- All 7 out of 7 eligible
patients with relapsed/refractory
chronic
lymphocytic
leukemia
(rrCLL),
with or without Richter’s
Transformation
(RT), responded to treatment (Objective
Response Rate of 100%)1
- GLPG5201 showed no cytokine
release syndrome (CRS) higher than grade 2, or immune effector
cell-associated neurotoxicity syndrome
(ICANS)2
- A functionally closed,
automated manufacturing platform for cell therapies at the
point-of-care will be shown at the Galapagos booth A.103
at the EHA 2023
congress
Mechelen, Belgium; 5
June
2023,
22:01 CET;
Galapagos NV (Euronext & NASDAQ: GLPG) today announced
that it will feature
the CAR-T point-of-care
manufacturing platform and will
present previously disclosed
initial Phase 1/2 data with CD19 CAR-T
candidate,
GLPG5201, at
the European Hematology
Association (EHA) 2023 congress,
taking place from 8 June
to 11 June 2023
in Frankfurt,
Germany.
“Patients who develop rrCLL and become resistant to new agents
have a very poor prognosis and a significant high unmet medical
need for novel therapeutic options such as CAR-T cell therapy. The
previously disclosed initial efficacy, safety and feasibility data
from the ongoing EUPLAGIA-1 study with our CD19 CAR-T candidate,
GLPG5201, manufactured at point-of-care, are encouraging, and we
are on track to provide Phase 1 topline results around mid this
year,” said Jeevan Shetty, Head of Clinical Development Oncology at
Galapagos. “Our innovative approach in CAR-T cell therapy
development and manufacturing underscores our commitment to
accelerating transformational innovation to address the unmet needs
of patients with advanced cancers, and we very much look forward to
meeting and connecting with you at our booth.”
Details of the abstract
P1399:
Title |
Authors |
Presentation date/time |
Initial Clinical Results of Euplagia-1, a Phase I/II Trial of
Point-of-CareManufactured GLPG5201 in R/R CLL/SLL with or without
Richter's transformation |
Nuria Martinez-Cibrian, Sergi Betriu, Valentin Ortiz-Maldonado,
Daniel Estban, Leticia Alserawan, Mercedes Montoro, Anna DD van
Muyden, Maike Spoon, Margot J. Pont, Christian Jacques, Julio
Delgado |
AbstractPoster presentation on9 June 2023, 18:00 - 19:00 CET |
At the safety and efficacy analysis cut-off date of 9 January
2023, 7 patients diagnosed with rrCLL (including 4 patients with
RT) were enrolled in the EUPLAGIA-1 study (n=4 at dose level 1
(DL1); n=3 at dose level 2 (DL2)). All patients received GLPG5201
as a fresh infusion with a median vein-to-vein time of 7 days. The
dose levels that are evaluated in the Phase 1 part of the study are
35x106 (DL1), 100x106 (DL2) and 300x106 (dose level 3 (DL3)) CAR+
viable T cells. The initial results from these 7 patients that were
eligible for efficacy analysis (cut-off date: 9 January 2023)
indicated that a 7-day vein-to-vein time is feasible and
demonstrated strong and consistent in vivo CAR-T expansion levels.
Moreover, the initial efficacy results are encouraging with an
objective response rate (ORR) of 100% observed. 6 out of 7 patients
(86%) reached a complete response (CR) and all Richter’s patients
achieved a CR. A duration of response of up to 7.9 months has been
reported and follow-up is ongoing. Only 1 patient (DL1) progressed
(progressive disease, (PD) after partial response (PR)) and had a
CD19-negative relapse with confirmed RT.
In the safety analysis of these 7 patients, adverse events were
consistent with the known toxicities of CD19 CAR-T treatment. None
of the patients experienced a CRS higher than grade 2 at both dose
levels and no ICANS was reported. No dose limiting toxicities
(DLTs) were reported and the majority of grade ≥3 adverse events
were hematological. Only one serious adverse event was reported at
DL2 with a patient experiencing a CRS grade 2, but the event was
resolved after 7 days. Patient recruitment of the study is
ongoing.
