Mustang Bio Announces MB-106 CD20-Targeted CAR-T Data Selected for Presentation at 65th American Society of Hematology (ASH) Annual Meeting
Updated interim data from Mustang’s multicenter Phase 1/2 clinical trial demonstrate favorable safety and efficacy profile of MB-106 in heavily pre-treated lymphoma patients
WORCESTER, Mass., Nov. 02, 2023 (GLOBE NEWSWIRE) -- 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, today announced that interim Phase 1/2 data from Mustang’s multicenter clinical trial of MB-106, a CD20-targeted, autologous CAR-T cell therapy for patients with relapsed or refractory B-cell non-Hodgkin lymphomas (“NHL”) and chronic lymphocytic leukemia (“CLL”), have been selected for a poster presentation at the 65th American Society of Hematology (“ASH”) Annual Meeting, taking place December 9-12, 2023 in San Diego. MB-106 is being developed in a collaboration between Mustang and Fred Hutchinson Cancer Center (“Fred Hutch”).
The abstract posted today on the ASH Annual Meeting website reported on four patients who received MB-106 at dose level 1 (“DL1”), 3.3×106 cells/kg: two patients with follicular lymphoma (“FL”) who achieved complete response as demonstrated by both PET-CT and bone marrow biopsy, one patient with Waldenstrom macroglobulinemia (“WM”) who achieved a very good partial response (“VGPR”), and one patient with transfusion-dependent hairy cell leukemia variant (“HCL-v”) who continued to have stable disease with decreased bone marrow disease and who achieved complete transfusion independence which is ongoing at 6 months. All patients displayed MB-106 expansion, with peak levels between 7-14 days post-infusion, and CAR-T cell persistence is ongoing at 6 months. From a safety perspective, 3 patients experienced Grade 1 cytokine release syndrome and no occurrences of immune effector cell-associated neurotoxicity syndrome were reported. Dose-limiting toxicities (“DLT”) were monitored through day 28, and no DLTs were observed at DL1. Because of this favorable safety profile, MB-106 is infused in the outpatient setting if allowed by the institution, except for the first patient in each DL cohort, who is kept for overnight observation after MB-106 administration.
All four patients were heavily pre-treated, with a median of 5.5 prior lines of treatment. The WM patient in particular had nine prior treatments, including autologous stem cell transplant, and a high disease burden, and the patient’s VGPR was notable for complete metabolic response by PET-CT, morphologic clearance of lymphoma in bone marrow and resolution of the immunoglobulin M paraprotein. Other high-risk features were observed in each of the two FL patients: progression of disease within 24 months of first-line treatment in one patient and prior CD19-targeted CAR-T therapy in the other. Finally, the HCL-v patient received non-conforming material following FDA authorization.
Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, “We’re encouraged by the promising initial safety and efficacy data from our ongoing Phase 1/2 multicenter MB-106 clinical trial, which align with the data from the ongoing Phase 1/2 single-institution clinical trial at Fred Hutch. MB-106 continues to demonstrate a favorable safety and efficacy profile, including complete responses from both trials in patients previously treated with CD19-targeted CAR-T cell therapy. In particular, we are excited about the very good partial response in WM, our lead indication for MB-106 and a disease where complete responses are extremely rare. We look forward to the upcoming presentation at the ASH Annual Meeting, during which we anticipate sharing additional data from the Phase 1 indolent NHL arm, including all patients treated at the second and final dose level, 1×107 cells/kg, who have had at least 28-day follow-up. Looking beyond this meeting, we expect to treat the first patient in the pivotal Phase 2 WM trial in mid-2024, which could enable disclosure of top-line data from this trial as early as mid-2026.”
Details of the presentation are as follows:
Title: Efficacy and Safety of a Third Generation CD20 CAR-T (MB-106) for Treatment of Relapsed/Refractory Indolent B-Cell Non-Hodgkin Lymphoma: Phase-1 Results from a Multicenter Trial
Session Name: 704. Cellular Immunotherapies: Early Phase and Investigational Therapies: Poster I
Date and Time: Saturday, December 9, 2023, 5:30 pm - 7:30 pm PT
Location: San Diego Convention Center, Halls G-H
Abstract Number: 2102
Presenter: Mazyar Shadman, M.D., M.P.H., Study Chair, Innovators Network Endowed Chair at Fred Hutch, Associate Professor and physician at Fred Hutch and University of Washington
For more information, please visit the 65th ASH Annual Meeting and Exposition website at https://www.hematology.org/meetings/annual-meeting/abstracts.
About Mustang Bio
Mustang Bio, Inc. is 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. Mustang aims to acquire rights to these technologies by licensing or otherwise acquiring an ownership interest, to fund research and development, and to outlicense or bring the technologies to market. Mustang has partnered with top medical institutions to advance the development of CAR-T therapies across multiple cancers, as well as lentiviral gene therapies for severe combined immunodeficiency. Mustang’s common stock is registered under the Securities Exchange Act of 1934, as amended, and Mustang files periodic reports with the U.S. Securities and Exchange Commission (“SEC”). Mustang was founded by Fortress Biotech, Inc. (Nasdaq: FBIO). For more information, visit www.mustangbio.com.
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Jaclyn Jaffe and Nicole McCloskey
Mustang Bio, Inc.
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Released November 2, 2023