The Belgian biotech firm Galapagos has decided to realign its strategic focus by deprioritizing its junior CD19 CAR-T therapy, GLPG5201. Initially, the company had planned to seek FDA approval in early 2025 for a phase 1/2 study of this treatment targeting relapsed/refractory chronic lymphocytic leukemia (CLL) and Richter transformation (RT). However, the company recently announced that it will streamline its operations by concentrating resources on its flagship CD19 CAR-T program, GLPG5101. This decision comes as part of a broader effort to optimize the company's portfolio and enhance efficiency.

In an effort to streamline its business, Galapagos has shifted its attention from GLPG5201 to its more advanced CD19 CAR-T candidate, GLPG5101. The decision was driven by compelling data presented at the American Society of Hematology annual meeting in December, which showcased promising results for GLPG5101 in treating various types of lymphoma. Specifically, the therapy demonstrated a 69% objective response rate among patients with diffuse large B-cell lymphoma. Following this success, Galapagos has secured FDA approval to expand its clinical trials into the U.S., further broadening the scope of indications to include CLL and RT.

This strategic pivot reflects Galapagos' commitment to maximizing the impact of its resources. By prioritizing GLPG5101, the company aims to advance its development in additional aggressive B-cell malignancies, including Richter transformation of CLL and double-refractory CLL. CEO Paul Stoffels emphasized the importance of this shift, stating that it aligns with the company's goal of becoming a more focused and efficient organization. The move also supports the planned split-up of Galapagos, which will result in one entity dedicated to cell therapies and another focusing on innovative medicines through transformative transactions.

Through this reorganization, Galapagos is positioning itself to capitalize on the potential of its lead CD19 CAR-T program while efficiently managing its resources. The company's decision to deprioritize GLPG5201 underscores its dedication to advancing treatments that can deliver the greatest benefit to patients with aggressive hematological malignancies. As Galapagos continues to evolve, it remains committed to delivering groundbreaking therapies that address unmet medical needs.