Medigene AG Announces Lead Selection for MDG2021,Expanding TCR-T KRAS Library Targeting Solid Tumours

June 20, 2024 – Drug DeliveryMedigene, oncology

20 June 2024,  Planegg/Martinsried, Germany- Medigene AG (Medigene, the “company”, FSE: MDG1, Prime Standard), an immuno-oncology platform company focusing on the discovery and development of T cell immunotherapies for solid tumours, announces today that it has selected its lead candidate for MDG2021, a T cell receptor engineered T cell (TCR-T) therapy targeting Kirsten rat sarcoma viral oncogene homologue (KRAS) G12D with human leukocyte antigen (HLA)-A*11 being developed in combination with the company’s PD1-41BB costimulatory switch protein (CSP) technology.

With its proprietary End-to-End (E2E) Platform, the company has successfully generated an optimal KRAS G12D-HLA-A*11 TCR that meets the company’s selection criteria for highly specific, sensitive and safer (3S) TCRs as the lead that will now advance into the pre-clinical stage. The company’s evaluation criteria for TCR selection included sensitive and precise tumour cell recognition combined with simultaneous display of a high safety profile demarked by lack of recognition of panels of healthy cells and tissues, matched and mismatched for HLA.

“We are delighted to announce that we have successfully generated a novel 3S TCR targeting KRAS G12D-A*11 that meets our rigorous selection criteria of high specificity, heightened sensitivity, and promising potential for enhanced safety,” said Dr. Selwyn Ho, chief executive officer at Medigene.

“The selection of this KRAS G12D lead-TCR expands our library of TCRs against neoantigens and cancer-testis antigens. Further, with the addition of our armouring & enhancement technology, PD1-41BB CSP to our TCR-T therapies, we are confident that our approach will yield best-in-class TCR-T therapies, providing improved outcomes for patients with to date, difficult-to-treat solid tumours such as colorectal cancer and pancreatic cancer. We are looking forward to presenting initial pre-clinical data on MDG2021 at upcoming scientific conferences in the second half of 2024.”

The company’s E2E Platform continues to generate 3S TCRs with unique and distinctive attributes that will be utilized across multiple therapeutic modalities, including TCR-T therapies, TCR-guided T cell engagers and TCR natural killer cell therapies. The new 3S TCR is designed for co-expression with Medigene’s PD1-41BB CSP to enhance the proliferation, persistence, and cytotoxic function of TCR-T cells, while simultaneously mitigating immunosuppressive effects of the tumour microenvironment.

Following the lead announcement of Medigene’s first KRAS program MDG2011 (KRAS G12V-A*11) in June 2023, MDG2021 is the latest program now in preclinical development within Medigene’s library of neoantigens that comprises multiple KRAS mutations and HLAs. The MDG20xx program is dedicated to further develop the company’s TCR library, exploring other KRAS neoantigen mutations and HLAs.

About Medigene AG: Medigene AG (FSE: MDG1) is an immuno-oncology platform company dedicated to developing differentiated T cell therapies to effectively eliminate cancer. Its end-to-end platform consists of multiple proprietary and exclusive technologies that generate optimal T cell receptors, armour and enhance these T cells to overcome the immunosuppressive tumour microenvironment (TME), and ensure the T cells drug product composition maximizes safety, efficacy and durability of response. This creates potential best-in-class, T cell receptor engineered T cell (TCR-T) therapies to treat multiple solid tumour indications for both its in-house product pipeline and partnering. Medigene’s lead TCR-T program MDG1015 is on track for IND filing in Q3 2024 and CTA filing in Q4 2024. Visit https://medigene.com/