Mustang Bio Announces Vision for CAR T-Cell Therapy Platform Expansion into Autoimmune Diseases
- None.
- None.
Insights
MB-106's transition from oncology to autoimmune disease treatment represents a significant pivot within Mustang Bio's strategic focus. The underlying science suggests that CD20-targeted therapies, which have shown efficacy in cancer, could be repurposed to modulate the immune system in autoimmune conditions. This is not unprecedented; rituximab's dual use in both lymphoma and rheumatoid arthritis sets a clinical precedent. The potential expansion into autoimmune diseases could open a new revenue stream for Mustang, diversifying its portfolio and possibly reducing its risk profile.
However, the shift from cancer to autoimmune diseases is not without challenges. The therapeutic window in autoimmune conditions is narrower, given the lower tolerance for severe toxicities. The safety profile of MB-106 will be under intense scrutiny, especially considering the adverse effects associated with existing CAR-T therapies. The long-term impact on Mustang's financials will depend on the clinical trial outcomes, regulatory approvals and the ability to scale up manufacturing to meet potential demand.
Investor interest in Mustang Bio is likely to be influenced by the company's expansion into a new therapeutic area. The initiation of a Phase 1 trial for MB-106 in autoimmune diseases could act as a catalyst for the stock, contingent upon positive early-stage data. The strategic collaboration with Fred Hutchinson Cancer Center could also be seen as a risk mitigation strategy, leveraging external expertise to enhance the trial's design and execution.
From a financial perspective, the cost-effectiveness of an investigator-sponsored trial is notable. It suggests a prudent use of capital, which is critical for biotech firms with limited revenue streams. The potential future financial benefit from Fred Hutch's discoveries also hints at a shared risk and reward model, which could have implications for Mustang's royalty and milestone payment structures in the future.
The autoimmune disease market is burgeoning, with a growing prevalence of conditions such as rheumatoid arthritis and systemic lupus erythematosus. MB-106's entry into this space could position Mustang Bio competitively, provided the therapy demonstrates a favorable efficacy and safety profile. The market demand for innovative treatments in autoimmune diseases is high and a successful CAR T-cell therapy could disrupt the current treatment paradigm.
Furthermore, the timing of the trial's initiation and subsequent pivotal trial for Waldenstrom macroglobulinemia is crucial. Should these trials be successful and MB-106 receive regulatory approval, Mustang Bio could capitalize on first-mover advantage in certain autoimmune indications. Nevertheless, the competitive landscape, including the presence of established therapies and other emerging treatments, will be a significant factor in MB-106's market penetration and pricing strategy.
Planning for proof-of concept Phase 1 investigator-sponsored clinical trial evaluating MB-106 CD20-targeted CAR T-cell therapy in autoimmune diseases is underway and expected to initiate in the fourth quarter of 2024
MB-106 data in B-cell non-Hodgkin lymphoma (NHL) provide a strong foundation for future development in autoimmune disease; pivotal trial for Waldenstrom macroglobulinemia (WM) is expected to initiate in the second half of 2024
WORCESTER, Mass., March 28, 2024 (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 its expansion into autoimmune diseases with MB-106, a personalized CD20-targeted, 3rd-generation autologous CAR T-cell therapy. MB-106 is being developed in a collaboration between Mustang and Fred Hutchinson Cancer Center (“Fred Hutch”). Mustang and Fred Hutch are in preliminary discussions to explore a potential Phase 1 investigator-sponsored clinical trial to evaluate MB-106 for the treatment of autoimmune diseases.
“Mustang is leveraging its expertise in developing cell therapies to explore a new frontier in patient care,” said Manuel Litchman, M.D., President and Chief Executive Officer of Mustang. “MB-106’s observed safety profile, encouraging efficacy data, and our robust manufacturing capabilities have the potential to translate to improved outcomes for patients with autoimmune diseases. We believe an investigator-sponsored clinical trial is the fastest and most cost-effective way to embark on this program and aim to enroll the first patient in a Phase 1 trial in the fourth quarter of this year to demonstrate clinical proof-of-concept. We are in discussions with Fred Hutch to determine the autoimmune indication(s) we plan to pursue in the first trial and look forward to sharing more details in the near future.”
This expansion is supported by promising scientific evidence. Several antibody therapies targeting CD20 on B-cells have successfully transitioned from cancer to autoimmune diseases, such as rituximab for both lymphoma and rheumatoid arthritis. Additionally, clinical studies with CAR-T therapies have already demonstrated early success in the treatment of autoimmune conditions, with published reports showing remission in patients with refractory systemic lupus erythematosus and other autoimmune diseases.
MB-106 is currently in a Mustang-sponsored multicenter Phase 1/2 clinical trial for relapsed or refractory B-cell non-Hodgkin lymphomas (“NHL”) and chronic lymphocytic leukemia (“CLL”). Mustang expects to enroll the first patient in a registrational study evaluating MB-106 for Waldenstrom macroglobulinemia (“WM”), a rare type of B-Cell NHL, in the second half of this year.
Dr. Litchman continued, “Data from the MB-106 Phase 1/2 multicenter trial presented at the recent 65th American Society of Hematology Annual Meeting demonstrate strong clinical activity and a favorable safety profile, establishing feasibility of outpatient administration and building a foundation for the treatment of autoimmune diseases, where tolerance for the more severe toxicities observed with approved CAR-Ts is lower. Mustang believes MB-106 has the potential to bring personalized CAR T-cell therapy to a broader patient population through the expansion of indications and accessibility.”
Scientists at Fred Hutch played a role in developing these discoveries, and Fred Hutch and certain of its scientists may benefit financially from this work in the future.
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.
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
When is the Phase 1 investigator-sponsored clinical trial for MB-106 in autoimmune diseases expected to start?
What is the autoimmune disease targeted by MB-106 in the upcoming trial?
Which organization is collaborating with Mustang for the development of MB-106?
What type of therapy is MB-106?
What type of cancer has MB-106 shown promising results in?
