US-based, China-owned biotech Ambrx Biopharma Inc. (NYSE: AMAM) has announced plans to end the development of its HER2-targeted antibody drug conjugate (ADC) pipeline candidate ARX788. The decision follows a strategic assessment of factors including cash runway, pipeline near-term value creation opportunities, and other considerations. As a result, the company also plans to reduce its workforce by 15%.
Decision to Cut ARX788
ARX788 had reached the Phase III clinical trial stage, but the decision to halt its development was influenced by significant shifts in the HER2 metastatic breast cancer competitive landscape over the past year. AstraZeneca and Daiichi Sankyo’s HER2-targeted ADC Enhertu (trastuzumab deruxtecan) was first approved in the United States for breast cancer in August this year. Ambrx’s interim CEO, Kate Hermans, noted that the company now aims to focus on its earlier-stage pipeline, particularly ARX517, a potentially world-first prostate-specific membrane antigen (PSMA)-targeted ADC.
Seeking Partnerships for ARX788
Ambrx will now seek a partner for ARX788 in markets outside of China. In the Greater China territory, Ambrx had previously granted development and commercial rights for the ADC to Novocodex Biopharmaceuticals Ltd, a subsidiary of Zhejiang Medicine Co., Ltd, in a 2013 deal. Novocodex later returned the China rights for another Ambrx ADC, the CD70-targeted ARX305, in a 2019 deal.
Company Background and Future Outlook
Ambrx was acquired by a consortium of Chinese entities in 2015, including Shanghai Fosun Pharmaceutical Group, HOPU Investments, China Everbright Limited’s healthcare fund, and WuXi PharmaTech. The company’s former CEO, Dr. Feng Tian, resigned two months prior to this announcement. Additionally, in July 2022, Bristol-Myers Squibb decided to cancel the development of a relaxin drug for heart failure licensed from Ambrx. Moving forward, Ambrx aims to focus on its early-stage pipeline to offer first- or best-in-class solutions in the oncology space.-Fineline Info & Tech
