The Company expects to initiate a Phase 1 clinical trial in PD in 2H 2024.

NKGen Biotech, Inc. , a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic and CAR-NK natural killer (“NK”) cell therapeutics, today announced that the U.S. Food and Drug Administration (“FDA”) has cleared the Company’s Investigational New Drug (“IND”) application for SNK01 NK cell therapy for the treatment of Parkinson’s disease (“PD”). SNK01 is an autologous, nongenetically modified NK cell product that has enhanced cytotoxicity and activating receptor expression, potentially addressing a novel approach to tackling Parkinson’s disease.

The FDA IND clearance enables NKGen to initiate a Phase 1/2a clinical trial evaluating the safety, tolerability, and exploratory efficacy of SNK01 in patients with PD. The trial is designed to enroll up to 30 patients (20 receiving SNK01 and 10 receiving placebo). NKGen expects to begin the trial, with the first patient dosed, in the second half of 2024.

“The IND clearance marks a significant milestone as we advance our pipeline of NK cell therapy in neurodegenerative diseases,” said Paul Y. Song, MD, Chairman and Chief Executive Officer of NKGen. “This is our second IND approval for SNK01 within the past several months and underscores our focused dedication towards developing safe and effective treatments that target both protein deposition and neuroinflammation for patients with neurodegenerative diseases such as Alzheimer’s and Parkinson’s. We are excited to start our first clinical trial in PD as there currently is a high unmet medical need in this indication.”

Dr. Song further commented, “Given the encouraging outcomes regarding the reduction in neuroinflammation observed in our Phase 1 Alzheimer’s trials, we are optimistic about the potential benefits that may emerge in our Parkinson’s trial. Although these two neurodegenerative diseases differ, both share a neuroinflammatory component, which has led to our hypothesis that SNK01 may be beneficial in both indications. While directly inhibiting neuroinflammation, whether as an independent approach or in conjunction with other interventions, may not address the etiology, it can potentially decrease the production of factors that contribute to neurotoxicity, thereby hopefully leading to clinical improvements.”