About point-of-care manufacturing CellPoint (a
Galapagos company) has developed, in a strategic collaboration with
Lonza, a novel point-of-care supply model, which is designed to
enable clinicians to administer fresh CAR-T cells within 7 days of
leukapheresis, without complex logistics or cryopreservation,
thereby aiming to address important limitations of current CAR-T
treatments. The proprietary platform consists of CellPoint’s
end-to-end xCellit workflow management and monitoring software, and
Lonza’s Cocoon® Platform, a functionally closed, automated
manufacturing platform for cell therapies. This novel point-of-care
model is compliant with the EMA and FDA guidance for clinical
trials.
About the EUPLAGIA-1 study (EudraCT
2021-003815-25)EUPLAGIA-1 is an ongoing Phase 1/2
open-label, multi-center study evaluating the feasibility, safety,
and efficacy of point-of-care manufactured GLPG5201 in patients
with rrCLL and small cell lymphocytic lymphoma (rrSLL), with or
without RT. GLPG5201 is a second generation anti-CD19/4-1BB CAR-T
product candidate, administered as intravenous infusion of a fresh
product candidate in a single fixed 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 safety and determine the recommended dose for the Phase
2 part of the study. The primary objective of the Phase 2 part of
the study is to assess the ORR and the secondary objectives include
the analysis of the complete response rate (CRR), duration of
response, progression free survival, overall survival, safety
pharmacokinetic profile, and feasibility of point-of-care
manufacturing.
The dose levels that are evaluated in the Phase 1 part of the
study are 35x106 (DL1), 100x106 (DL2) and 300x106 (DL3) CAR+ viable
T cells. The study uses a Bayesian Optimal Interval (BOIN) design
(n=15 patients) for Phase 1. Following screening and enrolment,
patients will receive ibrutinib daily until leukapheresis of
mononuclear cells. During GLPG5201 manufacturing, patients receive
cyclophosphamide (300 mg/m2/day)/fludarabine (30 mg/m2/day) for 3
days. After a resting period of at least 2 days, GLPG5201 is
administered via intravenous infusion. All patients remain
hospitalized for at least 7 days and the end-of-study visit is at
Week 14 post CAR-T infusion. Phase 1 patient recruitment is ongoing
to establish a recommended dose for Phase 2.About
chronic
lymphocytic
leukemia and
small cell
lymphocytic
lymphomaChronic lymphocytic leukemia (CLL) is one
of the chronic lymphoproliferative disorders (lymphoid neoplasms).
It is characterized by a progressive accumulation of functionally
incompetent lymphocytes, which are usually monoclonal in origin.
CLL and small cell lymphocytic lymphoma (SLL) are essentially the
same type of B-cell non-Hodgkin lymphoma (NHL), with the only
difference the location where the primary cancer occurs. CLL
affects B-cells in the blood and bone marrow and SLL cancer cells
are located in lymph nodes and/or the spleen3. RT is an uncommon
clinicopathological condition observed in patients with CLL. It is
characterized by the sudden transformation of the CLL into a
significantly more aggressive form of large cell lymphoma and
occurs in approximately 2-10% of all CLL patients. CLL/SLL usually
follows an indolent course and is an incurable disease. Patients
who develop relapsed and refractory disease and become resistant to
new agents have a dismal prognosis and a high unmet medical need
for new therapeutic options such as CAR-T cells. With estimated
incidence of 4.7 new cases per 100,000 individuals, CLL/SLL are the
most prevalent lymphoid malignancies and are the most common adult
leukemias in the US and in Europe 4.
About Galapagos Galapagos is a fully integrated
biotechnology company united around a single purpose: to transform
patient outcomes through life-changing science
and innovation for more years of life and quality of
life. We focus on the key therapeutic areas of immunology and
oncology, where we have developed a deep scientific expertise in
multiple drug modalities, including small molecules and cell
therapies. Our portfolio comprises discovery through to
commercialized programs and our first medicine for rheumatoid
arthritis and ulcerative colitis is available in Europe and Japan.
