GLPG - Galapagos presents at EBMT-EHA annual meeting 2024 | Benzinga

Showcases meaningful advances in decentralized CAR T-cell manufacturing and presents translational and clinical data from ongoing Phase 1/2 CD19 CAR-T studies

Mechelen, Belgium; 15 February 2024, 22:01 CET; Galapagos NV ((Euronext &amp, NASDAQ:GLPG) to present new preliminary translational data and previously disclosed data at the European Society for Blood and Marrow Transplantation (EBMT)-European Hematology Association (EHA) 6^th European CAR T-cell meeting taking place from 15–17 February 2024 in Valencia, Spain.

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). Further, previously disclosed safety, efficacy and feasibility data from EUPLAGIA-1 and ATALANTA-1 support the potential of Galapagos' innovative approach to CAR-T manufacturing and of the transformational impact on patients with severe hematologic cancers.

"At Galapagos, we are committed to accelerating transformative innovation to address the unmet needs of patients with advanced cancers, and the data we are presenting today demonstrates our positive momentum toward this goal," said Dr Jeevan Shetty, M.D., Head of Clinical Development Oncology at Galapagos. "We are pleased for the opportunity to present encouraging data that supports the potential of our innovative, decentralized approach to CAR-T manufacturing and the transformational impact CAR-T treatment could have on patients with serious hematologic cancers."

Summary of preliminary translational data from EUPLAGIA-1 with GLPG5201 (cut-off date: 6 September 2023):
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. All 15 Phase 1 batches were manufactured at the point-of-care and infused as a single fresh, fit product within a median vein-to-vein time of seven days, with 80% of patients receiving the product in seven days.

GLPG5201 final product showed an increase in early phenotypes of CD4+ and CD8+ CAR-T cells (naïve, stem cell memory (T_N/SCM) and central memory) compared to apheresis starting material. A robust in vivo expansion of GLPG5201 occurred with a median time-to-peak expansion of 14 days, regardless of dose level, and a higher exposure for patients infused with DL2 compared to DL1. GLPG5201 expansion and exposure were similar in patients with rrCLL and in patients with RT. Persisting CAR-T cells were detected up to 15 months post-infusion. Moreover, the abundance of both CD4+ and CD8+ T_N/SCM CAR-T cells in the final product correlated with CAR-T-cell exposure in patients.

Key data highlights accepted by EBMT-EHA:

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