Medigene to Present Favorable Safety Profile of TCR-T Cells upon Addition of Costimulatory Switch Protein with a Poster Presentation at AACR 2024 Annual Meeting

Medigene to Present Favorable Safety Profile of TCR-T Cells upon Addition of Costimulatory Switch Protein with a Poster Presentation at AACR 2024 Annual Meeting

GlobeNewswire

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*Planegg/Martinsried, **March 6, 2024.* Medigene AG (Medigene or the “Company”, FSE: MDG1, Prime Standard), an immuno-oncology platform company focusing on the discovery and development of T cell immunotherapies for solid tumors, will present a poster at the American Association for Cancer Research Annual Meeting (AACR) 2024 taking place from April 5-10, 2024 in San Diego, USA as well as an oral presentation at the ELRIG-Forum 2024 to be held in Darmstadt, Germany on March 7, 2024.

*Poster presentation:*

*AACR 2024
*https://www.aacr.org/meeting/aacr-annual-meeting-2024/*
*Location: San Diego Convention Center, San Diego*
*Date: April 5-10, 2024

*Details on the poster presentation are as follows:*

Abstract title:* TCR-gated control of costimulatory switch protein (CSP) activation in rTCR-T cells expressing PD1-41BB*
Maja Buerdek, Petra U. Prinz, Kathrin Mutze, Andrea Coluccio, Stefanie Tippmer, Miriam Bosch, Giulia Longinotti, Mario Catarinella, Kathrin Davari, Christiane Geiger, Barbara Loesch, Kristy Crame, Dolores J. Schendel.
*Session details:* PO.IM01.13 - Adoptive Cell Therapies 1: Tumor Antigen-Specific T-cells and TCR-T, Sunday, April 7, 1:30 PM - 5:00 PM local time

The work to be presented shows that recombinant T cell receptor engineered T cells (rTCR-T cells), when armored and enhanced by the PD1-41BB CSP, exhibit superior TCR-T cell functionality and safety as well as a favorable safety profile, revealing the strong potential for improving treatment of cancer patients suffering from advanced solid tumor malignancies.

The abstract for this research has been published online at https://www.abstractsonline.com/pp8/#!/20272/presentation/6084 and the poster will be available online after the conference at https://medigene.com/science/abstracts/.

The Company is planning a first-in-human trial for MDG1015, a TCR-T therapy incorporating the CSP in gastric cancer, ovarian cancer, myxoid/round cell liposarcoma and synovial sarcoma with IND/CTA filing targeted for 2H 2024. MDG1015 is a first-in-class, third generation TCR-T therapy targeting NY-ESO-1/ LAGE-1a, armored and enhanced by the PD1-41BB CSP.

*Oral presentation:*

*ELRIG-Forum 2024*
https://www.elrig.de/index.php/elrig-foren/elrig-forum-2024
Location: Darmstadtium Convention Centre, Darmstadt *
*Date and time: March 7, 2024, 11:10 – 11:30am local time
Presenter: Dr. Barbara Lösch, Head, Technology & Innovation
Title: *Evolution by Innovation: Connecting the Dots of TCR-T Therapies*

Dr. Lösch will provide an overview on the Company’s proprietary End-to-End (E2E) Platform and highlight various tools within the E2E Platform that can enhance TCR-T cell functionality, safety and efficacy for generation of best-in-class, differentiated TCR-T therapies.

This presentation will available on Medigene’s website on March 7, 2024: https://medigene.com/science/abstracts/

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*About Medigene AG*

Medigene AG (FSE: MDG1) is an immuno-oncology platform company dedicated to developing differentiated T cell therapies for treatment of solid tumors. Its End-to-End Platform is built on multiple proprietary and exclusive technologies that enable the Company to generate optimal T cell receptors against both cancer testis antigens and neoantigens, armor and enhance these T cell receptor engineered (TCR) -T cells to create best-in-class, differentiated TCR-T therapies, and optimize the drug product composition for safety, efficacy and durability. The End-to-End Platform provides product candidates for both its own therapeutics pipeline and partnering. Medigene’s lead TCR-T program MDG1015 is expected to receive IND/CTA approval in the second half of 2024. For more information, please visit https://medigene.com/

*About Medigene’s End-to-End 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, differentiated TCR-T therapies. The platform includes multiple TCR generation and optimization technologies (e.g., Allogeneic-HLA (Allo-HLA) TCR Priming), as well as product enhancement technologies (e.g., PD1-41BB and CD40L-CD28 Costimulatory Switch Proteins, Precision Pairing) to address challenges in developing effective, durable and safe TCR-T therapies. Partnerships with multiple companies including BioNTech and 2seventy bio, continue to validate the platform’s assets and technologies.

*About Medigene’s PD1-41BB Costimulatory Switch Protein*

Checkpoint inhibition via PD-1/PD-L1 pathway:

Cells of solid tumors are sensitive to killing by activated T cells but can escape this killing activity by producing inhibitory molecules known as ‘checkpoint proteins’, such as the Programmed Death Ligand 1 (PD-L1), on their surface. When this occurs, activated T cells which express PD-1, the natural receptor for PD-L1, are inactivated. The expression of PD-L1 is an adaptive immune resistance mechanism for tumors that can help them survive and grow.

The 4-1BB (CD137) costimulatory signaling pathway:

Effective T cell immune responses to antigens typically require both a primary antigenic stimulation via the T cell receptor (TCR) and costimulatory signals. The intracellular signaling domains of the 4-1BB protein offer a well-characterized pathway to costimulation and enhanced T cell responses.

Medigene’s PD1-41BB switch receptor turns the tumor’s attempted self-defense mechanism against the tumor by substituting the inhibitory signaling domain of PD-1 with the activating signaling domain of 4-1BB. Therefore, instead of inactivating T cells, the switch receptor delivers an activating signal to TCR-T cells. PD1-41BB-modified TCR-T cells proliferate strongly in the presence of PD-L1-positive tumor cells and kill more tumor cells upon repeated exposure. Additionally, switch receptor signals enable TCR-T cells to function better with low levels of glucose or high levels of TGFß, two conditions characteristic of strongly hostile tumor microenvironments.

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 AG*

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

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