GC Cell’s U.S. affiliate Artiva Biotherapeutics will advance its lead cell therapy candidate AlloNK into a phase 3 trial for refractory rheumatoid arthritis after reporting early clinical data and pricing a $300 million stock offering.
GC Cell’s U.S. affiliate Artiva Biotherapeutics will advance AlloNK into a phase 3 rheumatoid arthritis trial after reporting early autoimmune disease data and pricing a $300 million stock offering.
The San Diego-based biotech company said it reached alignment with the U.S. FDA on a single registrational phase 3 trial of AlloNK, also known as AB-101, in patients with refractory rheumatoid arthritis.
The planned study will evaluate AlloNK in combination with rituximab compared with rituximab alone in about 150 patients who have had an inadequate response to two or more biologic or targeted synthetic disease-modifying anti-rheumatic drugs (b/tsDMARDs) from different classes.
Artiva plans to begin patient dosing in the second half of 2026, report primary efficacy data in the second half of 2028, and potentially submit a biologics license application in 2029. The primary endpoint will be the ACR50 response rate at six months, which measures at least a 50 percent improvement in rheumatoid arthritis symptoms.
The phase 3 plan follows initial clinical data from Artiva’s ongoing phase 2a basket trial and an investigator-initiated basket trial in B-cell-driven autoimmune diseases. As of the April 3 data cutoff, the pooled dataset included 21 refractory rheumatoid arthritis patients with at least 12 weeks of follow-up, including 13 patients with six months of follow-up.
In the company-sponsored Phase 2a basket trial, 5 of 7 rheumatoid arthritis patients with at least 6 months of follow-up achieved an ACR50 response. In a separate investigator-initiated basket trial, 5 of 6 patients with 6 months of follow-up showed more than 50% improvement in at least 4 of 5 measured components, although Artiva said the ACR50 could not be fully assessed in that trial because some measures were not collected.
The patients included in the rheumatoid arthritis dataset had longstanding and highly active disease, with a mean disease duration of 14.8 years. Artiva said 81 percent of the patients had failed two or more prior b/tsDMARD classes. The company also reported clinically meaningful reductions in both CDAI and DAS28-ESR disease activity scores in 19 of 21 patients.
Artiva also reported pharmacodynamic data supporting AlloNK’s B-cell depletion mechanism. Complete B-cell depletion was observed in all 28 evaluable rheumatoid arthritis patients using a high-sensitivity assay, while consistent peripheral B-cell depletion was seen by Day 13 in all 51 patients treated with cyclophosphamide, fludarabine, AlloNK, and rituximab who had available samples.
AlloNK is an allogeneic, off-the-shelf, non-genetically modified, and cryopreserved NK cell therapy candidate designed to enhance antibody-dependent cellular cytotoxicity of monoclonal antibodies and drive B-cell depletion. In autoimmune diseases, the candidate is being studied in combination with anti-CD20 monoclonal antibodies after conditioning with low-dose cyclophosphamide and fludarabine.
Artiva said the safety profile so far supports outpatient administration. More than 70 patients with autoimmune diseases have initiated treatment with AlloNK across ongoing trials at more than 40 active clinical sites, with all patients treated in the outpatient setting and most in community rheumatology clinics.
No cytokine release syndrome, no immune effector cell-associated neurotoxicity syndrome, and no treatment discontinuations due to adverse events were reported.
The company also presented early data on other autoimmune diseases. The broader dataset included 11 patients with Sjögren disease and five patients with systemic sclerosis.
The responses in those groups were consistent with the rheumatoid arthritis data, and AlloNK is being evaluated across multiple B-cell-driven autoimmune diseases, including refractory rheumatoid arthritis, Sjögren disease, systemic sclerosis, and idiopathic inflammatory myopathies.
Alongside the clinical update, Artiva announced the pricing of an underwritten offering expected to raise about $300 million in gross proceeds before underwriting discounts, commissions, and other expenses.
The offering consists of 23,871,526 shares of common stock priced at $11.52 per share and pre-funded warrants to purchase 2,170,138 shares of common stock at $11.5199 per share.
The offering included participation from global healthcare and investment funds, including Blackstone Multi-Asset Investing, Viking Global Investors, RA Capital Management, Venrock Healthcare Capital Partners, EcoR1 Capital, and Samsara BioCapital. GC Corporation and GC Cell also participated in the offering.
The offering is expected to close on or about May 11, subject to customary closing conditions. Jefferies, TD Cowen, and Cantor are acting as joint book-running managers, while Wedbush PacGrow and Needham & Company are acting as co-lead managers.
Lee Han-soo
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