Posted by Michael Wonder on 29 Apr 2025
Incyclix Bio granted US FDA fast track designation for INX-315 to treat CCNE1-amplified platinum-resistant/refractory ovarian cancer
29 April 2025 - Incyclix Bio today announced that the US FDA has granted fast track designation for INX-315 for the treatment of CCNE1-amplified platinum-resistant/refractory ovarian cancer.
INX-315 is a novel, potent and selective CDK2 inhibitor that is being evaluated in INX-315-01, an on-going first-in-human Phase 1/2 clinical trial to evaluate its safety, tolerability, pharmacokinetics and preliminary anti-tumour activity in patients with recurrent advanced/metastatic cancer.
