GLPG5101 / Galapagos - LARVOL DELTA

Galapagos NV Announces U.S. FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to GLPG5101 for the Treatment of Relapsed/Refractory Mantle Cell Lymphoma (GlobeNewswire) - "Galapagos NV...announced that the United States Food and Drug Administration (FDA) has granted RMAT designation to GLPG5101, a second generation anti-CD19/4-1BB CAR-T product candidate for the treatment of relapsed/refractory mantle cell lymphoma (R/R MCL)....Clinical data derived from the ongoing ATALANTA-1 study with GLPG5101 in patients with R/R B-cell Non-Hodgkin Lymphoma (B-NHL), including a subset of patients with MCL, supported the RMAT designation. These data demonstrated both high objective and high complete response rates, with a manageable safety profile, including low rates of high-grade cytokine release syndrome (CRS), immune effector cell associated neurotoxicity syndrome (ICANS) and low dropout rates."

FDA event • Mantle Cell Lymphoma

Advancing the Cell Therapy Pipeline and Platform Under Current Planning, Subject to Ongoing Strategic Review (Galapagos Press Release) - "GLPG5101 is being advanced toward pivotal development in mantle cell lymphoma (MCL), with enrollment expected to start in 2026. Following updates to the clinical study design, the Biologics License Application (BLA) filing is anticipated in 2028 with approval now expected in 2029...Total net revenues for the six months ended June 30, 2025 amounted to €140.3 million, compared to €140.3 million for the six months ended June 30, 2024. The revenue recognition related to the exclusive access rights granted to Gilead for Galapagos’ drug discovery platform amounted to €115.1 million for the first six months of both 2025 and 2024."

Commercial • FDA approval • FDA filing • Mantle Cell Lymphoma

HIGH CR AND MRD NEGATIVITY RATES WITH GLPG5101, A FRESH, STEM-LIKE, EARLY MEMORY CD19 CAR T WITH 7-DAY VEIN-TO-VEIN TIME: FULL RESULTS FROM ATALANTA-1 COHORT 3 (iNHL) (ICML 2025) - P1/2 | "CR and MRD negativity rates after GLPG5101 infusion were high in heavily pretreated pts with R/R iNHL in the ongoing ATALANTA-1 study. A fresh, fit product was delivered with a 7-day VTV time, obviating the need for bridging therapy, with a low drop-out rate. In vivo expansion of CAR T cells was robust and persistence was durable."

Minimal residual disease • Follicular Lymphoma • Indolent Lymphoma • Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • CD4 • CD8

LOW RATES OF HIGH-GRADE TOXICITIES WITH GLPG5101, A FRESH, STEM-LIKE, EARLY MEMORY PHENOTYPE ANTI-CD19 CAR T-CELL THERAPY IN PATIENTS WITH NHL IN THE ATALANTA-1 STUDY (ICML 2025) - P1/2 | "The ongoing ATALANTA-1 study in pts with R/R NHL evaluates a fresh and fit CD19-directed CAR T-cell product with a stem-like, early memory phenotype. Results demonstrate a manageable safety profile in the context of robust CAR T-cell peak expansion and durable persistence. Cases of CRS and ICANS were few and predominantly low grade, with only a single G3 report of each."

CAR T-Cell Therapy • Clinical • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma

LOW RATES OF HIGH-GRADE TOXICITIES WITH GLPG5101, A FRESH, STEM-LIKE, EARLY MEMORY PHENOTYPE ANTI-CD19 CAR T-CELL THERAPY WITH A 7-DAY VEIN-TO-VEIN TIME IN PATIENTS WITH NON-HODGKIN LYMPHOMA IN THE ATALANTA-1 STUDY (EHA 2025) - P1/2 | "The ongoing ATALANTA-1 study in pts with R/R NHL evaluates a fresh and fit CD19-directed CAR T-cell product with a stem-like, early memory phenotype. Results demonstrate a manageable safety profile in the context of robust CAR T-cell peak expansion and durable persistence. Cases of CRS and ICANS were few and predominantly low-grade, with only a single G 3 report of each."

