troculeucel (SNK01) / NKGen Biotech, Hekabio - LARVOL DELTA

NKGen Biotech to Present on Potential of Troculeucel in Neurodegenerative Diseases at Biologics Manufacturing Korea 2026 (GlobeNewswire) - "Dr. Song’s presentation will discuss the use of troculeucel in neurodegenerative diseases, including troculeucel’s mechanism of action in reducing cerebrospinal fluid ('CSF') neuroinflammatory and protein biomarkers, clinical experience with troculeucel in patients with Alzheimer’s disease ('AD'), Parkinson’s disease ('PD'), and frontotemporal dementia ('FTD'), and the regulatory landscape in Asia that may help expedite the development and commercialization of troculeucel."

Clinical • Alzheimer's Disease • Dementia • Parkinson's Disease

NKGen Biotech to Present on Troculeucel for Neurodegenerative Diseases at 4th Great Bay Cell and Gene Therapy Forum (GlobeNewswire) - "Dr. Song’s presentation will explore the application of troculeucel in neurodegenerative diseases, with a focus on its proposed mechanism of action, changes observed in neuroinflammatory and protein biomarkers in cerebrospinal fluid, and clinical experience in patients with Alzheimer’s disease. The presentation will also discuss Parkinson’s disease and frontotemporal dementia as potential areas for further evaluation of troculeucel."

Clinical data • Alzheimer's Disease • Dementia • Parkinson's Disease

NKGen Biotech to Present at the 2026 BIOCHINA Global Forum on Troculeucel’s Potential in Alzheimer’s Disease and Other Neurodegenerative Conditions (GlobeNewswire) - "Dr. Song’s presentation will provide an overview of troculeucel, the Company’s lead investigational program currently being evaluated in a Phase 2 clinical trial for Alzheimer’s disease, and discuss NKGen’s ongoing efforts to advance its innovative NK cell therapy platform for additional neurodegenerative diseases, such as amyotrophic lateral sclerosis (ALS), frontotemporal dementia (FTD), and Parkinson’s disease."

Clinical data • Alzheimer's Disease • Amyotrophic Lateral Sclerosis • Dementia • Parkinson's Disease

NKGen Biotech…announced the activation of three additional clinical trial sites in the United States for its ongoing Phase 2 study of troculeucel in moderate Alzheimer’s disease (GlobeNewswire) - "The new sites include Rutgers Health in Newark, New Jersey, Alzheimer’s Disease Research Center in Albany, New York, and K2 Medical Research in Orlando, Florida. Together, these additions expand the Company’s U.S. clinical footprint and improve geographic access for patients in the Northeast and Southeast regions....All three newly added sites are now active and available for patient screening and enrollment as part of the ongoing Phase 2 trial."

Trial status • Alzheimer's Disease

SNK01-AD01: Clinical Study of SNK01 in Participants With Moderate Alzheimer's Disease (clinicaltrials.gov) - P1/2 | N=36 | Recruiting | Sponsor: NKGen Biotech, Inc. | Trial completion date: Jun 2026 ➔ Jun 2027 | Trial primary completion date: Dec 2025 ➔ Dec 2026

IO biomarker • Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders

NKGen Biotech to Present Troculeucel Mechanism Data in Alzheimer’s and Frontotemporal Dementia at the Neuroimmunology Drug Development Summit (GlobeNewswire) - "The presentation will include an overview of the Company's expanding mechanistic dataset, including evidence that troculeucel selectively targets autoreactive T cells and may modulate key neuroinflammatory pathways implicated in disease progression....Dr. Song will also review clinical observations from early-stage studies, including encouraging biomarker trends and reductions in neuroinflammatory signals measured in cerebrospinal fluid."

Clinical • Alzheimer's Disease • Frontotemporal Lobar Degeneration

PLASMA GFAP AS A BIOMARKER FOR ANTI-INFLAMMATORY RESPONSE AND COGNITIVE IMPROVEMENT IN PHASE 1 TRIALS OF TROCULEUCEL FOR ALZHEIMER'S DISEASE (ADPD 2026) - P1, P1/2 | "These findings suggest plasma GFAP is a responsive biomarker for monitoring the anti-inflammatory effects of troculeucel and its cognitive benefits in AD. The data support troculeucel's therapeutic potential and highlight plasma GFAP as a valuable indicator of treatment efficacy in early-phase clinical trials."

