Incyclix Bio announces FDA clearance of investigational new drug application for INX-315 in patients with advanced or metastatic cancer. INX-315 is a novel, potent and selective inhibitor of Cyclin-dependent kinase 2 (CDK2) with compelling pre-clinical efficacy and safety data.
CDK2 is thought to play an important role in driving proliferation of certain cancers, including those harboring CCNE1 amplification and breast cancers that have acquired resistance to CDK4/6 inhibitors (CDK4/6i).