Hangzhou-based Zhejiang Medicine, or ZMC, has started Phase I work in Australia and New Zealand on an antibody candidate targeting HER2-positive breast cancer with San Diego-based Ambrx, building on a 2013 partnership.
The development costs for the Oceania leg will be covered by ZMC, which has also filed with the China FDA to hold trials in China where it holds rights to the candidate, ARX788, according to a press release.
China's top CRO WuXi PharmaTech will handle the development plan for the China leg while ZMC plans to make the drug in China and also for any Ambrx in the case of development outside of China.
"This is the first exciting step to demonstrate the clinical application of our proprietary EuCODE technology for the improvements of cancer patient lives," Ambrx CEO Alex Qiao said in the release.
|Ambrx CEO Alex Qiao|
"This is not only an important milestone for our ARX788 program, but also is a major event for our unique site-specific protein conjugation technology platform as we hope to leverage this same technology to develop ADC drugs for a number of different cancers."
In May last year, a consortium of Chinese biomedical- and healthcare-focused funds bought Ambrx, which abandoned an initial public offering in 2014.
China Everbright's healthcare fund, Shanghai Fosun Pharmaceutical Group, HOPU Investments, as well as WuXi PharmaTech, announced the deal without providing financial details.
In addition to ARX788, Ambrx has a leading candidate in Its leading candidate is ARX618, a long-acting fibroblast growth factor 21 for Type 2 diabetes, for which collaboration partner Bristol-Myers Squibb ($BMY) is conducting Phase II clinical trials in the United States.
The company has also worked with Merck ($MRK), Eli Lilly ($LLY) and Agensys.
- here's the release from Ambrx