India Pharma Outlook Team | Friday, 31 January 2025
Houston-based March Biosciences, an emerging clinical stage biotechnology company committed to combating challenging cancers and other diseases, announced that the US Food and Drug Administration (FDA) granted orphan drug designation to MB-105, the company’s first-in-class CD5-targeted CAR-T cell therapy, for the treatment of relapsed/refractory CD5-positive T-cell lymphoma.
“Beyond an important regulatory milestone, securing orphan drug designation for MB-105 from the US FDA underscores the critical need for new therapeutic options for patients with T-cell lymphoma,” said Sarah Hein, co-founder and CEO of March Biosciences. “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 phase 2 clinical trial in early 2025.”
The US FDA’s Office of Orphan Products Development grants orphan designation status to drugs and biologics that are intended for the treatment of rare diseases affecting fewer than 200,000 people in the United States. Orphan Drug designation provides various development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions, and seven years of market exclusivity following US FDA approval.