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Ambrx Partner NovoCodex Seeking Approval in China for HER2-Targeted Breast Cancer Therapy

NEW YORK – Ambrx Biopharma on Wednesday said its partner NovoCodex Biopharmaceuticals will submit a marketing application to China's National Medical Products Administration for ARX788 after the HER2-directed antibody-drug conjugate demonstrated promising activity during an interim analysis in the ACE-Breast-02 trial.

In the Phase III trial involving 441 previously treated patients with HER2-positive metastatic breast cancer, those on ARX788 had statistically significantly better progression-free survival compared to those on Novartis' Tykerb (lapatinib) and capecitabine, an independent data monitoring committee found.

In addition to ACE-Breast-02, ARX788 is under investigation in several clinical trials in China and the US. For example, in the Phase II ACE-Breast-03 trial, Ambrx is studying ARX788 in advanced HER2-positive breast cancer patients previously on AstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan). In the I-SPY trial, ARX788 is one of various treatment strategies researchers are assessing in breast cancer using biomarker signatures.

Beyond breast cancer, La Jolla, California-based Ambrx is studying ARX788 in gastric cancer and other solid tumors with Shaoxing, China-based NovoCodex. The US Food and Drug Administration has granted fast-track designation to ARX788 in HER2-positive metastatic breast cancer and orphan drug designation in gastric cancer.

NovoCodex, a subsidiary of Zhejiang Medicine, has commercial rights to ARX788 in China under a 2013 agreement between Zhejiang and Ambrx. Under that agreement, Ambrx retains commercial rights to ARX788 outside of China and is entitled to royalties on sales of the drug in China.