Drug intelligence / Profile preview

ASP0113

Development stage
Phase 3
Lead developer
Astellas Pharma Global Development, Inc.
Modality
Prophylactic Vaccines → Vaccines & Immunotherapeutics, DNA Vaccines → Plasmid DNA → DNA Therapeutics → Nucleic Acid Therapeutics
Administration
Intramuscular
01

Overview

**ASP0113** is an investigational bivalent therapeutic **plasmid DNA vaccine** for prevention of cytomegalovirus infection, reactivation, and CMV disease in immunocompromised transplant recipients. Originally developed by Vical and licensed to Astellas, it contains two plasmids encoding human cytomegalovirus glycoprotein B and tegument phosphoprotein 65, intended to induce CMV-specific humoral and cellular immune responses after intramuscular administration. The program reached Phase 3 in CMV-seropositive recipients of allogeneic hematopoietic cell transplants, but the HELIOS study did not meet its primary or secondary efficacy endpoints; the ASP0113 program was subsequently terminated. ([thelancet.com](https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370%2821%2900067-5/fulltext))

Brand names
TransVax
Other names
CMVpp65/gB plasmid vaccine
02

Targets

gB (Human cytomegalovirus glycoprotein B)pp65 (Cytomegalovirus phosphoprotein 65)

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