Medigene AG: Medigene and EpimAb Biotherapeutics Enter into a Co-Development Partnership for TCR-Guided T Cell Engagers

Planegg/Martinsried (pta007/27.02.2025/09:00 UTC+1)

Planegg/Martinsried and Shanghai, February 27, 2025. Medigene AG (Medigene, FSE: MDG1, Prime Standard) and EpimAb Biotherapeutics, Inc. (EpimAb), announced that the companies have entered a strategic co-development agreement to research and develop off-the-shelf T cell receptor (TCR)-guided T Cell Engagers (TCR-TCEs) for the treatment of immune-related disorders, such as solid tumors.

The multi-target collaboration combines the respective expertise of each company with Medigene's 3S (sensitive, specific and safe) TCR generation and characterization capabilities and EpimAb's proprietary CD3 antibody and T-FIT (TCR-Fab in tandem) platform. The resultant bispecific therapeutics are expected to provide highly specific targeted immune responses with minimized off-target effects and thus, improved patient outcomes.The companies aim to co-develop TCR-TCE constructs, which will be owned equally by both partners.

"We are delighted to partner with EpimAb and their proprietary T-FIT platform, which is well validated with strong clinical data and a number of prominent recent partnering deals, to develop potential best-in-class TCR-TCEs, leveraging our expert 3S TCR generation capabilities," said Selwyn Ho, CEO of Medigene AG. "This co-development agreement further expands the application of Medigene's TCRs into off-the-shelf TCR-guided modalities and underscores our commitment to forging value-driven partnerships that expand our pipeline in areas of high unmet patient need."

"EpimAb is looking forward to discover new TCR-TCEs with Medigene's unique TCRs," said Chengbin Wu, CEO and Founder of EpimAb. "Together we can open up new possibilities for our T-FIT and CD3 binding platforms to develop novel targeted therapies for cancer patients."

The market for bispecific therapies represents a significant opportunity in the fight against cancer, addressing the critical unmet need in both solid and hematologic tumors. Annually, over 5 million cancer patients worldwide, suffering from solid and hematologic cancers, face low five-year survival rates, highlighting the urgent demand for innovative treatments. Bispecific TCR-TCEs offer a promising solution, leveraging the body's immune system to target and eradicate cancer cells with heightened precision.

The market for these therapies is projected to experience compound annual growth rate of 40.9% from 2023 to 2030, underscoring the robust and accelerating interest in this field. By 2030, the market is estimated to exceed USD80 billion (Source: KBV Research), reflecting its substantial potential to improve patient outcomes and revolutionize treatment of cancer and other diseases.

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About Medigene AG

Medigene AG (FSE: MDG1) is an immuno-oncology platform company dedicated to developing T cell receptor (TCR)-guided therapies to effectively eliminate cancer. Its End-to-End Platform generates optimal 3S (sensitive, specific and safe) T cell receptors with unique and distinctive attributes that can be utilized in multiple therapeutic modalities, such as off-the-shelf TCR-guided T cell engager (TCR-TCE) therapies (MDG3010), TCR-natural killer cell (TCR-NK) therapies and T cell receptor engineered T cell (TCR-T) therapies (MDG1015). For more information, please visit https://medigene.com/

About EpimAb Biotherapeutics, Inc

EpimAb Biotherapeutics, Inc is a clinical stage biopharmaceutical company specializing in the development of multispecific antibodies. Utilizing our broad range of in-house research and technology capabilities, including the proprietary FIT-Ig® (Fabs-In-Tandem Immunoglobulin) and MAT-Fab (Monovalent Asymmetric Tandem Fab) bispecific platforms, EpimAb is generating and globally advancing a unique pipeline of transformative preclinical and clinical assets that aim to benefit cancer patients. For further information, please visit: www.epimab.com

About TCR-guided T cell engagers

TCR-guided T cell engagers (TCR-TCEs) represent an innovative 'off-the-shelf' immunotherapy that leverages the specificity of TCRs to guide T cells towards cancer cells. Unlike conventional antibodies, TCRs can recognize both intracellular and extracellular targets presented by peptide-HLA complexes on cancer cells, allowing for a broader range of targetable antigens.

As part of its End-To-End Platform, Medigene discovers natural TCR sequences with high specificity, sensitivity and safety (3S). These optimal 3S TCRs can subsequently be merged with a Cluster of Differentiation 3 (CD3) T cell engaging antibody.

The TCR-TCEs specifically redirect the patient's own T cells towards the cancer cells via binding of the 3S TCR to a target (cancer-testis antigen or neoantigen) that is almost exclusively present on tumor cells. The T cells, when brought into proximity of cancer cells, are activated through the CD3-engaging antibody, leading to release of cytokines and cytotoxic molecules that facilitate cancer cell killing.

Development of highly specific TCR-TCEs provides 'off-the-shelf' anti-cancer agents with potential to achieve similar or complementary anti-cancer effects to those of adoptive cell therapies.

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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EpimAb Biotherapeutics, Inc

Investor Contact

Dr. David Gu

Phone: +86-21-61951011

E-mail: IR@epimab.com

BD Contact

Dr. Jason Tang

Phone: +86-21-61951014

E-mail: partnering@epimab.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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