Galapagos to Present Results of Pioneering Innovation in Cancer Cell Therapy at ASH 2024
2024年11月6日 - 6:01AM
- New Phase 1/2 data support the
potential of our CAR T-cell therapy candidates, GLPG5101 and
GLPG5201, in addressing unmet needs for patients with poor
prognoses.
- Our innovative decentralized
cell therapy manufacturing platform delivers fresh, fit cells
within a median vein-to-vein time of seven days, with potentially
encouraging patient outcomes.
- Three abstracts, including one
oral presentation for GLPG5101 in relapsed/refractory non-Hodgkin
lymphoma, and a company showcase, will spotlight our cutting-edge
cell therapy innovations in blood cancers and solid
tumors.
Mechelen, Belgium; November 5, 2024,
22:01 CET; Galapagos NV (Euronext & NASDAQ: GLPG) today
announced that it will present new data from its CAR T- and TCR
T-cell therapy pipeline at the 66th
American Society of Hematology (ASH) Annual Meeting and
Exposition in San Diego, CA, 7-10 December 2024.
Three abstracts, including one oral
presentation, will feature new data from our proprietary cell
therapy programs in relapsed/refractory (R/R) non-Hodgkin lymphoma
(NHL), and R/R chronic lymphocytic leukemia (CLL) and Richter
transformation (RT), in addition to preclinical data in head &
neck (H&N) cancer, developed in partnership with Adaptimmune.
Galapagos will also host a company showcase, titled: Fresh, Fit,
and Fast: Pioneering the Future of Cell Therapy through
Decentralized Manufacturing.
“We are committed to advancing breakthrough
innovations to expand the reach of cell therapies for patients with
rapidly progressing cancers,” said Jeevan Shetty, MD, Head of
Clinical Development Oncology at Galapagos. “We are excited to
present promising new clinical data for our CD19 CAR T-cell therapy
candidates, which continue to support the hypothesis that
delivering fresh, fit cells quickly could improve outcomes for
patients. Additionally, the preclinical proof-of-concept data we
will present with our partner Adaptimmune highlight the potential
of our innovative approach in treating solid tumors, expanding our
reach to critically-ill patients beyond hematological cancers.”
The data to be presented are summarized
below:
- The oral presentation for GLPG5101,
our CD19 CAR-T candidate in relapsed/refractory non-Hodgkin
lymphoma, including R/R large B-cell lymphoma (DLBCL), mantle cell
lymphoma (MCL), follicular lymphoma (FL), and marginal zone
lymphoma (MZL), will feature new safety, efficacy, and longer
follow-up data for 45 patients in the ongoing Phase 1/2 ATALANTA-1
study (data cut-off: April 25, 2024). The presentation will also
demonstrate the feasibility of our decentralized manufacturing
platform, delivering a fresh, stem-like early memory cell therapy
with a median vein-to-vein time of seven days, robust in vivo
expansion, and durable persistence.
- The poster presentation for
GLPG5201, our CD19 CAR-T candidate in relapsed/refractory chronic
lymphocytic leukemia (R/R CLL) and Richter transformation (RT),
will include additional safety, efficacy, and translational data
from 15 patients (cut-off date: February 21, 2024) in the ongoing
Phase 1/2 EUPLAGIA-1 study, consistent with previously disclosed
findings. The presentation will also highlight that decentralized
manufacturing of GLPG5201, delivered as fresh cells in a median
vein-to-vein time of seven days, results in an increase in
stem-like early memory phenotypes versus starting material, robust
in vivo expansion, and durable persistence.
- The poster presentation for
uza-cel, a MAGE-A4 directed TCR T-cell therapy candidate in head
& neck (H&N) cancer, in partnership with Adaptimmune, will
highlight preclinical proof-of-concept data demonstrating that
Galapagos’ innovative decentralized cell therapy manufacturing
platform can produce uza-cel with features that may result in
improved efficacy and durability of response in the clinic compared
with the existing manufacturing procedure.
The dates and times for accepted
abstracts, presentations and our company showcase are as
follows:
Abstract title |
Authors (Presenter) |
Presentation date/time |
Galapagos-driven original abstracts |
ATALANTA-1: A Phase 1/2 Trial of GLPG5101, a Fresh, Stem-Like,
Early Memory CD19 CAR T-Cell Therapy with a 7-Day Vein-to-Vein
Time, for the Treatment of Relapsed/Refractory Non-Hodgkin
Lymphoma |
Marie José Kersten, Kirsten Saevels, Evelyne Willems, Marte C.
Liefaard, Stavros Milatos, Margot J. Pont, Claire Vennin, Eva
Santermans, Anna D.D. Van Muyden, Jeevan Shetty, Esmée P. Hoefsmit,
Omotayo Fasan, Maria T. Kuipers, Sébastien Anguille, Joost S.P.
