Galapagos Updates Phase 2 Data for GLPG5101

Galapagos announced new and updated Phase 2 data from the ongoing ATALANTA-1 study with its CD19 CAR T-cell therapy candidate, GLPG5101, during an oral presentation at the American Society of Hematology annual meeting. As of September 2, 26 heavily pretreated MCL patients had undergone leukapheresis and 25 had received an infusion of GLPG5101. Of these, 24 patients received a fresh product, with 23 infused within seven days after apheresis. Among infused patients, the objective response rate was 100%, with a complete response rate of 96%. Duration of response and progression-free survival rates were both 83% at a median follow-up of nine months. Overall, 9 of 10 of minimal residual disease-evaluable patients were MRD-negative at CR and 7 of 9 MRD-negative patients remained in CR at the time of the data cut-off. GLPG5101 showed an encouraging safety profile. The most common grade greater than or equal to 3 treatment-emergent adverse events were hematologic. No grade greater than or equal to 3 CRS was observed, and only one case of Grade greater than or equal to 3 ICANS occurred. GLPG5101 demonstrated in vivo CAR T-cell expansion and long-term persistence with an enrichment of early memory phenotypes. As announced on October 21, and following an evaluation and sales process, Galapagos remains focused on the intention to wind down the cell therapy activities. This intention is subject to the conclusion of consultations with works councils in Belgium and the Netherlands, during which Galapagos will continue to operate the business and conduct ongoing clinical studies. Galapagos would still consider any viable proposal to acquire all, or part of the cell therapy business, should such a proposal emerge during the wind down process.