Incyclix Bio Receives FDA Fast Track Designation For INX-315 To Treat CCNE1-Amplified Platinum-Resistant/Refractory Ovarian Cancer

Incyclix Bio, LLC, a next-generation cell cycle control company focused on developing innovative therapies for advanced and resistant cancers, has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to INX-315. This novel, potent, and selective CDK2 inhibitor is being developed for the treatment of CCNE1-amplified platinum-resistant/refractory ovarian cancer.

The Fast Track designation is granted by the FDA to expedite the development and review of drugs that treat serious conditions and address unmet medical needs. Drugs receiving Fast Track designation benefit from more frequent communication with the FDA throughout their development process. Additionally, these treatments may be eligible for Accelerated Approval and Priority Review if they meet the necessary criteria.

CCNE1 amplification is observed in a wide range of solid tumors and is particularly prevalent in high-grade serous ovarian cancer (HGSOC), which is the most common form of ovarian cancer. This genetic alteration is also linked to resistance to platinum-based chemotherapy, creating a significant unmet need for effective treatments in this patient population. 

Patrick Roberts, PharmD, PhD, Chief Executive Officer and Co-Founder of Incyclix Bio, said, “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. We look forward to working closely with the FDA to advance the clinical development of INX-315 to bring it to patients as soon as possible.”

INX-315, currently being evaluated in the ongoing first-in-human Phase 1/2 clinical trial (INX-315-01), aims to assess its safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity in patients with recurrent advanced or metastatic cancers. It is important to note that INX-315 is an investigational drug and has not been approved by the FDA.