NKGen Biotech Announces International and U.S. Expansion of Phase 1/2a Troculeucel Alzheimer’s Trial with Activation of Clinical Sites in Canada and Florida
- Expansion to two new clinical sites in Canada and Florida broadens patient access and accelerates recruitment
- Addition of renowned neuroscientist Dr. Bergeron, who has overseen 60+ clinical trials, strengthens the research team
- Successfully received Health Canada clearance for Clinical Trial Application
- Geographic expansion enhances patient diversity and trial efficiency
- None.
Insights
NKGen's Alzheimer's trial expansion to Canada and Florida accelerates patient recruitment and strengthens their clinical development strategy.
NKGen Biotech's expansion of their Phase 1/2a trial for troculeucel to include sites in Canada and Florida represents a strategic enhancement of their clinical development program. The activation of the Ottawa Memory Clinic and AdventHealth Orlando sites is significant as it addresses one of the most common challenges in clinical trials - patient recruitment and enrollment. By expanding geographically, NKGen is likely to accelerate their timeline for completing the study and potentially advance to later-stage trials more quickly.
The company's troculeucel therapy, a cryopreserved expanded autologous NK cell treatment, targets moderate Alzheimer's disease - a condition with immense unmet medical need affecting millions globally. The addition of Dr. Richard Bergeron, who brings experience from over 60 clinical trials, strengthens the trial's scientific oversight. His expertise specifically in both disease-modifying and symptomatic Alzheimer's treatments is particularly valuable for a novel approach like NK cell therapy.
This geographic diversification should also enhance patient diversity in the trial, which is increasingly important for regulatory considerations. While this news doesn't provide efficacy or safety data, it indicates the company is executing its clinical development strategy effectively and maintaining momentum in a challenging therapeutic area where many experimental treatments have failed. The expansion suggests NKGen has the operational capabilities and regulatory relationships necessary to conduct multinational clinical research in neurodegenerative diseases.
SANTA ANA, Calif., June 23, 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 activation of two additional clinical trial sites for its ongoing Phase 1/2a trial evaluating troculeucel, cryopreserved expanded autologous NK cell therapy, in patients with moderate Alzheimer’s disease (“AD”). An activated clinical site refers to a site that has completed all necessary preparations, such as staff training and protocol set up, enabling the site to begin recruiting and enrolling patients. Site activation is key to initiating patient recruitment and ensuring the trial advances as planned. The newly activated sites, Ottawa Memory Clinic in Canada and AdventHealth Orlando in Florida, USA, are now open for patient enrollment, broadening access and accelerating recruitment for the trial.
NKGen received clearance from Health Canada for its Clinical Trial Application (“CTA”), as disclosed in a prior press release, thus allowing the inclusion of Canadian patients in the Phase 1/2a trial (link). In Canada, the Ottawa Memory Clinic, a leader in Alzheimer’s disease research, will serve as a key site for Canadian patients. The AdventHealth Orlando site, led by Dr. Anita Fletcher, also previously disclosed in a prior press release, strengthens the trial’s presence on the U.S. East Coast (link).
The Ottawa Memory Clinic site will be led by Richard Bergeron, M.D., Ph.D., a renowned neuroscientist with a deep background in neurodegenerative disease research, particularly Alzheimer’s disease. Dr. Bergeron has overseen more than 60 clinical trials, from early safety studies to large-scale pivotal trials, and is recognized for his work in both disease-modifying and symptomatic treatments. As Founder and CEO of both the Ottawa and Montreal Memory Clinics, Dr. Bergeron brings a wealth of expertise in managing international, multi-site neurodegenerative disease trials.
“We are thrilled to welcome Dr. Bergeron to our global clinical trial team,” said Dr. Paul Y. Song, M.D., Chairman and Chief Executive Officer at NKGen. “ His expertise in Alzheimer’s disease research will be invaluable as we expand patient trial access to troculeucel and work toward fulfilling our enrollment goals. As Alzheimer’s is a global health problem, we are committed to working with more international experts and clinical sites. The activation of the U.S. East Coast and Canadian sites is a step towards expanding the geographic footprint of our Phase 1/2a trial, enhancing patient diversity and trial efficiency.”
More information on the trial, including contact details for the newly activated sites, can be found at www.clinicaltrials.gov website: NCT06189963
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 Richard Bergeron, M.D., PhD., FRCPC
Dr. Richard Bergeron is a neuroscientist and psychiatrist with extensive experience in clinical trials for neurodegenerative diseases, particularly Alzheimer’s disease. As Founder and CEO of the Ottawa and Montreal Memory Clinics, he has led over 60 clinical trials ranging from early-phase safety studies to late-stage pivotal trials, focusing on disease-modifying therapies and symptomatic treatments. With a strong academic background, including a Ph.D. from McGill and postdoctoral training at Harvard, Dr. Bergeron integrates clinical care with research to advance early diagnosis and access to innovative therapies for cognitive disorders
About Ottawa Memory Clinic
The Ottawa Memory Clinic is a leading Canadian center specializing in the early diagnosis, treatment, and research of neurodegenerative diseases, particularly Alzheimer’s disease and mild cognitive impairment (MCI). Since its establishment, the clinic has become a key site for industry-sponsored and academic clinical trials, contributing to the development of new therapeutic approaches for cognitive decline.
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 patient 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 Contacts:
Kevin Gardner
Managing Director
LifeSci Advisors, LLC
kgardner@lifesciadvisors.com
FAQ
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