Mustang Bio Announces FDA Acceptance of IND Application for MB-109, a Novel Combination of MB-101 (IL13Rα2‐targeted CAR-T cell therapy) and MB-108 (HSV-1 oncolytic virus), for the Treatment of Recurrent Glioblastoma and High-Grade Astrocytoma
26 Ottobre 2023 - 3:00PM
Mustang Bio, Inc. (“Mustang” or the “Company”) (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 that the U.S. Food and Drug
Administration (“FDA”) has accepted the Company’s Investigational
New Drug (“IND”) application of MB-109 for the treatment of
recurrent glioblastoma (“GBM”) and high-grade astrocytoma. Mustang
is planning to initiate a Phase 1 multicenter clinical trial at
City of Hope (“COH”) and the University of Alabama at Birmingham
(“UAB”) to assess the safety, tolerability and efficacy of MB-109,
a novel combination of MB-101 (COH-developed IL13Rα2‐targeted CAR-T
cell therapy) and MB-108 [Nationwide Children’s Hospital-
(“Nationwide”) developed HSV-1 oncolytic virus] in adult patients
with recurrent GBM and high-grade astrocytomas that express IL13Rα2
on the surface of the tumor cells.
As previously reported, preclinical data
presented at the American Association for Cancer Research (“AACR”)
Annual Meeting in 2022 supported this combination therapy to
potentially optimize results to treat recurrent GBM. The
combination leverages MB-108 to reshape the tumor microenvironment
(“TME”) and make cold tumors “hot,” thereby potentially improving
the efficacy of MB-101 CAR-T cell therapy. Data presented
separately on MB-101 and MB-108 showed that administration of these
therapies was well tolerated in recurrent GBM patients. Two
patients treated solely with MB-101 who had high levels of
intratumoral CD3+ T cells pre-therapy (i.e., “hot” tumors) achieved
complete responses lasting 7.5 and 31+ months, respectively.
Importantly, of the 53 COH Phase 1 patients disclosed at AACR in
2022, these 2 complete responses were observed in the 2 patients
with the “hottest” tumors prior to treatment with MB-101. Phase 1
clinical trials of MB-101 at COH and of MB-108 at UAB continue to
enroll patients.
Manuel Litchman, M.D., President and Chief
Executive Officer of Mustang, said, “We are very pleased with the
FDA’s acceptance of our IND application for MB-109, which allows
Mustang to initiate a Phase 1 clinical trial to further evaluate
combining MB-108 and MB-101, an attractive strategy for improving
outcomes for patients with recurrent GBM and high-grade
astrocytomas. Recurrent GBM remains a major challenge to treat,
with a median overall survival rate of 6 months. We are committed
to finding better treatment options for patients living with
difficult-to-treat cancers and look forward to initiating our
MB-109 Phase 1 clinical trial in 2024. The fact that this will be
the first ever industry-sponsored trial to combine a CAR-T cell
therapy with an oncolytic virus underscores Mustang’s commitment to
innovation in the oncology and cell therapy space. Furthermore, FDA
acceptance of our IND within 30 days of initial submission –
despite the innovative aspect of the combination therapy and the
complexity of the trial design – is testimony to the talent and
resourcefulness of our team.”
About MB-109
(MB-101 (IL-13Rα2 targeted CAR-T
cells) + MB-108 oncolytic virus)MB-109 is Mustang’s
designation for the treatment regimen combining MB-101
(COH-developed IL13Rα2‐targeted CAR-T cell therapy) with MB-108
(Nationwide-developed HSV-1 oncolytic virus). The combination is
designed to leverage MB-108 to make cold tumors “hot” and
potentially improve the efficacy of MB-101 CAR-T cell therapy.
MB-108 oncolytic virus is first injected to infect tumor cells
which, in turn, leads to reshaping of the TME through recruitment
of endogenous CD8- and CD3-positive effector T-cells. This inflamed
TME potentially permits MB-101 CAR-T cells injected into and around
the tumor to better infiltrate into and throughout the tumor mass,
undergo activation and, ideally, effect tumor cell killing.
About Mustang BioMustang 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 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, risks related to whether
the Company’s third-party manufacturer 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 of the consummation of the sale of the Company’s
manufacturing facility 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; our need
for substantial additional funds; 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 30, 2023, 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
Media Relations Contact:Tony Plohoros6
Degrees(908) 591-2839tplohoros@6degreespr.com
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