Galapagos is dropping its junior CD19 CAR-T as part of the Belgian biotech’s seemingly never-ending mission to recalibrate the business.
The company had been planned to secure permission from the FDA in “early 2025” to launch a phase 1/2 study of the therapy, dubbed GLPG5201, in relapsed/refractory chronic lymphocytic (CLL) leukemia and Richter transformation (RT). Galapagos had already obtained the nod from the European Medicines Agency for a phase 2 dose expansion study of GLPG5201 in the same patient population, with enrollment penciled in for this year.
But the biotech is now deprioritizing the therapy, Galapagos revealed in its fourth-quarter earnings release.
The decision was made with the goal of “streamlining” the business, said Galapagos, which wants to focus its resources on its “flagship” CD19 CAR-T program, GLPG5101.
In the release, Galapagos CEO Paul Stoffels, M.D., pointed to “compelling” phase 1/2 data from GLPG5101 in three types of lymphoma that had been presented at the American Society of Hematology annual meeting in December. The findings included an objective response rate of 69% among 13 evaluable patients with diffuse large B-cell lymphoma.
That study is ongoing in Europe, and Galapagos has recently secured FDA permission to expand the trial to the U.S. The range of indications being assessed will also stretch to include CLL and RT.
“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,” Stoffels said in the Feb. 13 postmarket release.
“We are expanding the development of GLPG5101, our most advanced asset by extending its reach into additional aggressive B-cell malignancies, including Richter transformation of CLL, and are taking action to expand into double-refractory CLL,” the CEO added. “We are deprioritizing activities related to GLPG5201, our second CD19 CAR-T candidate, pending the advancement of GLPG5101 in those additional indications.”
The planned split-up of Galapagos, which the company announced last month, remains on track, according to yesterday’s release. The move will leave one company with the Galapagos name and its portfolio of cell therapies, while the other, as yet unnamed, entity will “focus on building a pipeline of innovative medicines through transformational transactions,” the biotech explained at the time.