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

• 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

SHANGHAI and MUNICH, Aug. 8, 2024 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), and Medigene AG (Medigene, FSE: MDG1, Prime Standard) today announced that they have entered 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™ .

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."

"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."

WuXiBody^TM is a leading proprietary bispecific antibody platform developed by WuXi Biologics. It can effectively break through the discovery and CMC barriers for the development of many bispecific antibodies with high expression yield, high stability, good solubility, and easy purification to homogeneity, expedite the process by 6-18 months and significantly reduce manufacturing costs, limitations still faced by many other current bispecific platforms. WuXiBody^TM platform enables almost any mAb sequence pairs to be assembled into bispecific constructs, which are expected to have low immunogenicity risk and longer in vivo half-life. WuXiBody^TM platform also has a unique structural flexibility, which makes it convenient to build various formats with different combinations of valencies (1+1, 1+2, 2+2) to meet the requirements of different target biology.

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 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