NKGen Appoints Dr. Anita Fletcher as National Principal Investigator for Phase 2a Troculeucel Trial Evaluating Moderate Alzheimer's Disease with AdventHealth Orlando as First East Coast Site
SANTA ANA, Calif., Feb. 19, 2025 (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 and allogeneic natural killer ("NK") cell therapeutics, today announced that Anita Fletcher, M.D. has been appointed as the National Principal Investigator ("PI") for its Phase 2a clinical trial of troculeucel, expanded enhanced autologous NK cell therapy, for the treatment of moderate Alzheimer's disease (NCT06189963). In addition to Dr. Fletcher's appointment as National PI, NKGen is pleased to announce AdventHealth Research Institute, Neuroscience Research in Orlando will be the first clinical site on the East Coast with the intent of enrolling moderate stage Alzheimer's Disease (AD) patients in the very near term.
"We are both honored and delighted that Dr. Fletcher has agreed to serve as our National PI. Her extensive expertise in neuroimmunology provides her with a deep understanding of our approach using enhanced activated NK cells (troculeucel), not only for the treatment of Alzheimer's disease where roughly 30% of Alzheimer's patients have moderate stage disease for which there is no approved disease modifying therapy, but also for other neurodegenerative diseases as well," said Paul Y. Song, M.D., Executive Chairman and Chief Executive Officer of NKGen Biotech.
"Alzheimer's disease continues to impact far too many people in our community, which is why it's an honor to serve as the national PI for troculeucel, an expanded NK cell therapy for individuals living with the disease, offering hope for improved quality of life for those affected by neurodegenerative disorders," said Dr. Fletcher. "This groundbreaking work embodies the whole person care AdventHealth is committed to pioneering through advanced research and the collaboration with Dr. Song and NKGen Biotech reflects a shared commitment to furthering cellular therapeutic interventions."
Previously reported highlights from the dose escalation Phase 1 trial:
- Despite 70% of subjects being treated at relatively low doses of troculeucel for only four total doses, 90% of all evaluable subjects had either stable or improved (±0.1) composite ADCOMS scores at Week 11 (one-week after the final dose) as previously disclosed.
- One-week post-final dose, improvement in CSF biomarkers were observed in 70% p-Tau181, 60% AB42/40 ratio, 60% GFAP, 40% GDF-15, 30% LTBP2, and 30% NF-L.
- Despite suboptimal dosing for two/thirds of the subjects, troculeucel was able to positively affect biomarkers that are associated with increased AD development.
- No treatment related adverse events were observed.
The current randomized Phase 2a trial is utilizing the cryopreserved product delivered at the highest dose of 6 x 109 cells every three weeks for one full year.
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 Anita Fletcher, M.D.
Dr. Fletcher is a board-certified neurologist specializing in neuroimmunology and neuroinfectious diseases and is currently the Director of Neuroscience Clinical Research at AdventHealth Neuroscience Institute in Orlando, FL. She completed a Neuroimmunology and Neuroinfectious disease fellowship at the National Institutes of Health ("NIH") in Bethesda, MD where she also served as Director of the Neuroimmunology Clinic for the National Institute for Neurological Disorders and Stroke.
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.
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.
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.
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