Medigene AG Extends KRAS Library Protection with New Patent for MDG2021

On September 25, 2024, Medigene AG, an oncology-focused company (FSE: MDG1, Prime Standard), announced the filing of a new patent application for MDG2021. This T cell receptor engineered T cell (TCR-T) therapy targets Kirsten rat sarcoma viral oncogene homologue (KRAS) G12D, combined with human leukocyte antigen (HLA)-A*11. Additionally, it incorporates the Company’s PD1-41BB costimulatory switch protein (CSP) technology. The patent application has been submitted to the European Patent Office.

MDG2021 is the second candidate targeting KRAS G12D (HLA-A*11) in Medigene's KRAS library. The initial lead selection for this candidate was announced in June 2024. The incorporation of MDG2021 significantly broadens the range of patients that can be treated, as KRAS G12V and KRAS G12D mutations constitute about 50% of all KRAS mutations across various cancers and over 70% in pancreatic adenocarcinoma.

Selwyn Ho, CEO of Medigene, expressed enthusiasm about the new patent filing, lauding MDG2021 as a sensitive, specific, and safe TCR targeting KRAS G12D (HLA-A*11). “This filing reaffirms our commitment to expanding our intellectual property for TCRs targeting both neoantigens and cancer testis antigens,” Ho stated. These TCRs have potential applications in various TCR-guided treatment modalities, including TCR-T therapies like MDG2021, TCR-guided T cell engager therapies (MDG3010), and TCR-natural killer cell therapies.

Medigene is continuously extending and fortifying its patent portfolio, introducing new technologies and expanding existing patents into new jurisdictions. The Company boasts 29 different patent families worldwide, safeguarding Medigene's 3S TCRs and exclusive End-to-End (E2E) Platform technologies.

Medigene AG is an immuno-oncology platform company concentrating on developing T cell receptor (TCR)-guided therapies to combat cancer. Its E2E Platform is designed to generate optimal 3S (sensitive, specific, and safe) T cell receptors with unique attributes deployed in multiple therapeutic modalities. These include TCR-T therapies, TCR-guided T cell engager therapies, and TCR-natural killer cell therapies for both in-house product pipelines and external partnerships.

The company's leading TCR-T program, MDG1015, aims to be a best-in-class therapy for treating various solid tumors. The E2E Platform technologies enable the enhancement and armoring of these T cells to overcome the immunosuppressive tumor microenvironment. This ensures that the T cell drug products achieve maximum safety, efficacy, and response durability. MDG1015 received IND approval in Q3 2024 and is planning a CTA filing for Q4 2024.

Medigene’s immunotherapy approach leverages the natural power of T cell receptors. By integrating TCRs with different immune system components like T cells, natural killer (NK) cells, or a CD3 complex (T cell engager), the company creates highly specific, sensitive, and safe modalities. These can activate or complement the body’s defense systems against cancer.

The E2E Platform, based on proprietary and advanced technologies, propels the development of highly specific TCR-guided therapies. It includes innovations in TCR-T, TCR-NK, and TCR-TCE drug products. The platform features sophisticated TCR generation and optimization methods, such as Allogeneic-HLA TCR Priming, and integrates advanced product armoring and enhancement elements like PD1-41BB and CD40L-CD28 Costimulatory Switch Proteins, and iM-TCR. The E2E Platform is also equipped to develop optimal cell therapy drug products, improving their safety, efficacy, and durability.

Collaborations with partners such as BioNTech, Regeneron, and WuXi Biologics highlight the platform's capabilities and its potential to revolutionize cancer treatment.