Artiva ends AlloNK development after two trial deaths

Artiva Biotherapeutics is halting development of AlloNK, its experimental cell therapy for autoimmune conditions, after two patients died in a clinical trial. The company said investigators did not link either death to AlloNK. In one case, an investigator and independent safety review said a fatal neurological event was likely linked to fludarabine, a chemotherapy used to prepare patients for treatment. The cause of the second patient’s death remains undetermined, and the investigator did not link it to the study drug or treatment regimen.

Artiva said longer-term follow-up showed the therapy’s clinical response was not durable enough to support further development. The company will lay off 94% of its staff and seek strategic alternatives. The first death was reported to the FDA, which asked Artiva to pause its Phase 2a trial. Artiva also stopped planned enrollment and dosing in a Phase 3 trial, which will not go ahead. The company plans to share details of the fludarabine-associated death in a scientific publication.