CAR T-Cell Therapy • Clinical • Anemia • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Hemophagocytic lymphohistiocytosis • Immunology • Infectious Disease • Leukopenia • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Pneumonia • Rare Diseases • Respiratory Diseases • Septic Shock • Thrombocytopenia

Galapagos Presented New Data at ICML 2025 From Cohort 3 of ATALANTA-1 in Relapsed/Refractory Indolent NHL Patients, Demonstrating High Complete Response and MRD Negativity Rates With CAR-T Candidate GLPG5101 (GlobeNewswire) - P1/2 | N=250 | ATALANTA-1 (NCT06561425) | Sponsor: Galapagos NV | "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: (i) 94% (30 patients) received a fresh product; (ii) 93% (28 patients) received it with a 7-day vein-to-vein time, avoiding the need for cytotoxic bridging therapy; (iii) 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..."

P1/2 data • Follicular Lymphoma • Marginal Zone Lymphoma

Galapagos to Present New ATALANTA-1 CAR-T Data at EHA 2025, Highlighting Low Toxicity and Rapid, Decentralized Delivery of Fresh, Early-Memory-Enriched GLPG5101 in R/R NHL (GlobeNewswire) - P1/2 | N=250 | ATALANTA-1 (NCT06561425) | Sponsor: Galapagos NV | "The oral presentation at EHA features new safety and longer follow-up data for GLPG5101 in 64 patients with R/R large B-cell lymphoma (DLBCL, n=17), mantle cell lymphoma (MCL, n=13), follicular lymphoma (FL, n=29), and marginal zone lymphoma (MZL, n=5) from the ongoing ATALANTA-1 Phase 1/2 study....GLPG5101 showed an encouraging safety profile in the context of robust CAR T-cell peak expansion and durable persistence, with the majority of Grade ≥ 3 treatment emergent adverse events being hematological. Cases of CRS and ICANS were few and predominantly low-grade with only a single Grade 3 report of each. Dose-limiting toxicities were found in 8% of patients (5/61). Durable CAR T-cell persistence was observed up to 21 months across tumor types, phases, and dose levels."

P1/2 data • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma

Clinical Pipeline: Near-Term Value Driver - ATALANTA-1 Phase 1/2 study of GLPG5101 (GlobeNewswire) - "First U.S. patient dosed, with continued enrollment progressing across existing European clinical trial sites; Preparations underway to add a chronic lymphocytic leukemia (CLL) cohort, with patient enrollment anticipated to start in the second half of 2025, subject to study protocol approval; Fully enrolled the indolent NHL (follicular lymphoma/marginal zone lymphoma) cohort, with new Phase 1/2 topline results expected to be presented at a medical conference in the first half of 2025;Patient enrollment in the Mantle Cell Lymphoma (MCL) cohort is progressing, with updated Phase 1/2 topline results expected to be presented at a medical conference in the second half of 2025."

P1/2 data • Trial status • Chronic Lymphocytic Leukemia • Follicular Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma

Galapagos Reports First Quarter 2025 Financial Results, Recent Business Highlights and Near-Term Catalysts (GlobeNewswire) - "Mantle cell lymphoma (MCL), a high-unmet-need hematological malignancy, selected as lead indication for the GLPG5101 program; Pivotal development planned to start in 2026 and aiming for approval in 2028; €3.3 billion in cash and financial investments as of March 31, 2025; Normalized annual cash burn guidance, excluding restructuring costs, in the range of €175 million - €225 million reaffirmed...Galapagos plans to initiate clinical development of a novel CAR-T candidate before the end of 2025 and to select at least one program for IND-enabling studies in 2025. In 2026, the pipeline is expected to be expanded with at least one additional next-generation program."

