NKGen Biotech, Inc, a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic natural killer cell therapeutics, announced that the US Food and Drug Administration (FDA) has granted fast track designation for the investigation of troculeucel, ex vivo expanded autologous natural killer cell therapy, for the treatment of moderate Alzheimer’s disease.
The US FDA fast track designation is intended to accelerate the development and review process for therapies addressing serious health conditions and unmet medical needs and offers hope for faster access to promising new treatments.
“We are pleased with the US FDA’s decision to grant Fast Track designation for troculeucel. This decision underscores the significant unmet need for effective treatments for patients with moderate AD. We specifically targeted the moderate stage population as they represent about 30% of all Alzheimer’s cases and most, if not all, of the current focus has been on early/mild patients,” said Paul Y. Song, MD, Chairman and CEO of NKGen. “This designation comes after promising safety and efficacy results from our phase 1 trial, which shows early signs of clinical benefit in patients treated with troculeucel. Receiving fast track designation will significantly accelerate the drug development process, bringing us one step closer to delivering this promising therapy to Alzheimer’s disease patients in need, and ensuring faster access to a potentially life-changing treatment.”
NKGen is currently enrolling patients in its phase 2a trial for moderate Alzheimer’s disease and expects to share updated clinical data by the end of 2025.
The US FDA Fast Track designation is intended to facilitate the development and expedite the review of drug candidates to treat serious medical conditions and fulfill unmet medical needs. To qualify for this designation, both clinical and non-clinical data must demonstrate the drug candidate’s potential to address the identified medical need. A drug granted Fast Track status may benefit from enhanced communication with the US FDA throughout the development process, and, if applicable criteria are met, may also qualify for accelerated approval and priority review as well as for a rolling review of the regulatory dossier.
Troculeucel is a novel cell-based, patient specific ex vivo expanded autologous natural killer cell, immunotherapeutic drug candidate. NKGen is developing troculeucel for the treatment of neurodegenerative disorders and a broad range of cancers. Troculeucel is the International Nonproprietary Name for SNK01 assigned by the World Health Organization (WHO). The WHO International Nonproprietary Name approval of troculeucel establishes a universally recognized nonproprietary drug name for SNK01 and marks a significant step on our journey toward bringing this therapy to market.
