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Biopharma announced that its research-resistant CD40 antibody (YH003) has been used in combination with Junshi Biosciences' anti-PD-1 antibody Toripalimab (TUOYI®) to demonstrate anti-tumor activity in Phase I/II clinical trials.
The trial is a multi-center, open-label study with a multi-dose upgrade phase designed to assess the safety, tolerance, pharmacogenetics and initial efficacy of YH003 in the joint treatment of advanced solid tumors with Toripalimab;
for example, a 68-year-old woman with eye melanoma and liver metastasis is resistant to a joint protocol of first-line Nivolumab (anti-PD-1 antibody) and second-line Nivolumab/Ipilimumab (anti-CTLA-4 antibody).
the subject underwent a three-week single-drug treatment cycle of YH003 and then a three-cycle YH003/Toripalimab combined treatment for a total of 12 weeks.
imaging assessment showed a partial response in the 10th week after treatment, with a 38.5% reduction in the total diameter of all target lesions.
dose-limiting toxicity (DLT) was not observed in the study.
YH003 promotes CD40 activity on antigen delivery cells, thereby stimulating the effect factor of anti-tumor T cells.
whether used alone or in combination with anti-PD-1 antibodies, YH003 showed strong anti-tumor effects in CD40 humanized mice and significantly increased the proportion of anti-tumor T-cells.
in mice and primates, YH003 showed good safety at very high doses.
