FDA Fast Tracks INX-315 for Tough-to-Treat Ovarian Cancer

INX-315 received FDA fast track designation for patients with CCNE1-amplified platinum-resistant ovarian cancer: © stock.adobe.com.

The Food and Drug Administration (FDA) granted fast track designation to treatment with INX-315, a novel, potent and selective CDK2 inhibitor, to treat CCNE1-amplified platinum-resistant/refractory ovarian cancer, according to a press release from Incyclix Bio.

“The FDA’s decision to grant Fast Track designation [to] 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,” Patrick Roberts, chief executive officer and co-founder of Incyclix Bio, said in the news release. “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 speed up the development and review of drugs for serious conditions that address unmet medical needs, according to the release. The designation allows for more frequent interactions with the FDA and may make treatments eligible for accelerated approval and priority review if criteria are met.

INX-315 is an investigational drug and has not yet been approved by the FDA. 

INX-315 and Platinum-Resistant Cancer

Amplification of CCNE1 and CCNE2 occurs across many solid tumors and in a large portion of patients with high-grade serous ovarian cancer. CCNE1 amplification is also linked to resistance to platinum-based chemotherapy, highlighting a significant unmet need in this population, prompting investigators to evaluate other options for this patient population.

INX-315 is an orally bioavailable small molecule that inhibits cyclin-dependent kinase 2 (CDK2), potentially slowing tumor growth by causing cell cycle arrest and apoptosis, according to the National Cancer Institute’s website, cancer.gov. CDK2 is a serine/threonine kinase involved in regulating cell cycle progression and is often overexpressed in cancer cells.

Platinum-resistant disease describes cancer that initially responds to platinum-based drugs — such as cisplatin or carboplatin — but returns within a set time, often six months. Identifying platinum resistance, such as in ovarian cancer, can help guide future treatment decisions.

The INX-315-01 Trial

INX-315 is being studied in a first-in-human phase 1/2 trial (INX-315-01) to assess the agent’s safety, tolerability, pharmacokinetics and early antitumor activity in patients with recurrent advanced or metastatic cancer, including ovarian and hormone receptor (HR)–positive or HER2-negative breast cancer.

The trial is studying INX-315 alone and in combination with other drugs.

Patients may be eligible if they have advanced cancer and meet certain criteria, such as having ovarian cancer with a CCNE1 gene amplification or breast cancer that progressed after CDK4/6 treatment.

Part A of the trial is evaluating different doses of INX-315 alone and with fulvestrant in patients with breast cancer. Part B will enroll patients with platinum-resistant or platinum-refractory ovarian cancer with CCNE1 amplifications and will test selected doses from Part A. Part C will enroll patients with HR+/HER2- breast cancer to receive INX-315 in combination with abemaciclib and fulvestrant.

Up to 140 patients may join the study across all parts, depending on eligibility and safety results. The trial is expected to be fully completed in 2026.

Study locations include Atlanta and Augusta, Georgia; Boston, Massachusetts; Detroit, Michigan; Charlotte and Durham, North Carolina; Canton, Ohio; Dallas, Texas; South Brisbane and Parkville, Australia.

Incyclix Bio, based in Research Triangle Park, North Carolina, is developing precision treatments that target uncontrolled cell growth in cancer. The company specializes in cyclin-dependent kinases as therapeutic targets for cancers including ovarian, breast and lung. Incyclix Bio was founded by experts in CDK inhibitor research and development.

Details about the trial are available at clinicaltrials.gov (NCT05735080).

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