Incyclix Bio, a next-generation cell cycle control company, announced it has secured $11.25 million in Series B extension financing to advance its ongoing Phase 1/2 clinical trial of INX-315, a novel CDK2 inhibitor targeting treatment-resistant breast and ovarian cancers. The funding round included participation from Eli Lilly and Company, Eshelman Ventures, Pharmacosmos, and new investor Cape Fear BioCapital.
The additional capital will enable completion of the INX-315-01 trial (NCT05735080), a first-in-human study evaluating the safety, pharmacokinetics, and preliminary antitumor activity of the selective CDK2 inhibitor in patients with recurrent advanced/metastatic cancer.
Targeting Treatment-Resistant Cancer Populations
INX-315-01 is designed as an open-label, dose escalation and dose-expansion study focusing on patients with advanced/metastatic cancers, specifically those with CDK4/6 inhibitor (CDK4/6i) resistant estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) breast cancer or CCNE1-amplified solid tumors.
"This additional funding is a validation of the best-in-class potential of INX-315, and we are grateful for the continued support to advance our clinical trial, which could address the unmet needs of patients with advanced, treatment-resistant breast and ovarian cancers," said Patrick Roberts, Pharm.D., Ph.D., Chief Executive Officer and Co-Founder of Incyclix Bio. "With the additional capital, we're positioned to complete this critical study and unlock key milestones that bring us closer to delivering precision treatments to patients."
Clinical Progress and Timeline
The company has already presented interim clinical data from the dose escalation portion of the study at the 2024 San Antonio Breast Cancer Symposium (SABCS). Study completion remains on track for mid-2026, according to the company's timeline.
Fred Eshelman, Co-Founder and Chairman of the Board and founder of Eshelman Ventures LLC, emphasized the therapeutic potential of the approach: "INX-315 has shown the promise of CDK2 as a meaningful target in treating patients with resistant forms of breast and ovarian cancer. We're excited to continue supporting Incyclix's knowledgeable and dynamic team as they bring this promising therapy through the clinic."
Precision Cell Cycle Control Strategy
Incyclix Bio positions itself as a scientific leader in understanding cyclin-dependent kinases (CDKs) and their role in the cell cycle as therapeutic targets across multiple tumor types, including ovarian, breast and lung cancers. The company's lead compound, INX-315, is described as a potent and selective cyclin-dependent kinase 2 (CDK2) inhibitor designed to target the aberrant proliferation driving many cancers.
The Research Triangle Park, North Carolina-based company was founded by pioneers in CDK inhibitor discovery, research and development, focusing on precision treatments that address the cell cycle dysregulation characteristic of cancer progression.
