Mustang Bio Announces Phase 1/2 Interim Data Update for CD20 MB-106 Targeted CAR T in Patients with Relapsed or Refractory Non-Hodgkin B-Cell Lymphoma and Chronic Lymphocytic Leukemia
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Data presented at European Hematology Association 2021 Virtual Congress shows favorable safety profile and convincing clinical activity
93% overall response rate and 67% complete response rate in patients treated with a modified cell-making process
Key Opinion Leaders Webinar Tuesday, June 15, 2021 at 1 p.m. ET
WORCESTER, Mass., June 11, 2021 (GLOBE NEWSWIRE) – Mustang Bio, Inc. (“Mustang”) (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs into cell and gene therapies as potential treatments for hematologic cancers, solid tumors and rare genetic diseases, today announced provisional updates from the ongoing Phase 1/2 clinical trial focusing on the safety and the efficacy of autologous targeted CAR T cell therapy MB-106 CD20 for the treatment of B- non-Hodgkin cell lymphoma (“B-NHL”) and chronic lymphocytic leukemia (“CLL”). MB-106 is developed in collaboration between Mustang and Fred Hutchinson Cancer Research Center (“Fred Hutch”).
Data presented in an electronic poster session at the 2021 European Hematology Association Virtual Congress (“EHA2021”) by Mazyar Shadman, MD, MPH, Associate Professor, Clinical Research Division of Fred Hutch, included data on the safety and efficiency of the cell manufacturing process. which has been modified to combine the culture of CD4 + and CD8 + cells. In the 15 patients treated, the overall response rate (“ORR”) was 93% (14/15) with a complete response rate (“CR”) of 67% (10/15). In 11 patients with follicular lymphoma (“FL”), ORR and CR were 91% (10/11) and 82% (9/11), respectively. At the time of electronic poster submission to EHA2021, all patients who achieved CR remained in remission. One patient with FL had an initial partial response with subsequent disease progression, had spontaneous CR and remains in remission. The CLL patient also had CR and measurable residual disease undetectable in peripheral blood and bone marrow by flow cytometry (10-4) (uMRD4) on day 28. CAR T persistence was observed at all dose levels (“DL”) and, while expansion was faster in the higher LDs, levels were comparable on day 28 .
From a safety profile perspective, cytokine release syndrome (“CRS”) occurred in 6 patients (40%): 3 grade 1 patients and 3 grade 2 patients. Neurotoxicity syndrome (“ICANS ”) And none of the 11 patients with FL had any grade of ICANS. No CRS or ICANS grade 3 or above were observed in any patient.
Dr Shadman commented: “MB-106 continues to demonstrate a very favorable safety and efficacy profile, as well as sustained complete responses. This convincing clinical activity, including complete remissions in 67% of the trial patients, demonstrates the potential of MB-106 as a viable CD20 targeted CAR T cell therapy. We are pleased that all complete responders continue to remain in remission, and we continue to enroll all eligible CD20 + NHL and LLC patients in this trial. “
Manuel Litchman, MD, President and CEO of Mustang, said, “We are encouraged by the updated safety and efficacy data for MB-106 presented by Dr. Shadman today. As reported last month, the FDA accepted Mustang’s IND application to initiate a multi-center phase 1/2 clinical trial investigating the safety, tolerability and efficacy of MB-106 for B-NHL and Relapsed or refractory LLC. We look forward to starting the trial later this year and advancing MB-106 for patients with B-NHL and CLL who need new treatment options.
On Tuesday, June 15, 2021, at 1 p.m. ET, Mustang will host a webinar with Dr. Shadman and his colleague Brian Till, MD, both of Fred Hutch, to discuss updated interim results from the Phase 1 clinical trial / 2 Ongoing the safety and efficacy of the targeted CAR T MB-106 CD20 for B-NHL and CLL. The Mustang management team will also provide further details on the MB-106 Phase 1/2 clinical trial that will be conducted as part of Mustang’s Investigational New Drug Application (“IND”). The Company recently announced that the United States Food and Drug Administration (“FDA”) has accepted its IND to initiate a multi-center phase 1/2 clinical trial investigating the safety, tolerability and efficacy of MB- 106 for B-NHL and relapsed or refractory CLL. After the formal presentations, the Mustang team, along with Drs. Till and Shadman will be available for questions. To register for the webinar, please Click here. An archived replay will be available on the Events page of the Investor Relations section of the Mustang website: www.mustangbio.com for approximately 30 days after the call.
About MB-106 (CD20 Targeted CAR T Cell Therapy)
CD20 is a membrane-integrated surface molecule that plays a role in the differentiation of B cells into plasma cells. The CAR T was developed by Mustang research collaborator Fred Hutch in the labs of the late Oliver Press, MD, Ph.D., and Brian Till, MD, associate professor in the clinical research division, and under license Mustang-exclusive 2017 MB-106 has been optimized as a third-generation CAR derived from a fully human antibody and is currently in an open-label phase 1/2 dose escalation trial at Fred Hutch at patients with B-NHL and CLL. Additional information about the trial is available at http://www.clinicaltrials.gov using the username NCT03277729.
About Mustang Bio
Mustang Bio, Inc. (“Mustang”) is 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 genetic diseases. rare. Mustang aims to acquire rights to these technologies by licensing or acquiring an interest, to fund research and development, and to license or bring the technologies to market. Mustang has partnered with leading medical institutions to advance the development of CAR T therapies for several cancers, as well as lentiviral gene therapy for XSCID. Mustang is registered under the Securities Exchange Act of 1934, as amended, and files periodic reports with the United States Securities and Exchange Commission (“SEC”). Mustang was founded by Fortress Biotech, Inc. (NASDAQ: FBIO). For more information visit www.mustangbio.com.
This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Such statements include, without limitation, any statement relating to our growth strategy and product development programs and any other statements which are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could adversely affect our business, results of operations, financial condition and the value of our shares. Factors that could cause actual results to differ materially from those currently anticipated include: risks related to our growth strategy; our ability to secure, execute and maintain funding and strategic agreements and relationships; risks linked to the results of research and development activities; risks associated with the timing of the start and end of clinical trials; uncertainties relating to preclinical and clinical trials; our dependence on third party suppliers; our ability to attract, integrate and retain key personnel; the initial stage of products under development; our need for substantial additional funds; government regulations; patent and intellectual property issues; competition; as well as other risks described in our documents filed with the SEC. We expressly disclaim any obligation or commitment to publicly release any update or revision to any forward-looking statement contained herein to reflect any change in our expectations or any change in the events, conditions or circumstances upon which such statement is based, except as required by law, and we claim safe harbor protection for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.
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Mustang Bio, Inc.
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