Medigene AG: Medigene Expands Patent Portfolio in Japan for iM-TCR Technology to Control TCR-T Safety and Efficacy

Planegg/Martinsried (pta006/04.03.2024/08:00 UTC+1)

Planegg/Martinsried, March 4, 2024. Medigene AG (Medigene, FSE: MDG1, Prime Standard), an immuno-oncology platform company focusing on the discovery and development of T cell immunotherapies for solid tumors, today announced that the Company has been issued a patent by the Japan Patent Office protecting its inducible Medigene T cell receptor (iM-TCR), a control mechanism to regulate efficacy and safety of its T cell receptor engineered T cell (TCR-T) therapies.

"We are delighted with the receipt of the patent grant for our iM-TCR from the Japan Patent Office as we continue to expand and strengthen our IP portfolio. The ability to control the level of TCR activity with our iM-TCR technology after dosing has the potential to deliver more individualized efficacy and safety for patients. This patent grant is further validation of this innovative iM-TCR technology," said Selwyn Ho, CEO at Medigene. "The iM-TCR is a key example of the breadth of our technologies within our End-to-End Platform, that also includes multiple proprietary armoring and enhancement technologies. Combining our optimal 3S (sensitive, specific and safe) TCRs with technologies such as our iM-TCR technology is part of our ambition to deliver innovative solutions that can optimize safety and efficacy of TCR-T therapies."

TCR-T therapies have demonstrated that they can effectively kill tumor cells. However, excessive activation of T cells may lead to premature exhaustion or cell death, as well as unwanted overactivity and potential development of inflammatory responses in the body. The iM-TCR technology modifies the TCR to achieve control of TCR surface expression, allowing for fine-tuning of activity against tumor cells and thereby reducing potential inflammatory responses in the body. This property is of potential benefit to sensitive organs damaged by a sustained inflammatory response of T cells, such as with brain or liver cancer.

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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 inducible TCR (iM-TCR)

The T cell receptor (TCR) assembly is a complex process. In humans, TCRs consist of an alpha (α) chain and a beta (β) chain and each chain possesses a constant and a variable part. Medigene´s proprietary iM-TCR technology prevents the normal pairing of the α and the β chains by introduction of specific engineered sequences into the constant part of each TCR chain. Each engineered chain is linked to an estrogen receptor sequence, which only allows the two iM-TCR chains to pair (dimerize) in the presence of Tamoxifen, and be expressed and function at the surface of TCR-T cells in a normal manner. As a consequence, to enable the iM-TCR-T cells to function in tumor cell recognition and killing, Tamoxifen administration is required but the levels required for dimerization and TCR-T function are orders of magnitude lower than the commonly used therapeutic doses.

Any TCR from Medigene's broad library of 3S TCRs can be equipped with the proprietary iM-TCR technology, which enables the function of tumor-specific TCR-T cell therapies to be finely tuned for safety and efficacy according to clinical needs. For more information on our iM-TCR technology, please visit https://medigene.com/platform/im-tcr/

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.

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
Email: 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
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