Medigene AG Secures European Patent for its PD1-41BB Costimulatory Switch Protein

Planegg/Martinsried, September 27, 2023. Medigene AG (Medigene, the “Company”, FSE: MDG1, Prime Standard), an immuno-oncology platform company focusing on the discovery and development of T cell immunotherapies for solid tumors, announces today that the Company has been issued a patent (EP3 433 269) by the European Patent Office protecting its PD1-41BB costimulatory switch protein (CSP) technology. Medigene’s PD1-41BB CSP was developed by its partner Helmholtz Munich and is exclusively licensed to Medigene.

“We are delighted to have been granted the European Patent for our PD1-41BB CSP, one of the key technologies of Medigene’s End-to-End (E2E) Platform. This complements our PD1-41BB IP-portfolio with similar patents already granted in the United States, China and Japan, and strengthens our patent portfolio worldwide,” said Selwyn Ho, CEO at Medigene AG. “At Medigene, we are committed to creating best-in-class, differentiated T cell receptor engineered T cells (TCR-T) therapies optimized for safety, efficacy and durability.The grant of this European patent in combination with the expansion of our exclusive license for the PD1-41BB CSP to be used in all cell types beyond TCR-T therapies validates our approach to continuously innovate to address the unmet need of patients with solid tumors.”

Medigene constantly extends and strengthens its patent portfolio with new technologies and expands existing patents into additional jurisdictions. The Company maintains over 20 different patent families worldwide covering applications protecting Medigene’s 3S (specific, sensitive and potentially safer) TCRs as well as the armoring and enhancement technologies of its E2E Platform.

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About Medigene AG

Medigene AG (FSE: MDG1) is an immuno-oncology platform company dedicated to developing T cell therapies to effectively eliminate cancer. Its End-to-End Platform, built on multiple proprietary and exclusive TCR generation and optimization, as well as product enhancement 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 safety, efficacy and durability. 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 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, 2seventy bio, and Hongsheng Sciences, continue to validate the platform’s assets and technologies. For more information, please refer to the recent publication by Dolores J. Schendel, published in Frontiers in Oncology, section Molecular and Cellular Oncology: Evolution by Innovation as a Driving Force to Improve TCR-T Therapies.

About Medigene’s TCR-T Cells

T cells are at the center of Medigene’s therapeutic approaches. Medigene’s immunotherapies help activate the patient’s own defense mechanisms, and harness T cells in the battle against cancer. Medigene’s therapies arm the patient’s own T cells with tumor-specific T cell receptors (TCRs) creating TCR-modified T cells with enhanced potential to detect and efficiently kill cancer cells.

Medigene’s approach to immunotherapy is designed to overcome the patient’s tolerance of cancer cells and tumor-induced immunosuppression. By activating the patient’s T cells outside the body, genetically modifying them with tumor-specific TCRs and expanding the resultant activated TCR-T cells, patients can rapidly be given large numbers of tumor-specific T cells to fight their cancer.

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 costimulatory switch protein 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 protein 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, these switch protein 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

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

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