Mustang Bio Starts Phase 1/2 Trial of CAR T Cell Therapy Lymphoma, Leukemia

  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 hematologic cancers, solid tumors and rare genetic diseases, today announced that the first patient has been treated in its multicenter, open-label, non-randomized Phase 1/2 clinical trial evaluating the safety and efficacy of MB-106, Mustang’s first-in-class CD20-targeted, autologous CAR T cell therapy for the treatment of relapsed or refractory B-cell non-Hodgkin lymphomas (“B-NHL”) and chronic lymphocytic leukemia (“CLL”). The patient did not experience cytokine release syndrome (“CRS”) or immune effector cell-associated neurotoxicity syndrome (“ICANS”). MB-106 is being developed in a collaboration between Mustang and Fred Hutchinson Cancer Center (“Fred Hutch”). The multicenter trial under Mustang’s Investigational New Drug Application (“IND”) builds upon the initial, ongoing Phase 1/2 clinical trial taking place at Fred Hutch in a single-center study under Fred Hutch’s IND.

Manuel Litchman, M.D., President and Chief Executive Officer of Mustang said, “The first clinical trial under Mustang’s IND is an important milestone in the ongoing development and evaluation of MB-106. Data presented at several prestigious medical meetings earlier this year from the initial, ongoing Phase 1/2 clinical trial at Fred Hutch show that MB-106 continues to demonstrate high efficacy and a favorable safety profile across patients with a wide range of hematologic malignancies. We look forward to providing updates on our multicenter MB-106 clinical trial as it progresses and anticipate reporting efficacy data in the fourth quarter of this year.”

Interim data from 28 patients treated in the initial, ongoing Phase 1/2 investigator-sponsored clinical trial at Fred Hutch continue to support MB-106 as a viable CAR T cell therapy for B-NHLs and CLL. As of September 9, 2022, the interim data show:

• An overall response rate of 96% and complete response (“CR”) rate of 75% in a wide range of hematologic malignancies including follicular lymphoma (“FL”), CLL, diffuse large B-cell lymphoma, and Waldenstrom macroglobulinemia
• Twelve patients have experienced CR for more than 12 months (10 ongoing); four patients with CR for more than two years and the longest patient with CR is at 33 months
• Six patients with partial response (“PR”) improved to CR and all remain in ongoing CR
• All three patients previously treated with CD19 CAR T cell therapy have responded to treatment with MB-106
• A favorable safety profile for MB-106 as an outpatient therapy remains with no CRS or ICANS ≥ Grade 3
• CAR-T persistence results in deepening responses following initial 28-day assessments

https://www.biospace.com/article/releases/mustang-bio-announces-first-patient-treated-in-its-multicenter-phase-1-2-clinical-trial-of-mb-106-a-first-in-class-cd20-targeted-autologous-car-t-cell-therapy-to-treat-b-cell-non-hodgkin-lymphoma-and-chronic-lymphocytic-leukemia/