Galapagos NV and CellPoint presented encouraging initial data from the ongoing ATALANTA-1 Phase 1/2 study with GLPG5101 at the64thAnnual 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.

CellPoint has developed, in a strategic collaboration with Lonza, a novel point-of-care supply model, which is designed to enable clinicians to administer fresh CAR T cells within 7 days of leukapheresis, without complex logistics or cryopreservation, thereby aiming to address important limitations of current CAR-T treatments. The proprietary platform consists of CellPoint's end-to-end xCellit workflow management and monitoring software and Lonza's Cocoon® Platform, a functionally closed, automated manufacturing platform for cell therapies. ATALANTA-1 is an ongoing Phase 1/2, open-label, multicenter study to evaluate the feasibility, safety, and efficacy of point-of-care manufactured GLPG5101, a CD19 CAR-T product candidate, in patients with relapsed/refractory Non-Hodgkin Lymphoma (rrNHL).

GLPG5101 is a second generation anti-CD19/4-1BB CAR-T product candidate, administered as an intravenous infusion of a fresh product candidate in a single fixed dose. Each enrolled patient will be followed for 24 months. The primary objective of the Phase 1 part of the study is to evaluate safety and to determine the recommended dose for the Phase 2 part of the study.

Secondary objectives include assessment of efficacy and feasibility of point-of-care manufacturing of GLPG5101. The planned dose levels that are evaluated in the Phase 1 are 50x106, 110x106 and 250x106 CAR T cells. The primary objective of the Phase 2 part of the study is to evaluate the objective response rate (ORR) while the secondary objectives include complete response rate (CRR), duration of response, progression free survival, overall survival, safety, pharmacokinetic profile, and feasibility of point-of-care manufacturing.

The study is currently enrolling rrNHL patients in Europe and the first expansion cohort for Mantle Cell Lymphoma, a form of NHL, is currently open for recruitment. The company aims to broaden the study to include US patients in 2023 and to provide topline results in the first half of 2023.