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news.Ambrx and Zhejiang Medicine have initiated First-In-Human phase I clinical trial with ARX788, Ambrx's most advanced internally developed site-specific antibody drug conjugate (ADC) targeting Her2.
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Ambrx ARX788 may hold the potential for a broader patient population than the currently available Her2 targeting therapies. The multicenter study will be conducted at several sites within Australia and New Zealand.
The primary end point is safety and tolerability, and the pharmacokinetics of ARX788 will also be evaluated. The application for the initiation of clinical trial in China was submitted to the China FDA early this year.
Ambrx and Zhejiang Medicine Co. Ltd entered into collaboration on June 14, 2013 to develop ARX788 into a world class standard in China. Zhejiang receives commercial rights in China while Ambrx retains commercial rights outside of China.
WuXi Apptec provided preclinical services and successfully manufactured Ambrx site-specific ADC under CGMP regulation.
Ambrx CEO Alex Qiao said: "We are very happy about the collaboration with ZMC. This is an important milestone for this partnership.
"This is the first exciting step to demonstrate the clinical application of our proprietary EuCODE technology for the improvements of cancer patient lives. 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."
ZMC chairman Chunbo Li said: "We are very happy to see ARX788 entering into clinical trial.
"We hope our collaboration with Ambrx in this innovative program will eventually benefit cancer patients around the world."