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

Rallybio Corporation and Avenzo Therapeutics Announce Merger Agreement to Advance Next-Generation Oncology Therapies and $215 Million Concurrent Private Placement (Businesswire) - "Upon completion of the Merger, the combined company is expected to operate under the name Avenzo Therapeutics....The combined company expects its cash balance at closing to fund operations into late 2028 and support advancement of its four clinical-stage programs through multiple clinical milestones."

M&A • Solid Tumor

A phase 1/2, first-in-human study of AVZO-021, a selective cyclin-dependent kinase 2 inhibitor (CDK2i), as monotherapy and in combination for patients with advanced solid tumors, including hormone receptor–positive (HR+)/human epidermal growth factor receptor 2–negative (HER2−) breast cancer (BC) and cyclin E1 (CCNE1)–amplified solid tumors: Updated safety and efficacy results. (ASCO 2026) - P1/2 | "With longer follow-up, AVZO-021 as monotherapy and in combination with fulvestrant continues to show an encouraging tolerability profile and clinically meaningful efficacy. Gastrointestinal and hematologic adverse events continue to be of low incidence and severity allowing for prolonged treatment and potential safe combination with AVZO-023, a highly potent and selective CDK4i currently enrolling patients with HR+/HER2- BC in combination with fulvestrant."

Clinical • First-in-human • Metastases • Monotherapy • P1/2 data • Breast Cancer • Endometrial Cancer • Fallopian Tube Cancer • Gastrointestinal Disorder • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Neutropenia • Oncology • Ovarian Cancer • Solid Tumor • Uterine Cancer • CCNE1 • CDK1 • CDK4 • CDKN2A • HER-2

Avenzo Therapeutics Announces First Patient Dosed in Combination Cohort Evaluating CDK4 Selective Inhibitor (AVZO-023) with CDK2 Selective Inhibitor (AVZO-021) In Ongoing Phase 1/2 ORION-1 Study (Businesswire) - "The Phase 1/2 first-in-human, open-label ORION-1 clinical study is designed to assess the safety, tolerability, and preliminary clinical activity of AVZO-023 with endocrine therapy as well as the combination of AVZO-023 and AVZO-021 with endocrine therapy. The combination cohort will evaluate AVZO-023 and AVZO-021 with fulvestrant in patients with HR+/HER2- advanced or metastatic breast cancer."

First-in-human • Trial status • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer

Avenzo Therapeutics Advances the Combination of CDK4 Selective Inhibitor (AVZO-023) with CDK2 Selective Inhibitor (AVZO-021) in Ongoing Phase 1/2 ORION-1 Study in HR+/HER2- Breast Cancer (Businesswire) - "The Phase 1/2 first-in-human, open-label ORION-1 clinical study is designed to assess the safety, tolerability, and preliminary clinical activity of AVZO-023 with endocrine therapy as well as the combination of AVZO-023 and AVZO-021 with endocrine therapy. The combination cohort will evaluate AVZO-023 and AVZO-021 with fulvestrant in patients with HR+/HER2- metastatic breast cancer."

First-in-human • Trial status • 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

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) - P1/2 | "AVZO-023 showed strong anti-tumor activity in vivo, which was further enhanced in combination with the selective CDK2i AVZO-021 in palbociclib-sensitive and palbociclib-resistant xenograft models.Trial DesignThis Phase 1 AVZO-023-1001 trial (NCT06998407) will assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor activity of AVZO-023 as a single agent and in combination with endocrine therapy and/or AVZO-021...Patients with HR+/HER2- BC enrolled in Parts A or B will have the option to add fulvestrant to their study treatment. Part C will study the combination of AVZO-023 + letrozole ± AVZO-021...Primary objectives are safety/tolerability and secondary objectives include preliminary anti-tumor activity. The trial has activated and will enroll patients at approximately 50 centers across North America, Europe and the Asia-Pacific region."

Clinical • Combination therapy • Metastases • P1/2 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • CDK2 • CDKN2A • HER-2

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

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

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