Arvinas Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s investigational new drug application (IND) for ARV-110, an oral androgen receptor (AR) PROTAC™ protein degrader, for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). Arvinas expects to begin enrollment of a Phase 1 clinical trial for ARV-110 in the first quarter of 2019. ARV-110 was developed using Arvinas’ proprietary technology platform – PROTAC (proteolysis-targeting chimera) protein degraders – that uses small molecules to harness the body’s own natural protein recycling system (the ubiquitin proteasome system) to selectively and efficiently remove disease-causing proteins. ARV-110 is a PROTAC protein degrader specifically designed to target and degrade AR, and has demonstrated activity in preclinical models of AR overexpression and AR mutations, which are both common resistance mechanisms to current standard-of-care agents in men with prostate cancer. The Phase 1 study will investigate the safety and tolerability of ARV-110 in patients with mCRPC who have progressed on at least two standard of care treatment regimens and includes exploratory measures of efficacy.