SANTA ANA, CA, USA I October 17, 2023 I 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 presented a poster with interim Phase I trial data on the use of its investigational NK cell therapy, SNK01, to treat patients with Alzheimer’s disease (“AD”) at the XXVI World Congress of Neurology (WCN) Annual Meeting in Montreal, QC, Canada and online.
The poster, entitled “Use of Expanded Non-Genetically Modified Natural Killer Cells (SNK01) with Enhanced Cytotoxicity in Patient’s with Alzheimer’s Disease – Interim Report of a Phase I Trial”, provided interim results from a single center, open label Phase I trial evaluating the safety, tolerability, and exploratory efficacy of SNK01 in patients with mild cognitive impairment (“MCI”) and AD. SNK01 was administered intravenously every three weeks for a total of four treatments using a 3 + 3 dose escalation design (1, 2 & 4 x 109 cells) in patients with either mild, moderate or advanced disease confirmed by MRI and PET scans. Severity of AD was based on the baseline Clinical Dementia Rating-Sum of Boxes, or CDR-SB score. Primary endpoint was safety and secondary endpoints included changes in cognitive assessments (CDR-SB, Mini-Mental State Examination [MMSE], The Alzheimer’s Disease Assessment Scale-Cognitive Subscale [ADAS-Cog]) and biomarker levels.
“The results from our Alzheimer’s trial demonstrate that SNK01 has the potential to cross the blood-brain barrier as evidenced by the CSF biomarker data,” said Paul Y. Song, CEO of NKGen Biotech. “Furthermore, despite the fact that 2/3rds of enrolled patients in this dose escalation safety trial received what we consider sub-therapeutic doses, SNK01 showed signs of effectively reducing neuroinflammation, a critical factor to effectively treating Alzheimer’s. The pressing need for effective Alzheimer’s treatments cannot be overstated, and we are committed to addressing this healthcare challenge. We are excited to share additional trial data in Alzheimer’s expected later this year as we embark on this new chapter as a publicly traded company.”
Highlights from the Poster Presentation:
- Cognitive Assessments (CDR-SB, ADAS-Cog and MMSE), CSF, and plasma biomarker analyses were performed at baseline and at one week and twelve weeks after the final dose.
- Ten AD patients from the first three cohorts in the dose escalation were analyzed (5 patients with mild AD, 3 patients with moderate AD, and 2 patients with severe AD).
- The median baseline score for CDR-SB was 9 (4–18), for ADAS-Cog was 27.5 (18–65) and for MMSE was 14 (2–23).
- No treatment related adverse events were observed.
- Based on the CSF biomarker data, intravenous SNK01 appears to cross the blood brain barrier to improve CSF AB42/40 and reduce pTau181 levels.
- SNK01 appears to reduce neuroinflammation in a dose-dependent manner.
Please visit our website at https://nkgenbiotech.com/scientific-publications/ to view a copy of the poster.
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 (NK) cell therapeutics. NKGen is headquartered in Santa Ana, California, USA. For more information, please visit www.nkgenbiotech.com.
SOURCE: NKGen Biotech
Post Views: 135
SANTA ANA, CA, USA I October 17, 2023 I 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 presented a poster with interim Phase I trial data on the use of its investigational NK cell therapy, SNK01, to treat patients with Alzheimer’s disease (“AD”) at the XXVI World Congress of Neurology (WCN) Annual Meeting in Montreal, QC, Canada and online.
The poster, entitled “Use of Expanded Non-Genetically Modified Natural Killer Cells (SNK01) with Enhanced Cytotoxicity in Patient’s with Alzheimer’s Disease – Interim Report of a Phase I Trial”, provided interim results from a single center, open label Phase I trial evaluating the safety, tolerability, and exploratory efficacy of SNK01 in patients with mild cognitive impairment (“MCI”) and AD. SNK01 was administered intravenously every three weeks for a total of four treatments using a 3 + 3 dose escalation design (1, 2 & 4 x 109 cells) in patients with either mild, moderate or advanced disease confirmed by MRI and PET scans. Severity of AD was based on the baseline Clinical Dementia Rating-Sum of Boxes, or CDR-SB score. Primary endpoint was safety and secondary endpoints included changes in cognitive assessments (CDR-SB, Mini-Mental State Examination [MMSE], The Alzheimer’s Disease Assessment Scale-Cognitive Subscale [ADAS-Cog]) and biomarker levels.
“The results from our Alzheimer’s trial demonstrate that SNK01 has the potential to cross the blood-brain barrier as evidenced by the CSF biomarker data,” said Paul Y. Song, CEO of NKGen Biotech. “Furthermore, despite the fact that 2/3rds of enrolled patients in this dose escalation safety trial received what we consider sub-therapeutic doses, SNK01 showed signs of effectively reducing neuroinflammation, a critical factor to effectively treating Alzheimer’s. The pressing need for effective Alzheimer’s treatments cannot be overstated, and we are committed to addressing this healthcare challenge. We are excited to share additional trial data in Alzheimer’s expected later this year as we embark on this new chapter as a publicly traded company.”
Highlights from the Poster Presentation:
- Cognitive Assessments (CDR-SB, ADAS-Cog and MMSE), CSF, and plasma biomarker analyses were performed at baseline and at one week and twelve weeks after the final dose.
- Ten AD patients from the first three cohorts in the dose escalation were analyzed (5 patients with mild AD, 3 patients with moderate AD, and 2 patients with severe AD).
- The median baseline score for CDR-SB was 9 (4–18), for ADAS-Cog was 27.5 (18–65) and for MMSE was 14 (2–23).
- No treatment related adverse events were observed.
- Based on the CSF biomarker data, intravenous SNK01 appears to cross the blood brain barrier to improve CSF AB42/40 and reduce pTau181 levels.
- SNK01 appears to reduce neuroinflammation in a dose-dependent manner.
Please visit our website at https://nkgenbiotech.com/scientific-publications/ to view a copy of the poster.
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 (NK) cell therapeutics. NKGen is headquartered in Santa Ana, California, USA. For more information, please visit www.nkgenbiotech.com.
SOURCE: NKGen Biotech
Post Views: 135
