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Form manufacturing collaboration following successful IND filing for AVB-S6-500
February 6, 2018
By: Tim Wright
Editor-in-Chief, Contract Pharma
Aravive Biologics and WuXi Biologics have expanded their biologics manufacturing collaboration, based on the success achieved in the process development, scale-up and cGMP manufacture of Aravive’s lead drug candidate, AVB-S6-500. The decision follows the successful filing of a U.S. Investigational New Drug application (IND) for AVB-S6-500, a novel GAS6-AXL pathway inhibitor which Aravive is developing for the treatment of cancer and non-malignant fibrotic conditions. “Since selecting WuXi Biologics to produce our lead therapeutic candidate for preclinical studies, our efforts with the firm on the production and scale-up of AVB-S6-500 have been extremely successful, quickly advancing from plasmid to U.S. IND in less than 16 months,” said Ray Tabibiazar, chairman, Aravive. “We look forward to building on our relationship with WuXi Biologics as we move forward with our plans to advance AVB-S6-500 into clinical testing and expand the Aravive pipeline over the coming years.” Chris Chen, chief executive officer, WuXi Biologics, said, “We are very pleased to be part of the continuing development of AVB-S6-500 and are excited about the potential that this first-in-class molecule has shown to date as an innovative new therapy for people with cancer and fibrotic disease. We also look forward to collaborating with Aravive over the coming years on further molecules in their pipeline. Aravive’s desire to continue and build upon its relationship with WuXi Biologics is a strong validation of the premier quality and global excellence of our services. We strive to make life-saving biologics more affordably produced and available to patients around the world.” In August 2017, WuXi Biologics’ cGMP facility at Wuxi city was the first China-based manufacturing facility to complete a U.S. FDA pre-license inspection for any biologics drug under FDA review, which paved the way for biologics commercial manufacturing.
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