NKGen Biotech Presents Additional Phase 1 Clinical Trial Data in Alzheimer’s Disease at the Tau2024 Global Conference
- Positive Phase 1 trial data presented at Tau2024 Global Conference
- Improvements in cognitive function, CSF, and plasma Tau proteins observed
- No treatment-related adverse events reported
- Potential clinical activity in Alzheimer's disease patients shown
- Promising results on biomarkers and cognitive scores
- None.
Insights
The data from NKGen Biotech's Phase 1 trial of SNK01 in Alzheimer's disease patients presents a promising development in the field of neurodegenerative disease treatment. Specifically, the improvement in cognitive scores and the reduction of Tau proteins in both cerebral spinal fluid and plasma are significant because Tau proteins are implicated in the neurofibrillary tangles that are a hallmark of Alzheimer's pathology. The ability of SNK01 to cross the blood-brain barrier, as suggested by the data, is particularly noteworthy. This characteristic is a important challenge for many therapies targeting brain conditions due to the protective nature of this barrier.
From a medical research perspective, the use of autologous NK cell therapy is a relatively new approach in treating Alzheimer's disease. The immune system's role in neurodegeneration is a growing area of interest, with NK cells being a type of immune cell that could have potential in modulating disease progression. The safety profile mentioned, with no treatment-related adverse events observed, is encouraging for the continued development of this therapy. However, it's important to note that this is early-stage research and the sample size of the trial is small. The longer and larger Phase 1/2a trial will be critical in validating these preliminary findings.
The announcement by NKGen Biotech regarding their Phase 1 clinical trial results for SNK01 could have implications for the company's valuation and investor sentiment. The biotech sector is highly sensitive to clinical trial outcomes, especially for treatments targeting diseases like Alzheimer's, which have a significant unmet medical need and a large potential market. The positive results could lead to increased investor interest and potentially drive up NKGen Biotech's stock price in the short term.
However, the long-term impact on the company's financials will depend on the outcomes of subsequent trials, regulatory approvals and the therapy's commercial viability. The fact that the company is moving towards a higher dosing and prolonged regimen in their Phase 1/2a trial indicates confidence in the treatment's potential and could signal a strategic move to position SNK01 as a disease-modifying treatment in a market that is currently limited in such options. Investors will be closely monitoring the progress of the larger trial for more definitive data that could solidify the company's standing in the biotech industry.
The reported Phase 1 clinical trial results of SNK01 show potential in addressing cognitive decline in Alzheimer's disease, which is a significant concern for clinicians and patients alike. The Mini-Mental State Examination (MMSE) and Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) are widely used cognitive assessments in clinical settings and improvements or stability in these scores are promising. The reported changes in Tau protein levels are also of clinical interest, as these biomarkers are associated with disease progression.
As a neurologist, the data suggesting that SNK01 may reduce levels of pathological Tau and potentially improve cognitive function is intriguing. However, it is important to remain cautious until larger and more extensive trials are conducted. The complex nature of Alzheimer's disease, with its multifactorial pathogenesis, means that treatments must be thoroughly vetted through rigorous clinical testing. The safety and tolerability of SNK01, as reported, are positive, but efficacy and long-term safety must be established in larger, controlled studies. The next phases of clinical trials will be pivotal in determining whether this therapy could be integrated into clinical practice.
SNK01 autologous NK cell therapy demonstrated a positive effect on cerebral spinal fluid (“CSF”) and plasma Tau proteins in Alzheimer’s patients.
The additional Phase 1 SNK01 trial data suggest clinical activity regarding cognitive function in patients with advanced Alzheimer’s disease in addition to previously disclosed positive effects on amyloid protein and neuroinflammation biomarkers.
SANTA ANA, Calif., March 25, 2024 (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 (“NK”) cell therapeutics, today presented additional Phase 1 clinical trial data on the use of its investigational autologous NK cell therapy, SNK01, to treat patients with Alzheimer’s disease (“AD”) at the Tau2024 Global Conference in Washington, D.C.
