Medigene Announces U.S. FDA Clearance of IND Application for MDG1015, a First-in-Class, Third Generation T Cell Receptor Engineered T Cell (TCR-T) Therapy for Multiple Solid Tumor Indications

Planegg/Martinsried, September 5, 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, announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for its lead program MDG1015 for the treatment of advanced gastric cancer, ovarian cancer, myxoid/round cell liposarcoma and synovial sarcoma in the phase 1 clinical trial (EPITOME1015-I) .

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 very excited to reach this milestone with our lead program MDG1015 which reinforces our ambition to become a leading company with a range of different TCR-guided therapies for patients suffering from multiple advanced solid tumor types,“ said Selwyn Ho, CEO of Medigene AG. “In preclinical studies, MDG1015 has shown strongly enhanced and persistent T cell-driven anti-tumor activity and the ability to mitigate the effects of PD-L1, one of the major immunosuppressive signals present in the tumor microenvironment of solid cancers which hinder the effectiveness of TCR-T therapies. This very first FDA clearance of an IND Application for a Medigene TCR-T therapy represents a pivotal achievement, and we look forward to commencing our MDG1015 phase 1 study EPITOME1015-I targeting multiple solid tumors, subject to additional financing.”

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) with a natural and optimal affinity 3S (specific, sensitive and safe) TCR and human leukocyte antigen (HLA)-A*02. The TCR-T cells are further armored and enhanced by the addition of the proprietary PD1-41BB costimulatory switch protein (CSP) technology and has 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.

To complement the IND approval, a Clinical Trial Application (CTA) submission for MDG1015 to the European Medicines Agency (EMA) is on track for the fourth quarter of 2024. Pending additional financing, the Company plans to initiate the phase 1 clinical trial EPITOME‑1015-I, which consists of a dose escalation followed by an expansion segment, by the end of 2024. Based on this timeline, the Company expects to be able to present early data from the dose escalation phase towards the end of 2025.

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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 MDG1015 Program

MDG1015 is a first-in-class, 3rd generation T cell receptor engineered T cell (TCR-T) therapy targeting NY-ESO-1 / LAGE-1a, a well-recognized and validated cancer-testis antigen, which is expressed in multiple tumor types. MDG1015 contains our optimal affinity 3S (sensitive, specific and safe) NY-ESO-1 /LAGE-1a TCR combined with our proprietary PD1-41BB costimulatory switch protein (CSP) that blocks the PD-1/PD-L1 inhibitory axis while simultaneously activating the T cell through the well described –4-1BB (CD137) pathway further enhancing the activity and persistence of the TCR-T cell in the hostile tumor microenvironment. The effects of the PD1-41BB are gated, with activation only occurring following binding of the TCR to NY-ESO1 / LAGE-1a, optimizing MDG1015’s on-target / on-tumor effects and further enhancing safety. Medigene received IND approval in Q3 2024 and is on track for CTA filing in Q4 2024 for its lead TCR-T program MDG1015 and intends to initiate the phase 1 clinical trial EPITOME1015-I by the end of 2024 pending additional financing.

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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