On November 4, 2020 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, reported that interim Phase 1/2 data on MB-106, a CD20-targeted, autologous CAR T cell therapy for patients with relapsed or refractory B-cell non-Hodgkin lymphoma ("NHL"), have been selected for a poster presentation at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) ("ASH") Annual Meeting, which is being held virtually from December 5 – 8, 2020 (Press release, Mustang Bio, NOV 4, 2020, View Source [SID1234569867]). MB-106 is being developed in a collaboration between Mustang and Fred Hutchinson Cancer Research Center ("Fred Hutch").
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In the abstract posted today on the ASH (Free ASH Whitepaper) website, Fred Hutch reported on four patients treated following a major revision in the cell manufacturing process. Complete remissions were observed in two follicular lymphoma patients (one each at dose levels 1 and 2), as well as a partial remission in a mantle cell lymphoma patient at dose level 2 and progressive disease in a follicular lymphoma patient at dose level 1. Dose level 1 was 3.3 x 105 CAR-T cells/kg and dose level 2 was 1 x 106 CAR-T cells/kg. As previously disclosed, no responses were seen in the 7 patients treated prior to cell process revision. Among the 11 total patients reported in the abstract, there was one occurrence of cytokine release syndrome (grade 3 – unexplained alkaline phosphatase elevation in the setting of fever in a patient treated prior to cell process revision) and no occurrences of immune effector cell-associated neurotoxicity syndrome (any grade). No dose-limiting toxicity was observed.
Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, "We are pleased that Fred Hutch will present interim data at ASH (Free ASH Whitepaper) from the ongoing Phase 1/2 trial of MB-106, and at that time we expect to disclose data on at least eight total patients treated since the major cell process revision. In February 2020, we reported that the first patient treated in the trial with the revised MB-106 manufacturing process achieved a complete response at the lowest starting dose. The additional data disclosed today further indicate that MB-106 has an extremely favorable safety profile with evidence of promising clinical activity, even at low dose levels. We look forward to continuing progress on this CD20-targeted CAR T cell therapy program for patients with relapsed or refractory B-cell non-Hodgkin lymphomas."
Details of the presentation are as follows:
Title: Third Generation CD20 Targeted CAR T-Cell Therapy (MB-106) for Treatment of Patients with Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma
Session: 704. Immunotherapies: Poster I
Abstract: 1443
Date and Time: Saturday, December 5, 2020, 10:00 a.m. – 6:30 p.m. ET
Presenter: Mazyar Shadman, M.D., M.P.H., Associate Professor, Clinical Research Division, Fred Hutch, Seattle, WA
For more information, please visit the 62nd ASH (Free ASH Whitepaper) Annual Meeting and Exposition website at View Source
About B-cell Non-Hodgkin Lymphoma (NHL)
There are several forms of NHL, including follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, lymphoplasmacytic lymphoma and small lymphocytic lymphoma, which account collectively for about 45% of all cases of NHL. Most types of NHL are incurable with available therapies, except for allogenic hematopoietic stem cell transplant (allo-SCT). More than 70,000 new cases of B-cell NHL are diagnosed each year in the United States, and more than 19,000 patients die annually due to this group of diseases.
About MB-106 (CD20-targeted CAR T Cell Therapy)
CD20 is a membrane-embedded surface molecule which plays a role in the differentiation of B-cells into plasma cells. The CAR T was developed by Mustang’s research partner, Fred Hutchinson Cancer Research Center ("Fred Hutch"), in the laboratory of Oliver Press, M.D., Ph.D., and Brian Till, M.D., in the Clinical Research Division and exclusively licensed to Mustang Bio in 2017. MB-106 has been optimized as a third-generation CAR derived from a fully human antibody and is currently in a Phase 1/2 open-label, dose-escalation trial at Fred Hutch in B-cell non-Hodgkin lymphoma patients. Additional information on the trial can be found at View Source using the identifier NCT03277729.