WuXi Biologics, a leading global Contract Research, Development and Manufacturing Organization (CRDMO), and Toregem BioPharma, a biotech startup company from Kyoto University, announced that they have signed a Memorandum of Understanding (MOU) to form a strategic partnership in the development of TRG035, a monoclonal antibody targeting USAG-1 for the treatment of congenital adentia.
Within the partnership, Toregem BioPharma will have access to WuXi Biologics’s integrated CMC services in cell line development, cell banking and testing services, cell culture development, biologics GMP manufacturing, bioassay development, and related services. WuXi Biologics will support Toregem BioPharma on the TRG035 project for its Investigational New Drug (IND) application.
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“We are glad to be collaborating with WuXiBiologics as they are experienced in enabling universities to turn advanced technologies into promising products,” said Dr. Honoka Kiso, CEO of Toregem BioPharma. “By utilizing WuXi Biologics’ comprehensive IND-enabling capabilities and large global footprint with extensive GMP production capacities, Toregem BioPharma will be able to focus on realizing and maximizing the therapeutic potential of TRG035. WuXi Biologics is the best partner for us as we step forward to conduct the clinical trial and realize the eventual commercialization of our unique product. We look forward to bringing this tooth regeneration drug to the global market, treating patients across the world.”
Dr. Chris Chen, CEO of WuXi Biologics, commented, “We are very pleased to partner with Toregem BioPharma, and this is one of the first integrated CMC projects in Japan that we have supported – with our integrated services and experience – from early academic research phase all the way to clinical phase. WuXi Biologics is proud to support all kinds of global partners in bringing new biologics solutions to life for patients in multiple markets worldwide.”
Toregem Bio Pharma Co., Ltd. is a startup venture from Kyoto University that was founded in May, 2020, for the purpose of research and development and launch of a tooth regeneration antibody drug based on the research results of Dr. Katsu Takahashi, Oral and Maxillofacial Surgery, Kyoto University. (Takahashi K., Inflamm Regen, 40, 21, 2020, Murashima-Suginami A., Sci Adv, 7,eabf, 2021.)