NKGen Biotech

NKGen Biotech is a clinical-stage biotechnology company focused on developing and commercializing innovative autologous, allogeneic, and CAR-NK natural killer (NK) cell therapies to treat neurodegenerative and oncological diseases. The company utilizes its proprietary SNK (super-activated) platform to enhance NK cell therapies, which improve a patient’s ability to target and eliminate diseased cells. NKGen Biotech’s SNK01 is an autologous NK cell therapy candidate with active and planned clinical trials in oncology and neurodegeneration, while SNK02 is an allogeneic NK cell therapy candidate currently in Phase 1 clinical trials. The company’s U.S. headquarters is a state-of-the-art cGMP cell therapy manufacturing facility located in Santa Ana, California, spanning 25,000 square feet with 12,000 square feet dedicated to GMP production. NKGen Biotech’s SNK cell therapy involves the infusion of highly pure NK cells harvested from the patient’s blood, activated, and infused back into the patient’s body. This autologous therapy is not genetically modified and has a lower chance of side effects compared to other therapies such as CAR-T treatments. The SNK cell therapy has broad therapeutic potential within the areas of cancer, autoimmune, and neurodegenerative diseases. SNK01 therapy is being evaluated in clinical trials for its potential benefits in treating advanced solid tumors, Alzheimer’s disease, and refractory solid tumors. The company has received FDA clearance for investigational new drug (IND) applications for SNK01 in Parkinson’s disease and Alzheimer’s disease and has a collaboration with the Parkinson’s Foundation to accelerate SNK01 for the treatment of advanced Parkinson’s disease. NKGen Biotech’s SNK cells can be produced in large quantities and cryopreserved while maintaining high levels of cytotoxicity and activating receptor expression after thawing and reconstitution. The SNK cell therapy is designed to improve immune system function, eliminate diseased or abnormal cells, and prevent recurrence. It is being evaluated for its potential to cross the blood-brain barrier and reduce proteins and neuroinflammation in Alzheimer’s disease. SNK01 therapy has shown promising results in Phase 1 clinical trials for Alzheimer’s disease, with potential benefits in cognitive function and reduction of tau proteins. It is also being evaluated in combination with immune checkpoint inhibitors for the treatment of advanced sarcoma and non-small cell lung cancer. The FDA has granted compassionate use authorization for SNK01 in advanced, heavily pre-treated sarcoma patients, where it has shown durable responses and disease control in patients with chemotherapy-resistant advanced soft tissue sarcomas.