Qurient Co. Ltd. announced that the U.S. Food and Drug Administration has cleared its investigational new drug application for Q901, a small molecule oncology drug candidate targeting cyclin dependent kinase 7. The company plans to enroll up to 70 patients with advanced solid tumors in a Phase 1/2 clinical study taking place in the United States. The goal of the study will be to determine the maximum tolerated dose, dose-limiting toxicities, and the recommended Phase 2 dose of Q901.

Q901 is a highly selective CDK7 inhibitor that has been shown in vitro studies to only inhibit CDK7 in the human kinome. CDK7 is a master regulator of cell cycle checkpoints and an essential component of transcription machinery. Additional data from preclinical studies has demonstrated that selective inhibition of CDK7 specifically kills cancer cells with aberrant cell division cycle or transcriptional regulation.

Nonclinical pharmacology studies of Q901 have demonstrated that the selective inhibition of CDK7 exerts tumor growth inhibition in a number of murine cell-derived and patient-derived xenograft models, including breast, ovarian, prostate, pancreatic, small-cell lung, and colorectal cancers. Qurient licensed the CDK7 inhibitor program at lead stage from Lead Discovery Center and the Max-Planck Society and further optimized the program, completed the IND-enabling studies, and submitted the IND application.