Artiva Biotherapeutics is discontinuing development of its AlloNK cell therapy and cutting its workforce by approximately 94% after longer-term clinical data and two recent patient deaths.
The company said longer-term follow-up of AlloNK did not show the level of durability of clinical response needed to support continued development, according to an Oct. 27 news release. No additional patients will be dosed in ongoing AlloNK studies, and a planned phase 3 pivotal trial will not begin.
One participant in a phase 2a trial experienced a fatal neurological event, leukoencephalopathy, that an investigator and independent safety review assessed as likely related to fludarabine-associated neurotoxicity. The FDA subsequently asked Artiva to pause enrollment and dosing in the study.
A second participant died suddenly approximately two months after starting study treatment. The investigator assessed the death as unrelated to AlloNK or any other component of the study treatment regimen, and the cause of death has not been determined.
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