DSM to work with NKT on cGMP manufacture of lead mAb, while ScinoPharm will produce API for Clinical Data’s approved MDD therapy.
Contract research and manufacturing companies DSM Biologics and ScinoPharm both report new agreements today. DSM inked a contract with biotech firm NKT Therapeutics for the process development and cGMP manufacture of the latter’s lead product, iNKT mAb. Taiwanese firm ScinoPharm will commercially manufacture vilazodone hydrochloride, the API in Clinical Data’s Viibryd™, which was granted FDA approval on January 24 for the treatment of major depressive disorder in adults.
ScinoPharm has research and manufacturing facilities in both Taiwan and China. The firm will be the sole API supplier of vilazodone hydrocholoride for Clinical Data during the drug’s launch. “Beginning from process research through timely development and optimization of a long and complicated synthetic process, we have established a win-win partnership,” comments Jo Shen, Ph.D., ScinoPharm president and CEO.
DSM’s new client, NKT, meanwhile, is focused on developing a pipeline of antibody therapeutics that can either activate or inactivate natural killer T (NKT) cell function for the potential treatment of cancer, infectious diseases, autoimmune diseases, asthma, and dermatitis. The firm’s lead program is centered on an antibody targeting the invariant T cell receptor.
NKT says moving its lead program into cGMP manufacture represents a major milestone. “Manipulation of NKT cells is an exciting new therapeutic strategy,” remarks Robert Marshal, Ph.D., CEO. “Following on the heels of our successful studies in primates, we are on track to file an IND next year. DSM provides us with numerous options and flexibility in our manufacturing programs.”