Artiva halts its autoimmune cell therapy after two trial deaths and cuts 94% of staff

The company disclosed two deaths in its Phase 2a trial. One patient died of leukoencephalopathy, a brain disorder that the investigator and an independent safety review assessed as likely caused by fludarabine, a chemotherapy drug used to prepare patients for treatment; the FDA then asked Artiva to pause enrollment and dosing. A second patient died suddenly about two months after starting treatment, an event the investigator assessed as unrelated to the study regimen, with the cause not determined.

Artiva also said longer-term data showed clinical responses did not last as long as it needed to keep going. It is cutting about 94% of its workforce and reviewing strategic options, including a merger, asset sale or liquidation, with about $319.1M in cash and investments as of September 30.

Why it matters: BioPharma Dive reported that Artiva is the third company to recently disclose deaths in an autoimmune cell therapy trial, after Novartis and Bristol Myers Squibb, and Artiva said it plans to publish details of the fludarabine case because the drug is widely used in cell therapy.