Medigene presents streamlined 6-day, high stemness TCR-T therapy production process

Planegg/Martinsried, April 25, 2024. Medigene AG (Medigene or the “Company”, FSE: MDG1, Prime Standard), an immuno-oncology platform company focusing on the discovery and development of T cell immunotherapies for solid tumors, today presents a comprehensive overview of its lead candidate MDG1015, a first-in-class 3rd generation T cell receptor engineered T cell (TCR-T) therapy, at CHI's 8^th Annual Immuno-Oncology Summit Europe from April 23-25, 2024, in London. MDG1015, which is advancing towards the clinic, targets NY-ESO-1 / LAGE-1a (New York esophageal squamous cell carcinoma 1 / L Antigen Family Member-1a) and is armored and enhanced by the PD1-41BB costimulatory switch protein

The presentation with the title “MDG1015: a 3rd Generation TCR-T Therapy Incorporating the PD1-41BB Costimulatory Switch Protein, Advancing to the Clinic” is available on Medigene’s website: https://medigene.com/science/abstracts/

Targeting tumors expressing cancer-testis antigens (CTAs) shows promising clinical benefits. However, improving efficacy, safety, and ensuring a sustained response are areas needing improvement. Medigene tackles these challenges with a comprehensive approach, which starts with the development of a potential best-in-class, 3S (sensitive, specific, and safe) TCR. Next, the 3S TCR is enhanced with the Company’s exclusive PD1-41BB costimulatory switch protein (CSP) on the engineered TCR-T cells. Finally, Medigene generates a meticulously customized drug product (DP) composition.

"At Medigene, our innovative approach not only enhances TCR-T cell functionality by combining our 3S TCRs with the PD1-41BB costimulatory switch protein but also places a significant emphasis on the DP manufacturing process. This process is vital for producing effective, safe, and durable TCR-T therapies," stated Kirsty Crame, MD, VP Clinical Strategy & Development. "With our focus on the DP composition, we aim to reduce the time required to manufacture DP ex-vivo and hence reduce the overall vein-to-vein timeframe for patients, while maintaining the highest standards of safety, efficacy and durability."

Medigene has developed a streamlined 6-day manufacturing process that focuses on the enrichment of CD8+ T cells whilst simultaneously maintaining a high degree of stemness. This allows for creating highly effective DPs, as the field has shown that more stem-like DPs exhibit greater potency and durability of response. The inclusion of the PD1-41BB CSP eliminates the need for CD4+ T cells within the DP, as CD8+ T cells are empowered to autonomously produce supporting cytokines. By doing so, the potential risks posed by CD4+ T cells can be circumvented and therefore potentially enhance both clinical safety and therapeutic efficacy.