Incyclix Bio Announces Clinical Trial Collaboration and Supply Agreement with Lilly to Evaluate INX-315 in Combination with Verzenio® (abemaciclib) and Fulvestrant in HR+/HER2- Breast Cancer

INX-315, a potential best-in-class CDK2 inhibitor, to be evaluated in combination with Verzenio® (abemaciclib) and fulvestrant

Combination therapy to be evaluated as part of ongoing Phase 1/2 study in patients with HR+/HER2- metastatic breast cancer

Incyclix will sponsor the trial and Lilly will provide Verzenio

Incyclix plans to initiate combination cohorts with INX-315 in fourth quarter of 2024

RESEARCH TRIANGLE PARK, N.C., Nov. 18, 2024 (GLOBE NEWSWIRE) — 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 a clinical trial collaboration and supply agreement with Eli Lilly and Company (Lilly) for supply of its CDK4/6 inhibitor Verzenio® (abemaciclib) for use in combination with INX-315 and fulvestrant for treatment of patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer who progressed on a prior CDK4/6i regimen.

“We are pleased to enter this clinical trial collaboration with Lilly as it marks another milestone in our commitment to bring INX-315 to patients with advanced cancer,” said Patrick Roberts, Pharm.D., Ph.D., Chief Executive Officer and Co-Founder of Incyclix Bio. “Previous studies of Verzenio plus fulvestrant have demonstrated clinical benefit in patients with HR+, HER2- breast cancer who had disease progression on or after prior treatment with a CDK4/6 inhibitor. We are excited to explore how the addition of our CDK2 inhibitor, INX-315, to this combination can improve clinical outcomes for patients with advanced breast cancer.”

Under the terms of the agreement, Lilly will provide abemaciclib to Incyclix Bio, who will conduct and sponsor the combination study. Incyclix and Lilly will retain all development and commercial rights to their respective compounds, including as monotherapy or as combination therapies.

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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