By Daniella Parra
March Biosciences said that the FDA granted regenerative medicine advanced therapy its first-in-class CD5-targeted CAR-T cell therapy for relapsed or refractory CD5-positive T-cell lymphoma.
The designation is based on encouraging early Phase 2 data showing clinical activity and manageable safety.
March Bio also plans to pursue international development as data mature. MB-105 has Orphan Drug and RMAT designations and is being tested in a Phase 2 multicenter trial across 12 U.S. sites for multiple CD5-positive blood cancers, including T-cell lymphoma, T-ALL, CLL, and MCL, they said.
“The FDA’s RMAT designation further validates MB-105’s potential to address a critical unmet medical need for patients with relapsed/refractory T-cell lymphoma, who face a median survival of only six months with current therapies,” said Sarah Hein, Co-Founder and Chief Executive Officer of March Biosciences.
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