Benzinga | Dec 7, 2020 07:36AM EST

Mustang Bio Highlights Presentation Of Interim Phase 1/2 Data For MB-106 In Patients With Relapsed Or Refractory B-cell Non-Hodgkin Lymphoma At ASH Meeting

Data presented at the 62nd American Society of Hematology (ASH) Annual Meeting

show extremely favorable safety profile and clinical activity

89% overall response rate and 44% complete response rate in patients treated with modified cell manufacturing process

Key opinion leader conference call on Wednesday, December 9, 2020, at 1 p.m. EST

WORCESTER, Mass., Dec. 07, 2020 (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 hematologic cancers, solid tumors and rare genetic diseases, today announced interim data from the ongoing Phase 1/2 clinical trial of MB-106, a CD20-targeted, autologous CAR T cell therapy for patients with relapsed or refractory B-cell non-Hodgkin lymphoma ("NHL"). MB-106 is being developed in a collaboration between Mustang and Fred Hutchinson Cancer Research Center ("Fred Hutch").

The data presented in a poster session at the 62nd American Society of Hematology ("ASH") Annual Meeting by Mazyar Shadman, M.D., M.P.H., Associate Professor, Clinical Research Division of Fred Hutch, included safety data from both the original and modified cell manufacturing processes (n=16) and efficacy data from the modified process (n=9). Dose level 1 was 3.3 x 105 CAR-T cells/kg, dose level 2 was 1 x 106 CAR-T cells/kg, and dose level 3 was 3.3 x 106 CAR-T cells/kg. At the 28-day evaluation, an extremely favorable safety profile was observed in all 16 patients, with no reported immune effector cellassociated neurotoxicity syndrome (any grade) and only two patients experiencing cytokine release syndrome, with one grade 3 occurrence -- unexplained alkaline phosphatase elevation in the setting of fever in a patient treated prior to cell process modification. Additionally, an overall response rate (ORR) of 89% and complete response (CR) rate of 44% was observed in the nine patients who were treated with the modified process. In patients with follicular lymphoma (n=7), the ORR was 85% and CR was 57%.

Mazyar Shadman, M.D., M.P.H., commented, "We are very pleased to observe an extremely favorable safety profile as well as complete and partial responses with the modified cell manufacturing process of MB-106, our third generation fully human CD20 targeted CAR T cell therapy for treatment of relapsed or refractory B-cell non-Hodgkin lymphoma. It is important to note that all complete responders continue to remain in remission as of the ASH presentation date."

Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, "The interim data presented by Dr. Shadman at ASH highlight the very favorable safety profile and compelling clinical activity MB-106 has demonstrated to date in patients with relapsed or refractory B-cell non-Hodgkin lymphoma. We are highly encouraged by the responses observed in patients who received treatment with the revised cell manufacturing process and look forward to the continued progression of this CD20-targeted CAR T cell therapy program."

Mustang plans to file an Investigational New Drug ("IND") application in the first quarter of 2021 to enable the initiation of a multicenter Phase 2 trial of MB-106. The ongoing Phase 1/2 trial continues to enroll eligible patients with CD20+ NHL and has recently been modified to include patients with chronic lymphocytic leukemia as well. For more information on this trial, please visit www.clinicaltrials.gov using the identifier NCT03277729.