SANTA ANA, Calif. — NKGen Biotech Inc., 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 it has received a No Objection Letter (“NOL”) from Health Canada for its Clinical Trial Application (“CTA”) for a Phase 1/2a study to evaluate the safety, tolerability, and exploratory efficacy of SNK01 natural killer (“NK”) cell therapy for treatment of patients with moderate Alzheimer’s Disease (“AD”). SNK01 is an autologous, non-genetically modified NK cell product that has enhanced cytotoxicity and activating receptor expression.
Phase 1 is an open label safety evaluation to determine the maximum tolerated dose and/or recommended Phase 2 dose of SNK01. Phase 2 is a randomized, placebo controlled, multicenter trial evaluating the safety and efficacy of SNK01 in moderate AD patients. This approved trial of approximately 36 patients with moderate AD is expected to commence in December 2023 with the first interim data expected in Q3 2024.
NKGen’s SNK01 program continues to show positive progress in Alzheimer’s Disease, as demonstrated by the most recent results reported at the Clinical Trials on Alzheimer’s Disease (“CTAD”) Annual Meeting in October 2023. Data from a Phase 1, 3 + 3 dose-escalation trial of SNK01 in patients with AD, suggested that SNK01 was well tolerated, and appeared to cross the blood-brain barrier to have a positive effect on brain protein aggregates as well as on neuroinflammation without any related serious adverse effects observed. 90% of patients demonstrated improvement or maintained stable cognitive function as per Alzheimer’s disease composite score (“ADCOMS”) at 11 weeks (one week after the last dose).
“It is estimated that more than 350 people in Canada develop some form of dementia each day. We believe the CTA clearance by Health Canada further validates the potential of our neurodegenerative disease program to help address this growing problem,” said Paul Y. Song, Chief Executive Officer of NKGen Biotech. “While the main focus of existing therapeutics continues to be on individuals with mild cognitive impairment, Health Canada has granted us the opportunity to direct our endeavors towards a more advanced population currently lacking any approved disease modifying therapy. Based on data generated from our Phase I dose escalation safety trial, presented at the recent CTAD conference, we are optimistic that our upcoming Phase 1/2a clinical trial (which incorporates a higher dose and more prolonged dosing schedule), might lead to greater cognitive benefits and a larger reduction in neuroinflammation and proteins.”
About NKGen Biotech
NKGen is a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic, and CAR-NK natural killer cell therapeutics. NKGen is headquartered in Santa Ana, California, USA
Contact:
Denise Chua, MBA, CLS, MT (ASCP)
Vice President, Investor Relations and Corporate Communications
949-396-6830
[email protected]