NKGen Biotech Administers First Dose of Troculeucel to Alzheimer’s Patient Who Continued to Decline Cognitively While on Prior Amyloid-Targeting Therapy
SANTA ANA, Calif., July 10, 2025 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (OTC: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic natural killer (“NK”) cell therapeutics, today announced the administration of the first dose of troculeucel, an expanded autologous NK cell therapy, under a single compassionate use, Investigational New Drug (“IND”) authorization cleared by the U.S. Food and Drug Administration (“FDA”), to a patient with mild-stage Alzheimer’s disease who exhibited continued cognitive decline despite ongoing treatment with lecanemab, an amyloid targeting therapy. This exploratory work is being conducted in collaboration with Anita Fletcher, M.D., a board-certified neurologist with specialized training in neuroimmunology, who also serves as Director of Neuroscience Clinical Research at AdventHealth Neuroscience Institute in Orlando, Florida.
While NKGen’s ongoing double-blind randomized Phase 2a trial is focused on moderate-stage Alzheimer’s disease (NCT06189963), this single-IND marks the company’s first potential expansion into the treatment of mild Alzheimer’s, particularly for patients who fail to respond to existing first-line therapies. This initiative highlights NKGen’s dedication to advancing treatment options for Alzheimer’s disease, particularly in patients who have not achieved lasting benefit from current therapies. A positive outcome could not only support the broader application of troculeucel in earlier-stage disease, where treatment choices remain limited, but may also inform future clinical development.
“Currently, there are two FDA-approved amyloid-targeting therapies available for Alzheimer’s patients with mild cognitive impairment. While both have been shown to slow the rate of cognitive decline, they do not halt disease progression or improve cognitive function,” said Paul Y. Song, M.D., Chairman and Chief Executive Officer of NKGen. “In our clinical experience to date, troculeucel has been very well-tolerated and crosses the blood-brain barrier, improving levels of amyloid, α-synuclein, and tau proteins in the cerebrospinal fluid (“CSF”), while also reducing neuroinflammation, as evidenced by decreased levels of glial fibrillary acidic protein (“GFAP”). If we can demonstrate clinical improvement in Alzheimer’s patients who continue to progress on standard amyloid-targeting therapies, this could offer important insights into underlying disease mechanisms and potentially support the rationale for combination treatment strategies.”
Anita Fletcher, M.D., Director of Neuroscience Clinical Research at AdventHealth Orlando, commented, “The field has moved forward with targeted anti-amyloid therapies that lead to slowed progression of Alzheimer’s disease; however, the inflammatory changes that lead to neurodegeneration remain critical and underexplored and have potential to provide a new mechanism for meaningful clinical benefit. It is important to see if patients who progress on amyloid targeting therapies demonstrate measurable responses to therapies targeting other pathways.”
About NKGen Biotech
NKGen is a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic NK cell therapeutics. NKGen is headquartered in Santa Ana, California, USA. For more information, please visit www.nkgenbiotech.com.
About Troculeucel
Troculeucel is a novel cell-based, patient specific, ex vivo expanded autologous NK cell immunotherapeutic drug candidate. NKGen is developing troculeucel for the treatment of neurodegenerative disorders and a broad range of cancers. Troculeucel is the International Nonproprietary Name (“INN”) for SNK01 assigned by the World Health Organization (“WHO”). The WHO INN approval of troculeucel establishes a universally recognized nonproprietary drug name for SNK01 and marks a significant step on NKGen’s journey toward bringing this therapy to market.
About AdventHealth Central Florida Division
AdventHealth’s Central Florida Division encompasses 17 hospitals and ERs in four counties across metro Orlando. The world-class hospitals, combined with a comprehensive outpatient care network, see more than 5.9 million patient visits annually.
AdventHealth also has an expansive research portfolio in Central Florida, with more than 675 clinical trials and studies in progress.
The organization, which has more than 33,000 Central Florida team members, has a deep commitment to serving the community, with a community investment of more than $1.26 billion in 2023.
The division’s flagship campus — AdventHealth Orlando — boasts nationally and internationally recognized programs and serves as a major tertiary and quaternary referral hospital for much of the Southeast, the Caribbean and Latin America. Quality specialty care is provided through AdventHealth Institutes, which is nationally recognized in numerous specialties.
AdventHealth Orlando has been recognized by U.S. News & World Report, Healthgrades, Newsweek and the Leapfrog Group.
Learn more about the Central Florida Division on our Newsroom.
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 troculeucel and SNK02, including the expected timing of completing and announcing further results from its ongoing clinical studies; 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, MLS (ASCP)
SVP, Corporate Affairs
949-396-6830
dchua@nkgenbiotech.com
External Contact:
Kevin Gardner
Managing Director
LifeSci Advisors, LLC
kgardner@lifesciadvisors.com
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