Insilico Medicine receives IND approval for novel AI-designed USP1 inhibitor for cancer

On May 25th, 2023, Insilico announced that the U.S. Food and Drug Administration (FDA) recently approved the initial investigational new drug (IND) application for ISM3091, a USP1 inhibitor for the treatment of patients with solid tumors. This is Insilico's first oncology program to advance to the clinical validation stage.

The open-label, multicenter Phase I clinical trial of ISM3091 will be conducted simultaneously in the U.S. and China to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy in patients with advanced solid tumors through dose escalation. Insilico has filed the IND submission to the U.S. FDA and the NMPA and expects to initiate the study in the U.S. center in July 2023.