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On September 25, 2024,  Joint Biosciences announced that its self-developed Class I innovative drug, OVV-01 (a vesicular stomatitis virus-based injection for 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 makes OVV-01 China’s first oncolytic virus product to secure dual FDA IND approvals simultaneously.

Dr. Zhou Guoqing, 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 investigator-initiated trials (IIT), and its entry into formal registrational clinical trials marks a critical milestone in our R&D journey. The concurrent clearance of Phase II and Phase I IND applications reflects the FDA’s comprehensive recognition of OVV-01’s potential, elevating Joint Biosciences from a preclinical-stage company to a mid-clinical-stage innovator. This achievement underscores our leadership in tumor immunotherapy and global competitiveness. We are actively advancing OVV-01’s regulatory submissions in China.”

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, lysing them to release multiple tumor antigens—including the highly immunogenic NY-ESO-1 antigen. This process modulates the tumor immune microenvironment, triggers tumor-specific immune responses, and enhances T-cell activation, proliferation, and recruitment. By overcoming immunosuppressive barriers, OVV-01 drives T-cell infiltration into tumors, amplifying antitumor efficacy.

About Joint Biosciences
Founded in 2020 and headquartered in Shanghai,  Joint Biosciences is a global leader in innovation-driven cancer immunotherapy, dedicated to pioneering First-in-Class and First-in-human therapeutics. The company’s proprietary OVV-Drive-IO Platform integrates oncolytic viral vaccines with combination immunotherapies for solid and hematologic malignancies. With cutting-edge intellectual property, world-class innovations, and expertise in operations, financing, and clinical development, RongRui focuses on delivering urgently needed cancer immunotherapies to save patients’ lives.