NKGen Biotech Announces FDA Clearance of Investigational New Drug Application for SNK01 NK Cell Therapy to Treat Alzheimer’s Disease

NKGen’s neurodegenerative program continues to advance with dosing in the Phase 1/2a clinical trial anticipated to commence by year-end 2023

NKGen’s SNK01 program continues to show positive progress in Alzheimer’s Disease, as demonstrated by results reported in recent poster presentations in July and October 2023 at AAIC and WCN, respectively.

SANTA ANA, Calif., Oct. 24, 2023 (GLOBE NEWSWIRE) -- NKGen Biotech Inc. (Nasdaq: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic, and CAR-NK natural killer cell therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for SNK01 natural killer (NK) cell therapy for treatment of moderate Alzheimer’s Disease (AD). SNK01 is an autologous, non-genetically modified NK cell product that has enhanced cytotoxicity and activating receptor expression.

This approved trial of 30 patients with moderate AD will look to commence before the end of this year and the first interim data is expected in early Q3 2024.

NKGen’s SNK01 program continues to show positive progress in Alzheimer’s Disease, as demonstrated by results reported in recent poster presentations in July and October 2023 at AAIC and WCN, respectively. The Phase I, 3 + 3 dose-escalation trial, data on the use of SNK01 to treat patients with Alzheimer’s Disease demonstrated that SNK01 was well tolerated and appeared to cross the blood-brain barrier to help reduce proteins and neuroinflammation in a dose-dependent manner without any related serious adverse effects observed. No dose-limiting toxicities were reported, while positive changes in cognitive function and cerebrospinal fluid biomarkers were observed.

“This represents a pivotal milestone for our company and our neurodegenerative disease program,” said Paul Y. Song, Chief Executive Officer of NKGen Biotech. “While most current therapeutics remain focused on the mild cognitive impairment or mild dementia population, the FDA has allowed us to focus our efforts on a more advanced population for which there is currently no approved disease-modifying therapy. We believe that the FDA’s clearance validates the potential and merit of our approach.”