SAN DIEGO, Aug. 17, 2016 /PRNewswire/ -- Ambrx announced today that their ARX788 US IND is now active. ARX788 is Ambrx's most advanced internally developed site-specific ADC targeting Her2. Ambrx ARX788 may hold the potential for a broader patient population than the currently available Her2-targeting therapies. Ambrx will open US sites for the first-in-human (FIH) study which is currently recruiting patients at several sites in Australia and New Zealand. The primary end point is safety and tolerability. The pharmacokinetics and antitumor activity of ARX788 will also be evaluated.
"The opening of the US IND for ARX788 represents an important milestone for Ambrx to advance the development of this innovative ADC drug in the world market, such as the US, in addition to China and other regions," said Alex Qiao, Chief Executive Officer of Ambrx. "This will help us accelerate the development timeline for ARX788 which will provide clinical validation of our proprietary EuCODE™ technology for the improvement of cancer patient lives."
Ambrx®, Inc. is a clinical stage biopharmaceutical company with a mission to deliver breakthrough protein therapeutics using an expanded genetic code. Unlike conventional conjugation techniques that create a mixture of suboptimal molecules, Ambrx technology combines site specific conjugation with proprietary linkers, payloads and pharmacokinetic extenders to create a single molecular species that is optimized for safety, efficacy and biophysical properties. We call this process Protein Medicinal Chemistry™.
The company is developing ARX788 - a site-specific antibody drug conjugate for breast cancer and gastric cancer. In addition to its ADC collaborations with Astellas, Bristol-Myers Squibb and Zhejiang Medicine Co. Ltd, Ambrx has collaborations to discover and develop products incorporating Ambrx technology with Bristol-Myers Squibb, Eli Lilly and Hisun. Ambrx is developing a robust portfolio of product candidates that are optimized for efficacy and safety in oncology.
At Ambrx, we are dedicated to assembling and developing an exceptional team and a novel technology to create the next generation of protein-based medicines. For additional information, visit www.ambrx.com.
SOURCE Ambrx, Inc.