Galapagos presented encouraging initial safety and efficacy data at
2023 EBMT-EHA for point-of-care manufactured CAR-T candidate,
GLPG5201, in rrCLL
- All 7 out of 7 eligible patients with
relapsed/refractory Chronic Lymphocytic Leukemia, with or without
Richter’s transformation, responded to treatment (Objective
Response Rate of 100%)
- GLPG5201 showed an acceptable safety
profile with no cytokine release syndrome (CRS) higher than grade
2, or immune effector cell-associated neurotoxicity syndrome
(ICANS) observed
Mechelen, Belgium; 9 February 2023, 22.01
CET; Galapagos NV
(Euronext & NASDAQ: GLPG) today
presented encouraging
data at the European
Society for Blood and Marrow Transplantation
(EBMT)-European
Hematology Association
(EHA)
5th European CAR T-cell
Meeting in
Rotterdam.
CD19-directed CAR-T therapy has the potential to
improve survival for patients with a broad range of B-cell
malignancies such as Chronic Lymphocytic Leukemia (CLL) and Small
Lymphocytic Lymphoma (SLL).
EUPLAGIA-1 is an ongoing Phase 1/2 study in heavily
pre-treated patients with rrCLL and rrSLL, with or without
Richter’s transformation (RT), to evaluate the safety, efficacy,
and feasibility of GLPG5201, a fresh CD19 CAR-T product candidate
manufactured at point-of-care. As of 9 January 2023, 7 patients
diagnosed with rrCLL (4 patients with RT) were enrolled in the
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 Richter’s transformation.
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 cytokine release
syndrome (CRS) higher than grade 2 at both dose levels and no
immune effector cell associated neurotoxicity syndrome (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.
“We were very pleased to present strong initial
data from the ongoing Phase 1/2 study of our fresh CD19 CAR-T
candidate manufactured at point-of-care. This marks an important
milestone in our journey to transform the lives of patients with
severe blood cancers, including patients with RT, through the
acceleration of innovation and breakthrough science”, said Dr. Paul
Stoffels1, CEO of Galapagos. “We look forward to reporting Phase 1
topline data around mid-year.”
Details of the poster
presentation:
Abstract 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 |
Poster Number: CART2023: 206Date: 9 February 2023, 13:15
CETSession: 704 |
About point-of-care manufacturing
(Cocoon®)
CellPoint 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.
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 relapsed/refractory Chronic Lymphocytic Leukemia (rrCLL) and
Small Lymphocytic Lymphoma (rrSLL), with or without Richter’s
transformation (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
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
objective response rate (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 planned 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
continuously 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. The study
is currently enrolling rrCLL/SLL patients in Europe, including
patients with Richter’s transformation, and we aim to provide
topline results for Phase 1 around mid-2023.
About Chronic Lymphocytic Leukemia and
Small Lymphocytic Lymphoma Chronic 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. Chronic Lymphocytic Leukemia (CLL) and Small
Lymphocytic Leukemia (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 spleen2. Richter's transformation is an uncommon
clinicopathological condition observed in patients with Chronic
Lymphocytic Leukemia (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 malignancy and
are the most common adult leukemias in the US and in Europe3.
About GalapagosGalapagos is a
fully integrated biotechnology company focused on discovering,
developing, and commercializing innovative medicines. We are
committed to improving patients’ lives worldwide by targeting
diseases with high unmet needs. Our R&D capabilities cover
multiple drug modalities, including small molecules and cell
therapies. Our portfolio comprises discovery through to Phase 4
programs in immunology, oncology, and other indications. Our first
medicine for rheumatoid arthritis and ulcerative colitis is
available in Europe and Japan. CellPoint was acquired by Galapagos
in June 2022. For additional information, please visit
glpg.com or follow us on LinkedIn or Twitter.
Contact
Media relations |
Investor relations |
Marieke Vermeersch |
Sofie Van Gijsel |
+32 479 490 603 |
+1 781 296 1143 |
|
|
Elisa Chenailler |
Sandra Cauwenberghs |
+41 79 853 33 54 |
+32 495 58 46 63 |
|
ir@glpg.com |
Hélène de Kruijs |
|
+31 6 22463921 |
|
media@glpg.com |
|
Forward Looking StatementsThis
press release contains forward-looking statements, all of
which involve certain risks and uncertainties. These statements are
often, but are not always, made through the use of words or phrases
such as “initial,” “feasible,” “will,” encouraging,” “potential,”
“forward,” “aim,” promising,” “believe,” “suggest,” “on track,” and
“planned,” as well as any similar
expressions. Forward-looking statements contained in this
release include, but are not limited to, any statements
regarding preliminary, interim and topline data from the
EUPLAGIA-1 study and other analyses related to CD19 CAR-T,
statements regarding our plans and strategy with respect
to the EUPLAGIA-1 study and CD19 CAR-T, statements
regarding the expected timing, design and readouts of the
EUPLAGIA-1 study, including the expected trial recruitment and
timing for topline results from the EUPLAGIA-1 study, statements
regarding the collaboration with Lonza, statements regarding our
regulatory and R&D outlook, and statements regarding our
strategy, portfolio goals, business plans, focus. Of note, the
EUPLAGIA-1 study is ongoing and these interim results may not
reflect any future or final results or be confirmed upon completion
of such study. Any forward-looking statements in this 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 may not be completed in the currently envisaged
timelines or at all, risks associated with clinical trials,
recruitment of patients for trials, and product development
activities, including the CD19 CAR-T clinical program and
the EUPLAGIA-1 study, the inherent risks and uncertainties
associated with competitive developments, risks related to
regulatory approval requirements (including, but not limited to,
the risk that data from the ongoing EUPLAGIA-1 study may not
support registration or further development due to safety, efficacy
concerns, or other reasons), risks related to the acquisition of
CellPoint, including the risk that we may not achieve the
anticipated benefits of the acquisition of CellPoint, the inherent
risks and uncertainties associated with target discovery and
validation or drug discovery and development activities, the risk
that the preliminary and topline data from the EUPLAGIA-1 study may
not be reflective of the final data, risks related to our reliance
on collaborations with third parties (including CellPoint’s
collaboration partner Lonza), 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, and risks related to the ongoing
COVID-19 pandemic. A further list and description of these or other
risks and uncertainties can be found in our filings and reports
with the US Securities and Exchange Commission (SEC), including in
our most recent annual report on Form 20‐F filed with the SEC and
our subsequent filings and reports filed with the SEC. 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 release. We expressly disclaim any obligation to
update any forward-looking statements in this release, unless
required by law or regulation.
1 Acting via Stoffels IMC BV2 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.2018.3
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 presented encouraging initial safety and efficacy
data at 2023 EBMT-EHA for point-of-care manufactured CAR-T
candidate, GLPG5201, in rrCLL
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