GLPG5301 / Galapagos - LARVOL DELTA

Rationale for and Design of Papilio-1: A Phase 1/2, Multicenter, Open-Label Study to Evaluate the Feasibility, Safety, and Efficacy of Point-of-Care–Manufactured Anti–B-Cell Maturation Antigen Chimeric Antigen Receptor T Cells (GLPG5301) in Relapsed/Refractory Multiple Myeloma (ASH 2023) - "Prior to infusion of GLPG5301, patients will receive fludarabine/cyclophosphamide lymphodepleting chemotherapy, followed by a resting period of at least 2 days. PFS and OS will be assessed using the Kaplan‒Meier method and calculated from the median survival time. Summary In Papilio-1, the feasibility, safety and efficacy of GLPG5301, a point-of-care–manufactured BCMA-directed CAR T-cell therapy, will be evaluated in adult patients with RRMM."

CAR T-Cell Therapy • Clinical • P1/2 data • Hematological Malignancies • Multiple Myeloma • Oncology

PAPILIO-1 Phase 1/2 study of GLPG5301: BCMA CAR-T candidate in relapsed/refractory multiple myeloma (R/R MM) (GlobeNewswire) - "Patient enrollment in the Phase 1 part is progressing with topline results expected in 2026, which will guide Galapagos’ development strategy; Galapagos expects to present Phase 1 topline data at a future medical conference."

P1 data • Trial status • Multiple Myeloma

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

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 pauses CAR-T cell therapy trial over Parkinsonism case (Fierce Pharma) - "Galapagos has paused enrollment in a trial of a BCMA-directed CAR-T cell therapy, pumping the brakes in response to an adverse event also seen in recipients of Bristol Myers Squibb and Johnson & Johnson’s rival drugs...Belgium’s Galapagos began the phase 1/2 trial late last year to assess BCMA CAR-T candidate GLPG5301 in adults with relapsed or refractory multiple myeloma...The biotech put enrollment on hold after one case of Parkinsonism, movement symptoms associated with Parkinson's disease. Galapagos has filed a protocol amendment with the European Medicines Agency and expects to resume enrollment in the coming months....The biotech plans to share data from the study in 2025."

Clinical protocol • P1/2 data • Trial suspension • Hematological Malignancies • Multiple Myeloma • 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 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

PAPILIO-1: PHASE 1/2, MULTICENTER, OPEN-LABEL STUDY TO EVALUATE FEASIBILITY, SAFETY AND EFFICACY OF POINT-OF-CARE–MANUFACTURED ANTI-BCMA CAR T-CELL THERAPY (GLPG5301) IN RELAPSED/REFRACTORY MULTIPLE MYELOMA (EBMT 2024) - "Exploratory assessments include additional GLPG5301 pharmacokinetics (PK) and pharmacodynamics (PD).After screening, patients will undergo leukapheresis of mononuclear cells for point-of-care manufacturing of GLPG5301, followed by fludarabine/cyclophosphamide lymphodepleting chemotherapy (Figure). In Papilio-1, the feasibility, safety and efficacy of GLPG5301, a point-of-care–manufactured BCMA-directed CAR T-cell therapy, will be evaluated in adult patients with rrMM. GLPG5301 will be administered as a fresh product, with a targeted vein-to-vein time of 7 days. >"

CAR T-Cell Therapy • Clinical • P1/2 data • Hematological Malignancies • Multiple Myeloma • Oncology

Papilio-1: Phase 1/2 Study of Point-of-care-manufactured CAR T-cell Therapy (EBMT-EHA 2024) - "After screening, patients will undergo leukapheresis of mononuclear cells for PoC manufacturing of GLPG5301, followed by fludarabine/cyclophosphamide lymphodepleting chemotherapy (Figure). In Papilio-1, the feasibility, safety and efficacy of GLPG5301, a PoC-manufactured BCMA-directed CAR-T therapy, will be evaluated in adults with rrMM. GLPG5301 will be administered as a fresh product, with a targeted vein-to-vein time of 7 days. >"

CAR T-Cell Therapy • P1/2 data

Galapagos announces start of PAPILIO-1 Phase 1/2 multiple myeloma study of point-of-care manufactured BCMA CAR-T candidate, GLPG5301 (GlobeNewswire) - "Galapagos NV...announced that the first patient has been dosed in PAPILIO-1, the Phase 1/2 study to evaluate the safety, efficacy, and feasibility of our seven-day vein-to-vein, point-of-care manufactured BCMA CAR-T candidate, GLPG5301, in adult patients with relapsed/refractory multiple myeloma (rrMM)....PAPILIO-1 is a Phase 1/2, open-label, multi-center study to evaluate the feasibility, safety, and efficacy of point-of-care manufactured GLPG5301, our BCMA CAR-T product candidate, in patients with relapsed/refractory multiple myeloma (rrMM) after ≥2 prior lines therapy."

Trial status • Multiple Myeloma

Galapagos announces first quarter 2023 financial results (GlobeNewswire) - "Mid-2023, we aim to announce topline results from the ATALANTA-1 and EUPLAGIA-1 Phase 1/2 studies with CD19 CAR-T candidates GLPG5101 and GLPG5201 in rrNHL and rrCLL (with or without RT) respectively, followed by the start of the dose-expansion cohorts in both studies. In addition, we expect to expand our point-of-care network throughout the year, and to submit an investigational new drug application (IND) in the US to start clinical development with our CD19 CAR-T candidate later this year. Finally, we aim to expand our CAR-T portfolio with the start of the Phase 1/2 PAPILIO-1 study in Europe with BCMA CAR-T candidate, GLPG5301, in patients with multiple myeloma (MM)."

IND • New trial • P1/2 data • Chronic Lymphocytic Leukemia • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology