Galapagos NV (GLPG), is slated to present new clinical data from its ongoing ATALANTA-1 Phase 1/2 study of GLPG5101 at the 30th European Hematology Association or EHA Congress.
The data demonstrate low rates of high-grade toxicities and support the feasibility of Galapagos' decentralized manufacturing platform, which enabled rapid delivery of fresh, early-memory-enriched CD19 CAR-T cells to relapsed/refractory non-Hodgkin's lymphoma or R/R NHL patients.
As of October 14, 2024, 64 patients had undergone leukapheresis in the study, with 61 or 95 percent receiving GLPG5101 treatment and 89 percent infused within 7 days, without the need for cryopreservation or cytotoxic bridging therapy.
The patient attrition rate was 5 percent, significantly lower than industry norms.
GLPG5101 showed a favorable safety profile, with most Grade =3 adverse events being hematologic in nature.
CRS and ICANS were mostly low-grade, with only one Grade 3 case of each. Durable CAR-T persistence was observed up to 21 months.
Omotayo Fasan, Clinical Development Program Head at Galapagos, said, "These promising results suggest that rapid delivery of fresh, stem-like early memory CAR-T cells may offer meaningful clinical benefit for patients with R/R NHL. Our decentralized approach may improve access to CAR-T therapy by reducing manufacturing times and patient attrition."
Pim Mutsaers added, "Decentralized cell therapy manufacturing is changing how we think about CAR-T eligibility. The use of fresh, early-memory cells in a rapid timeframe may open the door for patients who might otherwise be excluded."
Galapagos continues to advance GLPG5101 through clinical development while expanding its decentralized manufacturing capabilities across Europe and the U.S.
Currently, GLPG is trading at $28.66, down 0.73 percent on the Nasdaq.
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