NEW YORK – Medigene on Thursday said it will begin evaluating its T-cell receptor engineered T-cell (TCR-T) therapy, MDG1015, in a Phase I clinical trial involving patients with certain advanced solid tumors.
The US Food and Drug Administration cleared the firm's investigational new drug application for MDG1015, allowing Medigene to evaluate the autologous cell therapy as a treatment for patients with advanced ovarian cancer, gastric cancer, myxoid/round cell liposarcoma, or synovial sarcoma. Medigene will launch the Phase I trial by the end of 2024, if additional financing comes through.
The planned trial, dubbed EPITOME1015-I, will involve a dose-escalation portion followed by a dose-expansion portion. The firm aims to determine the cell therapy's safety, feasibility, and preliminary efficacy.
According to Martinsried, Germany-based Medigene, MDG1015 has demonstrated enhanced and persistent T-cell-driven anti-tumor activity in preclinical studies, suggesting the therapy can mitigate the immunosuppressive effects of PD-L1. The company designed MDG1015 to target NY-ESO-1/LAGE-1a in patients with HLA-A*02 positivity. MDG1015 also incorporates a costimulatory switch protein, PD1-41BB, that is supposed to block the PD1/PD-L1 axis and enhance the TCR-T therapy's persistence and anti-tumor activity.
According to Medigene, MDG1015 has a shorter manufacturing turnaround time relative to first-generation TCR-T therapies, which could keep the cells younger and fitter. The company estimated that the time between harvesting a patient's cells, expanding them, engineering them, and reinfusing them will be roughly 20 days.
Contingent on raising additional funds, the firm expects a data readout from EPITOME1015-I by the end of 2025. Medigene will also file a clinical trial application during Q4 2024, seeking permission from the European Medicines Agency to test this treatment.