Galapagos Streamlines CD19 CAR-T Portfolio, Deprioritizes GLPG5201

Belgian biotech company Galapagos has announced a strategic shift in its CD19 CAR-T therapy portfolio, opting to focus resources on its flagship program GLPG5101 while deprioritizing the development of GLPG5201. This decision, revealed in the company's fourth-quarter earnings release, aligns with Galapagos' ongoing efforts to streamline its business operations and concentrate on high-impact areas.

GLPG5101: Promising Results and Expanded Development

Galapagos CEO Paul Stoffels, M.D., highlighted "compelling" phase 1/2 data for GLPG5101 presented at the American Society of Hematology annual meeting in December. The study, which included patients with various types of lymphoma, showed an impressive objective response rate of 69% among 13 evaluable patients with diffuse large B-cell lymphoma.

Building on these encouraging results, Galapagos has secured FDA approval to expand the ongoing European trial of GLPG5101 to the United States. The company also plans to broaden the range of indications being assessed, including chronic lymphocytic leukemia (CLL) and Richter transformation (RT).

Deprioritization of GLPG5201

As part of its portfolio optimization, Galapagos has decided to deprioritize GLPG5201, its second CD19 CAR-T candidate. The company had previously planned to initiate a phase 1/2 study of GLPG5201 in relapsed/refractory CLL and RT patients in early 2025, with FDA permission anticipated. Additionally, the European Medicines Agency had already approved a phase 2 dose expansion study for the same patient population, with enrollment expected this year.

Stoffels explained the rationale behind this decision, stating, "In line with our goal of becoming a more focused and streamlined organization, we are optimizing our CD19 CAR-T portfolio by prioritizing resources where they can have the greatest impact."

Galapagos' Corporate Restructuring

The portfolio streamlining comes in the context of Galapagos' recently announced plans to split into two separate entities. This corporate restructuring, which remains on track according to the latest release, will result in:

1. A company retaining the Galapagos name, focused on the cell therapy portfolio.
2. An unnamed entity dedicated to "building a pipeline of innovative medicines through transformational transactions."

This strategic move underscores Galapagos' commitment to optimizing its operations and concentrating on areas with the highest potential for success in the competitive pharmaceutical landscape.