YH001: FDA Approved Investigational New Drug Application

The FDA approved the Investigational New Drug application for initiating a Phase 1/2 clinical study of YH001 in combination with envafolimab and doxorubicin to treat sarcoma patients, including patients who have not received prior therapy.

The Phase 1/2 trial aims to assess the safety and efficacy of YH001 and envafolimab in patients with the rare sarcoma subtypes of alveolar soft part sarcoma and chondrosarcoma. Additionally, the trial objective is to assess the safety and efficacy of another combination of YH001, envafolimab, and doxorubicin in the common sarcoma subtypes of leiomyosarcoma and dedifferentiated liposarcoma.

YH001 is an IgG1 antibody targeting CTLA-4. It showed enhanced antibody dependent cellular cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC) in vitro when compared with ipilimumab. Additionally, YH001 demonstrated superior T cell activation and superior tumor growth inhibition activity compared to ipilimumab as a single agent and when combined with a PD-(L)1 antibody in human transgenic mouse tumor models in preclinical studies. YH001 has been dosed as a single agent in a Phase 1 trial in China (NCT04699929) and in combination with the PD-1 antibody toripalimab in a Phase 1 trial in Australia (NCT04357756).