Incyclix Bio announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for INX-315, the company's novel CDK2 inhibitor, for the treatment of CCNE1-amplified platinum-resistant/refractory ovarian cancer.
The designation highlights the urgent need for new therapeutic options for patients with this difficult-to-treat form of ovarian cancer, which has limited treatment options after developing resistance to standard platinum-based chemotherapy regimens.
"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."
Understanding CCNE1 Amplification in Ovarian Cancer
Amplification of CCNE1 (cyclin E1) occurs in a significant subset of patients with high-grade serous ovarian cancer (HGSOC), the most common and aggressive form of ovarian cancer. This genetic alteration is particularly concerning as it correlates strongly with resistance to platinum-based chemotherapy, which remains the backbone of first-line treatment for ovarian cancer.
CCNE1 amplification drives dysregulated cell cycle progression through increased activation of cyclin-dependent kinase 2 (CDK2), promoting uncontrolled cancer cell proliferation. This mechanism creates a compelling rationale for targeting CDK2 specifically in these patients.
The INX-315 Development Program
INX-315 is an orally bioavailable small molecule designed to selectively inhibit CDK2, potentially inducing cell cycle arrest and apoptosis in cancer cells that depend on this pathway for survival and proliferation. The compound is currently being evaluated in the INX-315-01 trial, a first-in-human Phase 1/2 clinical study.
The trial is investigating the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of INX-315 in patients with recurrent advanced or metastatic cancer. The study has a multi-part design:
- Part A is evaluating different doses of INX-315 alone and in combination with fulvestrant in patients with breast cancer
- Part B will enroll patients with platinum-resistant or platinum-refractory ovarian cancer with CCNE1 amplifications
- Part C will study INX-315 in combination with abemaciclib and fulvestrant in patients with HR+/HER2- breast cancer
The trial is being conducted across multiple sites in the United States, including centers in Georgia, Massachusetts, Michigan, North Carolina, Ohio, and Texas, as well as sites in Australia. Up to 140 patients may be enrolled across all study parts, with full completion expected by 2026.
Implications of Fast Track Designation
The FDA's Fast Track program is designed to facilitate the development and expedite the review of drugs intended to treat serious conditions and fill unmet medical needs. For Incyclix Bio, this designation provides several potential advantages:
- More frequent meetings and communications with the FDA
- Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
- Rolling Review, which allows the company to submit completed sections of its New Drug Application (NDA) for review before the entire application is ready
These benefits could significantly reduce the time to potential approval if INX-315 demonstrates favorable results in clinical trials.
The Unmet Need in Platinum-Resistant Ovarian Cancer
Platinum resistance in ovarian cancer represents a significant clinical challenge. Patients whose cancer returns within six months after platinum-based therapy have limited treatment options and generally poor outcomes.
The link between CCNE1 amplification and platinum resistance creates a distinct patient population with particularly high unmet need. Current estimates suggest that approximately 20% of high-grade serous ovarian cancers harbor CCNE1 amplifications, representing thousands of patients annually who might potentially benefit from targeted therapies like INX-315.
About Incyclix Bio
Headquartered in Research Triangle Park, North Carolina, Incyclix Bio is focused on developing precision treatments that target aberrant cell cycle control in cancer. The company was founded by pioneers in CDK inhibitor discovery, research, and development.
Beyond ovarian cancer, Incyclix Bio is exploring applications of its CDK2 inhibitor technology in other tumor types where cell cycle dysregulation plays a key role, including breast and lung cancers.
INX-315 remains an investigational drug product that has not yet received FDA approval for any indication. Patients interested in learning more about the ongoing clinical trial can find information at clinicaltrials.gov (NCT05735080).
