Therapure Biopharma has been contracted to provide fill-and-finish services for nimotuzumab, a humanized monoclonal antibody licensed to YM Biosciences’ majority-owned Canadian subsidiary, CIMYM BioSciences, by the Centre of Molecular Immunology.
Therapure will formulate and fill nimotuzumab into sterile vials in its aseptic GMP-certified and Health Canada licensed fill suite in Mississauga, Canada. The facility is built to FDA, EMEA, MHRA, and Health Canada standards. The final product will be utilized by YM BioSciences and its licensees, Daiichi Sankyo in Japan, Kuhnil in South Korea, and Oncoscience in Europe for all activities and by Innogene Kalbiotech, YM’s licensee in Southeast Asia, for global clinical trials.
Nimotuzumab is currently being evaluated in 32 clinical studies worldwide in numerous indications, including multiple stages of non-small-cell lung cancer, pediatric and adult glioma, esophageal cancer, pancreatic cancer, gastric cancer, and head and neck cancer. Three Phase III trials and eight Phase II trials of those 32 are being conducted between YM and its four licensees.
Nimotuzumab has been approved for marketing in 23 countries including Argentina, Brazil, China, India, Indonesia, and, most recently, Mexico.