Biomarker • P1 data • Alzheimer's Disease • CNS Disorders • Inflammation • FAP • GFAP

FIRST-IN-CLASS NK CELL THERAPY TROCULEUCEL SHOWS COGNITIVE BENEFIT IN MODERATE ALZHEIMER'S: DOSE-DEPENDENT PHASE 1 FINDINGS (ADPD 2026) - P1, P1/2 | "Troculeucel demonstrated excellent tolerance and early signs of dose-dependent cognitive benefit in moderate AD."

P1 data • Alzheimer's Disease • CNS Disorders

Poster Presentation Highlights Strong and Consistent Plasma GFAP Correlations Supporting Its Potential as a Non‑Invasive Biomarker of Clinical Status in Alzheimer’s Disease (The Manila Times) - "Findings support further evaluation of troculeucel’s immunomodulatory approach in the ongoing Phase 2 trial...Baseline plasma GFAP levels correlated with CDR-SB (r=0.60, p=0.044) and ADCOMS (r=0.64, p=0.030); GFAP-cognition correlations remained robust following troculeucel treatment: After three months of therapy, plasma GFAP continued to correlate with CDR-SB (r=0.57, p=0.056) and ADCOMS (r=0.66, p=0.022), demonstrating consistency of biomarker-clinical relationships over time; In moderate AD patients receiving ≥4 billion cells (n=4), correlations strengthened further, with statistically significant associations observed across timepoints for CDR-SB (r=0.76, p=0.009) and ADCOMS (r=0.71, p=0.018)."

Biomarker • Enrollment status • P1 data • Alzheimer's Disease

Oral Presentation Shows Encouraging Dose‑Responsive Cognitive Activity and Maintenance of Benefit with Troculeucel in Moderate Alzheimer’s Disease (PRNewswire) - "Pooled analysis of two previously reported open‑label Phase 1 studies (NCT04678453; NCT06189963) evaluating troculeucel in moderate AD showed encouraging and consistent signs of biological activity across dose levels ranging from 1 to 6 billion cells. At the three‑month assessment, all patients showed stability or improvement across multiple standardized cognitive measures, with higher doses associated with greater directional benefit and more frequent achievement of clinically meaningful change...100% of patients were stable or improved across all established minimal clinically important difference (MCID) thresholds...Higher doses (4-6B cells) were associated with greater directional improvement and more frequent MCID exceedance."

Retrospective data • Alzheimer's Disease

NKGen Biotech to Present Integrated Phase 1 Clinical and Biomarker Analyses for Troculeucel in Alzheimer’s Disease at AD/PD 2026 (GlobeNewswire) - "The presentations will highlight a new integrated analysis of patient-level data from two previously completed Phase 1 studies evaluating troculeucel in patients with Alzheimer’s disease. In these analyses, participants across both trials were evaluated as a combined cohort to assess dose-response relationships on cognitive measures. Biomarker associations, including plasma glial fibrillary acidic protein ('GFAP') as an indicator of astrocytic injury and activation that may reflect disease state in Alzheimer’s disease, were also examined."

Biomarker • P1 data • Alzheimer's Disease

Drug Development. (PubMed, Alzheimers Dement) - P1, P1/2 | "Troculeucel is consistently produced from AD patients and can cross the blood-brain barrier via CXCR3 to improve CSF levels of amyloid and alpha-synuclein proteins, while targeting autoreactive T cells to reduce neuroinflammation. Reduction of GFAP appears to be correlated with stabilization or improvement in ADCOMS scores observed in the study."

Journal • Alzheimer's Disease • CNS Disorders • Inflammation • CXCR3 • GFAP • NKG2D

Open-Label Extension Protocol to SNK01-AD01 Study (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: NKGen Biotech, Inc.

New P2 trial • Alzheimer's Disease • CNS Disorders

EXPANDED NON-GENETICALLY MODIFIED NATURAL KILLER CELLS (TROCULEUCEL) WITH ENHANCED CYTOTOXICITY IN MODERATE/ADVANCED ALZHEIMER'S DISEASE. SCIENTIFIC RATIONALE WITH PRELIMINARY CLINICAL AND BIOMARKER RESULTS. (WCN 2025) - P1 | "Troculeucel is an autologous NK cell product with significant cytotoxicity and activating receptor expression.: In Phase 1 dose escalation study (NCT04678453), SNK01 was administered IV q 3 weeks 4xs using a 3+3 design in advanced disease patients (median MMSE 14)...: Troculeucel is safe and has clinical activity in AD while improving CSF/plasma protein and neuroinflammation biomarkers. A randomized phase II trial is moderate stage patients is underway."

