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.
"We congratulate our partner for achieving this critical milestone of dosing the first patient. 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," said Dr. Chris Chen, CEO of WuXi Biologics.
"We are very excited about this key achievement for our site-specific antibody drug conjugate programs. This demonstrates that our EuCodeTM technology platform is ready for commercial product development," said Dr. Alex Qiao, CEO of Ambrx. "We are also very happy about this collaboration. WuXi's integrated service enables Ambrx'sinnovative business model to bring our novel drug to patients with great efficiency."
"This project represents one of the first case studies of using the same CMC and preclinical package for global simultaneous filing," said Dr. Ge Li, Chairman and CEO of WuXi AppTec. "This collaboration showcases WuXi's integrated, open-access R&D services platform and enables our partners to develop innovative products efficiently and cost-effectively to benefit patients around the world."
About WuXi AppTec
WuXi AppTec is a leading open-access R&D capability and technology platform company serving the pharmaceutical, biotechnology, and medical device industries, with operations in China and the United States. As a research-driven and customer-focused company, WuXi AppTec provides a broad and integrated portfolio of services throughout the drug and medical device R&D process. WuXi AppTec is also building a platform to provide clinical diagnostic services directly to physicians and their patients globally. WuXi AppTec's services are designed to assist its global partners in shortening the cycle and lowering the cost of drug and medical device R&D. For more information, please visit: http://www.wuxiapptec.com.
About WuXi Biologics
WuXi Biologics, a wholly-owned subsidiary of WuXi PharmaTech, is a leading open-access technology capability and technology platform to enable anyone and any company to develop biologics. As a premier Contract Discovery, Development and Manufacturing Organization (CDMO), WuXi Biologics provides our worldwide clients with the necessary expertise, quality and capacities to develop biologics from concept to commercialization. Along with our WuXi AppTec affiliates, we provide the world with the ONE true single-source approach that saves our clients critical time and money. Our company history and achievements demonstrate our commitment to providing a truly ONE-stop service offering and value proposition to our global clients. For more information on WuXi's biologics services, please visit: http://www.wuxibiologics.com
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SOURCE WuXi AppTec