Medigene has halted FDA clearance of IND study of MDG1015 for more solid tumor indications

Planegg/Martinsried (pta020/05.09.2024/14:00 UTC+2)

The Medigene AG (Medigene oder das “Unternehmen”, FWB: MDG1, Prime Standard) is an oncological platform, which is the Research and Development of T-Zell-Rezeptor (TCR)-gesteuerten Immuntherapies for the treatment of Krebs spezialisiert, what heute Because the US FDA (Food and Drug Administration) has received the IND (Investigational New Drug) of the Unternehmens for its Leitprogramma MDG1015 with treatment of Fortgeschritem Magenkrebs, Eierstockkrebs, myxoids/rundzelligen Liposarkomen and synovial Sarcomen in the clinical phase 1 Study (EPITOME1015-I ) free found hat.

EPITOME1015-I set about a further dose assessment and a successful expansion phase in the future and will continue to report the health, safety and full health of MDG1015 in more solid tumor indications.

“We will be happy to help you with continuous TCR-stimulated therapies for patients with enhanced solid tumors,” says Selwyn Ho, CEO of Medigene AG. “In the clinical study that MDG1015 has done, a strong and anti-tumoral anti-tumoral effect of PD-L1 has occurred, making PD-L1 a strong immunosuppressive signal in the tumor microbial action of solid cancer, which is the effectiveness of TCR- The T-therapy is behind us. This first treatment is an IND drug for a TCR-T therapy by the FDA that has undergone a separate treatment, and will be a step beyond starting MDG1015 Phase 1 Study . EPITOME1015-I, who has left a different solid tumor, receives additional financing.”

MDG1015 is a novel TCR-T therapy of the controlled generation, which with a natural and optimally connected 3S-TCR (specific, sensitive and safe) ablates the human leukocyte antigen (HLA)-A*02 on the Krebs test antigen New York esophageal squamous cell carcinoma 1 / L Antigen Family Member-1a (NY-ESO-1 / LAGE-1a). The TCR-T cells were further developed and expanded by the enhanced PD1-41BB costimulatory switch protein (CSP) technology and have developed a significant antitumor effect against tumors, which induce ill-considered mixtures of PD-L1, one of the The signal that suppresses the immune system is caused by the micro-soldier tumor. What is here, the MDG1015 in the first generation TCR-T therapy with a 6-fold Zellexpansion test, was a young, higher treatment, which may have been a German new Zellzahl at the dosage and a cure zero time from a Vene to others for patients of etwa 20 days possible. The fact that a part of the population with a higher CD8+ population and a higher population density has grown for a number of years with stemmzellähnlichen peculiarities (~95%), was one of the best results of the Ansprechen, a larger growth and a larger growth of the Nebenwirkungen .

An IND application for a Clinical Trial Application (CTA) for MDG1015 is being filed with the European Medicines Agency (EMA) for the four quarters of 2024. Before the university’s financial factory was completed, the clinical Phase 1 Study EPITOME 1015-I was conducted with a number of dose and expansion phases, until the end of 2024 to start. Based on these time plans, the second phase of the year 2025 is announced, the first dates from the dosing phase can take place.

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About Medigene AG

Medigene AG (FWB: MDG1) is an immunology platform focused on the development of T-Zell receptor (TCR) therapy with effective treatment by Krebs. The end-to-end platform generates optimal 3S (sensitive, specific and safe) T-Zell receptors with unique and uncontrolled properties, which work in varying therapeutic regimens with T-Zell receptor-modified T-Zell therapies (TCR-T), TCR-managed T-Zell engager therapies and TCR therapies with natural killer cells, so that the own product pipeline is developed as one of the partnerships.

The MDG1015 TCR-T medical program is a powerful new TCR-T therapy with more solid tumor indications. The end-to-end platform technology works by treating the T-Zellen, an immunosuppressive tumor microtherapy (TME) with overcoming, and securing the treatment of the T-Zell drug products in the field of health, treatment and the best therapy maxime iert. Medigene has started executing the MDG1015 TCR-T program in the 3rd quarter of 2024, the IND approval and in the 4th quarter of 2024 in the CTA period. For more information, please visit http://www.medigene.de.

Über Medigenes MDG1015 program

MDG1015 is a novel current generation TCR-T therapy, which has appeared on NY-ESO-1/LAGE-1a, one of the existing and validated Krebs-Hoden antigen, which works in the different tumors. MDG1015 has developed NY-ESO-1/LAGE-1a TCR with optimal affinity (sensitive, specific and safe) in combination with our proprietary PD1-41BB costimulatory Switch Protein, which provides the PD1/PD-L1 hemorrhage blockade and the right time schedule T-cell over the well described -41BB (CD137) signaling pathway active, the active and persistent of the TCR-T cells in the final tumor microenvironment erhöht. The effects of PD1-41BB were soul-oriented, the active effect was first after the binding of the TCR and the NY-ESO1 / LAGE-1a editing, but the On-Target / On-Tumor effect of MDG1015 was optimized and the security remained higher. Medigene, which performed the IND approval in the fourth quarter of 2024 and completed the CTA procedure for its future TCR-T program MDG1015 in the fourth quarter of 2024. Medigene plans, subject to supplementary financing, the start of the clinical phase 1 study EPITOME 1015-I by the end of 2024.

This Mitteilung is best in the Zukunft-oriented Aussagen. These mirror the Meinung von Medigene zum Datum dieser Mitteilung more broadly. The Medigene tatsächlicherzielten Ergebnisse können von de zkunftsbezogeneen Aussagen erheblich abweichen. Medigene is not obliged to update the relevant information. Medigene® is a brand of Medigene AG. These markers can increase their ownership or ownership of the states.

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Medigene AG
Pamela Keck
Phone: +49 89 2000 3333 01
Email address: [email protected]

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