NKGen Biotech Presents Interim Phase I Trial Data at the XXVI World Congress of Neurology (WCN) Annual Meeting 2023
- NKGen Biotech presented interim Phase I trial data on the use of its investigational NK cell therapy, SNK01, to treat patients with Alzheimer's disease. The results showed that SNK01 has the potential to cross the blood-brain barrier and effectively reduce neuroinflammation.
- No treatment-related adverse events were observed during the trial.
- None.
SANTA ANA, Calif., Oct. 17, 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 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.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate”, “believe”, “could”, “continue”, “expect”, “estimate”, “may”, “plan”, “outlook”, “future” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Because such statements are subject to risks and uncertainties, many of which are outside of the Company’s control, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the Company’s plans and expected timing for developing SNK01, including the expected timing of completing and announcing further results from its ongoing Phase 1 clinical trial; and the Company’s expected timing for developing its product candidates and potential benefits of its product candidates. Risks that contribute to the uncertain nature of the forward-looking statements include: the Company’s ability to execute its plans and strategies; risks related to performing clinical studies; the risk that initial and interim results of a clinical study do not necessarily predict final results and that one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, and as more patient data become available; the ability of SNK101 to cross the blood-brain barrier and reduce neuroinflammation; potential delays in the commencement, enrollment and completion of clinical studies and the reporting of data therefrom; the risk that studies will not be completed as planned; the risk that the poster will not be published as planned including delays in timing, format, or accessibility; and NKGen’s ability to raise additional funding to complete the development of its product candidates. These and other risks and uncertainties are described more fully under the caption “Risk Factors” and elsewhere in the Company’s filings and reports, which may be accessed for free by visiting the Securities and Exchange Commission’s website at www.sec.gov and on the Company’s website under the subheading “Investors”. Investors should take such risks into account and should not rely on forward-looking statements when making investment decisions. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
Contacts:
Internal Contact:
Denise Chua, MBA, CLS, MT (ASCP)
Vice President, Investor Relations and Corporate Communications
949-396-6830
dchua@nkgenbiotech.com
External Contacts:
Chris Calabrese
Managing Director
LifeSci Advisors, LLC
ccalabrese@lifesciadvisors.com
Kevin Gardner
Managing Director
LifeSci Advisors, LLC
kgardner@lifesciadvisors.com
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