GLPG5201 / Galapagos - LARVOL DELTA

Galapagos Reports Full Year 2024 Results and Provides Fourth Quarter Business Update (GlobeNewswire) - "We are deprioritizing activities related to GLPG5201, our second CD19 CAR-T candidate, pending the advancement of GLPG5101 in those additional indications.....The Company plans to initiate clinical development of a novel CAR-T candidate in 2025 and expand its clinical pipeline of next-generation programs with the addition of two new clinical assets in 2026....Galapagos presented strong preclinical proof-of-concept data at ASH for uza-cel, a MAGE-A4 directed TCR T-cell therapy candidate in head and neck cancer, in partnership with Adaptimmune....Preparations are ongoing with the goal to start clinical development in 2026."

New trial • Pipeline update • Head and Neck Cancer • Hematological Malignancies

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 (ASH 2024) - "Conclusions : In this analysis of the ongoing EUPLAGIA-1 study, rapid, fresh decentralized manufactured GLPG5201 showed an increase in stem-like early memory phenotypes versus SM, robust in vivo expansion, and durable persistence. Infusion of fresh, fit GLPG5201 with a 7-day vein-to-vein time led to encouraging efficacy in pts with CLL and RT, and a manageable overall safety profile, with no ICANS or Grade ≥3 CRS."

CAR T-Cell Therapy • Clinical • P1/2 data • Bone Marrow Transplantation • Chronic Lymphocytic Leukemia • Cytomegalovirus Infection • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Immunology • Oncology • Richter's Syndrome • CD4 • CD8

Galapagos to Present Results of Pioneering Innovation in Cancer Cell Therapy at ASH 2024 (GlobeNewswire) - "The data to be presented are summarized below:...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."

P1/2 data • Chronic Lymphocytic Leukemia • Richter's Syndrome

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

Galapagos reports half-year 2024 financial results and provides second quarter business update (GlobeNewswire) - "IND filing for our Phase 1/2 EUPLAGIA-1 study of CD19 CAR-T candidate GLPG5201 in R/R CLL with or without RT on track for Q4 2024."

IND • Chronic Lymphocytic Leukemia

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

SEVEN-DAY VEIN-TO-VEIN POINT-OF-CARE–MANUFACTURED CD19 CAR T-CELL THERAPY (GLPG5201) IN RELAPSED/REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA INCLUDING RICHTER TRANSFORMATION: RESULTS FROM THE PHASE 1 EUPLAGIA-1 STUDY (EBMT 2024) - "The median (range) number of prior treatment lines was 3 (2–10); 14/15 patients received prior BTKi and/or venetoclax. Data from 15 patients enrolled in Ph1 of Euplagia-1 show that PoC CAR-T manufacturing with a vein-to-vein time of only 7 days is feasible and effective. There were no unexpected safety signals, and no CRS Grade ≥3 or ICANS occurred. Efficacy data were encouraging, with a best ORR of 93% and CRR of 57%; all patients at RP2D responded (100% ORR)."

CAR T-Cell Therapy • IO biomarker • P1 data • Chronic Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Richter's Syndrome • Small Lymphocytic Lymphoma • IGH • TP53

EUPLAGIA-1: SEVEN-DAY VEIN-TO-VEIN POINT-OF-CARE MANUFACTURED GLPG5201 ANTI-CD19 CAR-T CELLS DISPLAY EARLY PHENOTYPES IN RELAPSED/REFRACTORY CLL INCLUDING RT (EBMT 2024) - "The Galapagos PoC manufacturing platform enables a 7-day vein-to-vein infusion. Early phenotype CAR-T cells were enriched in the final product compared to apheresis starting material. GLPG5201 demonstrated robust expansion and durable persistence in CLL and CLL+RT patients post-infusion"

CAR T-Cell Therapy • Chronic Lymphocytic Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Richter's Syndrome • Small Lymphocytic Lymphoma • CD4 • CD8

EUPLAGIA-1: SEVEN-DAY VEIN-TO-VEIN POINT-OF-CARE MANUFACTURED GLPG5201 ANTI-CD19 CAR-T CELLS DISPLAY EARLY PHENOTYPES IN RELAPSED/REFRACTORY CLL INCLUDING RT (EBMT 2024) - "The Galapagos PoC manufacturing platform enables a 7-day vein-to-vein infusion. Early phenotype CAR-T cells were enriched in the final product compared to apheresis starting material. GLPG5201 demonstrated robust expansion and durable persistence in CLL and CLL+RT patients post-infusion"

CAR T-Cell Therapy • Chronic Lymphocytic Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Richter's Syndrome • Small Lymphocytic Lymphoma • CD4 • CD8

