NKGen Biotech's SNK01 NK Cell Therapy Approved for Phase 2 Alzheimer's Trial
NKGen Biotech, Inc., a clinical-stage biotechnology company, announced the advancement of its cryopreserved, autologous, enhanced natural killer cell therapy, SNK01, into Phase 2 clinical development following promising results in initial trials. The company focuses on creating innovative natural killer (NK) cell therapeutics for treating neurodegenerative diseases and a variety of cancers.
The Phase 1 study of SNK01, an open-label 3+3 dose escalation study, demonstrated that the therapy was safe and effective in crossing the blood-brain barrier to reduce amyloid, tau, and alpha-synuclein proteins, along with neuroinflammation. The trial involved administering four doses of 1, 2, or 4 billion cells intravenously. Remarkably, 90% of patients exhibited improved or stable cognitive function based on the Alzheimer's disease composite score (ADCOMS).
Building on these encouraging findings, NKGen received FDA clearance for a new Phase 1/2a study in moderate Alzheimer’s disease. This study involves higher doses of 6 billion cells administered every three weeks for a year, compared to the initial four doses. The Phase 1 study confirmed that SNK01 was well-tolerated with no drug-related adverse effects.
Following a detailed review by an independent Safety Review Committee, NKGen's Internal Review Board (IRB) greenlighted the progression to Phase 2. This crucial stage will involve a larger cohort of 30 patients with moderate Alzheimer’s disease, using a randomized, double-blind design where 20 patients receive SNK01 and 10 receive a placebo. The Phase 2 trial will delve deeper into the efficacy and safety of SNK01, offering valuable insights into its therapeutic potential.
Paul Y. Song, MD, Chairman and CEO of NKGen, expressed enthusiasm for reaching this milestone, emphasizing SNK01's potential as a groundbreaking treatment for advanced Alzheimer’s disease. He noted that SNK01 has shown a high tolerance among patients, with no reported drug-related adverse events. The company anticipates that the Phase 2 trial will generate critical clinical and biomarker data, further validating the therapeutic value of SNK01.
Dr. Jesse Carr, Medical Director of Behavioral Research Specialists, LLC, who oversees the trial site, highlighted the promising preliminary benefits observed in patients. These include improvements in cognitive function, daily living activities, and overall quality of life, all without treatment-related adverse events. Dr. Carr expressed optimism about the potential of SNK01 as the trial progresses.
About SNK01:
SNK01 is a novel, patient-specific, cell-based therapeutic drug candidate. It is an ex vivo expanded autologous natural killer (NK) cell therapy developed by NKGen Biotech for treating neurodegenerative disorders and various cancers.
About NKGen Biotech:
NKGen Biotech, headquartered in Santa Ana, California, is a clinical-stage biotechnology company. It specializes in developing and commercializing innovative autologous, allogeneic, and CAR-NK cell therapies.
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