MB-105, a CD5-Targeted CAR-T Cell Therapy, Receives FDA Orphan Drug Designation for T-Cell Lymphoma
核心洞察
March Biosciences (搜索)' MB-105, a first-in-class CD5 (搜索) CAR-T cell therapy, has received FDA Orphan Drug Designation for relapsed/refractory CD5-positive T-cell lymphoma (搜索).
The Orphan Drug Designation provides incentives including tax credits, user fee exemptions, and seven years of market exclusivity post-approval.
MB-105 demonstrated a 44% overall response rate in T-cell lymphoma (搜索) patients in a Phase 1 trial, showing promising safety and efficacy signals.
March Biosciences (搜索)' MB-105, a first-in-class CD5 (搜索)-targeted CAR-T cell therapy, has been granted Orphan Drug Designation by the FDA for the treatment of relapsed/refractory CD5-positive T-cell lymphoma (搜索). This regulatory milestone underscores the critical need for new therapeutic options for patients facing this challenging cancer. The company is preparing to advance MB-105 to a Phase 2 clinical trial in early 2025.
Sarah Hein, Co-Founder and Chief Executive Officer of March Biosciences (搜索), stated, "Beyond an important regulatory milestone, securing orphan drug designation for MB-105 from the FDA underscores the critical need for new therapeutic options for patients with T-cell lymphoma (搜索). Currently, patients with treatment-resistant or recurrent T-cell cancers face an extremely poor prognosis. The MB-105 Phase 1 trial has shown promising safety and efficacy signals in relapsed / refractory T-cell lymphoma patients. This designation further validates our development strategy as we prepare to initiate our Phase 2 clinical trial in early 2025."
The FDA's Office of Orphan Products Development grants orphan designation to drugs and biologics intended for rare diseases affecting fewer than 200,000 people in the U.S. This designation provides development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions, and seven years of market exclusivity following FDA approval.
About MB-105
MB-105 is an autologous CD5 (搜索)-targeted CAR-T cell therapy being developed for CD5-positive hematologic malignancies, including T-cell lymphoma (搜索) (TCL), T-cell acute lymphoblastic leukemia (搜索) (T-ALL), chronic lymphocytic leukemia (搜索) (CLL), and mantle cell lymphoma (搜索) (MCL). The therapy utilizes 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 (NCT03081910) for relapsed/refractory TCL and T-ALL. The Phase 1 trial demonstrated a 44% overall response rate in TCL patients.
March Biosciences' Pipeline
March Biosciences (搜索), launched from the Center for Cell and Gene Therapy (Baylor College of Medicine, Houston Methodist Hospital, Texas Children's Hospital), is dedicated to addressing challenging cancers unresponsive to current immunotherapies. MB-105 is their lead asset. The company recently closed a $28.4 million Series A financing to advance Phase 2 development of MB-105 and strengthen its manufacturing capabilities to support future commercialization. Beyond MB-105, March Bio is advancing a robust pipeline of cell therapies to further expand its potential to improve treatment options for difficult diseases and malignancies.