Ascletis Pharma Inc. announced the approval of the Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for in-house developed oral PD-L1 small molecule inhibitor, ASC61, for the treatment of advanced solid tumors. This is Ascletis' second U.S. IND approval in 2022 after ASC22 (Envafolimab) U.S. IND approval for functional cure of chronic hepatitis B (CHB).
The ASC61 Phase I trial in the U.S. is a dose-escalation study in patients with advanced solid tumors. The objectives of such study are to find a recommended Phase II dose (RP2D) and obtain preliminary efficacy in patients with advanced solid tumors. The first U.S. patient is expected to be dosed in the first half of 2022.
ASC61 is an oral potent and highly selective PD-L1 small molecule inhibitor and blocks PD-1/PD-L1 interaction through inducing PD-L1 dimerization and internalization. As a single agent, ASC61 demonstrated significant antitumor efficacy in multiple animal models such as the humanized mouse model. Preclinical studies showed that ASC61 has good safety and pharmacokinetic profiles in animal models.