Artiva ends AlloNK program and cuts 94% of staff

Artiva Biotherapeutics said it will discontinue development of AlloNK (AB-101), its experimental allogeneic natural-killer-cell therapy for autoimmune diseases, and will not proceed with a planned Phase 3 trial.

The decision followed two deaths among participants in a Phase 2a study. One fatal neurological event was assessed by an investigator and an independent safety review as likely related to fludarabine-associated neurotoxicity from the chemotherapy conditioning regimen. A second participant died suddenly about two months after treatment began; investigators assessed that death as unrelated to AlloNK or other study-treatment components, and its cause was undetermined.

The company also cited longer-term follow-up showing that clinical responses were not durable enough to justify continued development, despite earlier evidence of B-cell depletion and clinical activity.

Artiva plans to cut approximately 94% of its workforce and is reviewing strategic options, including a merger or business combination, asset sale or licensing, or dissolution and liquidation. It engaged Leerink Partners as a financial adviser.

The FDA asked the company to pause enrollment and dosing in the Phase 2a study after being notified of the first death. The company said no more patients would be dosed in its AlloNK studies.