Ascletis Pharma Inc. announces the approval of the Investigational New Drug (IND) application by 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).
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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.
ASC61 oral tablets, which will be used in the clinical trial, were developed with the in-house proprietary technology.
Compared to injectable PD-1/PD-L1 antibodies, ASC61, as an oral PD-L1 inhibitor, has the following benefits: (1) ease of dosing and no need for hospital visits for injections; (2) all-oral combinations with other oral anti-tumor drugs; and (3) rapid titration of doses for better management of immune-related adverse events (irAEs).
“We are excited about U.S. IND approval of ASC61,” said Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis, “This IND approval demonstrates Ascletis’ global R&D capability in oncology. As we are advancing the phase III clinical trial of ASC40, a fatty acid synthase (FASN) inhibitor, in combination with Bevacizumab for the treatment of recurrent glioblastoma (rGBM), this U.S. IND approval is another significant milestone for Ascletis’ oncology pipeline. Furthermore, we are exploring opportunities for all-oral combinations between oral PD-L1 small molecule inhibitor ASC61 and ASC40 as well as other oral anti-tumor drugs from our business partners.”