Commercial • Pipeline update • Mantle Cell Lymphoma

Galapagos Reports Full Year 2024 Results and Provides Fourth Quarter Business Update (GlobeNewswire) - "GLPG5101 (CD19 CAR-T) program:...ATALANTA-1 Phase 1/2 study:...Galapagos aims to present additional new data at a medical meeting in 2025....GLPG5301 (BCMA CAR-T) in relapsed/refractory multiple myeloma (R/R MM): The Phase 1 part of the PAPILIO-1 Phase 1/2 is currently recruiting patients. Upon completion of Phase 1 and analysis of the data, Galapagos will evaluate the most appropriate development strategy and next steps. The Company aims to present Phase 1 data at a future medical conference."

P1 data • P1/2 data • Trial status • Burkitt Lymphoma • CNS Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Multiple Myeloma

Catalent Announces Collaboration with Galapagos to Further Expand Galapagos’ Decentralized CAR-T Manufacturing Network in the U.S. (Catalent Pharma Press Release) - "Catalent, Inc...today announced a strategic collaboration with Galapagos NV...to support decentralized manufacturing for clinical studies of GLPG5101, Galapagos’ investigational CAR-T therapy for relapsed/refractory non-Hodgkin lymphoma (NHL) indications. Catalent’s commercial cell therapy manufacturing facility in Princeton, New Jersey, will support manufacturing for Galapagos’ upcoming trials in New Jersey, New York, and surrounding areas....Financial terms of the agreement are not disclosed."

Commercial • Non-Hodgkin’s Lymphoma

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 (ASH 2024) - "GLPG5101, a fresh, stem-like, early memory CD19 CAR T-cell therapy manufactured using a rapid decentralized platform, showed robust in vivo expansion and durable persistence. Treatment with GLPG5101 led to promising efficacy and safety across indications in heavily pretreated pts with R/R NHL."

CAR T-Cell Therapy • P1/2 data • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Burkitt Lymphoma • CNS Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD4 • CD8

Galapagos Announces Encouraging New Results from Ongoing Phase 1/2 Study of CD19 CAR T-Cell Therapy, GLPG5101, in Patients with Relapsed/Refractory Non-Hodgkin Lymphoma (GlobeNewswire) - P1/2 | N=195 | ATALANTA-1 (NCT06561425) | Sponsor: Galapagos NV | "The results, featured in an oral presentation at the 66th American Society of Hematology (ASH) Annual Meeting...demonstrate an encouraging efficacy and safety profile in patients with relapsed/refractory non-Hodgkin lymphoma (R/R NHL)....As of the April 25, 2024, data cut-off, 49 patients received CD19 CAR T-cell therapy infusion....High objective response rates (ORR) and complete response rates (CRR) were observed in the pooled Phase 1 and Phase 2 efficacy analysis set, split by indication: In patients with MCL, all 8 of 8 efficacy-evaluable patients responded to treatment (ORR and CRR 100%). In patients with MZL, FL, objective and complete responses were observed in 20 of 21 efficacy-evaluable patients (ORR and CRR 95%). In patients with DLBCL, 9 of 13 efficacy-evaluable patients responded to treatment (ORR 69%), with 7 patients achieving a complete response (CRR 54%)."

P1/2 data • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma

Galapagos to Present Results of Pioneering Innovation in Cancer Cell Therapy at ASH 2024 (GlobeNewswire) - "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."

P1/2 data • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma

Galapagos Reports Third Quarter 2024 Financial Results and Provides Business Update (GlobeNewswire) - "...for the Phase 1/2 ATALANTA-1 study of our CD19 candidate, GLPG5101, in R/R NHL...our goal is to activate clinical study sites and start enrolling patients in the U.S. before the end of 2024...Following the submission of a Clinical Trial Application (CTA) to the European Medicines Agency (EMA) for the Phase 2 dose expansion study of GLPG5201 in R/R CLL and RT, we aim to start enrolling patients in 2025; We resumed enrolment in the Phase 1/2 PAPILIO-1 study of our BCMA CAR-T candidate, GLPG5301, in R/R MM."

