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

A phase 1/2 study of AVZO-023, a next-generation selective cyclin-dependent kinase 4 inhibitor (CDK4i), as a single agent and in combination with AVZO-021, a selective cyclin-dependent kinase 2 inhibitor (CDK2i), and/or endocrine therapy in patients with advanced solid tumors (SABCS 2025) - "Abstract is embargoed at this time."

Clinical • Combination therapy • Metastases • P1/2 data • Breast Cancer • Oncology • Solid Tumor • CDKN2A

Avenzo Therapeutics to Present Initial Results from the Phase 1 Study of AVZO-021, a Potential Best-in-Class CDK2 Inhibitor, at the 2025 San Antonio Breast Cancer Symposium (Businesswire) - "Avenzo will present preliminary safety and efficacy results from the Phase 1 portion of its ongoing Phase 1/2 clinical study of AVZO-021, its potential best-in-class cyclin-dependent kinase 2 (CDK2) selective inhibitor. The company will also highlight the Phase 1/2 study design evaluating AVZO-023...as a single agent and in combination with AVZO-021 and/or endocrine therapy."

Clinical protocol • P1 data • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer

Avenzo Therapeutics Announces $60 Million Series B Financing (Businesswire) - "The proceeds will be used to support the advancement of Avenzo’s pipeline of potential best-in-class oncology drug candidates."

Financing • Hormone Receptor Positive Breast Cancer • Non Small Cell Lung Cancer • Urothelial Cancer

Study of AVZO-023 as a Single Agent and in Combination With AVZO-021, and/or Endocrine Therapy in Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=380 | Recruiting | Sponsor: Avenzo Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

Avenzo Therapeutics Initiates Phase 1/2 Clinical Study of AVZO-023, a Potential Best-in-Class, Novel CDK4 Selective Inhibitor (Businesswire) - "Avenzo Therapeutics...announced initiation of a Phase 1/2 clinical study of its potential best-in-class cyclin-dependent kinase 4 (CDK4) selective inhibitor, AVZO-023, 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....The Phase 1/2 first-in-human, open-label clinical study is designed to assess the safety, tolerability, and preliminary clinical activity of AVZO-023 as a single agent and in combination with endocrine therapy and with AVZO-021, Avenzo’s potential best-in-class CDK2 inhibitor."

Trial status • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer

Study of AVZO-023 as a Single Agent and in Combination With AVZO-021, and/or Endocrine Therapy in Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=380 | Not yet recruiting | Sponsor: Avenzo Therapeutics, Inc.

New P1/2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor

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