Medigene to Present Favorable Safety Profile of TCR-T Cells with Costimulatory Switch Protein at AACR 2024

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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