WuXi Biologics, a leading global open-access biologics technology platform company offering end-to-end solutions for biologics discovery, development and manufacturing, and Aravive Biologics, announced plans to expand their biologics manufacturing collaboration, based on the rapid success achieved in the process development, scale-up and cGMP manufacture of Aravive’s lead drug candidate, AVB-S6-500 (previously referred to as Aravive-S6).
Aravive Biologics (Houston, USA) is a biopharmaceutical company focused on developing novel, highly selective therapies designed to treat serious cancers and certain fibrotic diseases.
The decision follows the successful filing of 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, M.D., Chairman of 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.”
In August 2017, WuXi Biologics’ cGMP facility in Wuxi city became the first China-based manufacturing facility to complete a U.S. Food and Drug Administration Pre-License Inspection (PLI) for any biologics drug under FDA review, which paved the way for biologics commercial manufacturing.