NKGen Biotech, 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 Fast Track designation for the investigation of troculeucel, ex vivo expanded autologous NK cell therapy, for the treatment of moderate Alzheimer’s disease (“AD”). 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 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 Chief Executive Officer 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 AD 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 AD and expects to share updated clinical data by the end of 2025.
