Incyclix Bio Secures $11.25 Million Series B Extension to Advance the Phase 1/2 Clinical Trial of INX-315 in Patients with CDK4/6 Inhibitor Resistant ER+/HER2- Breast Cancer or CCNE1-Amplified Solid Tumors
Financing will enable the completion of the ongoing Phase 1/2 clinical trial of INX-315 in patients with recurrent advanced/metastatic cancer
RESEARCH TRIANGLE PARK, N.C., Aug. 25, 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 it has secured a $11.25 million extension to its Series B financing.
The Series B extension investors include Eshelman Ventures, Eli Lilly and Company, Pharmacosmos and new investor Cape Fear BioCapital. The additional financing will advance Incyclix’s ongoing INX-315-01 (NCT05735080), a first-in-human, Phase 1/2 clinical trial of INX-315, a novel, potent and selective CDK2 inhibitor, for the treatment of patients with recurrent advanced/metastatic cancer.
“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.”
“INX-315 has shown the promise of CDK2 as a meaningful target in treating patients with resistant forms of breast and ovarian cancer,” said Fred Eshelman, Co-Founder and Chairman of the Board and founder of Eshelman Ventures LLC. “We’re excited to continue supporting Incyclix’s knowledgeable and dynamic team as they bring this promising therapy through the clinic.”
INX-315-01 is a first-in-human, Phase 1/2, open-label, dose escalation and dose-expansion study to evaluate the safety, PK and preliminary antitumor activity of INX-315 in patients with advanced/metastatic cancers, including 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. The Company has presented interim clinical data from the dose escalation portion of the study at the 2024 San Antonio Breast Cancer Symposium (SABCS) and completion of the study is on track for mid-2026.
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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