Medigene Gets FDA Nod for IND Application of MDG1015 TCR-T Therapy for Solid Tumors

Planegg/Martinsried, September 5, 2024 – Medigene AG, a specialized oncology platform company, has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application. This approval pertains to the company’s primary program, MDG1015, which targets advanced stages of gastric cancer, ovarian cancer, myxoid/round cell liposarcoma, and synovial sarcoma, and will be tested in the phase 1 clinical trial known as EPITOME1015-I. The trial is designed to include a dose escalation phase followed by an expansion segment to evaluate the safety, feasibility, and preliminary efficacy of MDG1015 across multiple solid tumor types.

CEO Selwyn Ho expressed enthusiasm about this milestone for MDG1015, emphasizing the company’s goal to become a leader in developing various T cell receptor (TCR)-guided therapies for advanced solid tumors. Preclinical studies have demonstrated that MDG1015 significantly enhances and sustains T cell-driven anti-tumor activities, including mitigating the effects of PD-L1, a key immunosuppressive signal in the tumor microenvironment that often undermines TCR-T therapies. The FDA's clearance of the IND application for a Medigene TCR-T therapy marks a crucial achievement, allowing the company to initiate the phase 1 study EPITOME1015-I, contingent upon securing additional funding.

MDG1015 is a pioneering, third-generation TCR-engineered T cell (TCR-T) therapy that targets the cancer-testis antigen NY-ESO-1/LAGE-1a. This therapy uses a highly specific, sensitive, and safe TCR, paired with human leukocyte antigen (HLA)-A*02. The TCR-T cells are further enhanced using the proprietary PD1-41BB costimulatory switch protein (CSP) technology, which has shown significant improvements in anti-tumor activities against cells expressing various levels of PD-L1. The manufacturing process for MDG1015 involves a shortened, six-day cell expansion period, resulting in younger and fitter TCR-T cells. This reduction in manufacturing time could potentially lead to fewer cells needed for dosing and a shorter overall treatment time of approximately 20 days. The final drug product comprises nearly pure CD8+ T cells, with a high proportion of stemness-like qualities (~95%), potentially enhancing the durability of the response, efficacy, and reducing adverse events.

In addition to the FDA approval, Medigene plans to submit a Clinical Trial Application (CTA) to the European Medicines Agency (EMA) for MDG1015 in the fourth quarter of 2024. Pending further financing, the company aims to start the phase 1 clinical trial EPITOME1015-I by the end of 2024. Based on this timeline, preliminary data from the dose escalation phase of the trial could be available by late 2025.

Medigene AG is dedicated to developing TCR-guided therapies to combat cancer effectively. Its platform generates optimal T cell receptors, which are used in various therapeutic modalities, including TCR-engineered T cell therapies, TCR-guided T cell engager therapies, and TCR-natural killer cell therapies. Medigene’s technology enhances T cells to overcome the immunosuppressive tumor microenvironment, ensuring the safety, efficacy, and durability of the therapeutic response.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!