By Daniella Parra
March Biosciences was granted an orphan drug designation from the FDA to MB-105, its CD5-targeted CAR-T cell therapy, which has shown promising safety and efficacy in Phase 1 trials, with a 44% response rate in TCL patients, the company said.
This designation provides regulatory benefits, including tax credits, fee exemptions, and seven years of market exclusivity, they said.
“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,” said Sarah Hein, Co-Founder and Chief Executive Officer 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.”
March Bio said it recently secured $28.4 million in Series A funding to advance Phase 2 trials and expand manufacturing and the company is developing additional cell therapies for difficult-to-treat cancers and diseases.
