Medigene AG: Medigene and WuXi Biologics Enter into a Research Collaboration for Off-the-Shelf TCR-Guided T Cell Engagers

Planegg/Martinsried (pta019/08.08.2024/10:00 UTC+2)

• Partnership leverages Medigene's leadership for T cell receptor (TCR) generation and characterization and WuXi Biologics' unique anti-CD3 mAb, its T cell engager (TCE) platform and proprietary bispecific antibody platform WuXiBody™
• Collaboration is a three-year and potentially multi-TCR program partnership

Planegg/Martinsried, August 8, 2024. Medigene AG (Medigene, FSE: MDG1, Prime Standard) and WuXi Biologics (stock code: 2269.HK) enter into a three-year, multi-target strategic partnership to design and co-research T cell receptor (TCR)-guided T Cell Engagers (TCR-TCEs) for the treatment of difficult-to-treat tumors. The collaboration combines the respective expertise of each company with Medigene's 3S (sensitive, specific and safe) TCR generation and characterization capabilities and WuXi Biologics' unique anti-CD3 mAb, its industry-leading TCE platform and proprietary bispecific antibody platform WuXiBody™.

"We are confident that Medigene's known capabilities in generating potential best-in-class 3S TCRs for TCR-T cell therapies can also be applied to non-cellular modalities," said Selwyn Ho, CEO of Medigene. "As such, we are delighted to be able to partner with WuXi Biologics with their validated anti-CD3 mAb, and its industry-leading TCE platform and WuXiBody™ to support our strategy to apply Medigene's TCRs into new modalities, such as TCR-TCEs for use in patients where additional value can be created beyond TCR-T therapies, for patients and our shareholders."

Dr. Chris Chen, CEO of WuXi Biologics, commented, "We are excited to partner with Medigene, a leader in TCR generation and characterization. This collaboration will further enhance our research service capabilities in our CRDMO business model and underscore our commitment to enabling global partners to speed up their novel therapy discovery and development with our leading technologies and reliable services. I believe the partnership will be ultimately translated into better treatments for cancer patients worldwide."

The companies aim to co-research TCR-TCE constructs, which will be owned by both cooperation partners with options to Medigene to further advance their development. The resulting constructs will leverage Medigene's highly specific 3S TCRs for comprehensive target recognition, coupled with WuXi Biologics' unique anti-CD3 mAb, advanced bispecific antibody technology and leading TCE platform to activate T cells. The resultant bispecific therapeutics are expected to provide highly specific targeted immune responses that direct T cells to effectively attack and kill cancer cells while minimizing off-target effects, and thereby improve patient outcomes.

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 a remarkable 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 (https://www.kbvresearch.com/bispecific-antibodies-market/), 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 are utilized in multiple therapeutic modalities such as T cell receptor engineered T cell (TCR-T) therapies, TCR-guided T cell engager therapies and TCR-natural killer cell therapies for both its in-house product pipeline and partnering.

Medigene's lead TCR-T program MDG1015 is a potential best-in-class, TCR-T therapy to treat multiple solid tumor indications. The End-to-End Platform technologies enable armoring and enhancing of these T cells to overcome the immunosuppressive tumor microenvironment (TME) and ensure the T cell drug product composition maximizes safety, efficacy and durability of response. Medigene's MDG1015 is on track for IND filing in Q3 2024 and CTA filing in Q4 2024. For more information, please visit www.medigene.com

About WuXi Biologics

WuXi Biologics (2269.HK) is a leading global Contract Research, Development and Manufacturing Organization (CRDMO) offering end-to-end solutions that enable partners to discover, develop and manufacture biologics – from concept to commercialization – for the benefit of patients worldwide.

With over 12,000 skilled employees in China, the United States, Ireland, Germany and Singapore, WuXi Biologics leverages its technologies and expertise to provide customers with efficient and cost-effective biologics discovery, development and manufacturing solutions. As of December 31, 2023, WuXi Biologics is supporting 698 integrated client projects, including 24 in commercial manufacturing.

WuXi Biologics views Environmental, Social, and Governance (ESG) responsibilities as an integral component of our ethos and business strategy, and we aim to be an ESG leader in the biologics CRDMO sector. Our facilities use next-generation biomanufacturing technologies and clean-energy sources. We have also established an ESG committee led by our CEO to steer the comprehensive ESG strategy and its implementation, enhancing our commitment to sustainability.

For more information about WuXi Biologics, please visit: www.wuxibiologics.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
Email: investor@medigene.com

In case you no longer wish to receive any information about Medigene, please inform us by e-mail (investor@medigene.com).

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Emitter:	Medigene AG Lochhamer Straße 11 82152 Planegg/Martinsried Germany
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Phone:	+49 89 2000 3333 01
E-Mail:	investor@medigene.com
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