Trial status • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Richter's Syndrome

Galapagos Reports Third Quarter 2024 Financial Results and Provides Business Update (GlobeNewswire) - "We will present new data from the ATALANTA-1 and EUPLAGIA-1 studies along with pre-clinical data for uza-cel, our TCR-T cell therapy candidate produced on our decentralized manufacturing platform in collaboration with Adaptimmune, at the American Society of Hematology (ASH) Annual Meeting in December...We further advanced our early-stage proprietary pipeline and progressed a next-generation armed, bispecific CAR-T candidate in hemato-oncology and a potential best-in-class small molecule candidate in immunology into IND-enabling studies, targeting clinical development in 2025-2026; We are accelerating our early-stage pipeline of more than 15 programs in oncology and immunology with the objective of launching at least four IND/CTA-enabling studies in 2025 across different modalities and indications. From 2026 onward, our ambition is to fuel the clinical pipeline with at least two new clinical assets annually in various indications and across our cell therapy and small molecule..."

Clinical data • Pipeline update • Preclinical • Chronic Lymphocytic Leukemia • Hematological Malignancies • Immunology • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Excellos Selected as Decentralized Manufacturing Unit to Support Galapagos’ CAR-T Cell Therapy Clinical Study Close to Cancer Treatment Centers in the San Diego Area (Businesswire) - "Excellos Inc...announced that it has been selected to manufacture Galapagos’ CAR-T cell therapy candidate, GLPG5101, for its recently FDA cleared ATALANTA-1 clinical study in patients with relapsed/refractory non-Hodgkin lymphoma in the U.S....Excellos was selected upon completion of an extensive site audit and assessment process and will provide end-to-end manufacturing of Galapagos’ CAR-T cell therapy on Galapagos’ platform at Excellos’ new purpose-built manufacturing facility in downtown San Diego, CA."

Commercial • Non-Hodgkin’s Lymphoma

Galapagos announces FDA clearance of IND application for Phase 1/2 ATALANTA-1 study of CD19 CAR-T, GLPG5101, in relapsed/refractory non-Hodgkin lymphoma (GlobeNewswire) - "Galapagos NV...today announced that the U.S. Food and Drug Administration (FDA) has cleared Galapagos’ Investigational New Drug (IND) application for ATALANTA-1, a Phase 1/2 multicenter study evaluating the feasibility, safety, and efficacy of GLPG5101 in patients with relapsed/refractory non-Hodgkin lymphoma (R/R NHL)...The primary objective of the Phase 1 part of ATALANTA-1 is to evaluate the safety and preliminary efficacy of GLPG5101 to determine the recommended dose for Phase 2...The primary objective of the Phase 2 study is to evaluate the objective response rate."

IND • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Atalanta-1: A Study Evaluating the Safety and Efficacy of GLPG5101 (19CP02) in Participants With Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1/2 | N=195 | Recruiting | Sponsor: Galapagos NV

New P1/2 trial • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Galapagos presents encouraging new data for CD19 CAR-T candidate GLPG5101 in non-Hodgkin lymphoma at EHA 2024 (GlobeNewswire) - P1/2 | N=45 | ATALANTA-1 (2021-003272-13) | Sponsor: CellPoint B.V. | "In Phase 1, 14 of 16 efficacy-evaluable patients responded to treatment (objective response rate, ORR 87.5%), with 12 patients achieving a complete response (CR) (CR rate, CRR 75%). In Phase 2, 14 of 15 efficacy-evaluable patients responded to treatment (ORR 93.3%), and all responders achieved a complete response (CRR 93.3%)....High ORR and CRR were observed in the pooled Phase 1 and Phase 2 efficacy analysis set, split by indication: In patients with DLBCL, 7 of 9 efficacy-evaluable patients responded to treatment (ORR 78%), with 5 patients achieving a complete response (CRR 56%); In patients with FL or MZL, objective and complete responses were observed in 16 of 17 efficacy-evaluable patients (ORR and CRR 94%); In patients with MCL, all 5 of 5 efficacy-evaluable patients responded to treatment (ORR and CRR 100%)."

