NKGen Biotech

Company Overview

NKGen Biotech is a clinical-stage biotechnology company developing autologous, allogeneic, and CAR-NK natural killer cell therapies for treating neurodegenerative and oncological diseases. The company uses its proprietary SNK (super-activated) platform to create these therapies, which enhance patients' ability to target and eliminate diseased cells.

SNK Platform

The proprietary SNK (super-activated) platform is central to NKGen Biotech's efforts in developing NK cell therapies. This platform involves infusing highly pure NK cells harvested from the patient's blood. These cells are activated and infused back into the patient's body to improve immune system function, eliminate diseased or abnormal cells, and prevent recurrence. The SNK cell therapy is autologous, not genetically modified, and has shown a lower chance of side effects compared to other therapies like CAR-T treatments.

Clinical Trials and Research

NKGen Biotech is actively conducting clinical trials for its SNK01 and SNK02 NK cell therapy candidates. SNK01 is an autologous therapy being evaluated for 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 it collaborates with the Parkinson's Foundation on advancing treatment for advanced Parkinson's disease. SNK02, the allogeneic NK cell therapy candidate, is currently in Phase 1 trials.

Headquarters and Manufacturing Facility

The U.S. headquarters of NKGen Biotech is located in Santa Ana, California. This state-of-the-art, 25,000-square-foot cGMP cell therapy manufacturing facility includes 12,000 square feet dedicated to GMP production. This facility supports the large-scale production and cryopreservation of NKGen's SNK cells while maintaining high cytotoxicity levels and activating receptor expression after thawing and reconstitution.

Collaborations and Regulatory Approvals

NKGen Biotech collaborates with the Parkinson's Foundation to accelerate the therapeutic application of SNK01 for advanced Parkinson's disease. The company's SNK01 therapy has received compassionate use authorization from the FDA for treating advanced, heavily pre-treated sarcoma patients. FDA clearance has also been obtained for investigational new drug applications for SNK01 in Parkinson's disease and Alzheimer's disease.

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