Incyclix Bio LLC has received FDA approval of an IND application for INX-315, a novel, potent and selective cyclin-dependent kinase 2 (CDK2) inhibitor for advanced or metastatic cancers. The first-in-human phase I/II study will be conducted in patients with estrogen receptor (ER)-positive/HER2-negative breast cancer who have progressed on a CDK4/6 inhibitor regimen and CCNE1-amplified solid tumors that have progressed on standard-of-care treatment.