Galapagos announces FDA clearance of IND application for Phase 1/2 ATALANTA-1 study of CD19 CAR-T, GLPG5101, in relapsed/refractory non-Hodgkin lymphoma
2024年8月23日 - 2:00PM
Mechelen, Belgium; August 23, 2024, 07:00
CET; regulated information – inside information – Galapagos NV
(Euronext & NASDAQ: GLPG) today announced that the U.S. Food
and Drug Administration (FDA) has cleared Galapagos’
Investigational New Drug (IND) application for ATALANTA-1, a Phase
1/2 multicenter study evaluating the feasibility, safety, and
efficacy of GLPG5101 in patients with relapsed/refractory
non-Hodgkin lymphoma (R/R NHL).
GLPG5101 is an autologous CD19 CAR-T cell
therapy product candidate produced using Galapagos’ innovative
decentralized cell therapy manufacturing platform with the
potential for the administration of fresh, fit cells within a
median vein-to-vein time of seven days.
The primary objective of the Phase 1 part of
ATALANTA-1 is to evaluate the safety and preliminary efficacy of
GLPG5101 to determine the recommended dose for Phase 2. Secondary
objectives include assessment of efficacy and feasibility of
decentralized manufacturing of GLPG5101. The primary objective of
the Phase 2 study is to evaluate the objective response rate. The
secondary objectives include complete response rate, duration of
response, progression free survival, overall survival, safety,
pharmacokinetic profile, and the feasibility of decentralized
manufacturing. Each enrolled patient will be followed for 24
months.
The Phase 1/2 ATALANTA-1 study is currently
ongoing in Europe, and early data have shown encouraging results in
patients with R/R NHL.1
“We are dedicated to accelerating breakthrough
innovation that extends the reach of cell therapies to patients
with rapidly progressing cancers,” said Dr. Paul Stoffels2,
Galapagos’ CEO and Chairman of the Board of Directors. “Our
innovative, decentralized manufacturing platform is designed to
overcome many of the challenges faced by existing CAR-T production
methods. The Galapagos platform has the potential for greater speed
and scalability, with the delivery of fresh, fit cells with a
median vein-to-vein time of seven days, close to patients. The IND
clearance for the Phase 1/2 study of GLPG5101 marks a significant
milestone in our cell therapy clinical program, bringing us one
step closer to offering our CD19 CAR-T cell therapy to patients in
the U.S.”
About non-Hodgkin lymphoma and
GLPG5101GLPG5101 is a second generation anti-CD19/4-1BB
CAR-T product candidate, administered as a single fixed intravenous
dose. It is currently being assessed in the ATALANTA-1 Phase 1/2,
open-label, multicenter study to evaluate the safety, efficacy and
feasibility of decentralized manufactured GLPG5101 in patients with
relapsed/refractory non-Hodgkin lymphoma (R/R NHL). Non-Hodgkin
lymphoma is a cancer originating from lymphocytes, a type of white
blood cell which is part of the body’s immune system. Non-Hodgkin
lymphoma can occur at any age although it is more common in adults
over 50 years old. Initial symptoms usually are enlarged lymph
nodes, fever, and weight loss. There are many different types of
non-Hodgkin lymphoma. These types can be divided into aggressive
(fast-growing) and indolent (slow growing) types, and they can be
formed from either B lymphocytes (B cells) or in lesser extent from
T lymphocytes (T cells) or Natural Killer cells (NK cells). B-cell
lymphoma makes up about 85% of non-Hodgkin lymphomas diagnosed in
the US. Prognosis and treatment of non-Hodgkin lymphoma depend on
the stage and type of disease.
About Galapagos’ cell therapy
manufacturing platformGalapagos’ innovative, decentralized
cell therapy 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 and cell therapies in oncology and immunology. With
capabilities from lab to patient, including a decentralized cell
therapy 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.
This press release contains inside information
within the meaning of Regulation (EU) No 596/2014 of the European
Parliament and of the Council of 16 April 2014 on market abuse
(market abuse regulation).
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 +32 495 584
663ir@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’
plans, expectations and strategy with respect to the ATALANTA-1
study, and statements regarding the expected timing, design and
readouts of the ATALANTA-1 study, including the expected
recruitment for such trials, statements related to the IND
application for the Phase 1/2 ATALANTA-1 study. Forward-looking
statements involve known and unknown risks, uncertainties and other
factors which might cause Galapagos’ actual results to be
materially different from those expressed or implied by such
forward-looking statements. These risks, uncertainties and other
factors include, without limitation, the risk that preliminary or
interim clinical results may not be replicated in ongoing or
subsequent clinical trials; the risk that ongoing and future
clinical studies with GLPG5101 may not be completed in the
currently envisaged timelines or at all, the inherent uncertainties
associated with competitive developments, clinical trial and
product development activities and regulatory approval requirements
(including that data from the ongoing and planned clinical research
programs may not support registration or further development of
GLPG5101 due to safety, efficacy or other reasons), risks related
to Galapagos' reliance on collaborations with third parties
(including its collaboration partner Lonza), the risk that
Galapagos’ estimations regarding its GLPG5101 program and the
commercial potential of GLPG5101 may be incorrect, as well as those
risks and uncertainties identified in Galapagos’ Annual Report on
Form 20-F for the year ended 31 December 2023 filed with the U.S.
Securities and Exchange Commission (SEC) and its subsequent filings
with the SEC. 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.
1 Kersten, M.J., 2024. Seven-day vein-to-vein
point-of-care–manufactured CD19 CAR T cells (GLPG5101) in
relapsed/refractory non-Hodgkin lymphoma: Results from the Phase
1/2 ATALANTA-1 trial. EHA Library. Available at:
https://bit.ly/3xZj9Mr [Accessed 09 July 2024].2 Throughout this
press release, ‘Dr. Paul Stoffels’ should be read as ‘Dr. Paul
Stoffels, acting via Stoffels IMC BV’.
- GLPG Press Release IND Clearance_ENG_FINAL
Galapagos NV (NASDAQ:GLPG)
過去 株価チャート
から 7 2024 まで 8 2024
Galapagos NV (NASDAQ:GLPG)
過去 株価チャート
から 8 2023 まで 8 2024