INV-6452 / Ionova Life Sci - LARVOL DELTA

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of INV-6452 in Adult Patients With Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Advanced/Metastatic Breast Cancer or Locally Advanced/Metastatic Solid Tumor (clinicaltrials.gov) - P1/2 | N=201 | Recruiting | Sponsor: Shenzhen Ionova Life Sciences Co., Ltd.

First-in-human • New P1/2 trial • Breast Cancer • Endometrial Cancer • HER2 Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Ovarian Cancer • Solid Tumor • CCNE1

Discovery of INV-6452, a CDK2/4 inhibitor for the treatment of HR-positive HER2-negative breast cancer resistant to current CDK4/6 therapy (AACR 2025) - "CDK4/6 Inhibitors represented by palbociclib, ribociclib, abemaciclib and dalpiciclib, working through their inhibitory activities toward G1/S transition cyclin-dependent protein kinases 4 and 6 coupled with cyclins D1 and D3, have emerged as one of the mainstream therapies for HR positive HER2 negative breast cancer...Toward the goal of addressing these unmet medical needs, we have discovered and profiled INV-6452, a CDK2/4 inhibitor, and INV-2821, a highly selective CDK2 inhibitor...Additionally, INV-6452 had a limited impact on the proliferation and myeloid-specific differentiation of human hematopoietic stem and progenitor cells. The promising profiles of INV-6452 suggest its potential in addressing unmet medical needs, and its clinical development is being planned."

Late-breaking abstract • Breast Cancer • Endometrial Cancer • Eye Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Ovarian Cancer • Solid Tumor • CDK1 • CDK4 • CDK9 • HER-2