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
NKGen Biotech (NKGN) has appointed Dr. Anita Fletcher as National Principal Investigator for its Phase 2a clinical trial of troculeucel, an enhanced autologous NK cell therapy for moderate Alzheimer's disease. AdventHealth Research Institute in Orlando will be the first East Coast clinical site enrolling moderate-stage Alzheimer's patients.
The trial follows promising Phase 1 results where 90% of evaluable subjects showed stable or improved ADCOMS scores at Week 11. Improvements in CSF biomarkers were observed in multiple markers: 70% p-Tau181, 60% AB42/40 ratio, 60% GFAP, 40% GDF-15, 30% LTBP2, and 30% NF-L. No treatment-related adverse events were reported.
The Phase 2a trial will use cryopreserved product at the highest dose of 6 x 109 cells every three weeks for one year, targeting moderate Alzheimer's disease, for which there is currently no approved disease-modifying therapy.
NKGen Biotech (NKGN) ha nominato la Dr.ssa Anita Fletcher come Investigatrice Principale Nazionale per il suo studio clinico di Fase 2a di troculeucel, una terapia avanzata con cellule NK autologhe per l'Alzheimer moderato. L'AdventHealth Research Institute di Orlando sarà il primo centro clinico della costa est ad arruolare pazienti con Alzheimer in fase moderata.
Lo studio segue risultati promettenti della Fase 1, dove il 90% dei soggetti valutabili ha mostrato punteggi ADCOMS stabili o migliorati alla settimana 11. Sono stati osservati miglioramenti nei biomarcatori del liquido cerebrospinale in più marcatori: 70% p-Tau181, 60% rapporto AB42/40, 60% GFAP, 40% GDF-15, 30% LTBP2 e 30% NF-L. Non sono stati riportati eventi avversi correlati al trattamento.
La prova di Fase 2a utilizzerà un prodotto criopreservato alla dose massima di 6 x 10^9 cellule ogni tre settimane per un anno, mirato all'Alzheimer moderato, per il quale attualmente non esiste una terapia approvata per la modifica della malattia.
NKGen Biotech (NKGN) ha nombrado a la Dra. Anita Fletcher como Investigadora Principal Nacional para su ensayo clínico de Fase 2a de troculeucel, una terapia mejorada con células NK autólogas para la enfermedad de Alzheimer moderada. El AdventHealth Research Institute en Orlando será el primer sitio clínico de la costa este que inscriba pacientes con Alzheimer en etapa moderada.
El ensayo sigue resultados prometedores de la Fase 1, donde el 90% de los sujetos evaluables mostraron puntuaciones de ADCOMS estables o mejoradas en la Semana 11. Se observaron mejoras en los biomarcadores del líquido cefalorraquídeo en múltiples marcadores: 70% p-Tau181, 60% relación AB42/40, 60% GFAP, 40% GDF-15, 30% LTBP2 y 30% NF-L. No se informaron eventos adversos relacionados con el tratamiento.
El ensayo de Fase 2a utilizará un producto criopreservado a la dosis más alta de 6 x 10^9 células cada tres semanas durante un año, dirigido a la enfermedad de Alzheimer moderada, para la cual actualmente no hay terapia modificadora de la enfermedad aprobada.
NKGen Biotech (NKGN)는 Dr. Anita Fletcher를 자발적 알츠하이머 질환 치료를 위한 troculeucel의 2a상 임상 시험의 국가 수석 연구원으로 임명했습니다. 올랜도의 AdventHealth Research Institute는 중간 단계의 알츠하이머 환자를 모집하는 첫 번째 동부 해안 임상 사이트가 될 것입니다.
이 시험은 1상에서 90%의 평가 가능한 피험자가 11주차에 안정적이거나 개선된 ADCOMS 점수를 보였다는 유망한 결과를 따릅니다. 여러 바이오마커에서 CSF 바이오마커의 개선이 관찰되었습니다: 70% p-Tau181, 60% AB42/40 비율, 60% GFAP, 40% GDF-15, 30% LTBP2 및 30% NF-L. 치료와 관련된 부작용은 보고되지 않았습니다.
2a상 시험에서는 최대 6 x 10^9 세포의 동결 보존 제품을 사용하여 1년 동안 3주마다 치료할 예정이며, 현재 승인된 질병 수정 치료가 없는 중간 알츠하이머 질환을 목표로 합니다.
