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FDA clearance of Intravenous (IV) and intravenous + intratumoral (IV+IT) administration of OVV-01 for advanced solid tumor. Breakthrough Progress for First-in-Class Oncolytic Virus Drug!

Source:Release Time:2025.04.02

March 25, 2025, Shanghai — Joint Biosciences (SH) Ltd. today announced its oncolytic vesicular stomatitis virus (VSV), OVV-01, has received U.S. FDA Investigational New Drug (IND) clearance of intravenous (IV) and intravenous + intratumoral (IV+IT) administration in phase I clinical trials. The new injection routes aim to enhance systemic distribution of the therapy via blood circulation, particularly targeting metastatic cancers, overcoming the limitation of local injection, and improving antitumor efficacy.


Key Advantages of Intravenous (IV) and intravenous + intratumoral (IV+IT) Administration

IV Delivery: Enables widespread distribution of the oncolytic virus to metastatic lesions and circulating tumor cells.

IV + IT Combination: Delivers local treatment to primary tumors while activating systemic antitumor immunity, enabling a "comprehensive strike" against both primary and metastatic sites.

Expanded Applicability: Addresses challenges in treating advanced, disseminated cancers through dual-targeted mechanisms.


Dr. George Zhou, Founder and CEO of Joint Biosciences, stated:

“We are thrilled to achieve another breakthrough in oncolytic virus development. Systemic IV administration allows OVV-01 to reach metastatic lesions throughout the body, while combining it with intratumoral delivery at primary sites creates a multidimensional therapeutic strategy. This FDA clearance reflects global regulatory confidence in OVV-01's innovation and strength our leadership in tumor immunotherapy.”