On November 5, 2024 Galapagos NV (Euronext & NASDAQ: GLPG) reported that it will present new data from its CAR T- and TCR T-cell therapy pipeline at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in San Diego, CA, 7-10 December 2024 (Press release, Galapagos, NOV 5, 2024, View Source [SID1234647811]).
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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 Toxicities
Location: 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 PT
Session: 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, 2024
Time: 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 PT
Session: 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 platform
Galapagos’ 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.