NKGen Biotech Receives FDA Expanded Access Approval To Treat Multiple Neurodegenerative Diseases With Troculeucel

Author: Benzinga Newsdesk | July 21, 2025 08:16am

• Troculeucel, a cryopreserved, autologous enhanced natural killer cell therapy, has demonstrated preliminary clinical benefit without any drug-related adverse events in two Phase I clinical trials in Alzheimer's Disease.
• Company receives expanded access protocol authorization from the U.S. Food and Drug Administration (FDA) for troculeucel granted to treat patients with known diagnoses of multiple neurodegenerative diseases.
• IND approval allows for up to 20 patients to be enrolled; first patient enrollment is anticipated in Q3 2025.
  
  
  
   

SANTA ANA, Calif., July 21, 2025 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (OTC:NKGN) ("NKGen" or the "Company"), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic natural killer ("NK") cell therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted Expanded Access Program (EAP) authorization for its IND for an open-label, non-randomized, multi-center intermediate size expanded access protocol for use of troculeucel for neurodegenerative diseases. This includes its use for the treatment of several neurodegenerative diseases, many of which currently have no effective therapy.

While NKGen's ongoing double-blind randomized Phase 2a trial is focused on moderate-stage Alzheimer's disease (NCT06189963), this EAP IND marks the company's exploration into the treatment of other less common neurodegenerative diseases. In addition to earlier stage Alzheimer's Disease (AD), this IND includes the treatment of Parkinson's Disease (PD), Amyotrophic Lateral Sclerosis (ALS), Multiple System Atrophy (MSA), Progressive Supranuclear Palsy (PSP), Frontotemporal Dementia (FTD), Corticobasal degeneration (CBD), Multiple Sclerosis (MS) and Lewy Body Dementia (LBD).

This IND approval will allow NKGen to expand and explore the use of troculeucel in up to 20 patients.

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