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Incyclix Bio Announces Interim Clinical Data from 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
INX-315 was safe and well tolerated in monotherapy dose escalation
INX-315 monotherapy demonstrated antitumor activity in heavily pretreated patients with ER+/HER2- breast cancer and CCNE1-amplified ovarian cancer
Monotherapy and combination dose expansions are ongoing
Research Triangle Park, N.C. – December 13, 2024 – 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, announced interim clinical data from the dose escalation portion of INX-315-01, the Phase 1/2 clinical trial of INX-315 in patients 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. The data were presented at the 2024 San Antonio Breast Cancer Symposium (SABCS).
Highlights of the first-in-human trial include:
- Across 31 patients with CDK4/6i resistant ER+/HER2- breast cancer or CCNE1-amplified solid tumors, INX-315 monotherapy was safe and well tolerated with one dose-limiting toxicity and no treatment discontinuations due to adverse events.
- INX-315 monotherapy demonstrated antitumor activity in heavily pretreated patients with ER+/HER2- breast cancer and CCNE1-amplified ovarian cancer
- Among all response-evaluable patients in Part A, 3 (10%) had a partial response (PR) and 19 (63%) had stable disease (SD)
- In patients with ER+/HER2- breast cancer, PR was observed in 1 (10%) and SD was observed in 5 (50%)
- In patients with CCNE1-amplified high grade serous ovarian cancer (HGSOC)/fallopian, PR was observed in 2 (20%) and SD was observed in 8 (80%)
- Monotherapy safety and antitumor activity data support continued investigation of INX-315 as monotherapy in CCNE1-amplified solid tumors and in combination with standard of care therapies for ER+/HER2- breast cancer
“We are excited to unveil these compelling data, which underscore the safety, tolerability, and encouraging antitumor activity of our CDK2 inhibitor, INX-315, in heavily pretreated patients with advanced, treatment-resistant breast and ovarian cancers. Sharing these results with leading oncologists at SABCS is a significant milestone,” said Patrick Roberts, Pharm.D., Ph.D., Chief Executive Officer and Co-Founder of Incyclix Bio. “This progress reinforces the best-in-class potential of INX-315 and brings us closer to delivering a transformative treatment option for patients facing some of the most challenging cancer diagnoses.”
INX-315-01 (NCT05735080) is a Phase 1/2, open-label, dose-escalation, combination and dose-expansion trial to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary antitumor activity of INX-315 in patients with recurrent advanced/metastatic cancer, including ER+/HER2- breast cancer who progressed on a prior CDK4/6i regimen and patients with CCNE1-amplified HGSOC or other solid tumors, who progressed on prior standard of care treatment. The dose escalation portion of the trial (Part A) enrolled 31 patients, all of whom were evaluated for safety while 30 were evaluated for efficacy. Median age was 60 years old (range 29-78), 74% were female. Tumor types studied include ER+/HER2- breast cancer (n=10), HGSOC (n=10), and other solid tumors (n=11). Median prior lines of therapy were 4 (range of 1-9). INX-315-01 monotherapy and combination dose-expansion portions are ongoing. More information on the trial can be found at clinicaltrials.gov.
The full poster presented at SABCS 2024 is available in the ‘Publications’ section of the Incyclix website: incyclixbio.com/publications/.
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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