On June 20, 2025 Galapagos NV (Euronext & NASDAQ: GLPG) reported new data from the ongoing ATALANTA-1 Phase 1/2 study of its investigational CD19 CAR T-cell therapy, GLPG5101, in an oral presentation at the 18th International Conference on Malignant Lymphoma (ICML) (Press release, Galapagos, JUN 20, 2025, View Source [SID1234654019]). These data demonstrate high complete response (CR) and minimal residual disease (MRD) rates in heavily pretreated relapsed/refractory indolent non-Hodgkin lymphoma (R/R iNHL) patients (ATALANTA-1 Cohort 3). Additionally, with a rapid vein-to-vein time enabled by Galapagos’ decentralized manufacturing platform, 93% of patients treated in the study received fresh, non-cryopreserved GLPG5101, without the need for cytotoxic bridging therapy.

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"These safety, efficacy and manufacturing results represent a significant milestone for our GLPG5101 program in relapsed/refractory B-cell malignancies," said Omotayo Fasan, M.D., Clinical Development Program Head at Galapagos. "For patients who have often exhausted multiple lines of therapy and face limited treatment options, the favorable safety profile, high complete response rate, and consistent minimal residual disease negativity we observed are especially encouraging."

"I am encouraged by the 97% progression free survival rate at 12 months and the favorable safety profile of GLPG5101, as well as the enrichment of early phenotype cells in the final product," said Maria Kuipers, M.D., of the Department of Hematology at the Academic Center in Amsterdam (The Netherlands). "The ability to deliver a fresh, early-memory-enriched CAR T-cell product within seven days of leukapheresis without the need for cytotoxic bridging therapy is a promising advancement for the field. This turnaround not only helps mitigate the risk of disease progression during the waiting period, but also spares patients from additional chemotherapy and its associated toxicities. Together, these findings highlight the promise of decentralized CAR-T manufacturing in enabling timely, scalable, and personalized cell therapies "

The new ATALANTA-1 data for the completely enrolled Cohort 3 are summarized below:
The oral presentation at ICML features new safety, efficacy and manufacturing data for GLPG5101 from the completely enrolled cohort in R/R indolent NHL (Cohort 3) of the ongoing ATALANTA-1 Phase 1/2 study. As of the October 14, 2024 data cut-off, 34 patients with R/R iNHL (follicular lymphoma, FL, n=29); (marginal zone lymphoma, MZL, n=5) underwent leukapheresis, of whom 32 (94%) received an infusion of GLPG5101.

Of those 32 patients:
94% (30 patients) received a fresh product.
93% (28 patients) received it with a 7-day vein-to-vein time, avoiding the need for cytotoxic bridging therapy.
6% (2 patients) received a cryopreserved product with a 13-day vein-to-vein time.
The proportion of early phenotype CD4+ and CD8+ CAR-T cells increased significantly in the final product versus starting material.
GLPG5101 showed a promising efficacy profile with robust and durable CAR-T cell expansion:
At month 9, 100% of evaluable patients (13/13) had persisting CAR-T cells and CAR-T cells were detected up to 21 months.
A complete response (CR) rate of 97% was observed with 31/32 infused patients responding to treatment and 100% of evaluable patients (10/10) being MRD negative at time of CR.
The 12-month progression free survival (PFS) rate was 97%, with no reported relapses.
GLPG5101 showed a favorable safety profile:
The majority of Grade ≥ 3 treatment emergent adverse events were hematological.
Cases of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) were few and predominantly low-grade with only a single Grade 3 report of ICANS.
There were no deaths reported.

ORR (%) CRR (%) CR (n/N) No response (n/N)
FL (n=27) 96% 96% 26/27 1/27
MZ (n=5) 100% 100% 5/5 0/5
All iNHL (n=32) 97% 97% 31/32 1/32
Table 1: Objective and complete response rates (all GLPG5101 infused patients)

About GLPG5101 and ATALANTA-1 (EudraCT 2021-003272-13; NCT 06561425)
GLPG5101 is a second generation anti-CD19/4-1BB CAR-T product candidate, administered as a single fixed intravenous dose. The safety, efficacy and feasibility of decentralized manufactured GLPG5101 are currently being evaluated in the ATALANTA-1 Phase 1/2 study in eight1 hematological malignancies with high unmet need. The primary objective of the Phase 1 part of the study is to evaluate safety and to determine the recommended dose for the Phase 2 part of the study. Secondary objectives include assessment of efficacy and feasibility of decentralized manufacturing of GLPG5101. The dose levels that were evaluated in Phase 1 are 50×106 (DL1), 110×106 (DL2) and 250×106 (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 Rate (CRR), duration of response, progression free survival, overall survival, safety, pharmacokinetic profile, and the feasibility of decentralized manufacturing. Each enrolled patient will be followed for 24 months. The ATALANTA-1 study is currently enrolling patients in the U.S. and Europe.

About Galapagos’ cell therapy manufacturing platform
Galapagos’ innovative decentralized cell therapy manufacturing platform is designed to enable the administration of fresh, fit, stem-like early memory cells with 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.