On March 28, 2024 Mustang Bio, Inc. ("Mustang") (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for difficult-to-treat cancers and rare genetic diseases, reported its expansion into autoimmune diseases with MB-106, a personalized CD20-targeted, 3rd-generation autologous CAR T-cell therapy (Press release, Mustang Bio, MAR 28, 2024, View Source [SID1234641586]). MB-106 is being developed in a collaboration between Mustang and Fred Hutchinson Cancer Center ("Fred Hutch"). Mustang and Fred Hutch are in preliminary discussions to explore a potential Phase 1 investigator-sponsored clinical trial to evaluate MB-106 for the treatment of autoimmune diseases.
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"Mustang is leveraging its expertise in developing cell therapies to explore a new frontier in patient care," said Manuel Litchman, M.D., President and Chief Executive Officer of Mustang. "MB-106’s observed safety profile, encouraging efficacy data, and our robust manufacturing capabilities have the potential to translate to improved outcomes for patients with autoimmune diseases. We believe an investigator-sponsored clinical trial is the fastest and most cost-effective way to embark on this program and aim to enroll the first patient in a Phase 1 trial in the fourth quarter of this year to demonstrate clinical proof-of-concept. We are in discussions with Fred Hutch to determine the autoimmune indication(s) we plan to pursue in the first trial and look forward to sharing more details in the near future."
This expansion is supported by promising scientific evidence. Several antibody therapies targeting CD20 on B-cells have successfully transitioned from cancer to autoimmune diseases, such as rituximab for both lymphoma and rheumatoid arthritis. Additionally, clinical studies with CAR-T therapies have already demonstrated early success in the treatment of autoimmune conditions, with published reports showing remission in patients with refractory systemic lupus erythematosus and other autoimmune diseases.
MB-106 is currently in a Mustang-sponsored multicenter Phase 1/2 clinical trial for relapsed or refractory B-cell non-Hodgkin lymphomas ("NHL") and chronic lymphocytic leukemia ("CLL"). Mustang expects to enroll the first patient in a registrational study evaluating MB-106 for Waldenstrom macroglobulinemia ("WM"), a rare type of B-Cell NHL, in the second half of this year.
Dr. Litchman continued, "Data from the MB-106 Phase 1/2 multicenter trial presented at the recent 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting demonstrate strong clinical activity and a favorable safety profile, establishing feasibility of outpatient administration and building a foundation for the treatment of autoimmune diseases, where tolerance for the more severe toxicities observed with approved CAR-Ts is lower. Mustang believes MB-106 has the potential to bring personalized CAR T-cell therapy to a broader patient population through the expansion of indications and accessibility."
Scientists at Fred Hutch played a role in developing these discoveries, and Fred Hutch and certain of its scientists may benefit financially from this work in the future.