Medigene AG: Medigene AG Submits Clinical Trial Application in Europe for MDG1015 for Multiple Solid Tumor Indications

Planegg/Martinsried (pta031/16.12.2024/14:00) - Medigene AG ( http://www.medigene.com ) (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 submission of its Clinical Trial Application (CTA) to the European Medicines Agency (EMA) for its MDG1015 program for the treatment of advanced gastric cancer, ovarian cancer, myxoid/round cell liposarcoma and synovial sarcoma in the phase 1 clinical trial EPITOME1015-I. The CTA submission follows the Company's receipt of the U.S. Food and Drug Administration (FDA) clearance of the Investigational New Drug (IND) application for EPITOME1015-I earlier this year.

EPITOME1015-I consists of a dose escalation followed by an expansion segment and aims to assess safety, feasibility and preliminary efficacy of MDG1015 in multiple solid tumor indications.

"We are delighted to announce the submission of the CTA for MDG1015. This milestone is a significant step forward in the development of our differentiated cell therapy. The extensive experience of European clinical sites provides an ideal environment for this trial. The robust infrastructure and strong network of clinical investigators will facilitate efficient patient recruitment once funding is secured, which will enable us to then rapidly progress toward bringing this potentially transformative therapy to patients in need," said Selwyn Ho, CEO at Medigene AG.

MDG1015 is a first-in-class, third generation T cell receptor engineered T cell (TCR-T) therapy targeting the cancer-testis antigen New York esophageal squamous cell carcinoma 1 / L Antigen Family Member-1a (NY-ESO-1/LAGE-1a) in the context of human leukocyte antigen (HLA)-A*02 with a natural and optimal affinity 3S (specific, sensitive and safe) TCR. The TCR-T cells are further armored and enhanced by the addition of the proprietary costimulatory switch protein (CSP) PD1-41BB and have demonstrated significantly enhanced anti-tumor activities against tumor cells expressing varying levels of PD-L1, one of the most immunosuppressive signals emanating from the solid tumor microenvironment. Importantly, compared to first generation TCR-T therapies, MDG1015 will be manufactured with a short, 6-day cell expansion period, leading to younger, fitter cells, with the potential for a markedly reduced number of cells required during dosing and a shorter vein-to-vein time for patients of approximately 20 days. This has also resulted in a drug product with an almost pure CD8+ population and with a very high proportion of cells with stemness-like qualities ( ~ 95%) that could lead to improved durability of response, greater efficacy and reduced adverse events.

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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 can be utilized in multiple therapeutic modalities, such as off-the-shelf TCR-guided T cell engager (TCR-TCE) therapies (MDG3010), TCR-natural killer cell (TCR-NK) therapies and T cell receptor engineered T cell (TCR-T) therapies (MDG1015). For more information, please visit https://medigene.com/

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: investor@medigene.com

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