Galapagos presents at EBMT-EHA annual meeting 2024 (GlobeNewswire) - P1/2 | N=15 | EUPLAGIA-1 (2021-003815-25) | "The preliminary translational data from its EUPLAGIA-1 Phase 1/2 study demonstrate that Galapagos’ differentiated point-of-care manufacturing platform offers the potential for a single infusion of fresh early-phenotype CD19 CAR-T cells with robust expansion and persistence in patients with relapsed/refractory chronic lymphocytic leukemia (rrCLL) and patients with Richter transformation (RT)....Patient recruitment of the Phase 1 dose-finding part of EUPLAGIA-1 has been completed and 15 patients were enrolled (6 at dose level 1 (DL1); and 9 at dose level 2 (DL2)), all of whom were diagnosed with rrCLL and 9 with additional RT....GLPG5201 final product showed an increase in early phenotypes of CD4+ and CD8+ CAR-T cells (naïve, stem cell memory (TN/SCM) and central memory) compared to apheresis starting material....GLPG5201 expansion and exposure were similar in patients with rrCLL and in patients with RT."

P1/2 data • Chronic Lymphocytic Leukemia

Point-of-care–manufactured CD19 CAR T-cell Therapy in Relapsed/Refractory CLL: Euplagia-1 (EBMT-EHA 2024) - " Euplagia-1 (CTIS:2022-501686-47-00) is an ongoing Phase (Ph)1/2 study of PoC-manufactured anti-CD19/4-1BB CAR-T therapy (GLPG5201) administered as a fresh product in patients with relapsed/refractory CLL, including Richter’s transformation (RT)... Data from 15 patients enrolled in Ph1 of Euplagia-1 show that PoC manufacturing with a median vein-to-vein time of only 7 days was feasible. No ICANS or CRS Grade ≥3 occurred. Efficacy data were encouraging, with best ORR of 93% and CRR of 57%; all RT patients at RP2D responded (ORR 100%)."

CAR T-Cell Therapy • Chronic Lymphocytic Leukemia • Hematological Disorders • Inflammation • Neutropenia • Richter's Syndrome

Early-Phenotype GLPG5201 Anti-CD19 CAR-T Cells in CLL Including RT (EBMT-EHA 2024) - "The PoC manufacturing platform enables a 7-day vein-to-vein infusion of early-phenotype GLPG5201 CAR-T cells with robust expansion and persistence in patients."

CAR T-Cell Therapy • Chronic Lymphocytic Leukemia • CD4 • CD8

Seven-Day Vein-to-Vein Point-of-Care Manufactured CD19 CAR T Cells (GLPG5201) in Relapsed/Refractory CLL/SLL Including Richter's Transformation: Results from the Phase 1 Euplagia-1 Trial (ASH 2023) - "GLPG5201, an anti-CD19/41BB CAR-T therapy, is administered as a fresh product following fludarabine/cyclophosphamide lymphodepleting chemotherapy. Upon screening, pts receive daily ibrutinib until leukapheresis...Median prior lines of therapy were 4 (range 2–10); 10/12 pts received a BTK inhibitor, 9/12 pts venetoclax, and 1 pt an allogeneic stem-cell transplant. Five of 7 pts with RT relapsed after, or were refractory to, R-CHOP...GLPG5201 demonstrates rapid in vivo expansion and durable persistence post-infusion. Euplagia-1 is ongoing, and updated data will be presented."

CAR T-Cell Therapy • IO biomarker • P1 data • Bone Marrow Transplantation • Chronic Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Richter's Syndrome • Small Lymphocytic Lymphoma • Transplantation • CD4 • CD8 • IGH • TP53

Galapagos presents new encouraging data at ASH 2023 from ongoing CD19 CAR-T studies with GLPG5201 and GLPG5101 (GlobeNewswire) - P1/2 | N=30 | EUPLAGIA-1 (2021-003815-25) | Sponsor: CellPoint B.V. | "Patient recruitment of the Phase 1 dose-finding part of EUPLAGIA-1 has been completed and as of 6 September 2023 (cut-off date), 15 patients (6 at dose level 1 (DL1); and 9 at dose level 2 (DL2)) were enrolled, all of whom were diagnosed with rrCLL, with 9 of 15 with RT....Overall, 13 of 14 efficacy evaluable patients responded to treatment (Objective Response Rate (ORR) of 93%) and 8 of 14 patients achieved a Complete Response Rate (CRR of 57%). 8 of 9 patients with RT responded to treatment (ORR of 89%) and 6 of 9 RT patients achieved a Complete Response (CRR of 67 %)."

