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
17 Giugno 2024 - 2:30PM
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, 90%
(9/10) of the patients treated with MB-106 responded to treatment,
including 3 complete responses, 2 very good partial responses and 4
partial responses. In addition, 1 patient experienced stable
disease. One of the patients who achieved a complete response has
remained in remission for 31 months, with an immunoglobulin M (IgM)
level that decreased rapidly to the normal range after treatment
with MB-106 and has remained normal since. Patients had a median of
nine prior lines of therapy and only one patient has started
additional anti-WM treatment after being treated with MB-106. From
a safety perspective, cytokine release syndrome (CRS) occurred in
nine patients: five patients with grade 1 and four patients with
grade 2. One patient experienced grade 1 immune effector
cell-associated neurotoxicity syndrome (ICANS). No grade 3 or 4 CRS
or grade 2, 3 or 4 ICANS has been observed, despite dose
escalation.
“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 StatementsThis
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
McCloskeyMustang Bio, Inc.(781) 652-4500ir@mustangbio.com
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