Biomarker • Clinical • Metastases • Alzheimer's Disease • CNS Disorders • GDF15 • GFAP • LTBP2 • p-tau181

NKGen Biotech to Present on the Use of Troculeucel for Neurodegenerative Diseases at the XXVII World Congress of Neurology (GlobeNewswire) - "At this year’s congress in Seoul, South Korea, NKGen Biotech will present the scientific rationale and latest clinical findings for troculeucel, its investigational autologous, enhanced NK cell therapy for Alzheimer’s disease. This presentation reflects NKGen’s continued commitment to advancing neurological care and contributing to the future of Alzheimer’s treatment."

Clinical • Alzheimer's Disease

NKGen Biotech to Present on the Use of Troculeucel for Neurodegenerative Diseases at the 3rd China Great Bay Cell and Gene Therapy Forum (GlobeNewswire) - "Dr. Song will discuss the scientific rationale and recent clinical data supporting the use of the investigational autologous enhanced NK cell therapy, troculeucel, in the treatment of neurodegenerative diseases. This presentation underscores NKGen’s commitment to advancing innovative NK cell-based approaches in the rapidly evolving cell and gene therapy field."

Clinical data • CNS Disorders

AdventHealth Neuroscience Institute Among First in U.S. to Offer Phase IIa Clinical Trial of Troculeucel for Moderate Alzheimer’s Disease (AdventHealth) - "Under the leadership of principal investigator Anita Fletcher, MD, AdventHealth Neuroscience Institute is the first site on the East Coast and among the first in the nation to offer a new Phase IIa clinical trial to evaluate the safety, tolerability and efficacy of SNK01 (troculeucel) in participants with moderate Alzheimer’s disease....Study participants must have positive evidence for a diagnosis of Alzheimer’s disease via amyloid positron emission tomography (amyloid PET) of the brain within the past 6 months as well as a Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score of ≥ 9.5 and <16.0."

Trial status • Alzheimer's Disease

NKGen Biotech, Inc. Announces Completion of NKMax Co., Ltd. Acquisition; Gains Full Control of Global Manufacturing and Intellectual Property Assets (GlobeNewswire) - "Approximately $16.9 million paid to acquire 65% equity stake in recapitalized debt-free NKMax, with NKMax operations now expected to be funded through 2026....This transaction is a culmination of a multi-year journey that has seen NKGen overcome significant challenges, emerge stronger, and continue its unwavering commitment to advancing groundbreaking cell therapies."

M&A • Alzheimer's Disease • Frontotemporal Lobar Degeneration • Parkinson's Disease • Solid Tumor

AdventHealth Neuroscience Institute Administers First Dose of Investigative NK Cell Therapy to Person with Alzheimer’s Disease (AdventHealth) - "Under a single compassionate use Investigational New Drug (IND) authorization cleared by the U.S. Food and Drug Administration (FDA), the AdventHealth Neuroscience Institute worked with NKGen Biotech to administer the first dose of troculeucel (SNK01), an expanded autologous natural killer (NK) cell therapy, on July 10, 2025, to a patient with Alzheimer’s disease who exhibited continued cognitive decline despite ongoing treatment with lecanemab, an amyloid targeting therapy....AdventHealth Orlando is also the first site on the East Coast and among the first in the nation to offer an ongoing Phase IIa clinical trial to evaluate the safety, tolerability and efficacy of troculeucel (SNK01) in participants with moderate Alzheimer’s disease. Dr. Fletcher serves as National Principal Investigator for the study and expects to enroll the first patient at the Central Florida site soon."

