AVZO-021, a potential best-in-class CDK2 inhibitor, to be evaluated in combination with Trodelvy (sacituzumab govitecan-hziy), Gilead’s Trop-2 directed ADC

Combination therapy to be evaluated as part of the ongoing Phase 1/2 study in patients with HR+/HER2- metastatic breast cancer

Avenzo will sponsor the clinical trial and Gilead will provide Trodelvy

Avenzo plans to initiate combination cohorts with AVZO-021 in fourth quarter of 2024

Avenzo Therapeutics, Inc. (“Avenzo”), a clinical-stage biotechnology company developing the next generation of oncology therapeutics, today announced it has entered into a clinical study collaboration and supply agreement with Gilead Sciences, Inc. (“Gilead”) to evaluate the safety and efficacy of AVZO-021, its investigational, potentially best-in-class CDK2 inhibitor, in combination with Gilead’s Trodelvy^® (sacituzumab govitecan-hziy), a Trop-2 directed antibody-drug conjugate (ADC), as a potential treatment for patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer.

“We are excited to advance our oncology pipeline by entering this clinical collaboration with Gilead to evaluate the combination potential of AVZO-021,” said Athena Countouriotis, M.D., Co-founder, President and CEO of Avenzo Therapeutics. “We continue to believe AVZO-021 is a potential best-in-class CDK2 selective inhibitor that may provide a new treatment option to patients. We look forward to initiating combination cohorts with Trodelvy, as well as CDK4/6 inhibitors, in the Phase 1b portion of the ongoing clinical study in the fourth quarter of 2024.”

Under the clinical study collaboration and supply agreement, Gilead will provide Trodelvy to Avenzo, who will conduct and sponsor the combination study. Avenzo and Gilead will retain all development and commercial rights to their respective compounds, including as monotherapy or as combination therapies.

Trodelvy and Gilead are trademarks of Gilead Sciences, Inc., or its related companies.

About Avenzo Therapeutics

Avenzo Therapeutics is a clinical-stage biotechnology company focused on developing the next generation of oncology therapies for patients. The company’s lead drug candidate, AVZO-021, is a novel, highly potent and selective inhibitor of CDK2, a key enzyme involved in cell cycle regulation. AVZO-021 is being studied in a Phase 1 study in the U.S. 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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