Global platform biotech provider Ascletis recently announced the company is on the verge of being able to offer more options to patients with advanced solid tumors.
Company officials announced the completion of first patient dosing in the U.S. Phase I clinical trial of ASC61, an oral PD-L1 small molecule inhibitor prodrug, for treatment of advanced solid tumors, according to an Aug. 7 PR Newswire release. The trial is part of a dose-escalation study that measures the safety and tolerability of ASC61.
"Immunogenicity and the poor permeability of tumor tissues are the major disadvantages of therapeutic antibodies, which can cause a low response rate of PD-1/PD-L1 antibodies,” Dr. Jinzi J. Wu, founder, chairman and CEO of Ascletis, said in the release. “As a highly differentiated small molecule PD-L1 inhibitor, ASC61 has several advantages over antibodies, and showed promising preliminary efficacy and safety profile in preclinical studies. This progress of ASC61 on advanced solid tumors further demonstrated Ascletis' global R&D capability and execution. We expect to further advance the studies on ASC61 to provide more options for patients with advanced solid tumors."
In addition, the trial is also touted as a way to gauge the maximum tolerated dose, as well as a recommended Phase 2 dose of ASC61 in patients with advanced solid tumors who have disease progression during or following standard therapy, the release reported.
According to PR Newswire, in a head-to-head comparison study using the human PD-L1 expressing cells and fresh peripheral blood mononuclear cells co-culture assay, ASC61-A treatment induced secretion of IFNγ in a concentration dependent manner, with an EC50 of 2.86 nM. Maximal levels of IFNγ induced by ASC61-A were similar to that induced by Keytruda.