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Joint Biosciences Oncolytic Virus OVV-01 Receives Dual IND Clearances from U.S. FDA

Source:Release Time:2024.10.16


On September 25, 2024,  Joint Biosciences announced that its first-in-class drug, OVV-01 (vesicular stomatitis virus-based injection of oncolytic therapy), has received dual IND clearances from the U.S. Food and Drug Administration (FDA) for both Phase II and Phase I clinical trials. This milestone is China’s first oncolytic virus product to have dual FDA IND clearances.


Dr. George Zhou, Founder and CEO of Joint Biosciences, stated: “We are thrilled to share this breakthrough. The safety and efficacy of OVV-01 have been preliminarily validated in phase I trial, and this clearance made a critical milestone in our R&D development, and reflects the FDA’s comprehensive recognition of OVV-01’s potential, elevating us from a preclinical status to a clinical-stage innovator.”


About OVV-01

OVV-01 is a recombinant vesicular stomatitis virus (VSV) engineered to carry the NY-ESO-1 tumor-associated antigen. It selectively replicates within tumor cells, releasing the highly immunogenic NY-ESO-1 antigen. This dual mechanism modulates the tumor immune microenvironment, induces tumor-specific immune responses, and promotes T-cell activation, expansion, and recruitment. By enhancing T-cell infiltration into tumors and counteracting immunosuppression, OVV-01 achieves potent antitumor activity.


About Joint Biosciences
Founded in 2020 and headquartered in Shanghai,  
Joint Biosciences dedicates to First-in-Class and First-in-human therapeutic R&D. The company’s proprietary OVV and OVV-Drive-IO Platform integrates oncolytic viral vaccines with combination immunotherapy for solid and hematologic malignancies.