Vermaat |
Oral presentation
number: 93 Date: Saturday,
December 7, 2024 Time: 10:00 PT (session
09:30-11:00 PT) Session: 704. Cellular
Immunotherapies: Early Phase Clinical Trials and Toxicities: CAR-T
Cell Therapies for Lymphomas and ALL: New Strategies and
ToxicitiesLocation: Marriott Marquis San Diego
Marina, Marriott Grand Ballroom 11-13 |
EUPLAGIA-1: A Phase 1/2 Trial of GLPG5201, a Fresh Stem-Like Early
Memory CD19 CAR T-Cell Therapy with a 7-Day Vein-to-Vein Time, in
Patients with Relapsed/Refractory CLL and RT |
Valentin Ortiz-Maldonado, Nuria Martínez-Cibrián,
Leticia Alserawan, Sergi Betriu, Ana Triguero, Sandra Blum, Margaux
Faes, Marte C. Liefaard, Margot J. Pont, Maike Spoon, Kirsten Van
Hoorde, Anna D. D. van Muyden, Julio Delgado, Natalia
Tovar |
Poster presentation
number: 3452 Date: Sunday, December
8, 2024 Time: 18:00-20:00
PTSession: 704. Cellular Immunotherapies: Early
Phase Clinical Trials and Toxicities: Poster
II Location: San Diego Convention Center,
Halls G-H |
Galapagos company showcase |
Fresh, Fit, and Fast: Pioneering the Future of Cell Therapy through
Decentralized Manufacturing |
Dr. Jeevan Shetty, M.D., Head of Clinical Development Oncology,
Galapagos, Ms. Jacqueline Vink-Korndorffer, Head of Global Cell
Therapy Operations, Galapagos |
Date: Saturday, December 7,
2024Time: 13:45-14:00 PT
Location: Room 3, Upper Level, San Diego
Convention Center |
Adaptimmune-driven abstracts |
Preclinical Proof of Concept for Decentralized Manufacturing of a
MAGE-A4/CD8α–Expressing Autologous T-Cell Therapy for
Solid Tumors |
Melissa Herman, Stefania Gobessi, Laurens Sand, Karolin Wagner,
Ryan Yuan, Sterenn Davis, Ian Donaldson, Megan Butler, Natalie
Bath, Robert Harris, Nathaniel Golden, Alex Tipping, Joseph
Sanderson, John Mellors, Phillip Debnam |
Poster presentation
number: 2100 Date: Saturday,
December 7, 2024 Time: 17:30-19:30
PTSession: 711. Cell Collection and Manufacturing
of HSPCs, CAR-T Cells, and Other Cellular Therapy Products: Poster
I Location: San Diego Convention Center,
Halls G-H |
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 visibility, 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 transforming patient outcomes through life-changing
science and innovation 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 platform, and
the financial strength to invest strategically for the near- and
long-term, we are committed to challenging the status quo and
delivering results for our patients, employees, and shareholders.
Our goal is not just to meet current medical needs but to
anticipate and shape the future of healthcare, ensuring that our
innovations reach those who need them most. For additional
information, please visit www.glpg.com or follow us
on LinkedIn or X.
For further information, please
contact:
Media
inquiries:Srikant Ramaswami+1 412 699 0359 Marieke
Vermeersch +32 479 490 603 Jennifer
Wilson + 44 7539 359 676 media@glpg.com |
Investor
inquiries:Sofie Van Gijsel +1 781 296 1143Sandra
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,” “may,” as well as
similar expressions. Forward-looking statements contained in this
press release include, but are not limited to, statements regarding
preliminary, interim and topline data from the ATALANTA-1 and
EUPLAGIA-1 studies and other analyses related to Galapagos’ CD19
CAR-T programs, statements related to Galapagos’ plans,
expectations and strategy with respect to the ATALANTA-1 and
EUPLAGIA-1 studies, and statements regarding the expected timing,
design and readouts of the ATALANTA-1 and EUPLAGIA-1 studies,
including the expected recruitment for such trials, and the
potential benefits of Galapagos’ product candidates, including
GLPG5101, GLPG5201, and partnered programs, including uza-cel.
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 Galapagos’ product candidates,
including GLPG5101 and GLPG5201, 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 and GLPG5201 due to safety, efficacy or other reasons),
Galapagos' reliance on collaborations with third parties (including
its collaboration partners Lonza and Adaptimmune), and that
Galapagos’ estimations regarding its GLPG5101 and GLPG5201
development programs and regarding the commercial potential of
GLPG5101 and GLPG5201 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.
- ASH CURTAIN RAISER PR_EN FINAL
Galapagos (EU:GLPG)
過去 株価チャート
から 10 2024 まで 11 2024
Galapagos (EU:GLPG)
過去 株価チャート
から 11 2023 まで 11 2024