Incyclix Bio Establishes Steering Committee of Leading Breast Cancer Experts to Guide INX-315 Clinical Development

Incyclix Bio Establishes Steering Committee of Leading Breast Cancer Experts to Guide INX-315 Clinical Development

Appointment of distinguished oncology leaders comes as Incyclix prepares for a potential pivotal trial in 2027

RESEARCH TRIANGLE PARK, N.C., November 5, 2026 - 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 the formation of a Steering Committee of leading breast cancer experts to guide the continued clinical development of INX-315. The committee will be chaired by Seth Wander, MD, Ph.D., Director of Translational Research for the Breast Oncology Program and Director of Precision Medicine at the Termeer Center for Targeted Therapies at Massachusetts General Hospital.

"Drug resistance remains a significant challenge in breast cancer care, leaving many patients with limited treatment options," said Dr. Wander. "Encouraging data from the ongoing INX-315-01 clinical trial underscore the potential of CDK2 inhibition to address treatment resistance in patients with advanced or metastatic breast cancer. I look forward to collaborating with my fellow committee members and the Incyclix team to advance the clinical development of INX-315 for these patients."

Additional members of the Steering Committee include:

• Sheheryar Kabraji, BMBCh, Associate Professor of Oncology, Chief of Breast Medicine and Director of Breast Translational Research at Roswell Park Comprehensive Cancer Center in Buffalo, NY
• Antoinette Tan, MD, MHSc, Chief of Breast Medical Oncology and Co-Director of the Phase I Program at Atrium Health Levine Cancer Institute, Wake Forest University School of Medicine, NC
• Philippe Aftimos, MD, Medical Oncologist and Clinical Trials Development Leader at Institut Jules Bordet in Brussels, Belgium
• Sarah Premji, MD, Assistant Director of Breast Cancer Research at Sarah Cannon Research Institute in Nashville, TN
• Cynthia Ma, MD, Ph.D., Professor of Medicine in the Division of Oncology and Clinical Director of the Breast Cancer Program at Washington University School of Medicine in St. Louis, MO

"We are highly encouraged by the emerging clinical profile of INX-315 in breast cancer and have assembled this distinguished group of experts to help guide the program's next phase of development," said Patrick Roberts, Pharm.D., Ph.D., Chief Executive Officer and Co-Founder of Incyclix Bio. "Their collective clinical and research expertise will be invaluable as we advance INX-315 and evaluate its potential to address treatment resistance in patients with advanced or metastatic breast cancer following CDK4/6 inhibitor therapy, an area of significant unmet need."

Despite advances in treatment, patients with advanced or metastatic breast cancer whose disease progresses following CDK4/6 inhibitor therapy continue to face limited treatment options. Incyclix's ongoing Phase 1/2 clinical trial (NCT05735080) is evaluating INX-315 in patients with CDK4/6 inhibitor (CDK4/6i) resistant estrogen receptor positive/human epidermal growth factor 2 negative (ER+/HER2-) breast cancer. The Steering Committee will provide strategic guidance on the program's continued clinical development, including preparations for a potential pivotal trial expected to initiate in 2027.

The INX-315-01 trial is also evaluating INX-315 in patients with CCNE1-amplified ovarian cancer.

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 was founded by pioneers in CDK inhibitor discovery, research and development. For more information, visit incyclixbio.com.

###

Media Contact
Tony Plohoros
908-591-2839
[email protected]