality in immunocompromised patients, including transplant recipients. A completed preclinical program, with an allowed investigational new drug application (IND), using the company’s CyMVectin prophylactic vaccine formulated with its proprietary Vaxfectin adjuvant to prevent CMV infection during pregnancy. 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 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 plasmids (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 immunogens. Other Infectious Disease Programs In January 2015, the company and AnGes MG announced a collaboration to develop and commercialize an equine polyclonal antibody therapy for patients afflicted with Ebola virus disease. Government Collaborations The company has developed various vaccines targeting other diseases, including dengue, 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 Naval Medical Research Center, or NMRC, has completed a Phase 1 study of a tetravalent (serotypes 1, 2, 3, and 4) dengue DNA vaccine formulated with Vaxfectin. Adjuvant Development DNA Vaccines with Vaxfectin Vaxfectin is the company’s proprietary, cationic lipid formulation optimized to increase the immune response to vaccines. Vaxfectin formulations have demonstrated safety and adjuvant activity in pDNA vaccine applications in multiple animal models, including nonhuman primates. Studies of Vaxfectin-formulated pDNA vaccines against CMV and measles have shown enhanced immunogenicity in rodents and nonhuman primates. Other Vaxfectin Applications The company has a nonexclusive license with Bristol-Myers Squibb Company, or BMS, for ots patented platform DNA immunization technology and its Vaxfectin adjuvant for use in the production of antibodies. Strategy The key element
vical inc (VICL:NASDAQ CM)
10390 Pacific Center Court
San Diego, CA 92121
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