Clinical • Trial status • Alzheimer's Disease

NKGen Biotech Presents Troculeucel Mechanism of Action with Corresponding Phase 1 Biomarker Data at the Alzheimer’s Association International Conference 2025 (GlobeNewswire) - P1/2 | N=36 | NCT06189963 | P1 | N=10 | ASK-AD (NCT04678453) | Sponsor: NKGen Biotech, Inc. | "Preclinical and clinical trial data on the effect of troculeucel from two Phase 1 studies (NCT04678453 and NCT06189963) were presented...Elevated levels of chemokine CXCL9, CXCL10, and CXCL11 have been detected in cerebrospinal fluid ('CSF') during neuroinflammatory conditions...In AD, the accumulation of misfolded proteins elicits a cascade of autoreactive T-cell mediated neuroinflammation and neuronal damage...Troculeucel is a highly enhanced activated NK cell therapy with 91.25% CXCR3 expression....In vitro studies demonstrated that troculeucel was selectively activated in the presence of activated T cells, as evidenced by increased interferon-gamma production, elevated cytotoxicity, and enhanced CD107a expression...Twelve out of 13 patients (92%), with a median CDR-SB score of 10 at enrollment, had either stable or improved ADCOMS scores after three months of treatment."

Biomarker • P1 data • Preclinical • Alzheimer's Disease

NKGen Biotech and HekaBio Enter Strategic Partnership to Bring Novel NK Cell Therapy to Japan (GlobeNewswire) - "NKGen Biotech...and HekaBio...announced a strategic partnership to accelerate the regulatory, manufacturing and commercial development of NKGen’s autologous NK cell therapy, troculeucel, in Japan following HekaBio’s recently announced investment in common equity of NKGen. HekaBio will lead all clinical trials in Japan and oversee all regulatory activities with Japan's Pharmaceuticals and Medical Devices Agency for pre-market approval of troculeucel in several neurodegenerative disease indications, including Alzheimer’s and Parkinson’s Diseases....HekaBio will fully leverage the regulation and its domestic strategic partner network, aiming for first dosing in Japanese patients over the next 12 months."

Licensing / partnership • Alzheimer's Disease • Parkinson's Disease

NKGen Biotech to Present at the Alzheimer’s Association International Conference 2025 (GlobeNewswire) - "NKGen Biotech...announced that it will present on the mechanism of action for troculeucel, enhanced non-genetically modified NK cell therapy, in Alzheimer’s disease during a poster presentation at the upcoming Alzheimer’s Association International Conference 2025 ('AAIC 2025') to be held in Toronto, Canada and online from July 27-31, 2025."

Clinical • Alzheimer's Disease

NKGen Receives FDA Expanded Access Protocol Authorization for Landmark Treatment of Several Neurodegenerative Diseases (GlobeNewswire) - "IND approval allows for up to 20 patients to be enrolled; first patient enrollment is anticipated in Q3 2025...NKGen Biotech...announced that the U.S. Food and Drug Administration (FDA) has granted Expanded Access Program (EAP) authorization for its IND for an open-label, non-randomized, multi-center intermediate size expanded access protocol for use of troculeucel for neurodegenerative diseases. This includes its use for the treatment of several neurodegenerative diseases, many of which currently have no effective therapy....this EAP IND marks the company’s exploration into the treatment of other less common neurodegenerative diseases."

IND • CNS Disorders

NKGen Biotech Announces New Funding to Regain Compliance with Reporting Obligations and Listing Standards (GlobeNewswire) - "NKGen Biotech...announced that it has raised $2 million in new capital from a Japanese strategic investor, who will help NKGen bring its novel NK cell therapy, troculeucel, autologous expanded NK cell therapy, to the Japanese market. The new investment was made in the form of shares of the Company’s common stock priced at $0.25 per share and warrants, as described in the Company’s Form 8-K filed with the Securities and Exchange Commission on July 16, 2025. This new injection of capital, the Company’s ramping up of its Phase 2 clinical trial, the expected near-term satisfaction of public company reporting requirements and satisfaction of the previously disclosed payment obligation on the Company’s senior secured debt are all critical to position the Company for long-term success....NKGen is developing troculeucel for the treatment of neurodegenerative disorders and a broad range of cancers."

Financing • Alzheimer's Disease • Oncology

NKGen Biotech Administers First Dose of Troculeucel to Alzheimer’s Patient Who Continued to Decline Cognitively While on Prior Amyloid-Targeting Therapy (GlobeNewswire) - "NKGen Biotech...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....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."

Clinical • IND • Alzheimer's Disease