Galapagos Nv Released New Encouraging Data from Car-T Studies for Presentation At Ash 2023 . GLPG5201 (CD19 CAR-T) in relapsed/refractory chronic lymphocytic leukemia (CLL), with or without Richter?s transformation (RT) The Phase 1 dose-finding part of the EUPLAGIA-1-study has been completed and preparations to start the Phase 2 dose expansion are ongoing. New preliminary data (data cut-off: 26 April 2023), for 12 patients enrolled in EUPLAGIA-1, will be presented at ASH (see ASH abstract and poster presentation details below).

All 12 patients were diagnosed with rrCLL, 7 of 12 with RT. The results included in the abstract are summarized below: GLPG5201 showed an acceptable safety profile with most treatment emergent adverse events (TEAEs) of Grade 1 or 2. CRS Grade 1 or 2 was observed in 50% of the patients, and no CRS Grade = 3 or any ICANS were observed. No deaths were reported.

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. The data show that point-of-care platform has the potential to deliver fresh product in a median vein-to-vein time of 7 days.

GLPG5101 (CD19 CAR-T) in relapsed/refractory non-Hodgkin lymphoma (rrNHL) are in the final stages of the Phase 1 dose-finding part of the ongoing Phase 1/2 ATALANTA-1 study, which enrolled patients with diffuse large B cell lymphoma (DLBCL), mantle cell lymphoma and indolent lymphoma. The Phase 2 expansion cohorts for indolent lymphoma and mantle cell lymphoma are open and the first 10 patients have been dosed. Recruitment is ongoing.

New preliminary data (data cut-off: 2 May 2023) for 14 patients enrolled in ATALANTA-1 will be presented at ASH (see ASH abstract and poster presentation details below). 7 patients had diffuse large B-cell lymphoma, 3 had follicular lymphoma, 3 had mantle cell lymphoma and 1 had marginal zone lymphoma. The results included in the abstract are summarized below: GLPG5101 showed an acceptable safety profile with most TEAEs of Grade 1 or 2. No CRS Grade > 3 and no ICANS Grade = 2 were observed.

In two patients, Grade 3-4 infections were observed, and three patients experienced Grade 4 neutropenia. One Grade 5 intra-abdominal hemorrhage occurred 12 days post infusion caused by Grade 4 disseminated intravascular coagulation. This event occurred in an elderly patient with very rapidly progressive, primary refractory, double hit DLBCL, severe comorbidities, including a medical history of pulmonary embolism pre-CAR-T treatment, complicated by a Grade 3 CRS and respiratory insufficiency.

One patient developed Grade 5 sepsis at six months post infusion while the patient was in ongoing CR. 11 out of 13 evaluable patients responded to treatment (ORR of 85%) and 9 of 13 evaluable patients achieved a Complete Response (CRR of 69%). 5 of 6 patients treated with the higher dose achieved a CRR (83%).

7 of 13 patients reported an ongoing response at time of analysis, with a duration of up to 12 months (median follow-up of 4.5 months). Strong and consistent in vivo CAR-T expansion levels and a product consisting of early phenotype T cells were observed in all doses tested. data show that point-of-care platform has the potential to deliver fresh product in a median vein-to-vein time of 7 days.

Building a global CAR-T point-of-care network signed an agreement with Boston-based Landmark Bio and started the technology transfer for the decentralized production of CAR-T cell therapy candidates, a key milestone to expand CAR-T programs beyond Europe and start clinical development in the U.S.