SNK01 autologous NK cell therapy showed positive effects on cerebrospinal fluid (“CSF”) and plasma tau protein in Alzheimer's disease patients.
Additional Phase 1 SNK01 trial data suggests clinical activity on cognitive function in patients with advanced Alzheimer's disease, in addition to previously revealed positive effects on amyloid protein and neuroinflammatory biomarkers.
SANTA ANA, Calif., March 25, 2024 (GLOBE NEWSWIRE) — NKGen Biotech, Inc. (Nasdaq: NKGN) (“NKGen” or the “Company”) is an innovative autologous, allogeneic, CAR-NK natural killer company. (“NK”) cell therapy company today announced additional Phase 1 clinical trial data for the use of SNK01, an investigational autologous NK cell therapy, in the treatment of patients with Alzheimer's disease (“AD”). ) At the Tau2024 Global Conference held in Washington DC
This presentation includes data from the abstract entitled “Beneficial Effects on CSF and Plasma Tau Protein and Cognitive Function in Alzheimer's Disease Subjects Treated with Expanded Non-Genetically Recombinant Autologous Natural Killer Cells (SNK01)” I did. In this Phase 1 study, SNK01 was administered intravenously (“IV”) every three weeks for a total of four treatments using a 3+3 dose escalation design (1, 2, 4 x 10 doses). I did it.9 Patients with mild, moderate, or severe AD (median MMSE 14). Cognitive assessments and CSF/plasma pTau217 and pTau181 analyzes were performed at baseline and 1 and 12 weeks after the last dose. The primary endpoint was safety, and secondary endpoints included changes in cognitive measures and biomarker levels.
“The data presented today demonstrate further beneficial effects of SNK01 in the treatment of Alzheimer's disease,” commented Paul Y. Song, MD, CEO of NKGen. “Data from this Phase 1 study further validates SNK01's ability to improve pTau, amyloid Aβ42/40, and alpha-synuclein biomarkers and improve cognitive scores, consistent with what we have previously observed. Although the results were positive, the Phase 1 trial was a dose-escalation study with only four total doses administered over 11 weeks. Our Phase 1/2a SNK01 study used a dose 50% higher than the highest dose administered in previous Phase 1 studies and a long-term dosing regimen of over 1 year, and the study demonstrated the following results: We anticipate further significant clinical benefits. We will continue our research with the goal of providing NK cell therapy to Alzheimer's disease patients in need of disease-modifying treatments. I am excited.”
Presentation highlights:
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Of the 11 patients enrolled, 10 were evaluable, with a median MMSE of 14.
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SNK01 administered by simple IV appears to cross the blood-brain barrier and improve Aβ42/40, tau, and alpha-synuclein protein levels in the CSF.
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Even though 70% of patients were treated with relatively low doses of SNK01, the following results were observed at 1 week post-treatment (week 11):
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50-70% of all patients enrolled in the study had stable or improving CDR-SB, ADAS-Cog, and/or MMSE scores, including one patient whose MMSE score improved from 14 to 23 .
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90% had stable or improved ADCOMS scores.
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CSF pTau217 was decreased in 50% of patients.
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80% had stable/decreased CSF pTau181 compared to baseline values.
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30% had decreased plasma pTau217.
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40% had decreased plasma pTau181.
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Where data were available, this decrease occurred for all patients (n=4) for CSF pTau217, for 5/7 patients for CSF pTau181, and for 2/3 patients for plasma pTau217 at week 22 (last dose). (after 12 weeks). For plasma pTau181 in 3/4 patients.
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At week 11, the proportion of patients with stable/improved ADCOMS scores and decreased CSF pTau was 56% for pTau217 and 78% for pTau181.
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No treatment-related adverse events were observed.
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SNK01 appears to be safe and well-tolerated, and data suggest that SNK01 has potential clinical activity in AD and may also reduce CSF and plasma tau protein levels. A larger trial with higher doses/duration will begin in the US in 2023.
Copies of abstracts and presentation materials are available on the Scientific Publications page of our website. https://nkgenbiotech.com/ Once the presentation is finished. Previously disclosed phase 1 data on the positive effects of his SNK01 on amyloid and neuroinflammatory biomarkers are not included in this conference presentation focused on tau, but are also posted on the Scientific Publications page It has been.
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. For more information, please visit www.nkgenbiotech.com.
Forward-looking statements
Statements contained in this press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements include statements such as “anticipate,” “believe,” “may,” “continue,” “expect,” “estimate,” “may,” “plan,” or “outlook.” may be identified by the use of words such as “. “future” and “project” and other similar expressions that predict or imply future events or trends or that are not historical statements; Such statements are subject to risks and uncertainties, many of which are beyond the Company's control, which may cause actual results to differ materially from those expressed or implied by such forward-looking statements. there is. Such statements include, without limitation, statements regarding the Company's plans and anticipated timing for the development of SNK01. This also includes the expected timing of completion of the ongoing Phase 1 clinical trial and publication of further results. the timing of the Company's plans to develop its product candidates and the potential benefits of the product candidates; Risks that contribute to the uncertainty of forward-looking statements include: our ability to execute our plans and strategies; Risks Associated with Conducting Clinical Research. Initial and interim results of clinical studies do not necessarily predict final results, and as patient enrollment continues, more comprehensive reviews of data are conducted, and more patient data become available, 1 Risk that one or more clinical outcomes may change significantly. potential delays in the initiation, enrollment and completion of clinical studies and reporting of data obtained therefrom; the risk that research will not be completed as planned; the risk that the abstract will not be published as planned, including delays in timing, format, and accessibility; and NKGen's ability to obtain additional funding to complete the development of its product candidates. These and other risks and uncertainties are further described in the caption “Risk Factors” and elsewhere in our filings and reports. These documents and reports can be accessed free of charge on the Securities and Exchange Commission's website at www.sec.gov and on our website. The website has the subheading “Investors – Financials and Declarations''. Investors should consider such risks 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 are made. We undertake no obligation to update any such statements to reflect events or circumstances that occur after the date on which they are made, except as required by law.
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