RTP-based biotechnology company Incyclix Bio LLC has secured an additional $11.25 million in a Series B extension, aimed at advancing its first-in-human clinical trial for INX-315, an investigational oral inhibitor targeting cyclin-dependent kinase 2 (CDK2). The funding round included participation from existing backers Eshelman Ventures, Eli Lilly & Company, and Pharmacosmos, as well as a new investor, Cape Fear BioCapital.
INX-315 is being developed for advanced and treatment-resistant cancers, notably estrogen receptor-positive/human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancers that have become resistant to CDK4/6 inhibitors, and solid tumors with CCNE1 amplification. These are areas of high unmet need, as resistance mechanisms limit the efficacy of current treatments.
The first-in-human INX-315-01 trial is an open-label Phase 1/2 study, with a dose-escalation and dose-expansion design. It aims to assess safety, pharmacokinetics, and preliminary signs of anti-tumor activity in heavily pretreated patient populations. Early data, presented in December 2024 at the San Antonio Breast Cancer Symposium, indicate that the drug is generally safe and tolerated, with some evidence of activity.
With this infusion of capital, Incyclix Bio expects to complete the INX-315-01 trial by mid-2026, moving closer toward establishing CDK2 inhibition as a viable therapeutic strategy in cancers that are difficult to treat. CEO Patrick Roberts emphasized that this funding validates the “best-in-class potential” of INX-315 and supports the company’s mission to deliver precision therapies for patients with advanced, treatment-resistant cancers.