The presentation contained data from an abstract entitled, “Beneficial Effect on CSF and Plasma Tau Proteins and Cognitive Function in Alzheimer’s Disease Subjects Treated with Expanded Non-Genetically Modified Autologous Natural Killer Cells (SNK01).” 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, and 4 x 109 cells) in patients with either mild, moderate, or severe AD (Median MMSE of 14). Cognitive assessments and CSF/plasma pTau217 and pTau181 analyses were performed at baseline and at 1 and 12 weeks after the final dose. The primary endpoint was safety and secondary endpoints included changes in cognitive assessments and biomarker levels.
“The data presented today demonstrate additional beneficial effects of SNK01 for the treatment of Alzheimer’s disease,” commented Paul Y. Song, M.D., CEO of NKGen. “The data from this Phase 1 trial further validates the ability of SNK01 to improve pTau, amyloid Aβ42/40, and alpha-synuclein biomarkers as well as improving cognitive scores, consistent with what we have previously observed. While the results were positive, the Phase 1 trial was a dose-escalation trial that only administered four total doses over 11 weeks. However, our Phase 1/2a SNK01 trial in moderate Alzheimer’s patients, initiated in December 2023, utilizes a
Highlights from the Presentation:
- Of the 11 patients enrolled, 10 were evaluable – median MMSE was 14.
- SNK01 given via a simple IV appears to cross the blood brain barrier to improve Aβ42/40, Tau, and alpha-synuclein protein levels in CSF.
- Despite
70% of patients treated at relatively low doses of SNK01, at one-week post-treatment (week 11):- 50–
70% of all enrolled patients in the trial had either stable or improved CDR-SB, ADAS-Cog and/or MMSE scores including one patient whose MMSE score improved from 14 to 23. 90% had either stable or improved ADCOMS scores.50% of patients had a decrease in CSF pTau217.80% had stable/decreased CSF pTau181 compared to baseline values.30% had a decrease in plasma pTau217.40% had a decrease in plasma pTau181.
- 50–
- Where data were available, this decrease continued through week 22 (12 weeks after the last dose) for CSF pTau217 for all patients (n=4), for CSF pTau181 for 5/7 patients, for plasma pTau217 for 2/3 patients, and for plasma pTau181 for 3/4 patients.
- At week 11, the percent of patients with a stable/improved ADCOMS score who also had a decrease in CSF pTau was
56% for pTau217 and78% for pTau181. - No treatment related adverse events were observed.
- SNK01 appears safe and well tolerated and the data suggest SNK01 may have potential clinical activity in AD while also reducing CSF and plasma Tau protein levels. A larger trial with a higher dosing/duration was initiated in the U.S. in 2023.
A copy of the abstract and presentation materials will be available on the Scientific Publications page of the Company’s website at https://nkgenbiotech.com/ once the presentation has concluded. Previously disclosed Phase 1 data on the positive effects of SNK01 on amyloid and neuroinflammation biomarkers, which are not included in this Tau-focused conference presentation, can also be found on the Scientific Publications page.
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 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 study; 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; 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 abstract 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—Financial and Filings”. 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.
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
FAQ
What positive effects were demonstrated by SNK01 autologous NK cell therapy in Alzheimer's patients?
Were there any adverse events reported during the Phase 1 trial of SNK01?
What biomarkers were analyzed in the Phase 1 trial of SNK01 autologous NK cell therapy?
What was the median MMSE score of patients enrolled in the Phase 1 trial of SNK01?
Where can the abstract and presentation materials of the Phase 1 trial data be found?
What is the goal of NKGen Biotech, Inc. in offering NK cell therapy to Alzheimer's patients?
When was the Phase 1/2a trial of SNK01 initiated for moderate Alzheimer's patients?
What percentage of patients had a decrease in CSF pTau217 at one week post-treatment?
What percentage of patients experienced stable or improved CDR-SB, ADAS-Cog, or MMSE scores at week 11?
What was the dosing regimen of SNK01 in the Phase 1 trial for Alzheimer's patients?
What was the primary endpoint of the Phase 1 trial for SNK01 autologous NK cell therapy?
