INX-315

INX-315 is an orally bioavailable, potent, and selective small molecule inhibitor of cyclin-dependent kinase 2 (CDK2), developed for the treatment of advanced and resistant cancers. It induces cell cycle arrest in the G1 phase by inhibiting CDK2/cyclin E1 activity, leading to reduced phosphorylation of retinoblastoma protein (Rb) and decreased proliferation in cancer cells. INX-315 demonstrates high selectivity for CDK2 over other cyclin-dependent kinases and has shown robust antitumor activity in preclinical models, particularly in CCNE1-amplified tumor types. The drug is being evaluated as monotherapy and in combination with standard-of-care agents such as fulvestrant or abemaciclib for patients with CCNE1-amplified platinum-resistant/refractory ovarian cancer and hormone receptor-positive/HER2-negative breast cancer that have progressed on prior therapies[3][4][5][6][7].