GC Cell: U.S. ArtiViva Advances NK Cell Therapy to Phase 3 Clinical Trials

Major $300 Million Fundraising

ArtiViva, established based on GC Cell’s NK cell manufacturing technology, is set to begin Phase 3 clinical trials for its NK cell therapy ‘AlloNK’ (AB-101).

GC Cell announced on May 11 that its U.S. affiliate ArtiViva has advanced AB-101 into Phase 3 clinical trials and raised $300 million (approximately 400 billion won) in funding.

ArtiViva has reached an agreement with the U.S. Food and Drug Administration (FDA) on a single registration Phase 3 trial design. Unlike the conventional two Phase 3 trials, this pathway allows for a product approval application based on a single trial result. The company plans to start patient dosing in the second half of this year, generate key data in the second half of 2028, and aims to submit its approval application in 2029.

ArtiViva secured meaningful data in its ongoing Phase 2a trial targeting patients with refractory rheumatoid arthritis who do not respond to existing therapies (b/tsDMARDs). Among the patient group monitored for more than six months, 71% achieved ACR50 (50% improvement in symptoms), and the company reported that high-sensitivity analysis confirmed complete B-cell depletion in all 28 evaluable RA patients.

ArtiViva stated that, given the positive initial data in both Sjogren’s syndrome and systemic sclerosis, it has also agreed with the FDA to build a safety database for additional indications.

The company announced that it raised approximately $300 million through the issuance of common stock and prepaid warrants. The fundraising included participation from specialized healthcare investment institutions, as well as GC Cell and GC Holdings, who are partners in the underlying technology.

The secured funds will be used for the operation of the AlloNK rheumatoid arthritis Phase 3 trial, expansion to over 80 global clinical sites, and operational expenses through the planned approval application in 2029.

This content was produced with the assistance of AI translation services.