Medigene AG Selects Lead for MDG2021, Expands TCR-T KRAS Library for Solid Tumors

Planegg/Martinsried, June 20, 2024 - Medigene AG (FSE: MDG1), an immuno-oncology company specializing in the development of T cell immunotherapies for solid tumors, announced the selection of its lead candidate for MDG2021, a T cell receptor engineered T cell (TCR-T) therapy. This therapy targets the KRAS G12D mutation combined with human leukocyte antigen (HLA)-A*11, utilizing Medigene’s PD1-41BB costimulatory switch protein (CSP) technology.

Medigene’s proprietary End-to-End (E2E) Platform facilitated the creation of an optimal KRAS G12D-HLA-A*11 TCR, meeting the company's stringent criteria for specificity, sensitivity, and safety. This TCR will now move forward into the pre-clinical development phase. The company’s selection criteria focused on precise tumor cell recognition and high safety standards, ensuring no recognition of healthy cells and tissues.

Dr. Selwyn Ho, CEO of Medigene, expressed enthusiasm over the new development, stating, “We are thrilled to have generated a novel 3S TCR targeting KRAS G12D-A*11 that aligns with our rigorous standards of specificity, sensitivity, and safety. This selection not only expands our TCR library but also, with the incorporation of our PD1-41BB CSP technology, positions us to create superior TCR-T therapies for hard-to-treat solid tumors like colorectal and pancreatic cancer. We anticipate sharing pre-clinical data on MDG2021 at scientific conferences later in 2024.”

Medigene’s E2E Platform continues to innovate, producing 3S TCRs with unique attributes suitable for various therapeutic approaches, including TCR-T therapies and TCR-guided cellular therapies. The new 3S TCR is designed for co-expression with the company's PD1-41BB CSP to enhance TCR-T cell proliferation, persistence, and cytotoxicity, while counteracting the tumor microenvironment's immunosuppressive effects.

The recent selection of MDG2021 follows the announcement of Medigene’s first KRAS program, MDG2011 (KRAS G12V-A*11), in June 2023. MDG2021 now joins Medigene’s library of neoantigen-targeting programs, which includes various KRAS mutations and HLAs. The MDG20xx program aims to further expand the TCR library, exploring additional KRAS neoantigen mutations and HLAs.

Medigene AG is dedicated to creating advanced T cell therapies to combat cancer effectively. Utilizing its E2E Platform, the company develops optimal TCRs, enhances T cell function, and ensures the safety, efficacy, and durability of its TCR-T therapies. The company’s leading TCR-T program, MDG1015, is on track for IND filing in Q3 2024 and CTA filing in Q4 2024.

Medigene’s TCR-T cells are designed to activate the patient’s own immune response against cancer. By genetically modifying and expanding these T cells outside the body, the therapies ensure that patients receive a substantial number of tumor-specific T cells to fight cancer effectively.

The company’s PD1-41BB costimulatory switch protein technology is a significant advancement in overcoming the tumor’s immunosuppressive mechanisms. This technology replaces the inhibitory signal of PD-1 with the activating signal of 4-1BB, enhancing TCR-T cell proliferation and tumor-killing ability, even in challenging microenvironment conditions.

KRAS, a protein involved in cell proliferation and survival, is often mutated in various cancers, including pancreatic and colorectal cancers. These mutations create unique neoantigens, making KRAS an attractive target for TCR-T therapies. Unlike CAR-T cells, which require surface antigens, TCR-T cells can recognize a broader range of targets, including intracellular proteins like neoantigens, making them particularly suitable for targeting KRAS mutations.

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