For additional information, please visit www.glpg.com or
follow us on LinkedIn or Twitter.
Contacts
Media
relations contactMarieke
Vermeersch +32 479 490
603 media@glpg.com |
Investor
relations contact Sofie Van Gijsel +1 781 296
1143Sandra Cauwenberghs +32 495 58 46 63 ir@glpg.com |
Forward-looking statementsThis press
release includes forward-looking statements, all of
which involve certain risks and uncertainties. These statements are
often, but not always, made through the use of words or phrases
such as “initial,” “feasible,” “will,”
encouraging,” “forward,” “aim,” “on track,” and
“planned,” as well as any similar
expressions. Forward-looking statements contained in this
press release include, but are not limited to, statements
regarding preliminary, interim and topline data
from our studies, including, without limitation,
the EUPLAGIA-1 study, and other analyses related to
our oncology or CAR-T portfolio, statements regarding our
plans and strategy with respect to our oncology or CAR-T portfolio,
including, without limitation, the EUPLAGIA-1 study,
statements regarding the expected timing, design and readouts of
the EUPLAGIA-1 study, including the recruitment for
trials and timing for topline results from
the EUPLAGIA-1 study, statements regarding the
collaboration with Lonza, and statements regarding our R&D and
regulatory outlook. Any forward-looking statements in this
press release are based on our management’s current expectations
and beliefs, and are not guarantees of future performance.
Forward-looking statements may involve unknown and known risks,
uncertainties and other factors which might cause our actual
results, performance or achievements to be materially different
from any historic or future results, performance or achievements
expressed or implied by such statements. These risks,
uncertainties and other factors include, without limitation, the
risk that ongoing and future clinical studies (including the
EUPLAGIA-1 study) may not be completed in the currently
envisaged timelines or at all, the inherent risks and
uncertainties associated with competitive developments,
clinical trials, recruitment of patients, product development
activities and regulatory approval requirements (including that
data from ongoing and planned clinical research programs,
including, without limitation, the data from the
ongoing EUPLAGIA-1 study, may not support
registration or further development due to safety, efficacy, or
other reasons, or that data readouts in the future may not reflect
interim data results), the inherent risks and uncertainties
associated with target discovery and validation or drug discovery
and development activities, the risks related to our
reliance on collaborations with third
parties (including Lonza), and the risk that we will
not be able to continue to execute on our currently contemplated
business plan and/or will revise our business plan, including the
risk that our plans with respect to CAR-T may not be achieved on
the currently anticipated timeline or at all. A further list
and description of these risks, uncertainties and other factors can
be found in our filings and reports with the Securities and
Exchange Commission (SEC), including in our most recent annual
report on Form 20‐F filed with the SEC, as supplemented and/or
modified by any other filings and reports that we have made or will
make with the SEC in the future. Given these risks and
uncertainties, the reader is advised not to place any undue
reliance on such forward-looking statements. In addition, even if
our results, performance or achievements are consistent with such
forward-looking statements, they may not be predictive of results,
performance or achievements in future periods. These
forward-looking statements speak only as of the date of publication
of this press release. We expressly disclaim any obligation to
update any forward-looking statements in this press release, unless
required by law or regulation.
1 cut-off date for efficacy and safety analysis:
9 January 20232 cut-off date for efficacy and safety analysis: 9
January 20233 Wierda WG. Chronic lymphocytic leukemia/
Small lymphocytic lymphoma fact sheet. In: Foundation LR,
editor: https://www.lymphoma.org/wp-content/uploads/2018/04/LRF_FACTSHEET_CLL_SLL.pdf.20184
Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer Statistics, 2021.
CA: A Cancer Journal for Clinicians.
2021;71(1):7-33. https://www.ncbi.nlm.nih.gov/books/NBK493173
- Galapagos to showcase CAR-T point-of-care manufacturing and
initial Phase 1 2 CLL data with CD19 CAR-T candidate, GLPG5201 at
the EHA 2023 congress
Galapagos (EU:GLPG)
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