HOUSTON, Nov. 11, 2025 (GLOBE NEWSWIRE) — March Biosciences (March Bio), a clinical stage biotechnology company developing cell therapies for hard-to-treat cancers, today announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to MB-105, the Company’s first-in-class autologous CD5-targeted CAR-T cell therapy, in development for relapsed/refractory CD5-positive T-cell lymphoma.
The RMAT designation was granted based on data from March Bio’s ongoing multi-center Phase 2 clinical trial (NCT06534060). Preliminary findings from the safety run-in cohort suggest evidence of clinical activity with a manageable safety profile in a patient population with a significant unmet medical need. Initial results from this cohort will be presented at the American Society of Hematology 2025 Annual Meeting, with additional updates anticipated in 2026. The company plans to engage with the FDA on next steps to support an expedited development and review pathway for MB-105.
RMAT designation was established to expedite the development and review of regenerative medicine therapies for serious or life-threatening diseases where early clinical evidence indicates potential to address unmet medical need. The designation provides all the benefits of the FDA’s Breakthrough Therapy and Fast Track programs, including enhanced and frequent interactions with the Agency throughout development, and eligibility for expedited review mechanisms such as rolling and priority review.
“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. “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 will explore clinical and commercial development outside the United States and engage with regulators to define the most efficient path forward as data mature.
About MB-105
MB-105 is a potential first-in-class autologous CD5-targeted CAR-T cell therapy in development for CD5-positive hematologic malignancies, including T-cell lymphoma (TCL), T-cell acute lymphoblastic leukemia (T-ALL), chronic lymphocytic leukemia (CLL), and mantle cell lymphoma (MCL). The therapy employs a proprietary CAR design that enables selective targeting of malignant cells and streamlined manufacturing without additional genetic manipulation. MB-105 has received Orphan Drug Designation and the Regenerative Medicine Advanced Therapy designation from the FDA for the treatment of relapsed/refractory CD5-positive TCL. The multicenter Phase 2 trial (NCT06534060) is enrolling at twelve sites across the United States.
