Avenzo Therapeutics, Inc. (“Avenzo”), a clinical-stage biotechnology company developing next-generation oncology therapies, today announced that the first patient has been dosed in the Phase 1 portion of a Phase 1/2 clinical study evaluating its potential best-in-class EGFR/HER3 bispecific antibody-drug conjugate, AVZO-1418, in patients with advanced solid tumors.

“AVZO-1418 represents a unique approach to deliver a single targeted therapy to patients with diverse tumor types driven by EGFR and HER3 co-expression,” said Anthony Tolcher, M.D., FRCPC, CEO and Founder, NEXT Oncology. “We believe this bispecific approach has the potential to improve tumor cell selectivity and maximize therapeutic impact across multiple solid tumor types that share this biology.”

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 proud to have dosed the first patient just over a month after receiving IND clearance,” said Mohammad Hirmand, M.D., Co-founder and Chief Medical Officer of Avenzo Therapeutics. “This milestone highlights the strong momentum behind our program. We plan to evaluate this bispecific ADC in a range of indications – including lung, breast, and head and neck cancers – where treatment options remain limited, including for patients who have progressed on standard therapies.”

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, 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.

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