YH001 is a recombinant humanized anti-CTLA-4 IgG1 monoclonal antibody. We have primarily completed a Phase I clinical trial in Australia to evaluate the safety, tolerability and pharmacokinetics of YH001 when combined with toripalimab in patients with advanced solid tumors with the RP2D identified. Pre-clinical data show that YH001 has stronger blocking effect and ADCC activity than Yervoy. Pre-clinical and clinical data also demonstrate robust anti-tumor activities of YH001 in combination with toripalimab. Preliminary data from the Phase I clinical trial show a favorable safety and efficacy profile of YH001. We believe that YH001 is a potentially best-in-class anti-CTLA-4 antibody. We are initiating a Phase II MRCT of YH001 in the United States.
We received the IND approvals from the FDA in June 2021 and are applying for CTN/IND approval from the TGA, the Taiwan FDA and the NMPA. We will also explore the expansion of anti-CTLA-4 YH001 in combination of anti-PD-1 antibodies for the treatment of other solid tumor indications. In addition, we intend to conduct a clinical trial of YH001 in combination with YH002 in patients with advanced solid tumors in China and Australia.
Moreover, we plan to apply for a Phase I dose escalation in Australia to evaluate the safety, tolerability, preliminary efficacy and pharmacokinetics of YH001 and YH003 in combination with toripalimab in patients with advanced solid tumors. We will also further explore anti-CTLA-4 YH001 treatment for other solid tumor indications.
