YM BioSciences and Therapure Biopharma have entered into a service agreement, where by Therapure Biopharma will provide fill and finish services for Nimotuzumab, the humanized monoclonal antibody licensed to YM’s Canadian subsidiary, CIMYM BioSciences, by the Centre of Molecular Immunology (CIM). The announcement was made by David Allan, chairman and CEO of YM BioSciences and Thomas Wellner, president and CEO of Therapure Biopharma.
Under the terms of the agreement, Therapure will formulate and fill Nimotuzumab into sterile vials in their aseptic GMP certified and Health Canada licensed fill suite in Mississauga, Canada. Reportedly, 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 a humanized monoclonal antibody that targets and binds to the epidermal growth factor receptor (EGFR), the well-validated oncology target. 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 & 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.
David Allan said: “We have been very pleased with the performance of Nimotuzumab during our on-going clinical development program advancing it toward the market. Combining the supply of the active drug product from the Center Molecular Immunology with the fill/finish capabilities of Therapure’s manufacturing suite provides CIM and YM BioSciences with a cost-effective and complete Canadian solution that integrates the numerous skills required in the production of biologics and provides a North American GMP standard to the Nimotuzumab manufacturing process. Our product is well suited to Therapure’s flexible and modern Health Canada-licensed facility.”
Thomas Wellner said: “Therapure Biopharma is proud to be able to work with YM BioSciences and to apply our expertise to support the clinical evaluation of this differentiated drug, and we look forward to continuing the process through supply of the commercial product when marketing authorizations are granted in the major markets.
“Therapure Biopharma has much experience filling and finishing a variety of biopharmaceutical products in different formats. Working closely with YM BioSciences, another successful Canadian-based biotech company, has allowed us to meet their quality requirements for a successful globalization of this exciting cancer treatment.”