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- U.S. Phase I trial aims to find recommended Phase II dose and achieve preliminary efficacy in patients with advanced solid tumors
- First U.S. patient dose expected in first half of 2022
- ASC61 shows significant antitumor efficacy as a single agent in various animal models
HangzhouChina and Shaoxing, China, February 6, 2022 /PRNewswire/ — Ascletis Pharma Inc. (HKEX: 1672) today announced that the U.S. Food and Drug Administration (FDA) has approved an Investigational New Drug (IND) application for ASC61, an in-house developed oral PD-L1 small molecule inhibitor, For the treatment of advanced solid tumors. This is the second U.S. IND approval for Ascletis in 2022, following the U.S. IND approval of ASC22 (Envafolimab) for functional cure of chronic hepatitis B (CHB).
The ASC61 Phase I trial in the United States is a dose-escalation study in patients with advanced solid tumors. The purpose of such studies is to find a recommended phase II dose (RP2D) and achieve preliminary efficacy in patients with advanced solid tumors. The first US patient is expected to be dosed in the first half of 2022.
ASC61 is an orally potent and highly selective PD-L1 small molecule inhibitor that blocks PD-1/PD-L1 interaction by inducing PD-L1 dimerization and internalization. As a single drug, ASC61 exhibits significant antitumor efficacy in multiple animal models, such as humanized mouse models. Preclinical studies have shown that ASC61…
The full story is available on Benzinga.com
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