Artiva Biotherapeutics Receives FDA Fast Track Designation For AlloNK; Continued Execution And Enrollment Progress With More Than 20 Patients Treated With AlloNK + Monoclonal Antibody Therapy Across Company-sponsored And Investigator-Initiated Trials In Autoimmune Diseases

Author: Benzinga Newsdesk | October 16, 2025 03:08pm

SAN DIEGO, Oct. 16, 2025 (GLOBE NEWSWIRE) -- Artiva Biotherapeutics, Inc. (NASDAQ:ARTV) (Artiva), a clinical-stage biotechnology company whose mission is to develop effective, safe, and accessible cell therapies for patients with devastating autoimmune diseases and cancers, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to AlloNK® (also known as AB-101) for the treatment of refractory rheumatoid arthritis (RA) in combination with rituximab and that the Company has prioritized refractory RA as the program's lead indication. AlloNK is believed to represent the first drug candidate in the deep B-cell depleting therapeutic category to receive this designation in refractory RA.

"We are prioritizing refractory RA as our lead autoimmune indication for AlloNK given the size of this underserved population. Despite the many approved therapies in RA, there are over 100,000 patients in the United States who remain treatment refractory and could potentially benefit from a deep B-cell depleting therapy," said Fred Aslan, M.D., Chief Executive Officer of Artiva. "We look forward to sharing the emerging translational and safety data in mid-November, supporting AlloNK's profile as an outpatient-ready therapy capable of achieving deep B-cell depletion, followed by clinical response data in the first half of 2026 from more than 15 refractory RA patients, several of whom will have six or more months of follow-up. In addition, we are planning FDA interactions in the first half of 2026 that could enable AlloNK to become the first deep B-cell depleting therapy to advance to a pivotal trial in patients with RA."

AlloNK's Clinical Opportunity in RA:

RA is a chronic autoimmune disease that affects over 1.5 million people in the United States and can cause painful joint inflammation, progressive joint damage, and disability, if not adequately treated. While existing treatments such as methotrexate, TNF inhibitors, and B-cell depleting antibodies have improved outcomes for many patients, a significant subset becomes refractory and no longer responds to or tolerates these options. These patients face ongoing disease activity, increased risk of disability and joint destruction, and reliance on steroids or immunosuppressants that have long-term toxicity. AlloNK is designed to enhance the activity of B-cell-targeting antibodies, such as rituximab, through antibody-dependent cellular cytotoxicity. This mechanism of action is intended to drive deeper and more durable B-cell depletion than antibodies alone, potentially enabling long-term durable responses.

"I am encouraged by our early data with AlloNK in refractory RA patients. Having contributed to the development of leading RA therapies including Humira® and Orencia®, I have witnessed the unmet need among patients with refractory RA who continue to suffer from inadequate disease control," said Subhashis Banerjee, M.D., Chief Medical Officer of Artiva. "Of note, most patients with RA are treated at community rheumatology clinics rather than at large academic medical centers. Emerging deep B-cell depleting therapies such as CAR-T and T-cell engagers can be limited by the need for hospitalization or specialized oncology oversight, making them challenging for widespread use. With its infusion-ready, off-the-shelf format, and ease of use similar to IV-administered RA drugs, AlloNK in combination with rituximab has the potential to address this unmet need in a scalable and broadly accessible way."

Key Highlights:

• Company is prioritizing refractory RA as its lead indication, reflecting the opportunity to address this unmet need with a potentially impactful therapy that can be administered and managed in the community setting
• Received FDA Fast Track Designation for AlloNK in refractory RA, representing the first known drug candidate in the deep B-cell depleting therapeutic category to receive this designation in RA
• More than 20 patients treated with AlloNK + mAb across refractory RA, Sjögren's disease, systemic lupus erythematosus, lupus nephritis, and systemic sclerosis in company-sponsored trials and an investigator-initiated basket trial, at 1 billion and 4 billion cells per AlloNK dose
• Emerging translational and safety data expected to support AlloNK's profile as an outpatient-ready therapy capable of achieving consistent and deep B-cell depletion
• Depending on our regulatory interactions with the FDA, AlloNK has the potential to become the first therapy within the emerging deep B-cell depletion category, which includes auto-CAR-T and T-cell engagers, to advance to a pivotal trial for patients with refractory RA
  
   

Upcoming Milestones:

• Company plans to share initial safety and translational data for over 20 patients treated with AlloNK + mAb across multiple autoimmune diseases in mid-November, including insights into the patient journey from community rheumatology sites
  • Translational data expected to highlight uniform, consistent, deep B-cell depletion
  • Safety data expected to highlight tolerability and ease-of-use of the regimen, including cyclophosphamide/fludarabine conditioning regimen, when administered and managed in community clinics
• Company on track to share clinical response data across dose levels from more than 15 refractory RA patients in 1H 2026
• Company plans to conduct FDA regulatory interactions in 1H 2026 to align on the pivotal trial design for AlloNK in refractory RA

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