P1/2 data • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma

SEVEN-DAY VEIN-TO-VEIN POINT-OF-CARE–MANUFACTURED CD19 CAR T CELLS (GLPG5101) IN RELAPSED/REFRACTORY NON-HODGKIN LYMPHOMA: RESULTS FROM THE PHASE 1/2 ATALANTA-1 TRIAL (EHA 2024) - "Data for 34 pts with NHL in the Ph1/2 Atalanta-1 study demonstrate the feasibility of PoC CAR T-cellmanufacturing with a short vein-to-vein time (median 7 days). GLPG5101 in vivo expansion was robust, withdurable persistence. There were no unexpected safety findings."

CAR T-Cell Therapy • P1/2 data • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Galapagos and Blood Centers of America announce strategic collaboration to accelerate Galapagos’ decentralized CAR-T manufacturing network in the U.S. (GlobeNewswire) - "Galapagos NV...and Blood Centers of America (BCA) today announced that they have entered into a strategic collaboration for the decentralized manufacturing of Galapagos’ CAR-T cell therapies through BCA’s network in the U.S. Under the terms of the collaboration agreement, BCA will provide access to its extensive network of over 50 community blood centers in 43 states for Good Manufacturing Practice compliant manufacturing for Galapagos’ CAR-T hemato-oncology clinical program. This agreement complements existing collaborations between Galapagos and Landmark Bio and Thermo Fisher Scientific....Galapagos will leverage BCA’s network to initiate technology transfer to multiple sites in parallel for the decentralized manufacturing of its CAR-T product candidates, close to cancer treatment centers, while also accessing apheresis capacity at BCA sites when required."

Licensing / partnership • Hematological Malignancies • Oncology

Galapagos showcases innovative approach in hematological cancer care with clinical and translational data presentations at EBMT congress 2024 (GlobeNewswire) - "Galapagos NV...announced that four abstracts, including two oral presentations on encore preliminary clinical and translational data for its seven-day vein-to-vein CAR-T product candidates GLPG5101 and GLPG5201, will be presented at the 50th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT)....ATALANTA-1 and EUPLAGIA-1 are ongoing Phase 1/2 open-label, multi-center studies designed to assess the safety, efficacy and feasibility of point-of-care manufactured GLPG5101 and GLPG5201 in patients with relapsed/refractory NHL, and relapsed/refractory CLL and RT, respectively. The primary objective of the Phase 1 part of the studies is to evaluate the safety and preliminary efficacy to determine the recommended dose for the Phase 2 part of the study."

P1 data • Chronic Lymphocytic Leukemia • Non-Hodgkin’s Lymphoma • Richter's Syndrome

Galapagos announces full year 2023 results and outlook for 2024 (Galapagos Press Release) - "Galapagos NV...reports full year 2023 results and provides outlook for 2024...We aim to progress three CAR-T Phase 1/2 studies in hemato-oncology: GLPG5101 in rrNHL; GLPG5201 in rrCLL, with or without RT; and GLPG5301 in rrMM; We expect to file IND applications in the U.S. to begin clinical development of our CAR-T programs in hemato-oncology; We plan to further upscale our CAR-T network and operations in the U.S. and Europe, and potentially other key regions."

Commercial • IND • Trial status • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology

Galapagos halts lupus CAR-T program, confirms 100 layoffs so far this year (FierceBiotech) - "Galapagos also used the earnings report to disclose that it has decided to halt work on its CD19 CAR-T candidate aimed at refractory systemic lupus erythematosus. The release was light on details for the move, with Galapagos only ascribing the pipeline change to 'strategic reasons'....Galapagos reported that 'further progress' had been made in preparing to launch a phase 1b study of the CAR-T therapy, dubbed GLPG5101, in patients with refractory systemic lupus erythematosus. But there have been no updates since."

Discontinued • Systemic Lupus Erythematosus