NKGen Biotech (NKGN) a nommé Dr. Anita Fletcher comme Investigatrice Principale Nationale pour son essai clinique de Phase 2a de troculeucel, une thérapie améliorée par cellules NK autologues pour la maladie d'Alzheimer modérée. L'Institut de Recherche AdventHealth à Orlando sera le premier site clinique de la côte est à recruter des patients atteints d'Alzheimer à un stade modéré.
L'essai fait suite à des résultats prometteurs de la Phase 1, où 90 % des sujets évaluables ont montré des scores ADCOMS stables ou améliorés à la semaine 11. Des améliorations des biomarqueurs du LCR ont été observées pour plusieurs marqueurs : 70 % p-Tau181, 60 % rapport AB42/40, 60 % GFAP, 40 % GDF-15, 30 % LTBP2 et 30 % NF-L. Aucun événement indésirable lié au traitement n'a été signalé.
L'essai de Phase 2a utilisera un produit cryopréservé à la dose maximale de 6 x 10^9 cellules toutes les trois semaines pendant un an, ciblant la maladie d'Alzheimer modérée, pour laquelle il n'existe actuellement aucun traitement modificateur de la maladie approuvé.
NKGen Biotech (NKGN) hat Dr. Anita Fletcher zur nationalen Hauptprüferin für die Phase 2a-Studie von troculeucel ernannt, einer verbesserten autologen NK-Zelltherapie für die moderate Alzheimer-Krankheit. Das AdventHealth Research Institute in Orlando wird die erste klinische Einrichtung an der Ostküste sein, die Patienten mit moderatem Alzheimer rekrutiert.
Die Studie folgt vielversprechenden Ergebnissen aus Phase 1, bei denen 90 % der auswertbaren Probanden in Woche 11 stabile oder verbesserte ADCOMS-Werte zeigten. Verbesserungen bei CSF-Biomarkern wurden bei mehreren Markern beobachtet: 70 % p-Tau181, 60 % AB42/40-Verhältnis, 60 % GFAP, 40 % GDF-15, 30 % LTBP2 und 30 % NF-L. Es wurden keine behandlungsbedingten unerwünschten Ereignisse gemeldet.
Die Phase 2a-Studie wird ein kryokonserviertes Produkt in der höchsten Dosis von 6 x 10^9 Zellen alle drei Wochen über ein Jahr hinweg verwenden und sich auf die moderate Alzheimer-Krankheit konzentrieren, für die derzeit keine genehmigte krankheitsmodifizierende Therapie existiert.
- Phase 1 trial showed 90% of subjects had stable or improved ADCOMS scores
- Significant improvements in multiple CSF biomarkers observed
- No treatment-related adverse events reported in Phase 1
- Targeting an unmet medical need with no current disease-modifying therapy
- 70% of Phase 1 subjects were treated at relatively low doses
- Only four total doses were administered in Phase 1
Insights
The appointment of Dr. Fletcher and expansion to AdventHealth Orlando marks a important acceleration in NKGen's clinical program for troculeucel in moderate Alzheimer's disease. This development is particularly significant as approximately 30% of Alzheimer's patients have moderate-stage disease with no approved disease-modifying treatments available.
The Phase 1 trial data presents compelling evidence for further investigation. The observation that 90% of evaluable subjects showed stable or improved ADCOMS scores is noteworthy, especially considering that 70% of subjects received suboptimal dosing. The improvement in multiple CSF biomarkers - including p-Tau181, AB42/40 ratio, and GFAP - suggests potential disease-modifying effects across various pathological processes in AD.
The Phase 2a trial design shows strategic optimization, implementing the highest dose of 6 x 109 cells every three weeks for a full year, using cryopreserved product. This represents a significant intensification from Phase 1, potentially enhancing therapeutic impact. The clean safety profile observed in Phase 1 supports this more aggressive dosing strategy.
The expansion to the East Coast through AdventHealth Orlando is strategically important for several reasons: it diversifies the patient population, potentially strengthening the data's generalizability, and demonstrates the feasibility of delivering cryopreserved cell therapy products across different geographic locations - a important factor for eventual commercialization.
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
"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, and30% 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
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.
Internal Contact:
Denise Chua, MBA, CLS, MLS (ASCP)
SVP, Corporate Affairs
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
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