Galapagos and CellPoint presented encouraging initial data at ASH 2022 for GLPG5101, a CD19 CAR-T candidate manufactured at point-of-care

Galapagos NV (Euronext & NASDAQ: GLPG) and CellPoint (a Galapagos company) today presented encouraging initial data from the ongoing ATALANTA-1 Phase 1/2 study with GLPG5101 at the 64^th Annual American Society of Hematology (ASH) Congress taking place in New Orleans, Louisiana, from 10-13 December.

ATALANTA-1 is a Phase 1/2 study in heavily pre-treated rrNHL patients to evaluate the safety, efficacy, and feasibility of GLPG5101, a fresh CD19 CAR-T product candidate manufactured at point-of-care. The dose levels that are evaluated in the Phase 1 part of the study are 50x10⁶ (DL1), 110x10⁶ (DL2) and 250x10⁶ (DL3). As of 8 November 2022, 9 patients were enrolled; baseline and safety data for 8 patients were available (n=4 at DL1; n=4 at DL2). 7 patients reached the follow-up period of 28-days and were eligible for efficacy evaluation.

The initial results from 7 patients that were eligible for efficacy evaluation (cut-off date: 8 November 2022) indicated that a 7-day vein-to-vein time is feasible and demonstrated strong and consistent in vivo CAR-T expansion levels. Moreover, the initial efficacy results are encouraging with an objective response rate (ORR) of 86% observed and all responding patients achieving a complete response (CR). A duration of response of up to 7 months has been reported and follow-up is ongoing. Two patients who received DL1 that progressed after initial stable disease or CR respectively, had a CD19-negative escape. No CD19-positive relapses have been observed.

In the safety analysis of these 7 patients, adverse events were consistent with the known toxicities of CD19 CAR-T treatment. No grade 3 or higher cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) was observed in any of the patients. At DL2, CRS grade 1 or 2 was reported in 4 patients and ICANS grade 1 was reported in 3 patients. Patients at DL1 did not experience any grade of CRS or ICANS. Dose-limiting toxicity (neutropenia grade 4 for >21 days) was observed in 1 patient (DL2) and the majority of grade ≥3 adverse events were hematological toxicities.

“We are committed to accelerating transformational innovation to address unmet needs of patients with advanced cancers,” said Dr. Paul Stoffels¹, CEO and Chairman of the Board of Directors of Galapagos. “Despite significant medical advancements in recent years, many cancer patients relapse, become resistant to treatment or are diagnosed too late. We believe that differentiation and broader access to therapy can come from a disruptive CAR-T manufacturing model at the point-of-care, closer to patients. We are excited to present initial encouraging safety, efficacy and feasibility data from the ATALANTA-1 study with GLPG5101 manufactured at point-of-care, which support that potential. We are on track to report topline data from the completed study in the first half of 2023.”

The poster presentation was given by Marie José Kersten, MD, PhD, Professor of Hematology and Head of the Department of Hematology at the Academic Center in Amsterdam: