Cabaletta Bio and WuXi Advanced Therapies Announce Expansion of GMP Manufacturing Agreement to Include CABA-201
August 22 2023 - 8:00AM
Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology
company focused on developing and launching the first curative
targeted cell therapies for patients with autoimmune diseases,
today announced that it has entered into certain work orders
relating to Good Manufacturing Practice (GMP) manufacturing under
its existing master services agreement with WuXi Advanced Therapies
(WuXi ATU), a global Contract Testing, Development and
Manufacturing Organization (CTDMO). As part of the agreement, WuXi
ATU will serve as a cell processing manufacturing partner for the
planned global clinical development of CABA-201 in multiple
indications, including potential late-stage clinical trials and
commercial readiness activities for CABA-201.
“We have had a successful collaboration with WuXi ATU over the
past two years for the GMP compliant production of novel cell
therapies. Based on this initial collaboration, we chose to expand
our partnership to include WuXi ATU as a manufacturer for our
CABA-201 clinical programs,” said Gwendolyn Binder, Ph.D.,
President of Science and Technology of Cabaletta. “WuXi ATU’s
dedicated production capacity for CABA-201 supports our planned
global expansion and commercial preparedness efforts and will
enable us to dose patients in multiple clinical trials with
separate parallel cohorts, while maintaining a capital-efficient
manufacturing strategy.”
Under the terms of the agreement, WuXi ATU will provide GMP
manufacturing of CABA-201, a 4-1BB-containing fully human CD19-CAR
T cell investigational therapy, to support any of Cabaletta’s
planned clinical trials, including the previously announced
separate Phase 1/2 clinical trials of CABA-201 for the treatment of
patients with systemic lupus erythematosus and idiopathic
inflammatory myopathies, or myositis. In addition, WuXi ATU will
continue to serve as the Company’s cell processing manufacturing
partner for the MusCAARTes™ Phase 1 clinical trial of
MuSK-CAART.
“We are delighted to expand our partnership with Cabaletta to
advance the development of CABA-201 for patients with autoimmune
diseases,” said David Y. H. Chang, Ph.D., President and Chief
Technology Officer of WuXi ATU. “We look forward to applying our
expertise in cell and gene therapy manufacturing to better support
our customers to bring potentially life-saving treatments faster to
patients in need.”
About Cabaletta BioCabaletta Bio (Nasdaq: CABA)
is a clinical-stage biotechnology company focused on the discovery
and development of engineered T cell therapies that have the
potential to provide a deep and durable, perhaps curative,
treatment for patients with autoimmune diseases. The CABA™ platform
encompasses two strategies: the CARTA (chimeric antigen receptor T
cells for autoimmunity) strategy, with CABA-201, a 4-1BB-containing
fully human CD19-CAR T, as the lead product candidate being
evaluated in systemic lupus erythematosus and myositis, and the
CAART (chimeric autoantibody receptor T cells) strategy, with
multiple clinical-stage candidates, including DSG3-CAART for
mucosal pemphigus vulgaris and MuSK-CAART for MuSK myasthenia
gravis. The expanding CABA™ platform is designed to develop
potentially curative therapies that offer deep and durable
responses for patients with a broad range of autoimmune diseases.
Cabaletta Bio’s headquarters and labs are located in Philadelphia,
PA.
About WuXi Advanced Therapies (WuXi ATU)As the
advanced therapies business unit of WuXi AppTec, WuXi Advanced
Therapies is a Contract Testing, Development and Manufacturing
Organization (CTDMO) that offers integrated platforms to transform
the discovery, development, testing, manufacturing, and
commercialization of cell and gene therapies. Our services and
solutions accelerate time to market and support customer programs
around the world. For more information, please visit
www.advancedtherapies.com.
Forward-Looking StatementsThis press release
contains “forward-looking statements” of Cabaletta Bio within the
meaning of the Private Securities Litigation Reform Act of 1995, as
amended, including without limitation, express or implied
statements regarding its expectations regarding: Cabaletta’s
ability to capitalize on and the potential benefits of the expanded
scope of its collaboration with WuXi ATU; Cabaletta’s ability to
grow its autoimmune-focused pipeline; its plans around CABA-201,
including its ability to enroll the requisite number of patients,
dose each dosing cohort in the intended manner and advance the
separate Phase 1/2 clinical trials of CABA-201 in each indication;
the Company’s business plans and objectives; the progress and
results of its MusCAARTes™ Phase 1 trial, including Cabaletta’s
ability to enroll the requisite number of patients, dose each
dosing cohort in the intended manner, and progress the trial; the
expectation that Cabaletta Bio may improve outcomes for patients
suffering from systemic lupus erythematosus, myositis,
MuSK-associated myasthenia gravis, or other autoimmune diseases as
well as its expected therapeutic benefits; and the ability to
accelerate Cabaletta’s pipeline and develop meaningful therapies
for patients, including in collaboration with academic and industry
partners and the ability to optimize such collaborations on its
development programs.
Any forward-looking statements in this press release are based
on management’s current expectations and beliefs of future events,
and are subject to a number of risks and uncertainties that could
cause actual results to differ materially and adversely from those
set forth in or implied by such forward-looking statements. These
risks and uncertainties include, but are not limited to: risks
related to regulatory filings and potential clearance; the risk
that signs of biologic activity or persistence may not inform
long-term results; Cabaletta’s ability to demonstrate sufficient
evidence of safety, efficacy and tolerability in its preclinical
studies and clinical trials of DSG3-CAART, MuSK-CAART and CABA-201;
the risk that the results observed with the similarly-designed
construct employed in the recent Nature Medicine publication,
including due to the dosing regimen, are not indicative of the
results we seek to achieve with CABA-201; risks related to clinical
trial site activation or enrollment rates that are lower than
expected; risks related to unexpected safety or efficacy data
observed during clinical studies; risks related to volatile market
and economic conditions and public health crises; Cabaletta’s
ability to retain and recognize the intended incentives conferred
by Orphan Drug Designation and Fast Track Designation for its
product candidates, as applicable; risks related to Cabaletta’s
ability to protect and maintain its intellectual property position;
risks related to fostering and maintaining successful relationships
with Cabaletta’s collaboration and manufacturing partners;
uncertainties related to the initiation and conduct of studies and
other development requirements for its product candidates; the risk
that any one or more of Cabaletta’s product candidates will not be
successfully developed and/or commercialized; and the risk that the
initial or interim results of preclinical studies or clinical
studies will not be predictive of future results in connection with
future studies. For a discussion of these and other risks and
uncertainties, and other important factors, any of which could
cause Cabaletta’s actual results to differ from those contained in
the forward-looking statements, see the section entitled “Risk
Factors” in Cabaletta’s most recent annual report on Form 10-K as
well as discussions of potential risks, uncertainties, and other
important factors in Cabaletta’s other filings with the Securities
and Exchange Commission. All information in this press release is
as of the date of the release, and Cabaletta undertakes no duty to
update this information unless required by law.
Contacts:
Anup MardaChief Financial Officerinvestors@cabalettabio.com
William GramigStern Investor Relations,
Inc.william.gramig@sternir.com
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