Medigene (MDG1) R&D Event summary

Company overview and platform

• Medigene develops next-generation TCR-guided immunotherapies with operations in Munich and San Diego, leveraging a proprietary end-to-end platform to generate best-in-class TCRs for multiple modalities, supported by partnerships with BioNTech, Regeneron, and Wuxi Biologics.

• The platform enables the creation of highly specific, sensitive, and safe (3S) TCRs, supporting autologous, allogeneic, and off-the-shelf therapies for solid tumors, with a focus on validated cancer antigens and broad patient coverage.

Pipeline and clinical programs

• Lead program MDG1015, a 3rd generation TCR-T therapy targeting NY-ESO-1/LAGE-1a with PD1-41BB CSP, has IND approval and is set for a Phase 1 trial with first patient in expected by end of 2024 and early readout in Q4 2025.

• Additional pipeline includes KRAS-targeted TCR-T programs (MDG2011, MDG2021, MDG2012) and a co-developed TCR-TCE program (MDG3010) with Wuxi Biologics, with key data catalysts anticipated through 2027.

• Partnered programs with BioNTech and Regeneron are advancing, with Regeneron’s FIH study recruiting and BioNTech exploring new targets.

Technology and innovation

• Medigene’s 3S TCRs offer superior specificity, sensitivity, and safety compared to antibody-based approaches, overcoming challenges like antigen shedding and tumor heterogeneity.

• The UniTope & TraCR system enables universal tagging and tracking of TCR-T cells, streamlining regulatory development, drug product enrichment, and immune monitoring.

• Manufacturing innovations allow for rapid, 6-day CD8+ cell production, yielding high stemness and purity, reducing vein-to-vein time and potentially eliminating the need for bridging therapy.