NKGen Biotech Administers First Dose of Troculeucel to Alzheimer鈥檚 Patient Who Continued to Decline Cognitively While on Prior Amyloid-Targeting Therapy
NKGen Biotech (OTC: NKGN) has administered the first dose of troculeucel, an expanded autologous NK cell therapy, to a mild-stage Alzheimer's patient under FDA compassionate use authorization. The patient had shown continued cognitive decline despite treatment with lecanemab, an amyloid-targeting therapy.
The treatment is being conducted in collaboration with Dr. Anita Fletcher at AdventHealth Neuroscience Institute. While NKGen's current Phase 2a trial focuses on moderate-stage Alzheimer's, this marks their first potential expansion into mild Alzheimer's treatment, particularly for patients not responding to first-line therapies.
Troculeucel has demonstrated promising characteristics, including the ability to cross the blood-brain barrier and improve levels of various proteins in cerebrospinal fluid while reducing neuroinflammation.
NKGen Biotech (OTC: NKGN) ha somministrato la prima dose di troculeucel, una terapia con cellule NK autologhe espanse, a un paziente con Alzheimer in fase lieve, grazie all'autorizzazione per uso compassionevole della FDA. Il paziente aveva mostrato un declino cognitivo continuo nonostante il trattamento con lecanemab, una terapia mirata all'amiloide.
Il trattamento viene svolto in collaborazione con la Dott.ssa Anita Fletcher presso l'AdventHealth Neuroscience Institute. Sebbene l'attuale studio di fase 2a di NKGen sia focalizzato sull'Alzheimer in fase moderata, questo rappresenta il primo possibile ampliamento verso il trattamento dell'Alzheimer lieve, in particolare per pazienti non responsivi alle terapie di prima linea.
Troculeucel ha mostrato caratteristiche promettenti, tra cui la capacit脿 di attraversare la barriera emato-encefalica e migliorare i livelli di diverse proteine nel liquido cerebrospinale, riducendo al contempo la neuroinfiammazione.
NKGen Biotech (OTC: NKGN) ha administrado la primera dosis de troculeucel, una terapia con c茅lulas NK aut贸logas ampliadas, a un paciente con Alzheimer en etapa leve bajo autorizaci贸n de uso compasivo de la FDA. El paciente hab铆a mostrado un deterioro cognitivo continuo a pesar del tratamiento con lecanemab, una terapia dirigida a la amiloide.
El tratamiento se realiza en colaboraci贸n con la Dra. Anita Fletcher en el AdventHealth Neuroscience Institute. Aunque el ensayo actual de fase 2a de NKGen se centra en el Alzheimer de etapa moderada, esto marca su primera posible expansi贸n hacia el tratamiento del Alzheimer leve, especialmente para pacientes que no responden a las terapias de primera l铆nea.
Troculeucel ha demostrado caracter铆sticas prometedoras, incluyendo la capacidad de atravesar la barrera hematoencef谩lica y mejorar los niveles de varias prote铆nas en el l铆quido cefalorraqu铆deo, mientras reduce la neuroinflamaci贸n.
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鞚� 旃橂電� AdventHealth Neuroscience Institute鞚� 鞎勲媹韮� 頂岆爤觳� 氚曥偓鞕� 順戨牓頃橃棳 歆勴枆霅橁碃 鞛堨姷雼堧嫟. NKGen鞚� 順勳灛 2a靸� 鞛勳儊鞁滍棙鞚� 欷戨摫霃� 鞎岇笭頃橃澊毹胳棎 齑堨爯鞚� 毵烄稊瓿� 鞛堨毵�, 鞚措矆 鞁滊弰電� 1彀� 旃橂鞐� 氚橃潙頃橃 鞎婋姅 瓴届 鞎岇笭頃橃澊毹� 頇橃瀽 旃橂搿滌潣 觳� 頇曥灔 臧�電レ劚鞚� 鞚橂頃╇媹雼�.
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NKGen Biotech (OTC : NKGN) a administr茅 la premi猫re dose de troculeucel, une th茅rapie cellulaire NK autologue 茅tendue, 脿 un patient atteint d'Alzheimer 脿 un stade l茅ger, sous autorisation d'utilisation compassionnelle de la FDA. Le patient avait montr茅 un d茅clin cognitif continu malgr茅 un traitement par lecanemab, une th茅rapie ciblant l'amylo茂de.
Le traitement est r茅alis茅 en collaboration avec la Dr Anita Fletcher 脿 l'AdventHealth Neuroscience Institute. Alors que l'essai de phase 2a actuel de NKGen se concentre sur l'Alzheimer 脿 un stade mod茅r茅, cela marque leur premi猫re possible extension au traitement de l'Alzheimer l茅ger, en particulier pour les patients ne r茅pondant pas aux th茅rapies de premi猫re ligne.
Troculeucel a d茅montr茅 des caract茅ristiques prometteuses, notamment sa capacit茅 脿 traverser la barri猫re h茅mato-enc茅phalique et 脿 am茅liorer les niveaux de diverses prot茅ines dans le liquide c茅phalo-rachidien tout en r茅duisant la neuroinflammation.
