Incyclix Bio, a cell cycle-focused oncology company headquartered in Research Triangle Park, North Carolina, has raised an additional USD 5 million in Series B financing to support the clinical development of INX-315, its selective CDK2 inhibitor, in patients with advanced and metastatic breast and ovarian cancer.
The tranche was provided by Hatteras Venture Partners, a new entrant to the Series B syndicate, which also includes Boxer Capital, RA Capital Management, Eshelman Ventures, Eli Lilly and Company, Pharmacosmos, and Cape Fear BioCapital. As part of the arrangement, Hatteras partner Kseniya Simpson will join Incyclix Bio's board of directors, while Hatteras general partner Christy Shaffer will serve as a board observer. The funds will be directed toward advancing the ongoing Phase I/II clinical trial of INX-315.
INX-315 is being evaluated in an open-label, dose-escalation, combination, and dose-expansion Phase I/II trial (NCT05735080) in patients with recurrent advanced or metastatic cancer, including those with CDK4/6 inhibitor-resistant ER+/HER2- breast cancer and CCNE1-amplified solid tumors. CDK4/6 inhibitors have become standard of care in ER+ breast cancer, but resistance is common, with upregulation of Cyclin E/CDK2 activity identified as a key mechanism by which tumors bypass the CDK4/6-mediated cell cycle block. INX-315 targets CDK2 selectively, aiming to address that resistance mechanism while avoiding the toxicity profile associated with earlier, less selective pan-CDK inhibitors.