ARTS-023 / Allorion Therap, Avenzo Therap - LARVOL DELTA

Avenzo Therapeutics Announces FDA Clearance of Investigational New Drug Application for AVZO-023 (ARTS-023), a Potential Best-in-Class, Novel CDK4 Selective Inhibitor (Businesswire) - "Avenzo Therapeutics...announced clearance by the U.S. Food and Drug Administration (FDA) of its investigational new drug application (IND) for AVZO-023 (formerly ARTS-023), a potential best-in-class, novel cyclin-dependent kinase 4 (CDK4) selective inhibitor. Avenzo has also exercised its exclusive option for AVZO-023 from Allorion Therapeutics Inc., securing global (excluding Greater China) development, manufacturing, and commercialization rights. Under the IND, the company plans to initiate a Phase 1/2 first-in-human, open-label clinical study in the third quarter of this year. The Phase 1 portion will assess the safety, tolerability, and preliminary clinical activity of AVZO-023 as a single agent and in combination therapy with endocrine therapy and with AVZO-021...in patients with advanced or metastatic hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer and select other advanced solid tumors."

IND • Licensing / partnership • New P1/2 trial • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer

ARTS-023: a potent and selective CDK4 Inhibitor demonstrating anti-tumor activity in preclinical ER+ breast cancer models (AACR 2025) - "Additionally, it demonstrated robust synergistic effects when combined with the CDK2 inhibitor AVZO-021 in both palbociclib-sensitive cell line-derived xenograft models and palbociclib-resistant patient-derived xenograft models. Taken together, these findings establish ARTS-023 as a promising next-generation CDK4-selective inhibitor, offering improved efficacy and reduced toxicity for patients with ER+ breast cancer. Furthermore, the favorable toxicity profile of ARTS-023 supports the potential combination with CDK2 inhibitors to enhance therapeutic outcomes."

Preclinical • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • CCND1 • ER • HER-2