Mustang Bio Announces Favorable Efficacy and Safety Data from Complete Waldenstrom Macroglobulinemia Cohort of Phase 1/2 Clinical Trial of MB-106, CD20-Targeted Autologous CAR-T Therapy
Mustang Bio has announced positive efficacy and safety data from the Phase 1/2 clinical trial of MB-106, a CD20-targeted autologous CAR-T therapy, for Waldenstrom macroglobulinemia (WM). The trial demonstrated a 90% overall response rate among heavily pretreated patients, with durable responses noted, including one patient in complete remission for 31 months.
Outpatient administration was feasible, and no grade 3 or 4 CRS or severe neurotoxicity was observed. These results were presented at the European Hematology Association 2024 Hybrid Congress. Mustang Bio is developing MB-106 in collaboration with Fred Hutch Cancer Center and aims to advance the program further, contingent on acquiring additional funding or strategic partnerships.
- 90% overall response rate in the Phase 1/2 clinical trial.
- Durable responses with one patient in complete remission for 31 months.
- No grade 3 or 4 cytokine release syndrome (CRS) observed.
- Outpatient administration deemed feasible.
- Development in collaboration with Fred Hutch Cancer Center.
- All patients in the study were heavily pretreated and refractory, indicating a challenging patient population.
- Nine patients experienced cytokine release syndrome, albeit grade 1 or 2.
- The development of MB-106 is contingent on securing significant additional funding or a strategic partnership.
- Only one patient started new anti-WM treatment after MB-106, indicating long-term follow-up.
Insights
The recent data from the Phase 1/2 clinical trial of MB-106 provides promising insights for treating Waldenstrom macroglobulinemia (WM), a rare blood cancer. The trial reported a high overall response rate of
Significantly, the feasibility of outpatient administration is a important factor, as it can reduce healthcare costs and improve patient quality of life. The absence of severe adverse effects (grade 3 or 4) like cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome further supports MB-106's safety profile.
For retail investors, it is essential to recognize that while these results are encouraging, the next phases of clinical trials and the potential for securing additional funding or partnerships will be critical for bringing MB-106 to market. The company's future financial health and regulatory approvals are still uncertain, which investors should keep in mind.
The data presented by Mustang Bio for MB-106 shows considerable potential in treating patients with Waldenstrom macroglobulinemia. The response rate of
On the safety front, the manageable levels of cytokine release syndrome and the absence of severe adverse events are reassuring. This outcome, coupled with the feasibility of outpatient administration, could make MB-106 an attractive treatment option both clinically and economically.
However, it’s important to contextualize these findings within the broader landscape of CAR-T therapies, which are often expensive and resource-intensive. The potential market acceptance and insurance coverage for such treatments will largely depend on sustained positive outcomes and cost-management strategies.
From a market perspective, the positive clinical data for MB-106 could significantly elevate Mustang Bio's position within the biopharmaceutical industry. The promising results for a CAR-T therapy in an area with currently no FDA-approved treatments suggest a potential first-mover advantage. This could translate into substantial market share if MB-106 is successfully commercialized.
However, investors should be mindful of the financial and strategic challenges ahead. The development of CAR-T therapies is capital-intensive and Mustang Bio has indicated the necessity for additional funding or strategic partnerships to advance MB-106. The ability to secure these resources will be pivotal in translating these clinical successes into marketable treatments.
Furthermore, the competitive landscape for CAR-T therapies is dynamic, with numerous players targeting various hematologic malignancies. Mustang Bio's focus on a niche indication like WM could be a strategic advantage, but it also limits the immediate market size. Investors should weigh these factors carefully when considering the potential long-term benefits.
