Incyclix Bio Granted U.S. FDA Fast Track Designation for INX-315 to Treat CCNE1-Amplified Platinum-Resistant/Refractory Ovarian Cancer

Fast Track designation highlights potential of INX-315 to address unmet need for patients with recurrent advanced/metastatic cancer

RESEARCH TRIANGLE PARK, N.C., April 29, 2025 (GLOBE NEWSWIRE) — Incyclix Bio, LLC, a next-generation cell cycle control company developing INX-315, a novel, potent and selective CDK2 inhibitor for the treatment of advanced and resistant cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for INX-315 for the treatment of CCNE1-amplified platinum-resistant/refractory ovarian cancer.

“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, PhD, Chief Executive Officer and Co-Founder of Incyclix Bio. “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.”

The FDA grants Fast Track designation to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Treatments that receive Fast Track designation may benefit from more frequent interactions with the FDA throughout development. In addition, the Fast Track program allows for eligibility for Accelerated Approval and Priority Review, if relevant criteria are met.

Amplification of CCNE (cyclin E1 and E2) occurs in a broad range of solid tumors and in a significant subset of patients with high-grade serous ovarian cancer (HGSOC). CCNE1-amplification is also correlated with resistance to platinum-based chemotherapy, creating an area of high unmet need in patients with the most common type of ovarian cancer. INX-315 is a novel, potent and selective CDK2 inhibitor that is being evaluated in INX-315-01, an ongoing first-in-human Phase 1/2 clinical trial to evaluate its safety, tolerability, pharmacokinetics (PK) and preliminary antitumor activity in patients with recurrent advanced/metastatic cancer. INX-315 is an investigational drug product and has not been approved by the FDA. More information on the trial can be found at clinicaltrials.gov (NCT05735080).

About Incyclix Bio

Incyclix Bio is a next-generation cell cycle control company advancing precision treatments that target the aberrant proliferation driving many cancers. The company’s lead compound, INX-315, is a potent and selective cyclin-dependent kinase 2 (CDK2) inhibitor in clinical development. Incyclix Bio is a scientific leader in understanding cyclin-dependent kinases (CDKs) and their role in the cell cycle as attractive therapeutic targets across many tumor types, including ovarian, breast and lung cancers. Headquartered in Research Triangle Park, NC, Incyclix Bio is founded by pioneers in CDK inhibitor discovery, research and development. For more information, visit incyclixbio.com.

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