March Biosciences Receives FDA Orphan Drug Designation for MB-105, a First-in-Class CD5 CAR-T Cell Therapy, for T-Cell Lymphoma

Company prepares to advance to Phase 2 clinical trial in early 2025

HOUSTON, Jan. 28, 2025 (GLOBE NEWSWIRE) — March Biosciences (March Bio), an emerging clinical stage biotechnology company committed to combating challenging cancers and other diseases, today announced that the U.S. Food and Drug Administration (FDA) granted orphan drug designation to MB-105, the company’s first-in-class CD5-targeted CAR-T cell therapy, for the treatment of relapsed / refractory CD5-positive T-cell lymphoma.

“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. This designation further validates our development strategy as we prepare to initiate our Phase 2 clinical trial in early 2025.”

The FDA’s Office of Orphan Products Development grants orphan designation status to drugs and biologics that are intended for the treatment of rare diseases affecting fewer than 200,000 people in the United States. Orphan Drug designation provides various development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions, and seven years of market exclusivity following FDA approval.

MB-105 is March Bio’s lead program, launched from the Center for Cell and Gene Therapy (Baylor College of Medicine, Houston Methodist Hospital, Texas Children’s Hospital). The company recently closed a $28.4 million Series A financing to advance Phase 2 development of MB-105 and strengthen its manufacturing capabilities to support future commercialization. Beyond MB-105, March Bio is advancing a robust pipeline of cell therapies to further expand its potential to improve treatment options for difficult diseases and malignancies.

About MB-105
MB-105 is a 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 while preserving some normal T-cell function. MB-105 is currently being evaluated in a Phase 1 clinical trial (NCT03081910) for relapsed / refractory TCL and T-ALL, demonstrating a 44% overall response rate in TCL patients.

About March Biosciences
Houston-based March Biosciences, launched from the Center for Cell and Gene Therapy (Baylor College of Medicine, Houston Methodist Hospital, Texas Children’s Hospital), is dedicated to addressing challenging cancers unresponsive to current immunotherapies. Its lead asset, MB-105, is a CD5-targeted CAR-T cell therapy currently in Phase 1 trials in patients with refractory T-cell lymphoma and leukemia, with promising signals of efficacy and safety to date. A Phase 2 trial is expected to begin in early 2025. The company has raised over $52 million to date, inclusive of venture financing, support from the Cancer Prevention & Research Institute of Texas (CPRIT), and the NIH SBIR program. Learn more at www.march.bio.

Forward-Looking Statements
This press release contains forward-looking statements that involve risks and uncertainties. Any statement describing March Biosciences’ goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Words such as “believes,” “expects,” “anticipates,” “could,” “should,” “would,” “seeks,” “aims,” “plans,” “potential,” “will,” “milestone” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those projected in these forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, the clinical development of MB-105, the progress of clinical trials for pipeline candidates, regulatory approvals, market demand for new therapies, competitive dynamics in the biotechnology sector, and macroeconomic conditions.

Contacts:

Corporate:
Sarah Hein
Chief Executive Officer
sarah@march.bio

Media:
Jon Yu
ICR Healthcare
MarchBioPR@icrhealthcare.com