Medigene AG: Medigene presents first results for automated manufacturing of T cell receptor engineered T cells

Planegg/Martinsried (pta024/23.02.2023/14:00 UTC+1)

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, 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".

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: https://www.medigene.de/technologien/abstracts

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About Medigene

Medigene AG (FSE: MDG1) is a leading immuno-oncology company dedicated to developing T-cell therapies to effectively eliminate cancer. Its end-to-end technology platform, built on multiple proprietary and exclusive product enhancement and product development technologies, allows Medigene to create best-in-class differentiated, T Cell Receptor engineered T cell (TCR-T) therapies for multiple solid tumor indications that are optimized for both safety and efficacy. This platform provides product candidates for both its in-house therapeutics pipeline and partnering. For more information, please visit www.medigene.com

About Medigene's TCR-T Therapy Platform

Medigene's immunotherapies help activate the patient's own defense mechanisms by harnessing T cells in the battle against cancer. Medigene's end-to-end platform combines multiple exclusive and proprietary technologies to create best-in-class TCR-T therapies. The platform includes multiple product enhancement technologies, (e.g. PD1-41BB Switch Receptor, Precision Pairing) and development optimization technologies (e.g. Allogeneic-HLA (Allo-HLA) TCR Priming) to aid the development of differentiated TCR-T therapies. Partnerships with multiple companies including BioNTech, 2SeventyBio, and Hongsheng Sciences, continue to validate the platform's assets & technologies.

This press release contains forward-looking statements representing the opinion of Medigene as of the date of this release. The actual results achieved by Medigene may differ significantly from the forward-looking statements made herein. Medigene is not bound to update any of these forward-looking statements. Medigene® is a registered trademark of Medigene AG. This trademark may be owned or licensed in select locations only.

Medigene

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Phone: +49 89 2000 3333 01
E-mail: investor@medigene.com

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Emitter:	Medigene AG Lochhamer Straße 11 82152 Planegg/Martinsried Germany
Contact Person:	Medigene PR/IR
Phone:	+49 89 2000 3333 01
E-Mail:	investor@medigene.com
Website:	www.medigene.com
ISIN(s):	DE000A1X3W00 (Share)
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