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ASP0113 (formerly known as TransVax) is an investigational bivalent DNA vaccine developed by Vical in partnership with Astellas Pharma Inc. It was designed to prevent cytomegalovirus (CMV) infection and its associated complications in immunocompromised patients, particularly those undergoing hematopoietic cell transplantation (HCT) or solid organ transplantation. The vaccine consists of two plasmids encoding the CMV phosphoprotein 65 (pp65) and glycoprotein B (gB) antigens, which are formulated with a proprietary poloxamer-based delivery system (CRL1005) and benzalkonium chloride to enhance immune uptake. Its mechanism of action involves inducing both cellular (T-cell) and humoral (antibody) immune responses against CMV. Although it received Orphan Drug Designation and reached Phase 3 clinical trials (the HELIOS study), the vaccine failed to meet its primary endpoints of improving overall survival or reducing CMV end-organ disease, leading to the termination of its development.
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