GC Cell said on May 11 that Artiva Biotherapeutics will advance its NK cell therapy candidate AlloNK (AB-101) into Phase 3 clinical trials for rheumatoid arthritis following positive Phase 2 results.
Artiva Biotherapeutics reported meaningful data from an ongoing Phase 2a trial involving patients with refractory rheumatoid arthritis who did not respond to conventional biologic therapies and targeted synthetic disease-modifying antirheumatic drugs.
Among patients who completed at least six months of follow-up, 71% achieved ACR50, meaning a 50% improvement under the evaluation criteria of the American College of Rheumatology.
In addition, all 28 evaluable patients showed complete B-cell depletion.
On the safety side, more than 70 autoimmune disease patients have so far received outpatient treatment with the therapy. No severe adverse events, including cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS), were reported.
Artiva Biotherapeutics also said it reached an agreement with the U.S. Food and Drug Administration on the design of a single registrational Phase 3 trial.
The company plans to begin dosing the first patient in the second half of 2026, secure key data in the second half of 2028 and file for regulatory approval in 2029.
The company also reported early-stage data in Sjogren syndrome and Systemic sclerosis, and said it reached an agreement with the FDA to build an integrated safety database across multiple indications.
Sjogren syndrome is an autoimmune disorder that damages tear and salivary glands, causing dry eyes and mouth, while systemic sclerosis is a rare autoimmune disease characterized by fibrosis affecting the skin, blood vessels and internal organs.
Artiva Biotherapeutics also announced plans to raise about $300 million through the issuance of common stock and prepaid warrants. The proceeds will be used to support the Phase 3 rheumatoid arthritis trial and global clinical site operations.
Artiva Biotherapeutics was established based on GC Cell’s NK cell manufacturing technology.