WuXi Biologics and Medigene Collaborate on TCR-Guided T Cell Engagers

WuXi Biologics and Medigene AG have announced a three-year strategic partnership to develop T Cell Receptor-guided T Cell Engagers (TCR-TCEs) aimed at treating challenging tumors. This collaboration combines Medigene's expertise in TCR generation and characterization with WuXi Biologics' advanced anti-CD3 monoclonal antibody (mAb), its leading T Cell Engager (TCE) platform, and its proprietary bispecific antibody platform, WuXiBody™.

Dr. Chris Chen, CEO of WuXi Biologics, expressed enthusiasm about the partnership, highlighting that it will enhance the company's research service capabilities within its Contract Research, Development, and Manufacturing Organization (CRDMO) business model. The collaboration aims to expedite the discovery and development of novel therapies, ultimately benefiting cancer patients worldwide.

Selwyn Ho, CEO of Medigene, also expressed optimism, emphasizing Medigene's strong track record in generating top-tier TCRs for TCR-T cell therapies. He noted that this expertise could be transferred to non-cellular modalities. Ho stated that partnering with WuXi Biologics, with its validated anti-CD3 mAb and advanced TCE platform, supports Medigene's strategy to apply its TCRs to new modalities such as TCR-TCEs. This approach is expected to provide additional value for patients and shareholders beyond traditional TCR-T therapies.

WuXiBody™, WuXi Biologics' proprietary bispecific antibody platform, is a significant asset in this partnership. The platform overcomes many of the traditional barriers in bispecific antibody development, offering high expression yield, stability, solubility, and ease of purification. WuXiBody™ can expedite the development process by 6 to 18 months and significantly reduce manufacturing costs. Additionally, it can assemble almost any mAb sequence pairs into bispecific constructs with low immunogenicity risk and extended in vivo half-life. The platform's structural flexibility allows it to build various formats with different valencies to meet specific biological requirements.

WuXi Biologics is a leading global CRDMO that provides end-to-end solutions for the discovery, development, and manufacturing of biologics. With a workforce of over 12,000 skilled employees across multiple countries, the company leverages its technologies and expertise to offer efficient and cost-effective solutions. As of the end of 2023, WuXi Biologics supports 698 integrated client projects, including 24 in commercial manufacturing.

The company is also committed to Environmental, Social, and Governance (ESG) responsibilities, viewing them as integral to its business strategy. WuXi Biologics utilizes next-generation biomanufacturing technologies and clean energy sources. An ESG committee, led by the CEO, ensures the comprehensive implementation of the company’s ESG strategy, reinforcing its commitment to sustainability.

Medigene AG is an immuno-oncology platform company focused on developing TCR-guided therapies to target and eliminate cancer effectively. Its End-to-End Platform generates optimal 3S (sensitive, specific, and safe) T cell receptors, which are employed in various therapeutic modalities, including TCR-T cell therapies, TCR-guided T cell engager therapies, and TCR-natural killer cell therapies. These therapies are used both in Medigene's internal product pipeline and in partnership projects.

Medigene's leading program, MDG1015, is a TCR-T therapy designed to treat multiple solid tumor indications and is considered a potential best-in-class therapy. The End-to-End Platform technologies allow for the enhancement of these T cells to overcome the immunosuppressive tumor microenvironment, ensuring the safety, efficacy, and durability of the response. Medigene plans to file an Investigational New Drug (IND) application for MDG1015 in the third quarter of 2024 and a Clinical Trial Application (CTA) in the fourth quarter of 2024.

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