DB-1418

SAN DIEGO, CA, USA I June 05, 2025 I Avenzo Therapeutics, Inc. (“Avenzo”), a clinical-stage biotechnology company developing next-generation oncology therapies, today 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. “CDK4 is a key driver in HR+/HER2- breast cancer, and selective inhibition has emerged as a promising strategy to improve efficacy and minimize toxicity,” said Antonio Giordano, M.D., Ph.D., Clinical Director, Center for Cancer Therapeutic Innovation, Dana-Farber Cancer Institute. “Preclinically, AVZO-023 demonstrates best-in-class selectivity and potency, potentially enabling rational combinations with not only endocrine therapy but also CDK2 inhibitors to address emerging resistance.” 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. AVZO-021 is currently being studied in HR+/HER2- metastatic breast cancer and other advanced solid tumors. “We are excited to have initiated our third clinical trial – and our second study in a week – ahead of our anticipated timeline,” said Mohammad Hirmand, M.D., Co-founder and Chief Medical Officer of Avenzo Therapeutics. “We look forward to investigating the potential of AVZO-023, including in combination with AVZO-021, as we believe AVZO-023 and AVZO-021 both have the potential to make a difference in the lives of patients with HR+/HER2- breast cancer.” About Avenzo Therapeutics Avenzo Therapeutics is a clinical-stage biotechnology company focused on developing next-generation oncology therapies for patients. The company’s pipeline includes potential best-in-class small molecules and antibody-drug conjugates (ADCs). Avenzo’s small molecule inhibitors, AVZO-021 and AVZO-023, are novel, highly potent and selective inhibitors of CDK2 and CDK4, respectively, which are key enzymes involved in cell cycle regulation. AVZO-021, the company’s lead drug candidate, is being studied in a Phase 1 study in the U.S. and Australia for the treatment of advanced solid tumors and in combinations in HR+/HER2- metastatic breast cancer. AVZO-023 is being studied in a Phase 1/2 study for the treatment of advanced solid tumors and in combinations in HR+/HER2- metastatic breast cancer. Avenzo’s first ADC drug candidate, AVZO-1418, is a potential best-in-class, novel EGFR/HER3 bispecific ADC that is being studied in a Phase 1/2 study for the treatment of advanced solid tumors. Avenzo is headquartered in San Diego, California. For more information, visit us at www.avenzotx.com or on LinkedIn . SOURCE: Avenzo Therapeutics

SAN DIEGO, CA, USA I June 03, 2025 I Avenzo Therapeutics, Inc. (“Avenzo”), a clinical-stage biotechnology company developing next-generation oncology therapies, today announced initiation of a Phase 1/2 clinical study of its potential best-in-class EGFR/HER3 bispecific antibody-drug conjugate, AVZO-1418, in patients with advanced solid tumors. “HER3 is a key dimerization partner of EGFR, and their interaction is known to drive oncogenic signaling across a range of solid tumors, including non-small cell lung cancer, breast cancer, and head and neck cancer,” said Anthony Tolcher, M.D., FRCPC, CEO and Founder, NEXT Oncology. “Based on its preclinical data and differentiated design targeting this pathway, AVZO-1418 offers a promising approach for patients with 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-1418 as a single agent and in combination therapy in patients with advanced solid tumors. “We are excited to have initiated our company’s second clinical trial within 2 weeks of receiving IND clearance,” said Mohammad Hirmand, M.D., Co-founder and Chief Medical Officer of Avenzo Therapeutics. “This is another important milestone in our journey to advance potentially differentiated drug candidates that help fight cancers with high unmet medical needs.” About Avenzo Therapeutics Avenzo Therapeutics is a clinical-stage biotechnology company focused on developing next-generation oncology therapies for patients. The company’s pipeline includes potential best-in-class small molecules and antibody-drug conjugates (ADCs). Avenzo’s small molecule inhibitors, AVZO-021 and AVZO-023, are novel, highly potent and selective inhibitors of CDK2 and CDK4, respectively, which are key enzymes involved in cell cycle regulation. AVZO-021, the company’s lead drug candidate, is being studied in a Phase 1 study in the U.S. and Australia for the treatment of advanced solid tumors and in combinations in HR+/HER2- metastatic breast cancer. The company plans to initiate a Phase 1/2 study for AVZO-023 in the third quarter of 2025 in patients with advanced or metastatic HR+/HER2- breast cancer and other advanced solid tumors. Avenzo’s first ADC drug candidate, AVZO-1418, is a potential best-in-class, novel EGFR/HER3 bispecific ADC that is being studied in a Phase 1/2 study for the treatment of advanced solid tumors. Avenzo is headquartered in San Diego, California. For more information, visit us at www.avenzotx.com or on LinkedIn . SOURCE: Avenzo Therapeutics