March Biosciences (March Bio) has received US Food and Drug Administration (FDA) regenerative medicine advanced therapy (RMAT) designation for MB-105, an autologous CD5-targeted CAR-T cell therapy under development for relapsed/refractory CD5-positive T-cell lymphoma.
The RMAT designation was based on initial data from March Bio’s ongoing multi-centre Phase II clinical trial, which indicated clinical activity and a manageable safety profile in a population with considerable unmet medical need.
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The preliminary outcomes from the safety run-in cohort will be presented at the American Society of Hematology 2025 Annual Meeting. Additional updates are expected in 2026, as March Bio continues to collaborate with the FDA to establish an expedited development and review strategy for MB-105.
The RMAT status offers advantages that include enhanced communication with the agency during the development phase, accelerated review processes such as rolling and priority reviews, and access to the same advantages as the breakthrough therapy and fast track programmes.
March Bio co-founder and CEO Sarah Hein stated: “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.
“We are encouraged by the responses observed to date and look forward to working closely with the FDA to advance MB-105 as efficiently as possible.”
March Bio intends to investigate commercial and clinical development opportunities outside the US, collaborating with international regulatory bodies as the data for MB-105 progresses.
A first-in-class autologous CAR-T therapy, MB-105 targets CD5-positive haematologic malignancies, including mantle cell lymphoma, chronic lymphocytic leukaemia, T-cell lymphoma and T-cell acute lymphoblastic leukaemia.
This therapy employs a proprietary CAR design that enables the selective targeting of cancerous cells and facilitates streamlined manufacturing without the need for additional genetic modifications.
The FDA has granted MB-105 both RMAT and orphan drug designations for the treatment of relapsed or refractory CD5-positive T-cell lymphoma.
