Galapagos announces FDA clearance of ATALANTA-1 IND application

Galapagos announced that the FDA has cleared Galapagos’ investigational new drug, or IND, application for ATALANTA-1, a Phase 1/2 multicenter study evaluating the feasibility, safety, and efficacy of GLPG5101 in patients with relapsed/refractory non-Hodgkin lymphoma, or R/R NHL. GLPG5101 is an autologous CD19 CAR-T cell therapy product candidate produced using Galapagos’ innovative decentralized cell therapy manufacturing platform with the potential for the administration of fresh, fit cells within a median vein-to-vein time of seven days. The primary objective of the Phase 1 part of ATALANTA-1 is to evaluate the safety and preliminary efficacy of GLPG5101 to determine the recommended dose for Phase 2. Secondary objectives include assessment of efficacy and feasibility of decentralized manufacturing of GLPG5101. The primary objective of the Phase 2 study is to evaluate the objective response rate. The secondary objectives include complete response rate, duration of response, progression free survival, overall survival, safety, pharmacokinetic profile, and the feasibility of decentralized manufacturing. Each enrolled patient will be followed for 24 months. The Phase 1/2 ATALANTA-1 study is currently ongoing in Europe, and early data have shown results in patients with R/R NHL.