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Fast Track Designation (FTD), established by U.S. FDA, aims to accelerate the development of novel drugs for serious diseases with unmet clinical needs.

Following the granting of FTD, applicants gain enhanced opportunities for communication with FDA during subsequent drug development and review processes. This facilitates early identification and resolution, expediting the drug’s approval and commercialization. Additionally, applicants may submit investigational data for New Drug Applications (NDA/BLA) via a rolling submission, significantly streamlining the regulatory pathway. These benefits will strongly support the rapid development and approval of OVV-01, accelerating to market.

Dr. George Zhou, Founder and CEO of Joint Biosciences, commented: "We are very pleased to achieve this milestone in the field of oncolytic virus development. The FTD designation will accelerate the clinical development of OVV-01 and strength its potential for serious diseases and unmet medical needs. We will actively engage with the FDA to expedite the commercialization of this therapy and strive to provide safer, more effective treatment for advanced soft tissue sarcoma."

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.