Congratulations to our partners Ambrx and Zhejiang Medicine Company (ZMC) for completing dose of the first patient for ARX788, a novel antibody-drug conjugate (ADC) product candidate for treating breast cancer and gastric cancer in Australia. ARX788 was developed by Ambrx based on its innovative EuCodeTM technology platform. In June 2013, Ambrx and ZMC formed an innovative collaboration to develop ARX788 in China with world-class standards.
As part of the collaboration, WuXi provided comprehensive, integrated services for ARX788 from clones to IND. WuXi successfully scaled up manufacturing processes for the novel toxin/linker, the monoclonal antibody, the ADC drug substance and drug product under cGMP condition. These activities were all conducted at WuXi’s facilities within 100 miles, eliminating the complex transportation issues often associated with ADCs. This project represents the first site-specific ADC using a non-natural amino acid technology. It also represents the first reported case of large-scale manufacture of such an ADC for clinical applications. IND for ARX-788 was approved in Australia and New Zealand. The IND application was also accepted by Chinese CFDA last month. This project represents one of the first case studies of using the same CMC and preclinical package for global simultaneous filing. We are very pleased to have completed this complicated ADC project within only 20 months, which manifested our strong value proposition of the integrated solution provider.