Galapagos and Blood Centers of America announce strategic collaboration to accelerate Galapagos’ decentralized CAR-T manufacturing network in the U.S.
May 15 2024 - 4:01PM
- BCA's national network of
blood centers will provide decentralized manufacturing services for
Galapagos' CAR-T product candidates, close to cancer treatment
centers
- Collaboration enables rapid
deployment of Galapagos' decentralized CAR-T platform across the
U.S., improving patient access to potentially life-saving CAR-T
treatments
- Important milestone for
Galapagos' U.S. expansion strategy, supporting upcoming pivotal
trials and potential future commercial manufacturing of CAR-T
therapies
- Complements existing
collaborations with Galapagos’ other manufacturing
partners
Mechelen, Belgium; 15 May 2024, 22:01
CET; Galapagos NV (Euronext & NASDAQ: GLPG)
and Blood Centers of America (BCA) today announced that they have
entered into a strategic collaboration for the decentralized
manufacturing of Galapagos’ CAR-T cell therapies through BCA’s
network in the U.S.
Under the terms of the collaboration agreement,
BCA will provide access to its extensive network of over 50
community blood centers in 43 states for Good Manufacturing
Practice compliant manufacturing for Galapagos’ CAR-T
hemato-oncology clinical program. This agreement complements
existing collaborations between Galapagos and Landmark Bio and
Thermo Fisher Scientific.
Galapagos will leverage BCA’s network to
initiate technology transfer to multiple sites in parallel for the
decentralized manufacturing of its CAR-T product candidates, close
to cancer treatment centers, while also accessing apheresis
capacity at BCA sites when required. In addition, BCA will play a
crucial coordinating role by supporting site initiation and
onboarding to accelerate Galapagos’ efforts and ensure consistent
quality.
Galapagos’ innovative, decentralized
manufacturing platform could address many of the limitations that
currently available CAR-T production is facing. It has the
potential to offer greater speed and scalability, with the delivery
of fresh, fit cells with a vein-to-vein time of seven days and the
possibility for greater physician control and improved patient
experience.
“Our collaboration with Blood Centers of America
marks a major milestone for Galapagos’ U.S. expansion by
establishing centers for support of our pivotal studies, with the
potential to be used for commercial introduction. Working with
BCA’s extensive nationwide network allows us to efficiently scale
up decentralized CAR-T therapy manufacturing across the U.S., while
their established infrastructure helps us harmonize operations and
access apheresis capacity,” said Dr. Paul Stoffels1, CEO and
Chairman of the Board of Directors of Galapagos. “This agreement
complements the existing collaborations between Galapagos and
Landmark Bio and Thermo Fisher Scientific and translates to a
significant step forward in our aspiration to bring CAR-T therapies
to more patients with a vein-to-vein time of just seven days.”
“We are very pleased to partner with Galapagos
in expanding their nationwide CAR-T manufacturing network,” said
Delisa English, BCA Board Chair. “Our decades of experience and
advanced capabilities in regulatory compliant biologic processing
across the U.S. will facilitate seamless technology transfer across
multiple sites. We strongly believe that the combination of
Galapagos’ decentralized manufacturing platform and our national
cell therapy manufacturing footprint will ultimately benefit
patients by providing convenient access to our local facilities for
apheresis and local healthcare providers within their
communities.”
About Galapagos’ decentralized CAR-T manufacturing
platform
Galapagos’ decentralized, innovative CAR-T
manufacturing platform has the potential for the administration of
fresh, fit cells within a median vein-to-vein time of seven days,
greater physician control and improved patient experience. The
platform consists of an end-to-end xCellit™ workflow management and
monitoring software system, a decentralized, functionally closed,
automated manufacturing platform for cell therapies (using Lonza’s
Cocoon®) and a proprietary quality control testing and release
strategy.
About GalapagosWe are a
biotechnology company with operations in Europe and the U.S.
dedicated to developing transformational medicines for more years
of life and quality of life. Focusing on high unmet medical needs,
we synergize compelling science, technology, and collaborative
approaches to create a deep pipeline of best-in-class small
molecules, CAR-T therapies, and biologics in oncology and
immunology. With capabilities from lab to patient, including a
decentralized CAR-T manufacturing network, we are committed to
challenging the status quo and delivering results for our patients,
employees and shareholders. For additional information, please
visit www.glpg.com or follow us on LinkedIn or X (formerly
Twitter).
About BCA Cell Therapies
NetworkBlood Centers of America (BCA) is the largest blood
supply network in the United States. The BCA Advanced Therapies
Network is a diverse, integrated portfolio offering a full spectrum
of support for the development and delivery of advanced therapies.
With the largest network of facilities in advanced therapies, the
network brings unparalleled and coordinated access to a vast array
of members and clients with a variety of service offerings related
to starting material, testing, quality control, cryopreservation,
manufacturing and clinical applications. To learn more,
visit: bcaadvancedtherapies.com.
For further information, please contact:
Media
inquiries:Marieke Vermeersch +32 479 490
603 media@glpg.com Jennifer Wilson + 44
7444 896759media@glpg.com |
Investor
inquiries:Sofie Van Gijsel +1 781 296
1143ir@glpg.comSandra Cauwenberghs +32 495 58 46
63ir@glpg.com |
Forward-looking statementsThis
press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995, as
amended. These statements are often, but are not always, made
through the use of words or phrases such as “anticipate,” “expect,”
“plan,” “estimate,” “will,” “continue,” “aim,” “intend,” “future,”
“potential,” “could,” “indicate,” “forward,” as well as similar
expressions. Forward-looking statements contained in this release
include, but are not limited to, statements regarding Galapagos’
collaboration with Blood Centers of America, including the benefits
of such collaboration, and statements regarding Galapagos’ CAR-T
manufacturing platform. Forward-looking statements may involve
unknown and known risks, uncertainties and other factors which
might cause actual results to differ materially from those referred
to in the forward-looking statements and, therefore, the reader
should not place undue reliance on them. These risks, uncertainties
and other factors include, without limitation, the risk that
Galapagos’ expectations regarding the collaboration with Blood
Centers of America, including the potential benefits of such
collaboration, may be incorrect, the inherent uncertainties
associated with competitive developments and regulatory approval
requirements, risks associated with Galapagos’ reliance on
collaborations with third parties (including its collaboration
partners Lonza, Landmark Bio and Thermo Fisher Scientific), risks
associated with Galapagos’ CAR-T manufacturing platform, as well as
those risks and uncertainties identified in Galapagos’ Annual
Report on Form 20-F for the year ended 31 December 2023 and its
subsequent filings with the Securities and Exchange
Commission. All statements other than statements of
historical fact are statements that could be deemed forward-looking
statements. The forward-looking statements contained herein are
based on management’s current expectations and beliefs and speak
only as of the date hereof, and Galapagos makes no commitment to
update or publicly release any revisions to forward-looking
statements in order to reflect new information or subsequent
events, circumstances or changes in expectations, unless required
by law or regulation.
1 Throughout this press release, ‘Dr. Paul Stoffels’ should be
read as ‘Dr. Paul Stoffels, acting via Stoffels IMC BV’
- GLPG Press Release_BCA collaboration_ENG_15 May 2024
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