Planegg/Martinsried, September 25, 2024 – Medigene AG (Medigene or the “Company”, FSE: MDG1, Prime Standard), an oncology platform company focused on the research and development of T cell receptor (TCR)-guided therapies for the treatment of cancer, today announced the filing of a new patent application protecting 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, for the TCR-T therapy alone as well as in combination with the Company’s PD1-41BB costimulatory switch protein (CSP) technology to the European Patent Office. MDG2021 marks the second candidate within the KRAS library targeting KRAS G12D (HLA-A*11) for which the Company announced lead selection in June 2024. The addition of MDG2021 to Company’s KRAS targeting TCR library significantly impacts the addressable patient population with the combination of KRAS G12V and KRAS G12D mutations comprising ~50% of all KRAS mutations in all tumors (pan-cancer), or even >70% in pancreatic adenocarcinoma. (Yang et al., J Clin Med 2023)

“We are pleased to announce the patent filing for MDG2021, our optimal affinity 3S (sensitive, specific and safe) TCR targeting KRAS G12D (HLA-A*11), alone and in combination with our PD1-41BB armoring and enhancement CSP,” said Selwyn Ho CEO at Medigene. “This filing reaffirms our commitment to broaden our intellectual property for TCRs targeting both neoantigens and cancer testis antigens that have potential utility in multiple TCR-guided treatment modalities including TCR-T therapies such as MDG2021, as well as TCR-guided T cell engager therapies (MDG3010) and TCR-natural killer cell therapies.”

Medigene continually extends and strengthens its patent portfolio with new technologies and expands existing patents into additional jurisdictions. The Company maintains 29 different patent families worldwide covering applications protecting Medigene’s 3S TCRs as well as its exclusive E2E Platform technologies.

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About Medigene AG

Medigene AG (FSE: MDG1) is an immuno-oncology platform company dedicated to developing T cell receptor (TCR)-guided therapies to effectively eliminate cancer. Its End-to-End Platform generates optimal 3S (sensitive, specific and safe) T cell receptors with unique and distinctive attributes that are utilized in multiple therapeutic modalities, such as T cell receptor engineered T cell (TCR-T) therapies, TCR-guided T cell engager therapies and TCR-natural killer cell therapies for both its in-house product pipeline and partnering.

Medigene’s lead TCR-T program MDG1015 is a potential best-in-class, TCR-T therapy to treat multiple solid tumor indications. The End-to-End Platform technologies enable armoring and enhancing of these T cells to overcome the immunosuppressive tumor microenvironment (TME) and ensure the T cell drug product composition maximizes safety, efficacy and durability of response. Medigene’s MDG1015 received IND approval in Q3 2024 and is filing for CTA in Q4 2024. For more information, please visit https://medigene.com/

About Medigene’s End-to-End Platform

Medigene’s approach to immunotherapy harnesses the immense power of natural T cell receptors. By combining these TCRs with different components of the immune system such as T cells, natural killer (NK) cells or a CD3 complex (TCE, T cell engager), highly specific, sensitive and safe modalities are formed to either complement and/or activate the body’s defense systems against cancer. Medigene’s comprehensive End-to-End (E2E) Platform is built on a foundation of proprietary and cutting-edge technologies, driving the development of highly specific TCR-guided therapies, including the latest advancements in TCR-T, TCR-NK and TCR-TCE drug products. The E2E Platform incorporates sophisticated TCR generation and optimization techniques, such as Allogeneic-HLA TCR Priming, and integrates advanced product armoring and enhancement features like PD1-41BB and CD40L-CD28 Costimulatory Switch Proteins, and iM-TCR. In addition, the E2E Platform offers solutions to developing optimal cell therapy drug products for improved safety, efficacy and durability. Collaborations with partners like BioNTech, Regeneron and WuXi Biologics further underscore the platform’s capabilities and its potential to revolutionize cancer treatment.

This press release contains forward-looking statements representing the opinion of Medigene as of the date of this release. The actual results achieved by Medigene may differ significantly from the forward-looking statements made herein. Medigene is not bound to update any of these forward-looking statements. Medigene^? is a registered trademark of Medigene AG. This trademark may be owned or licensed in select locations only.

Medigene AG

Pamela Keck
Phone: +49 89 2000 3333 01
E-mail: [email protected]

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