Artiva, a U.S. affiliate of GC Cell, announced Tuesday that its NK cell therapy candidate "AlloNK (AB-101)" has entered Phase 3 clinical trials after confirming positive results in a Phase 2 study targeting refractory rheumatoid arthritis. The company also completed a fundraising round worth $300 million (approximately 400 billion won).
Artiva secured meaningful data in its ongoing Phase 2a trial involving patients with refractory rheumatoid arthritis who had not responded to existing treatments. Among patients followed for more than six months, 71% demonstrated therapeutic efficacy, with a 50% improvement in major symptoms such as joint pain and inflammation.
Artiva has reached an agreement with the U.S. Food and Drug Administration (FDA) on the design of a single registrational Phase 3 trial. The company aims to begin patient dosing in the second half of this year, generate key data in the second half of 2028, and file for marketing approval in 2029.
The company also confirmed positive early data in Sjögren's syndrome and systemic sclerosis, and agreed with the FDA to build an integrated safety database combining data from other indications. Both Sjögren's syndrome and systemic sclerosis are autoimmune diseases, with the former causing dry mouth and dry eyes, and the latter leading to fibrosis of the skin and organs.
Artiva successfully raised $300 million (approximately 400 billion won) through the issuance of common stock and pre-funded warrants. Healthcare-focused investment firms, along with source technology partners GC Cell and GC Holdings, participated in the funding round.
The company plans to use the proceeds to operate the Phase 3 trial of AlloNK and expand its clinical sites. The funds will serve as operating capital through the marketing approval application in 2029.
"The massive participation of major investment firms following the clinical data release reflects market expectations that Artiva's NK cell technology will be a 'best in class' in the autoimmune disease field," a GC Cell official said. "This signals that global commercialization is imminent."
