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ASP0113 Therapeutic CMV Vaccine

ASP0113 (formerly TransVax™) is a potentially first-in-class investigational DNA vaccine designed to prevent reactivation of latent cytomegalovirus (CMV) or introduction of the virus through donor cells or tissues in transplant recipients. ASP0113 is currently in a multinational Phase 3 registration trial in HCT recipients. Topline data are expected in the first quarter of 2018.

In July 2011, Vical entered into license agreements with Astellas Pharma Inc. granting Astellas an exclusive, worldwide, royalty-bearing license to develop and commercialize ASP0113 for the control and prevention of CMV infection in immunocompromised patients, including transplant recipients and transplant donors. Under the agreements, Astellas is responsible for further development and commercialization, including all costs. Vical will provide assistance to Astellas with ASP0113-related manufacturing, regulatory and certain development activities, for which Astellas will reimburse Vical, including personnel and external expenses. Vical will receive up to $65 million in upfront and milestone payments through commercial launch. Vical has an option to co-promote ASP0113 in the United States, and is entitled to receive double-digit royalties on net sales.

Approximately 70,000 allogeneic HCT procedures are performed annually worldwide. Currently there is no marketed CMV vaccine for these patients. The only approved antiviral treatment for CMV in HCT patients is Cytovene® (ganciclovir), although other antivirals (i.e., valganciclovir) are used off-label. A vaccine that enables the patient's immune system to control CMV reactivation, reducing the risk of complications from antiviral therapy and CMV disease, would provide a valuable therapeutic option for HCT recipients.

Background Information on CMV





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