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In September 15, 2024— Joint Biosciences unveiled groundbreaking clinical data for its core oncolytic virus product, OVV-01, in a late-breaking oral presentation at the 2024 European Society for Medical Oncology (ESMO) Congress, where the trial was selected from hundreds of global submissions. The results highlight OVV-01’s efficacy and safety in treating advanced solid tumor patients. 

The Phase I study, conducted in China, employed a dose-escalation design to evaluate the safety, tolerability, and preliminary efficacy of OVV-01 in advanced solid tumor patients via intratumoral injection. The trial utilized a traditional 3+3 dose-escalation model across four dose cohorts. 

Key Clinical Data (as of August 2024): 

?  18 patients enrolled, with 11 efficacy-evaluable patients per protocol. 

?  Objective Response Rate at 16 weeks (ORR16w): 27.3% (3/11). 

?  Disease Control Rate at 16 weeks (DCR16w): 63.6% (7/11). 

?  Higher-dose cohorts (≥Cohort 3) showed improved outcomes: 

-          ORR16w: 40% (2/5 patients). 

-          DCR16w: 80% (4/5 patients). 

?   Notable efficacy in soft tissue sarcoma**: 

-          ORR16w and DCR16w both reached 75%** (3/4 patients). 

-          Two patients achieved complete response (CR)** in the high-dose group. 

Safety Profile:

?   No dose-limiting toxicities (DLTs)** observed. 

?   Maximum tolerated dose (MTD)** not reached. 

?   Common treatment-related adverse events (TRAEs)** in ≥20% of patients included: 

-          Pyrexia (66.7%)

-          Vomiting (22.2%)

-          Lymphocyte count decreased (27.8%)

-          Anemia (22.2%)

These events were consistent with the known safety profile of oncolytic virus therapies.