Ambrx Biopharma Inc. Announces First Patient Dosed in its Global Phase 2 ACE-Breast-03 Clinical Study of ARX788 for the Treatment of HER2-Positive Metastatic Breast Cancer

Excerpt from the Press Release:

SAN DIEGO–(BUSINESS WIRE)–Ambrx Biopharma Inc., or Ambrx, (NYSE: AMAM), a clinical stage biopharmaceutical company using an expanded genetic code technology platform to create Engineered Precision Biologics, today announced the first patient has been dosed in its global ACE-Breast-03 Phase 2 clinical study of ARX788 in patients with HER2-positive metastatic breast cancer.

ARX788 is an anti-HER2 antibody drug conjugate (ADC) that is being studied broadly in breast cancer, gastric/GEJ cancer and other solid tumors. The FDA has granted ARX788 Fast-Track Designation for the treatment of HER2-positive metastatic breast cancer in December 2020.

“Dosing the first patient in this Phase 2 study of ARX788 in patients with HER2-positive metastatic breast cancer marks an important milestone for Ambrx,” said Feng Tian, Ph.D., Chairman of the Board, President, and CEO of Ambrx. “We have made excellent progress with our clinical development pipeline over the last few months, highlighted by our positive data of ARX788 for HER2-positive gastric cancer, as well as the dosing of the first patient in a Phase 1 trial of ARX517 for PSMA expressing tumors. Our growing clinical programs, coupled with an influx of capital from our IPO in June 2021, leaves Ambrx well-positioned to potentially attain several near-term clinical and corporate milestones.”

The global ACE-Breast-03 Phase 2 clinical study is a multicenter study to evaluate the efficacy and safety of ARX788 in HER2-positive, metastatic breast cancer patients whose disease is resistant or refractory to T-DM1, and/or T-DXd, and/or tucatinib-containing regimens. The primary outcome measure of the study will be the objective response rate.

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