This novel point-of-care model is compliant with the EMA and FDA guidance for clinical trials. The proprietary platform consists of CellPoint’s end-to-end xCellit workflow management and monitoring software, and Lonza’s Cocoon® Platform, a functionally closed, automated manufacturing platform for cell therapies. About point-of-care manufacturing CellPoint (a Galapagos company) has developed, in a strategic collaboration with Lonza, a novel point-of-care supply model, which is designed to enable clinicians to administer fresh CAR-T cells within 7 days of leukapheresis, without complex logistics or cryopreservation, thereby aiming to address important limitations of current CAR-T treatments. Patient recruitment of the study is ongoing. Only one serious adverse event was reported at DL2 with a patient experiencing a CRS grade 2, but the event was resolved after 7 days. No dose limiting toxicities (DLTs) were reported and the majority of grade =3 adverse events were hematological. None of the patients experienced a CRS higher than grade 2 at both dose levels and no ICANS was reported. In the safety analysis of these 7 patients, adverse events were consistent with the known toxicities of CD19 CAR-T treatment. Only 1 patient (DL1) progressed (progressive disease, (PD) after partial response (PR)) and had a CD19-negative relapse with confirmed RT. A duration of response of up to 7.9 months has been reported and follow-up is ongoing. 6 out of 7 patients (86%) reached a complete response (CR) and all Richter’s patients achieved a CR. Moreover, the initial efficacy results are encouraging with an objective response rate (ORR) of 100% observed. The initial results from these 7 patients that were eligible for efficacy analysis (cut-off date: 9 January 2023) indicated that a 7-day vein-to-vein time is feasible and demonstrated strong and consistent in vivo CAR-T expansion levels. The dose levels that are evaluated in the Phase 1 part of the study are 35x106 (DL1), 100x106 (DL2) and 300x106 (dose level 3 (D元)) CAR+ viable T cells. All patients received GLPG5201 as a fresh infusion with a median vein-to-vein time of 7 days. “Our innovative approach in CAR-T cell therapy development and manufacturing underscores our commitment to accelerating transformational innovation to address the unmet needs of patients with advanced cancers, and we very much look forward to meeting and connecting with you at our booth.”Īt the safety and efficacy analysis cut-off date of 9 January 2023, 7 patients diagnosed with rrCLL (including 4 patients with RT) were enrolled in the EUPLAGIA-1 study (n=4 at dose level 1 (DL1) n=3 at dose level 2 (DL2)). The previously disclosed initial efficacy, safety and feasibility data from the ongoing EUPLAGIA-1 study with our CD19 CAR-T candidate, GLPG5201, manufactured at point-of-care, are encouraging, and we are on track to provide Phase 1 topline results around mid this year,” said Jeevan Shetty, Head of Clinical Development Oncology at Galapagos. “Patients who develop rrCLL and become resistant to new agents have a very poor prognosis and a significant high unmet medical need for novel therapeutic options such as CAR-T cell therapy. 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 01-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 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%)1 GLPG5201 showed no cytokine release syndrome (CRS) higher than grade 2, or immune effector cell-associated neurotoxicity syndrome (ICANS)2 A functionally closed, automated manufacturing platform for cell therapies at the point-of-care will be shown at the Galapagos booth A.103 at the EHA 2023 congress Mechelen, Belgium 5 June 2023, 22:01 CET Galapagos NV (Euronext & NASDAQ: GLPG) today 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.
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