Galapagos Advances Cell Therapy Pipeline with FDA Clearance for GLPG5101 in NHL
核心洞察
Galapagos' GLPG5101, a CD19 (搜索) CAR-T therapy, received FDA IND clearance for a Phase 1/2 study (ATALANTA-1) in relapsed/refractory non-Hodgkin lymphoma (搜索), marking a key milestone.
Recruitment resumed for the Phase 1/2 PAPILIO-1 study of GLPG5301, a BCMA (搜索) CAR-T candidate, in relapsed/refractory multiple myeloma (搜索), expanding Galapagos' cell therapy efforts.
Galapagos is progressing its early-stage pipeline, including a next-generation armed, bispecific CAR-T candidate and a small molecule candidate in immunology, targeting clinical development in 2025-2026.
Galapagos NV has announced significant progress in its cell therapy pipeline, highlighted by the FDA's clearance of the Investigational New Drug (IND) application for GLPG5101, a CD19 (搜索) CAR-T candidate, in relapsed/refractory non-Hodgkin lymphoma (搜索) (R/R NHL). This clearance allows the initiation of the Phase 1/2 ATALANTA-1 study in the U.S., representing a crucial step forward in Galapagos' cell therapy strategy. The company aims to activate clinical study sites and begin enrolling patients before the end of 2024.
Advancing CAR-T Therapies
In addition to GLPG5101, Galapagos has resumed recruitment for the Phase 1/2 PAPILIO-1 study, evaluating GLPG5301, a BCMA (搜索) CAR-T candidate, in patients with relapsed/refractory multiple myeloma (搜索) (R/R MM). These developments underscore Galapagos' commitment to addressing unmet needs in oncology through innovative cell therapies.
Paul Stoffels, MD, Galapagos’ CEO and Chair of the Board of Directors, emphasized the significance of the FDA clearance, noting it as a pivotal step towards transforming patient outcomes through life-changing science and innovation. He highlighted that this marks the first-ever FDA clearance for a clinical study in the U.S. with a fresh CAR-T product candidate delivered in a median vein-to-vein time of seven days.
Decentralized Manufacturing and Collaboration
Galapagos is expanding its decentralized manufacturing unit (DMU) network to support clinical development and future commercial readiness. As part of its collaboration with Blood Centers of America (BCA), Excellos in San Diego has been selected as the first DMU within BCA’s network to manufacture GLPG5101 for the ATALANTA-1 study sites in the region.
Expanding the Pipeline
Galapagos is also advancing its early-stage proprietary pipeline, with a next-generation armed, bispecific CAR-T candidate in hemato-oncology and a potential best-in-class small molecule candidate in immunology progressing into IND-enabling studies. Clinical development for these candidates is targeted for 2025-2026.
The company anticipates submitting an IND in early 2025 for the Phase 1/2 EUPLAGIA-1 study of GLPG5201 in relapsed/refractory chronic lymphocytic leukemia (搜索) (R/R CLL) and Richter transformation (RT). Following the submission of a Clinical Trial Application (CTA) to the European Medicines Agency (EMA) for the Phase 2 dose expansion study of GLPG5201 in R/R CLL and RT, Galapagos aims to start enrolling patients in 2025.
Financial Position
As of September 30, 2024, Galapagos holds €3.3 billion in cash and financial investments. The company has reaffirmed its full-year 2024 cash burn guidance of €370 million to €410 million, which will support the advancement of its extensive pipeline.
Thad Huston, Galapagos’ CFO and COO, stated that the company is accelerating its internal pipeline with more than 20 active cell therapy and small molecule programs in oncology and immunology, while also assessing business development opportunities.
Upcoming Presentations
Galapagos plans to present new data from the ATALANTA-1 and EUPLAGIA-1 studies, along with preclinical data for uza-cel, its TCR-T cell therapy candidate developed in collaboration with Adaptimmune, at the American Society of Hematology (ASH) Annual Meeting in December.