FDA gives Fast Track designation to Incyclix Bio's ovarian cancer treatment
The U.S. Food and Drug Administration (FDA) has granted Incyclix Bio Fast Track designation for INX-315 to treat CCNE1-amplified platinum-resistant/refractory ovarian cancer. INX-315, the company’s lead compound, is being evaluated in an ongoing, first-human Phase 1/2 clinical trial.
Incyclix Bio founders were part of the research team at G1 Therapeutics before
launching the company in 2020 with an exclusive license for G1’s preclinical CDK2 inhibitor program.
“The FDA’s decision to grant Fast Track designation for INX-315 reflects the best-in-class potential of our CDK2 inhibitor, the strength of our preclinical and early clinical data and the urgency to address significant unmet need in patients with CCNE1-amplified platinum-resistant/refractory ovarian cancer,” said Patrick Roberts, PharmD., Ph.D., chief executive officer and co-founder of Incyclix Bio.
CCNE1 is critical to cell cycle regulation. Amplifications of it occur in a broad range of solid tumors and a significant subset of patients with high-grade serous cancer. CCNE1 amplification is also correlated with resistance to platinum-based chemotherapy.
In March 2022, the company closed a $30 million Series B financing round to support the clinical development of INX-315.