NEW YORK – Medigene on Monday said it is planning to launch a first-in-human clinical trial of its T-cell receptor engineered T-cell (TCR-T) therapy candidate MDG1015 in gastric cancer, ovarian cancer, myxoid/round cell liposarcoma, and synovial sarcoma.
The first-in-human trial is contingent on US and European regulatory clearances, which Medigene is anticipating during the second half of 2024.
MDG1015 is designed to target NY-ESO-1/LAGE-1a, and Medigene said it selected gastric cancer, ovarian cancer, and the two soft-tissue sarcoma types based on the expression of that target. Between 34 percent and 60 percent of gastric cancers express NY-ESO-1/LAGE-1a, and the same is true for between 35 percent and 55 percent of ovarian cancers and 75 percent and 80 percent of soft-tissue sarcomas.
Based on target expression, HLA-A*02 positivity, and yearly incidence rates, Medigene estimates that more than 100,000 patients with these cancers living in the world's top eight economies could be eligible for treatment with MDG1015.
The treatment incorporates a costimulatory switch protein, PD1-41BB, which blocks the PD1/PD-L1 axis and further enhances the TCR-T therapy's activity and persistence, according to Planegg-Martinsried, Germany-based Medigene.
"While clinical data for engineered cell therapies still in development has shown benefits in some of the selected indications, we believe there is still significant room for improvement in terms of efficacy and durability of progression-free survival," Medigene CEO Selwyn Ho said in a statement.
In 2023, the firm said it was also expanding its pipeline to include TCR-T therapies targeting KRAS and HLA mutations.