Medigene Secures FDA IND Clearance for Innovative Cancer Therapy
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Exciting News from Medigene: FDA Clearance for MDG1015
Medigene AG (FSE: MDG1), an innovative oncology platform company, recently celebrated a significant milestone. The U.S. Food and Drug Administration (FDA) has granted clearance for Medigene’s Investigational New Drug (IND) application concerning its leading program, MDG1015. This first-in-class, third-generation T cell receptor-engineered T cell (TCR-T) therapy aims at treating patients with advanced gastric cancer, ovarian cancer, myxoid/round cell liposarcoma, and synovial sarcoma.
Clinical Trial Plans for MDG1015
The upcoming clinical trial, named EPITOME1015-I, will consist of a dose escalation followed by an expansion segment. This trial aims to evaluate the safety and preliminary efficacy of MDG1015 in a diverse range of solid tumors.
Leadership's Enthusiasm and Vision
Selwyn Ho, the CEO of Medigene AG, expressed great enthusiasm about this development. He stated, “Reaching this milestone reinforces our ambition to lead the field with a range of TCR-guided therapies for patients fighting advanced solid tumors.” The preclinical studies of MDG1015 have indicated robust T cell-driven anti-tumor activity, which helps overcome the immunosuppressive signals present in solid tumors.
The Unique Technology Behind MDG1015
MDG1015 uniquely targets the NY-ESO-1/LAGE-1a cancer-testis antigen, combining an optimal affinity TCR with a proprietary PD1-41BB costimulatory switch protein (CSP) technology. This technology has demonstrated the ability to enhance T cell activity against tumor cells that express PD-L1. Notably, MDG1015 can be manufactured more quickly, with a short 6-day cell expansion period. This shorter production time results in stronger T cells with a high proportion exhibiting stemness-like properties, potentially leading to improved treatment durability and efficacy.
Next Steps in the Clinical Journey
In conjunction with the IND approval, Medigene is in the process of preparing a Clinical Trial Application (CTA) for submission to the European Medicines Agency (EMA) set for the fourth quarter of 2024. Following additional financing, the plan is to start the EPITOME1015-I clinical trial by the end of 2024, with expectations to present initial data from the trial’s dose escalation phase by the end of 2025.
Overview of Medigene AG
Medigene AG is dedicated to advancing immuno-oncology, specializing in TCR-guided therapies. Its proprietary End-to-End Platform technology facilitates the design of highly effective T cell receptors optimized for various therapeutic approaches, such as TCR-T therapies and TCR-guided T cell engagers. Medigene’s lead program, MDG1015, has recently achieved IND approval, and the company aims to more effectively combat solid tumors with this advanced therapeutic strategy.
Frequently Asked Questions
What is MDG1015?
MDG1015 is an innovative TCR-T therapy targeting advanced solid tumors known for its potential to enhance T cell activity against cancer.
What cancers are being targeted by MDG1015?
MDG1015 is specifically aimed at treating advanced gastric cancer, ovarian cancer, myxoid/round cell liposarcoma, and synovial sarcoma.
What distinguishes MDG1015 from previous TCR-T therapies?
MDG1015 features a unique combination of optimal affinity TCR and a proprietary costimulatory switch protein that improves T cell effectiveness in the tumor microenvironment.
When is the clinical trial for MDG1015 expected to start?
The EPITOME1015-I clinical trial is planned to initiate by the end of 2024, pending necessary funding.
How can I learn more about Medigene AG?
For further information about Medigene AG and its innovative therapies, please contact the company directly via their investor email: investor@medigene.com.
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