NKGen Biotech's SNK02 Cellular Therapy Granted FDA Fast Track Designation for Refractory Solid Tumors

SANTA ANA, Calif., Jan. 10, 2026 – NKGen Biotech, Inc., a clinical-stage biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for SNK02, its allogeneic, cryopreserved natural killer (NK) cell therapy. This designation is for the treatment of patients with refractory solid tumors, including those who have progressed on anti-PD-1/PD-L1 therapy.



The FDA's Fast Track program is designed to facilitate the development and expedite the review of therapies that treat serious conditions and fill an unmet medical need. This status enables more frequent interactions with the FDA throughout the clinical development process.

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SNK02 is derived from healthy donor peripheral blood mononuclear cells and is engineered to enhance its tumor-targeting and persistence capabilities. The company recently presented updated Phase I data at a major oncology conference, showing that SNK02, both as a monotherapy and in combination with pembrolizumab, demonstrated a promising safety profile and signals of clinical activity in heavily pre-treated patients with advanced solid tumors.



"We are pleased that the FDA has recognized the potential of SNK02 to address the critical need for new treatment options for patients with refractory solid tumors," said Dr. Paul Y. Song, Chairman of NKGen Biotech. "The Fast Track Designation will allow us to work closely with the agency to accelerate the clinical development of this novel, off-the-shelf NK cell therapy."

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Source: NKGen Biotech. (2026, January 10). NKGen Biotech Receives FDA Fast Track Designation for SNK02 for the Treatment of Refractory Solid Tumors.