Curated News
By: NewsRamp Editorial Staff
November 11, 2025
March Bio's Cancer Therapy Gets FDA RMAT Designation
TLDR
- March Biosciences gains FDA RMAT designation for MB-105, providing expedited development and potential first-mover advantage in treating relapsed T-cell lymphoma.
- MB-105 is an autologous CD5-targeted CAR-T cell therapy undergoing Phase 2 trials with preliminary data showing clinical activity and manageable safety profile.
- This therapy addresses critical unmet medical needs for T-cell lymphoma patients who currently face only six months median survival with existing treatments.
- March Biosciences' innovative CAR-T therapy selectively targets malignant cells without additional genetic manipulation, representing a novel approach to cancer treatment.
Impact - Why it Matters
This development matters because T-cell lymphoma represents one of the most challenging forms of blood cancer to treat, with current therapies offering limited effectiveness and patients facing extremely poor survival outcomes. The RMAT designation accelerates the development timeline for MB-105, potentially bringing a new treatment option to patients years sooner than traditional regulatory pathways would allow. For patients with relapsed or refractory T-cell lymphoma who have exhausted conventional treatments, this represents a crucial new hope. The therapy's targeted approach to CD5-positive cancers could also establish a new treatment paradigm for other hematologic malignancies, potentially transforming care for multiple cancer types where current immunotherapies have shown limited success.
Summary
March Biosciences, a clinical-stage biotechnology company developing cell therapies for hard-to-treat cancers, has achieved a significant regulatory milestone with the FDA granting Regenerative Medicine Advanced Therapy (RMAT) designation to MB-105, their first-in-class autologous CD5-targeted CAR-T cell therapy. This designation, awarded for the treatment of relapsed/refractory CD5-positive T-cell lymphoma, recognizes the therapy's potential to address a critical unmet medical need in patients who currently face a median survival of only six months with existing treatments. The RMAT designation provides substantial benefits including enhanced FDA interactions throughout development and eligibility for expedited review mechanisms, potentially accelerating the therapy's path to patients.
The regulatory decision was based on promising data from March Bio's ongoing multi-center Phase 2 clinical trial (NCT06534060), where preliminary findings from the safety run-in cohort demonstrated evidence of clinical activity with a manageable safety profile. 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, which originated from the Center for Cell and Gene Therapy at Baylor College of Medicine, Houston Methodist Hospital, and Texas Children's Hospital, plans to engage with the FDA on next steps to support an expedited development and review pathway for MB-105.
Beyond the immediate regulatory progress, March Biosciences will explore clinical and commercial development outside the United States and engage with international regulators as data mature. The company's MB-105 therapy represents a novel approach to treating CD5-positive hematologic malignancies, employing a proprietary CAR design that enables selective targeting of malignant cells without additional genetic manipulation. With backing from prominent life-sciences investors and non-dilutive support from organizations including the Cancer Prevention & Research Institute of Texas and the NIH SBIR program, March Biosciences is positioned to advance this promising therapy through the development pipeline efficiently.
Source Statement
This curated news summary relied on content disributed by Citybiz. Read the original source here, March Bio's Cancer Therapy Gets FDA RMAT Designation
