Medigene AG has announced FDA clearance for its Investigational New Drug (IND) application for MDG1015, a T-cell receptor engineered T-cell (TCR-T) therapy, paving the way for a Phase I clinical trial in patients with specific advanced solid tumors. The trial, EPITOME1015-I, aims to assess the therapy's safety, feasibility, and preliminary efficacy.
Trial Design and Objectives
The EPITOME1015-I trial will employ a dose-escalation phase followed by a dose-expansion phase. The primary objectives include determining the safety profile of MDG1015 and evaluating preliminary signs of efficacy. The study will enroll patients with advanced ovarian cancer, gastric cancer, myxoid/round cell liposarcoma, or synovial sarcoma who are HLA-A*02 positive.
MDG1015: Novel TCR-T Therapy
MDG1015 is designed to target NY-ESO-1/LAGE-1a, tumor-associated antigens expressed in various cancers. The therapy incorporates a costimulatory switch protein, PD1-41BB, intended to block the PD1/PD-L1 axis, thereby mitigating immunosuppressive effects and enhancing the TCR-T cells' persistence and anti-tumor activity. Preclinical studies have demonstrated enhanced and persistent T-cell-driven anti-tumor activity.
Manufacturing and Timeline
Medigene reports that MDG1015 has a shorter manufacturing turnaround time compared to first-generation TCR-T therapies, estimated at approximately 20 days from cell harvesting to reinfusion. This rapid turnaround is expected to yield younger and fitter cells, potentially improving therapeutic outcomes. Subject to securing additional funding, Medigene anticipates initiating the Phase I trial by the end of 2024 and expects a data readout by the end of 2025. The company also plans to submit a clinical trial application to the European Medicines Agency (EMA) in Q4 2024, seeking approval to test MDG1015 in Europe.
