March Bio wins orphan drug status for T-cell lymphoma CAR-T

The U.S. FDA has granted orphan drug designation to March Biosciences’ first-in-class CD5-targeted CAR-T cell therapy, for the treatment of relapsed/refractory CD5-positive T-cell lymphoma.

MB-105 is March Bio's lead program, launched from the Baylor College of Medicine’s Center for Cell and Gene Therapy. The first-in-class autologous CD5-targeted CAR-T cell therapy is in development for CD5-positive hematologic malignancies, including T-cell lymphoma, T-cell acute lymphoblastic leukemia, chronic lymphocytic leukemia and mantle cell lymphoma. The therapy employs a proprietary CAR design that enables selective targeting of malignant cells while preserving some normal T cell function.

MB-105 is currently being evaluated in a phase 1 clinical trial for relapsed/refractory TCL and T-ALL, demonstrating a 44% overall response rate in TCL patients. March plans to initiate a phase 2 clinical trial in early 2025.

The biotech recently closed a $28.4 million Series A financing to advance the phase 2 development of MB-105 and strengthen its manufacturing capabilities to support future commercialization.