P1/2 data • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

Galapagos reports third quarter 2023 results and releases new encouraging data from CAR-T studies for presentation at ASH 2023 (GlobeNewswire) - P1/2 | N=45 | EUPLAGIA-1 (EudraCT: 2021-003815-25) | "New preliminary data (data cut-off: 26 April 2023), for 12 patients enrolled in EUPLAGIA-1, will be presented at ASH....11 of 12 patients responded to treatment (Objective Response Rate, ORR of 92%). 9 of 12 patients achieved a Complete Response (CRR of 75%). 5 of 7 patients with RT achieved a CRR (71%). On the higher dose level, 6 of 6 patients responded to treatment (ORR of 100%) and 5 of 6 patients achieved a CRR (83%). Strong and consistent in vivo CAR-T expansion levels and a product consisting of early phenotype T cells were observed in all doses tested."

P1 data • Chronic Lymphocytic Leukemia • Small Lymphocytic Lymphoma

INITIAL CLINICAL RESULTS OF EUPLAGIA-1, A PHASE 1/2 TRIAL OF POINT-OF-CARE MANUFACTURED GLPG5201 IN R/R CLL/SLL WITH OR WITHOUT RICHTER'S TRANSFORMATION (EHA 2023) - P1/2 | "Following screening and enrollment, pts will receive daily ibrutinib continuously until mononuclear cell leukapheresis. During GLPG5201 manufacturing, pts receive cyclophosphamide (300 mg/m 2 /day)/fludarabine (30 mg/m 2 /day) for 3 days...GLPG5201 is a new CAR-T therapeutic option for pts with R/R CLL with or without RT, showing limited toxicity and promising efficacy based on current results (n=7). For all 7 pts, GLPG5201 was successfully manufactured at the PoC and administered as a fresh product, with a median vein-to-vein time of 7 days. Rapid complete responses have been observed with a 100% ORR in a heavily pre-treated pt population."

Clinical • P1/2 data • Chronic Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Richter's Syndrome • Small Lymphocytic Lymphoma

Galapagos to showcase CAR-T point-of-care manufacturing and initial Phase 1/2 CLL data with CD19 CAR-T candidate, GLPG5201, at the EHA 2023 congress (GlobeNewswire) - P1/2 | N=45 | EUPLAGIA-1 (2021-003815-25) | Sponsor: CellPoint B.V. | "Galapagos NV...announced that it will feature the CAR-T point-of-care manufacturing platform and will present previously disclosed initial Phase 1/2 data with CD19 CAR-T candidate, GLPG5201, at the European Hematology Association (EHA) 2023 congress, taking place from 8 June to 11 June 2023 in Frankfurt, Germany....All 7 out of 7 eligible patients with relapsed/refractory chronic lymphocytic leukemia (rrCLL), with or without Richter’s Transformation (RT), responded to treatment (Objective Response Rate of 100%). GLPG5201 showed no cytokine release syndrome (CRS) higher than grade 2, or immune effector cell-associated neurotoxicity syndrome (ICANS)."

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

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

Galapagos presented encouraging initial safety and efficacy data at 2023 EBMT-EHA for point-of-care manufactured CAR-T candidate, GLPG5201, in rrCLL (GlobeNewswire) - "Galapagos NV...presented encouraging data at the European Society for Blood and Marrow Transplantation (EBMT)-European Hematology Association (EHA) 5th European CAR T-cell Meeting in Rotterdam....EUPLAGIA-1 is an ongoing Phase 1/2 study in heavily pre-treated patients with rrCLL and rrSLL, with or without Richter’s transformation (RT), to evaluate the safety, efficacy, and feasibility of GLPG5201....As of 9 January 2023, 7 patients diagnosed with rrCLL (4 patients with RT) were enrolled in the study....The initial efficacy results are encouraging with an objective response rate (ORR) of 100% observed. 6 out of 7 patients (86%) reached a complete response (CR) and all Richter’s patients achieved a CR. A duration of response of up to 7.9 months has been reported and follow-up is ongoing. Only 1 patient (DL1) progressed (progressive disease, PD, after partial response, PR) and had a CD19-negative relapse with confirmed Richter’s transformation."

P1/2 data • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

+ND Capital's European Investment Strategy Delivers Again as Sale of CellPoint to Galapagos Paves the Way for Disruptive Point-of-Care Cell Therapy Model for Cancer Patients (PRNewswire) - "The Lausanne-based team of US investment firm, +ND Capital, today marked its second successful exit in the European biotechnology market as Belgian biotech company, Galapagos NV...announced that it will acquire Dutch cell therapy company CellPoint. +ND Capital was the sole venture investor in CellPoint, a company dedicated to developing CAR-T therapies at the point-of-care....Two Phase 1/2a studies in rrNHL and rrCLL with a CD-19 CAR-T candidate product have been initiated. Topline results, which are expected in the first half of 2023..."

M&A • P1/2 data • Trial status • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology