Two oral presentations and one poster on encore preliminary data from Phase 1/2
CD19 CAR-T studies in non-Hodgkin lymphoma (NHL) and chronic lymphocytic
leukemia (CLL) / Richter transformation (RT)
Mechelen, Belgium; 4 April 2024, 22:01 CET - Galapagos NV (Euronext & NASDAQ:
GLPG) today announced that four abstracts, including two oral presentations on
encore preliminary clinical and translational data for its seven-day vein-to-
vein CAR-T product candidates GLPG5101 and GLPG5201, will be presented at the
50(th) Annual Meeting of the European Society for Blood and Marrow
Transplantation (EBMT) to be held in Glasgow, UK, on 14-17 April 2024.
ATALANTA-1 and EUPLAGIA-1 are ongoing Phase 1/2 open-label, multi-center studies
designed to assess the safety, efficacy and feasibility of point-of-care
manufactured GLPG5101 and GLPG5201 in patients with relapsed/refractory NHL, and
relapsed/refractory CLL and RT, respectively. The primary objective of the Phase
1 part of the studies is to evaluate the safety and preliminary efficacy to
determine the recommended dose for the Phase 2 part of the study. The primary
objective of the Phase 2 part of the studies is to assess the Objective Response
Rate (ORR) and the secondary objectives include the analysis of the Complete
Response (CR), duration of response, progression free survival, overall
survival, safety, pharmacokinetic profile, and feasibility of point-of-care
manufacturing. GLPG5101 and GLPG5201 are second generation anti-CD19/4-1BB CAR-T
product candidates, administered as a single fixed intravenous dose.
"We are committed to accelerating breakthrough innovations to extend the reach
of CAR-T therapies to patients with rapidly progressing cancers," said Dr.
Jeevan Shetty, M.D., Head of Clinical Development Oncology at Galapagos. "We
believe that the preliminary safety and efficacy data from our ongoing Phase
1/2 studies with our CD19 CAR-T therapy candidates in patients with
relapsed/refractory NHL, CLL and RT, combined with our unique, innovative
decentralized manufacturing approach that enables a seven-day vein-to-vein time,
support the promise of GLPG5101 and GLPG5201 in addressing the critical needs of
patients facing poor prognosis."
The following table provides a summary of Galapagos' presentations at EBMT 2024:
+-----------------------------+--------------------------+---------------------+
|Abstract Title |Authors/Presenter |Presentation |
| | |date/time |
+-----------------------------+--------------------------+---------------------+
|Galapagos encore abstracts |
+-----------------------------+--------------------------+---------------------+
|Seven-Day Vein-to-Vein Point-|Marie José Kersten, |Oral presentation |
|of-Care Manufactured CD19 CAR|Kirsten Saevels, Sophie |number: OS16-04 |
|T-Cell Therapy (GLPG5101) in |Servais, Yves Beguin, |(https://ebmt2024.abs|
|Relapsed/Refractory Non- |Joost S.P. Vermaat, Eva |tractserver.com/progr|
|Hodgkin Lymphoma (NHL): |Santermans, Stavros |am/#/details/presenta|
|Results from the Phase 1 |Milatos, Maike Spoon, |tions/831) |
|ATALANTA-1 Trial |Marte C. Liefaard, Claire |Date: 17 April, |
| |Vennin, Margot J. Pont, |12:57-13:06 (session |
| |Anna D.D. van Muyden, |runs 12:30-13:45) |
| |Maria T. Kuipers, |Session: Oral Session|
| |Sébastien Anguille |16: CAR-T outcomes in|
| | |ALL |
+-----------------------------+--------------------------+---------------------+
|Seven-Day Vein-to-Vein Point-|Valentin Ortiz-Maldonado, |Oral presentation |
|of-Care-Manufactured CD19 CAR|Nuria Martinez-Cibrian, |number: OS16-05 |
|T-Cell Therapy (GLPG5201) in |Julio Delgado, Sergi |(https://ebmt2024.abs|
|Relapsed/Refractory Chronic |Betriu, Leticia Alserawan,|tractserver.com/progr|
|Lymphocytic Leukemia |Ana Triguero, Nadia |am/#/details/presenta|
|Including Richter |Verbruggen, Maike Spoon, |tions/835) |
|Transformation: Results from |Marte C. Liefaard, Anna |Date: 17 April, |
|the Phase 1 EUPLAGIA-1 Study |D.D. van Muyden, Natalia |13:06-13:15 (session |
| |Tovar |runs 12:30-13:45) |
| | |Session: Oral Session|
| | |16: CAR-T outcomes in|
| | |ALL |
| | | |
| | | |
| | | |
+-----------------------------+--------------------------+---------------------+
|EUPLAGIA-1: Seven-Day Vein- |Esmée P. Hoefsmit, Sandra |Poster number: A073 |
|to-Vein Point-of-Care |Blum, Claire Vennin, |(https://ebmt2024.abs|
|Manufactured GLPG5201 Anti- |Kirsten Van Hoorde, Sergi |tractserver.com/progr|
|CD19 CAR-T Cells Display |Betriu, |am/#/details/presenta|
|Early Phenotypes in |Leticia Alserawan, Julio |tions/1176) |
|Relapsed/Refractory CLL, |Delgado, Nadia Verbruggen,|Date: 15 April, |
|including RT |Anna D.D. van Muyden, |18:00-19:00 |
| |Henriëtte Rozema, Ruiz |Session: Printed |
| |Astigarraga, Margot J. |poster: CAR-based |
| |Pont |Cellular Therapy - |
| | |Clinical |
| | | |
+-----------------------------+--------------------------+---------------------+
|PAPILIO-1: Phase 1/2, |Niels W.C.J. van de Donk, |Poster number: P049 |
|Multicenter, Open-Label Study|Sébastien Anguille, Jo |(https://ebmt2024.abs|
|to Evaluate Feasibility, |Caers, Marte C. Liefaard, |tractserver.com/progr|
|Safety and Efficacy of Point-|Christian Jacques, Anna |am/#/details/presenta|
|of-Care-Manufactured Anti- |D.D. van Muyden |tions/1178) |
|BCMA CAR T-Cell Therapy | |Date: 14 April, |
|(GLPG5301) in | |08:30-18:00 |
|Relapsed/Refractory Multiple | |Session: ePoster: |
|Myeloma | |CAR-based Cellular |
| | |Therapy - Clinical |
+-----------------------------+--------------------------+---------------------+
About Galapagos' decentralized CAR-T manufacturing platform
Galapagos' decentralized, innovative CAR T-cell manufacturing platform near the
point-of-care offers the potential for the administration of fresh, fit cells
with a vein-to-vein time of seven days, greater physician control and a
significantly 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 the ATALANTA-1 study (EudraCT 2021-003272-13)
ATALANTA-1 is an ongoing Phase 1/2, open-label, multicenter study to evaluate
the safety, efficacy and feasibility of point-of-care manufactured GLPG5101, a
CD19 CAR-T product candidate, in patients with relapsed/refractory non-Hodgkin
lymphoma (rrNHL). GLPG5101 is a second generation anti-CD19/4-1BB CAR-T product
candidate, administered as a single fixed intravenous dose. The primary
objective of the Phase 1 part of the study is to evaluate the safety and
preliminary efficacy to determine the recommended dose for the Phase 2 part of
the study. Secondary objectives include assessment of efficacy and feasibility
of near the point-of-care manufacturing of GLPG5101. The dose levels that were
evaluated in Phase 1 are 50x10(6 )(DL1) and 110x10(6 )(DL2) and 250x10(6) (DL3)
CAR+ viable T cells. The primary objective of the Phase 2 part of the study is
to evaluate the Objective Response Rate (ORR), while the secondary objectives
include Complete Response (CR), duration of response, progression free survival,
overall survival, safety, pharmacokinetic profile, and the feasibility of point-
of-care manufacturing. Each enrolled patient will be followed for 24 months.
About the EUPLAGIA-1 study (EudraCT 2021-003815-25)
EUPLAGIA-1 is an ongoing Phase 1/2 open-label, multi-center study evaluating the
safety, efficacy and feasibility of point-of-care manufactured GLPG5201, a CD19
CAR-T product candidate, in patients with relapsed/refractory chronic
lymphocytic leukemia (rrCLL) and small cell lymphocytic lymphoma (rrSLL), with
or without Richter transformation (RT). GLPG5201 is a second generation anti-
CD19/4-1BB CAR-T product candidate, administered as a single fixed intravenous
dose. Patients with CD19+ rrCLL or rrSLL with >=2 lines of prior therapy are
eligible to participate, and patients with RT are eligible regardless of prior
therapy. The primary objective of the Phase 1 part of the study is to evaluate
the safety and preliminary efficacy to determine the recommended dose for the
Phase 2 part of the study. The dose levels that were evaluated in the Phase 1
part of the study are 35x10(6) (DL1) and 100x10(6) (DL2) CAR+ viable T cells.
The primary objective of the Phase 2 part of the study is to assess the
Objective Response Rate (ORR) and the secondary objectives include the analysis
of the Complete Response (CR), duration of response, progression free survival,
overall survival, safety, pharmacokinetic profile, and feasibility of point-of-
care manufacturing.
About Galapagos
We are a biotechnology company with operations in Europe and the US 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,
point-of-care 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 (https://www.glpg.com) or
follow us on?LinkedIn (https://www.linkedin.com/company/glpg/)?or?X (formerly
Twitter) (https://twitter.com/GalapagosGlobal).
Contact
Media inquiries: Investor inquiries:
Marieke Vermeersch Sofie Van Gijsel
+32 479 490 603 +1 781 296 1143
media@glpg.com (mailto:media@glpg.com) ir@glpg.com (mailto:ir@glpg.com)
Sandra Cauwenberghs
+32 495 58 46 63
Jennifer Wilson ir@glpg.com (mailto:ir@glpg.com)
+ 44 7539 359 676
media@glgp.com (mailto:media@glgp.com)
Forward-looking statements
This 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 preliminary, interim and topline data
from the EUPLAGIA-1 and ATALANTA-1 studies and other analyses related to
Galapagos' CD19 CAR-T program, statements related to Galapagos' plans,
expectations and strategy with respect to the EUPLAGIA-1 and ATALANTA-1 studies,
and statements regarding the expected timing, design and readouts of the
EUPLAGIA-1 and ATALANTA-1 studies, including the expected recruitment for such
trials. 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 GLPG5201 and 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 GLPG5201 and GLPG5101 due to safety, efficacy or other reasons),
Galapagos' reliance on collaborations with third parties (including its
collaboration partner Lonza) and that Galapagos' estimations regarding its
GLPG5201 and GLPG5101 development programs and regarding the commercial
potential of GLPG5201 and 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 2022 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.
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