NKGen Biotech (OTC: NKGN) hat die erste Dosis von troculeucel, einer expandierten autologen NK-Zelltherapie, an einen Patienten mit Alzheimer im Fr眉hstadium verabreicht, und zwar unter einer von der FDA genehmigten Anwendung im Rahmen der Mitgef眉hlstherapie. Der Patient zeigte trotz Behandlung mit Lecanemab, einer amyloidgerichteten Therapie, weiterhin kognitive Verschlechterungen.
Die Behandlung wird in Zusammenarbeit mit Dr. Anita Fletcher vom AdventHealth Neuroscience Institute durchgef眉hrt. W盲hrend sich die aktuelle Phase-2a-Studie von NKGen auf Alzheimer im moderaten Stadium konzentriert, stellt dies die erste potenzielle Erweiterung auf die Behandlung von Alzheimer im Fr眉hstadium dar, insbesondere f眉r Patienten, die nicht auf Erstlinientherapien ansprechen.
Troculeucel hat vielversprechende Eigenschaften gezeigt, darunter die F盲higkeit, die Blut-Hirn-Schranke zu 眉berwinden und die Spiegel verschiedener Proteine in der Gehirn-R眉ckenmarks-Fl眉ssigkeit zu verbessern, w盲hrend es gleichzeitig die Neuroinflammation reduziert.
- First potential expansion into mild Alzheimer's treatment, broadening the therapeutic scope
- Troculeucel demonstrates ability to cross blood-brain barrier and improve key biomarkers
- FDA granted compassionate use IND authorization for the treatment
- Potential for combination treatment strategies with existing therapies
- Only a single patient compassionate use case, not a full clinical trial
- Early-stage exploration with uncertain outcomes
- Current approved therapies do not halt disease progression
SANTA ANA, Calif., July 10, 2025 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (OTC: NKGN) (鈥淣KGen鈥� or the 鈥淐ompany鈥�), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic natural killer (鈥淣K鈥�) 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 (鈥淚ND鈥�) authorization cleared by the U.S. Food and Drug Administration (鈥淔DA鈥�), to a patient with mild-stage Alzheimer鈥檚 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鈥檚 ongoing double-blind randomized Phase 2a trial is focused on moderate-stage Alzheimer鈥檚 disease (NCT06189963), this single-IND marks the company鈥檚 first potential expansion into the treatment of mild Alzheimer鈥檚, particularly for patients who fail to respond to existing first-line therapies. This initiative highlights NKGen鈥檚 dedication to advancing treatment options for Alzheimer鈥檚 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.
鈥淐urrently, there are two FDA-approved amyloid-targeting therapies available for Alzheimer鈥檚 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,鈥� said Paul Y. Song, M.D., Chairman and Chief Executive Officer of NKGen. 鈥淚n our clinical experience to date, troculeucel has been very well-tolerated and crosses the blood-brain barrier, improving levels of amyloid, 伪-synuclein, and tau proteins in the cerebrospinal fluid (鈥淐SF鈥�), while also reducing neuroinflammation, as evidenced by decreased levels of glial fibrillary acidic protein (鈥淕FAP鈥�). If we can demonstrate clinical improvement in Alzheimer鈥檚 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.鈥�
Anita Fletcher, M.D., Director of Neuroscience Clinical Research at AdventHealth Orlando, commented, 鈥淭he field has moved forward with targeted anti-amyloid therapies that lead to slowed progression of Alzheimer鈥檚 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.鈥�
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聽.
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 (鈥淚NN鈥�) for SNK01 assigned by the World Health Organization (鈥淲HO鈥�). The WHO INN approval of troculeucel establishes a universally recognized nonproprietary drug name for SNK01 and marks a significant step on NKGen鈥檚 journey toward bringing this therapy to market.
About AdventHealth Central Florida Division
AdventHealth鈥檚 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
The division鈥檚 flagship campus 鈥� AdventHealth Orlando 鈥� 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聽.
Forward-Looking Statements
Statements contained in this press release may contain 鈥渇orward-looking statements鈥� 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 鈥渁nticipate鈥�, 鈥渂elieve鈥�, 鈥渃ould鈥�, 鈥渃ontinue鈥�, 鈥渆xpect鈥�, 鈥渆stimate鈥�, 鈥渕ay鈥�, 鈥減lan鈥�, 鈥渙utlook鈥�, 鈥渇uture鈥� and 鈥減roject鈥� 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鈥檚 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鈥檚 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鈥檚 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鈥檚 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鈥檚 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 鈥淩isk Factors鈥� and elsewhere in the Company鈥檚 filings and reports, which may be accessed for free by visiting the Securities and Exchange Commission鈥檚 website at www.sec.gov and on the Company鈥檚 website under the subheading 鈥淚nvestors鈥擣inancial and Filings鈥�. 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
External Contact:
Kevin Gardner
Managing Director
LifeSci Advisors, LLC
FAQ
What is troculeucel and how is NKGN using it for Alzheimer's treatment?
What stage of clinical development is NKGN's troculeucel for Alzheimer's?
How does troculeucel differ from existing Alzheimer's treatments?
What potential advantages does NKGN's troculeucel offer for Alzheimer's patients?
Who is collaborating with NKGN on this Alzheimer's treatment?
