This article originally appeared via NC Biotech’s blog.
RTP-based Incyclix Bio LLC has secured a $11.25 million extension to its Series B financing.
The additional funding will help Incyclix Bio advance its first-in-human clinical trial of INX-315, an oral inhibitor of cyclin-dependent kinase 2 (CDK2) being developed to treat advanced and resistant cancer.
The Series B extension investors include Eshelman Ventures, Eli Lilly and Company, Pharmacosmos and new investor Cape Fear BioCapital.
“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.”
Bringing cell growth under control
Although CDK2 is a known driver of uncontrolled cell growth in some cancers, developing effective drugs against this kinase has proven challenging. Drawing on its deep understanding of key structural features within CDK2’s drug-binding site, Incyclix Bio developed a potent and selective CDK2 inhibitor.
“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.”
The INX-315-01 study is a first-in-human, Phase 1/2, open-label trial evaluating INX-315 in patients with advanced or metastatic cancers. These cancers include 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 study uses a dose-escalation and dose-expansion design to assess safety, pharmacokinetics and preliminary antitumor activity.
In December 2024, the company presented interim clinical data from the dose escalation portion of the study at the San Antonio Breast Cancer Symposium (SABCS). The early results suggest the CDK inhibitor is generally safe and well-tolerated, with signs of potential antitumor activity in heavily pretreated patients with advanced, treatment-resistant breast and ovarian cancers. The study is on schedule for completion in mid-2026.
“Our ability to grow and attract strong investors to advance INX-315 has been driven by the supportive environment of RTP,” said Roberts. “We’re proud to be part of this thriving life science community fueling innovation and building a brighter future for patients.”
