Mustang Bio Reports Positive Results from Waldenstrom Macroglobulinemia Phase 1/2 Trial of MB-106 CAR-T Therapy

Mustang Bio, Inc., a clinical-stage biopharmaceutical company, has announced promising updated data from its ongoing Phase 1/2 clinical trial of MB-106. This CD20-targeted, autologous CAR T-cell therapy is being developed in collaboration with Fred Hutch Cancer Center to treat patients with relapsed or refractory B-cell non-Hodgkin lymphomas and chronic lymphocytic leukemia. The data was presented at the European Hematology Association 2024 Hybrid Congress.

The trial's results were shared by Dr. Brian Till, Associate Professor and physician at Fred Hutch and the University of Washington, during a poster session. The study included ten patients who had previously been treated with Bruton's tyrosine kinase inhibitors (BTKi), yet their disease continued to progress. The results showed a significant overall response rate of 90% among these heavily pretreated patients. Specifically, three patients achieved complete responses, two had very good partial responses, and four had partial responses. Additionally, one patient experienced stable disease. Notably, one patient who achieved a complete response has remained in remission for an impressive 31 months, with their immunoglobulin M (IgM) levels rapidly decreasing to normal after treatment and remaining stable.

The study's participants had a median of nine prior lines of therapy, and only one patient has needed to start additional anti-WM treatment post-MB-106 therapy. From a safety perspective, the treatment was well-tolerated. Cytokine release syndrome (CRS) was observed in nine patients, with five experiencing grade 1 CRS and four experiencing grade 2 CRS. Only one patient encountered grade 1 immune effector cell-associated neurotoxicity syndrome (ICANS). Importantly, no cases of grade 3 or 4 CRS or grade 2, 3, or 4 ICANS were reported, even with dose escalation.

Dr. Till expressed optimism about the trial's results, highlighting the safety and efficacy data and the observed improvements in response quality over time. He pointed out that these results demonstrate the expansion and persistence of MB-106 CAR T-cells.

Currently, there are no FDA-approved CAR-T treatments specifically for Waldenstrom macroglobulinemia (WM). The data from this trial suggest that MB-106 could potentially fill this gap, offering a new treatment avenue for patients with this rare form of blood cancer.

Mustang Bio, Inc. continues to focus on translating medical breakthroughs in cell therapies into potential cures for challenging cancers. The company aims to acquire and develop cutting-edge technologies, partnering with top medical institutions to advance CAR-T therapies. Mustang Bio's commitment to further developing the MB-106 program for hematologic malignancies will depend on securing additional funding or forming strategic partnerships.

Mustang Bio, a company founded by Fortress Biotech, Inc., is actively involved in the clinical-stage development of biopharmaceutical products. The company is dedicated to bringing innovative treatments to market, thereby improving the lives of patients with difficult-to-treat cancers.

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