Pharma Focus Europe

AGC Biologics and Medigene Collaborate on TCR-T Cell Services Agreement to Advance New Cell Therapy Products

Thursday, October 26, 2023

AGC Biologics, a prominent biopharmaceutical development and contract manufacturing organization (CDMO), has recently entered into a new service agreement with Medigene (FSE, abbreviated as MDG1, Prime Standard). We are pleased to announce this collaboration. Under the terms of this agreement, AGC Biologics will be responsible for formulating next-generation therapeutic products targeting the treatment of solid tumors. Additionally, AGC Biologics will provide support for Medigene's Investigational New Drug (IND) filing and subsequent clinical trials.

For products currently in the preclinical stage, AGC Biologics will oversee the process transfer and clinical manufacturing of Medigene's product candidates at CDMO's Cell and Gene Center of Excellence in Milan.

AGC Biologics Milano, expressed his excitement, stating, "The recent growth in T-cell immunotherapy has been remarkable. Despite the complexity of manufacturing, it offers unique therapeutic benefits to patients in need. Our team is experienced in managing complex cell therapy projects, and we are eager to take on this challenge and contribute to the development of cell therapy products in collaboration with Medigene, a pioneer in the field of solid tumor therapy. I look forward to it."

T-cell immunotherapy is expected to witness a growth of more than 30 percent over the next decade, primarily driven by its exceptional ability to target cancer cells and promising early clinical data, as per the latest industry research by Roots Analysis. Being a living therapy, T-cell therapy presents unique manufacturing challenges at a GMP scale. AGC Biologics' Milan office boasts 30 years of experience in the field of cell and genetics and is well-versed in managing intricate advanced cell therapy projects, such as the one at hand. The core team has successfully guided three cell therapy products from development to commercialization and has produced numerous batches of cell therapy for both clinical and commercial purposes.

Medigene, highlighted the collaboration, stating, "This partnership revolves around the optimal affinity TCR and PD1-41BB costimulatory switch proteins designed to target NY-ESO-1/LAGE-1a. It represents a crucial initial step in preparing our lead product candidate MDG1015, a combined third-generation TCR-T therapy, for GMP clinical evaluation. We are excited to partner with AGC Biologics and eagerly anticipate advancing MDG1015, delivering the industry's most distinguished TCR-T therapy to patients suffering from solid tumors."



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