Artiva Biotherapeutics has halted development of an autoimmune disease cell therapy and laid off 94% of its staff after two patients died and durability data fell short of expectations.
San Diego-based Artiva was developing AlloNK, its nongenetically modified allogeneic natural killer cell therapy, in rheumatoid arthritis (RA) and other B-cell-driven autoimmune diseases. The biotech planned to start a pivotal phase 3 trial in RA this year. However, a review of the overall risk-benefit profile has persuaded Artiva to scrap its plans.
Safety and efficacy data have deteriorated since Artiva committed to entering phase 3. Longer-term follow-up found AlloNK failed to provide the durable clinical responses that Artiva believes are needed to support further development.
At the same time, the deaths of two patients have raised safety concerns. One patient in the biotech’s phase 2a basket trial suffered a fatal neurological event. The investigator and an independent safety review ruled that the death was likely related to fludarabine, a chemotherapy drug used in Artiva’s lymphodepletion regimen. The FDA asked Artiva to pause enrollment and dosing in the phase 2a study.
Another participant died suddenly about two months after initiating treatment. The investigator ruled the death unrelated to AlloNK or any other component of the study treatment regimen. The cause of death is unknown.
The biotech has other assets, but, having pinned its hopes on AlloNK, it has made dramatic changes in response to the setback to its lead program. Artiva has laid off most of its workforce—the company had 115 full-time employees as of June 30—and started evaluating strategic alternatives. The biotech’s board is assessing internal options alongside alternatives, including a merger, asset sale and liquidation.
Artiva’s actions represent a U-turn. The biotech raised $300 million in May, and last month laid out plans to share updated data in multiple indications and enter phase 3 in RA this year. Artiva’s cash pile, which totaled $319.1 million at the end of September, and Nasdaq listing are now two of the resources that could interest a potential buyer.
The setback to AlloNK comes two months after Bristol Myers Squibb and Novartis independently paused development of CAR-T cell therapies in autoimmune diseases. Novartis pumped the brakes on its CD19 program in response to three deaths linked to serious immune effector cell-associated hemophagocytic syndrome.
Artiva, BMS and Novartis are part of a pack of companies that increased investment in autoimmune cell therapies after seeing evidence that using the modality to deplete B cells drives durable responses.