On February 23, 2023 Medigene AG (Medigene, FSE: MDG1, Prime Standard) is an early-stage immuno-oncology platform company focusing on the discovery and development of T cell immunotherapies for solid tumors. Prof. Dr. Dolores Schendel Medigene, Chief Scientific Officer, reporte that it has been invited to present at the CAR-TCR Summit in London on February 23, 2023, on the topic "Implementing Automation & Innovation to Improve Manufacturing of TCR-T Cells" (Press release, MediGene, FEB 23, 2023, https://www.pressetext.com/news/20230223024 [SID1234627652]).
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The presentation will focus on how Medigene is innovating its manufacturing capabilities to address the challenges of cost-effective and timely cell therapy manufacturing, by transitioning from a multi-modular to an enclosed automated system. Medigene selected the CliniMACSTM Prodigy System, a single automated, closed device that will simplify processes, decrease the risk of contamination, and reduce production and staffing time, ultimately reducing costs to manufacture individual patient TCR-T drug products.
Prof. Schendel will discuss how the new automated system is being assessed against Medigene’s existing validated multi-modular system using manufacturing benchmarks from the successful production of MDG1011 (MDG1011, a PRAME HLA-A2 TCR-T therapy) for its phase 1 trial (NCT03503968) in AML, MDS and MM blood cancers. Using the multi-modular system, appropriate cell levels were produced in 92% of patients despite patients being elderly and heavily pre-treated.
Initial results from the validation process of the new automated system demonstrate that it delivers high viabilities of manufactured cells using enriched CD8 T cells, improved rates of TCR transduction compared to the multi-modular system, and strong functional activities of the drug products after antigen stimulation. These results match or exceed the established multi-modular benchmarks and suggest that a successful transition to fully automated production of TCR-T cells is possible.
"We are very pleased with the successful results of our first steps in transitioning to a fully closed automated system," says Dolores Schendel, Chief Scientific Officer of Medigene. "This validates our overall approach to continuously improving our end-to-end technology platform. We expect these manufacturing innovations will eventually result in tangible benefits through more convenient and more cost-effective treatment for patients."
For more details, please find the presentation on Medigene’s website: View Source
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