Overall response rate of
All patients were heavily pretreated/refractory to BTK inhibitors, and only one patient has started new anti-WM treatment after MB-106
Outpatient administration was allowed and found to be feasible
Currently no FDA-approved CAR-T treatments for WM
Data presented at the European Hematology Association 2024 Hybrid Congress
WORCESTER, Mass., June 17, 2024 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (“Mustang” or the “Company”) (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell therapies into potential cures for difficult-to-treat cancers, today announced that updated data from the ongoing Phase 1/2 clinical trial of MB-106, a CD20-targeted, autologous CAR T-cell therapy, show a favorable safety and efficacy profile in patients with Waldenstrom macroglobulinemia (“WM”), a rare form of blood cancer. MB-106 is being developed in a collaboration between Mustang and Fred Hutch Cancer Center (“Fred Hutch”) to treat patients with relapsed or refractory B-cell non-Hodgkin lymphomas (“B-NHLs”) and chronic lymphocytic leukemia (“CLL”).
The updated results from the single-institution Phase 1/2 clinical trial were presented during a poster session at the European Hematology Association 2024 Hybrid Congress (“EHA2024”) by Brian Till, M.D., Associate Professor and physician at Fred Hutch and University of Washington.
All ten patients in the study were previously treated with Bruton's tyrosine kinase inhibitors (“BTKi”), and their disease continued to progress while on BTKi. Overall,
“We are very encouraged by the safety and efficacy data generated in WM, along with improvements in the quality of responses over time, which demonstrates MB-106 CAR T-cell expansion and persistence,” said Dr. Till.
For more information on the clinical trials, please visit www.clinicaltrials.gov using the identifier NCT05360238 for the multicenter trial and NCT03277729 for the ongoing trial at Fred Hutch.
Scientists at Fred Hutch played a role in developing these discoveries, and Fred Hutch and its scientists may benefit financially from this work in the future.
The Company’s ability to further develop the MB-106 program for hematologic malignancies is contingent upon raising a significant amount of additional funding and / or consummating a strategic partnership.
About Mustang Bio
Mustang Bio, Inc. is a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell therapies into potential cures for difficult-to-treat cancers. 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. 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.
Forward-Looking Statements
This press release contains “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, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. The Company’s forward-looking statements, include, but are not limited to, any statements relating to our growth strategy and product development programs, including the timing of and our ability to make regulatory filings such as INDs and other applications and to obtain regulatory approvals for our product candidates, statements concerning the potential of therapies and product candidates and any other statements that are not historical facts. Actual events or results may differ materially from those described in this press release due to a number of risks and uncertainties. Risks and uncertainties include, among other things, our need for substantial additional funds in the immediate future, risks that any actual or potential clinical trials described herein may not initiate or complete in sufficient timeframes to advance the Company’s corporate objectives, or at all, or that promising early results obtained therefrom may not be replicable, risks related to the satisfaction of the conditions necessary to transfer the lease of the Company’s manufacturing facility to a potential transferee and receive the contingent payment in connection with the sale of such facility in the anticipated timeframe or at all; whether the purchaser of the Company’s manufacturing facility is able to successfully perform its obligation to produce the Company’s products under the manufacturing services agreement on a timely basis and to acceptable standards; disruption from the sale of the Company’s manufacturing facility making it more difficult to maintain business and operational relationships; negative effects of the announcement or the consummation of the transaction on the market price of the Company’s common stock; significant transaction costs; the development stage of the Company’s primary product candidates, our ability to obtain, perform under, and maintain financing and strategic agreements and relationships; risks relating to the results of research and development activities; risks relating to the timing of starting and completing clinical trials; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate and retain key personnel; the early stage of products under development; government regulation; patent and intellectual property matters; competition; as well as other risks described in Part I, Item 1A, “Risk Factors,” in our Annual Report on Form 10-K filed on March 11, 2024, subsequent Reports on Form 10-Q, and our other filings we make with the SEC. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.
Company Contacts:
Jaclyn Jaffe and Nicole McCloskey
Mustang Bio, Inc.
(781) 652-4500
ir@mustangbio.com
FAQ
What is MB-106?
What were the results of the MB-106 Phase 1/2 clinical trial?
Were there any safety concerns in the MB-106 trial?
What is the significance of the MB-106 trial data?
What are the next steps for Mustang Bio's MB-106 program?
When and where were the MB-106 trial results presented?
What is the stock symbol for Mustang Bio?
