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

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

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 (GlobeNewswire) - "NKGen Biotech... 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....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."

Trial status • Alzheimer's Disease

Analysis of Clinical Benefit for a Phase 2 Basket Study Using DNG64 Cyclin G1 Inhibitor Gene Vector + Immunotherapy for CCNG1 Oncogene Expressing Tumors Predicts Successful Efficacy Endpoints (NCT04091295) (ASGCT 2025) - P | "Taken together, the data analyses indicate that: (1) All tested tumors show enhanced CCNG1 oncogene expression, reinforcing the use of intravenous DNG64 Cyclin G1 inhibitor therapy for advanced sarcoma, pancreatic and breast cancer; (2) An Overall Response Rate of 50% for all groups, a 66% ORR for DNG64, SNK01 and PD1 inhibitor group, and a clinical benefit rate of 75% for all groups, when categorized by both tumor CCNG1 expression level and cancer type, meet the Simon's 2-stage design threshold clinical benefit rate of 30%, thereby qualifying all groups for further studies of efficacy and safety in a randomized Phase 2 basket study using combination regimens of DNG64 + immunotherapy. Disease Focus of Abstract:Cancer Solid Tumors"

Clinical • IO biomarker • P2 data • Pan tumor • Breast Cancer • Oncology • Osteosarcoma • Pancreatic Cancer • Sarcoma • Solid Tumor • CCNG1

Use of Expanded Non-genetically Modified Natural Killer Cells (Troculeucel) with Enhanced Cytotoxicity in Patients with Alzheimer's Disease. Preliminary Clinical and Biomarker Results. (ASGCT 2025) - P1, P1/2 | " In this Phase 1 dose escalation study (NCT04678453), SNK01 was administered intravenously (IV) every three weeks for a total of 4 treatments using a 3+3 design in pts with mild, moderate or severe Alzheimer's Disease (AD) confirmed by complete evaluation including MRI and PET scans... Troculeucel has been shown to be very safe and well tolerated. It appears to have clinical activity in AD while also improving CSF protein levels and reducing neuroinflammation. A randomized phase II trial in moderate stage Alzheimer's patients is currently underway, and troculeucel is planned to be studied in Parkinson's Disease, Frontotemporal Dementia, and Lewy Body Dementia."

Biomarker • Clinical • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Frontotemporal Lobar Degeneration • Inflammation • Lewy Body Disease • Movement Disorders • Parkinson's Disease • CXCR3 • GDF15 • GFAP • LTBP2 • NKG2D • p-tau181

NKGen Biotech To Present on the Use of Troculeucel for Alzheimer’s and Parkinson’s Disease at the 7th China International Biotechnology Conference & Exhibition (GlobeNewswire) - "Dr. Song will present on the use of troculeucel in the treatment of patients with Alzheimer’s and Parkinson’s disease, highlighting the promising results previously observed in our Phase 1 clinical trials and compassionate use cases. Additionally, Dr. Song will provide an update on NKGen’s ongoing Phase 1/2a clinical trial for moderate Alzheimer’s disease, with recent data presented at the AD/PD 2025 conference."

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

NKGen Biotech Presents Data from Phase 1/2a Clinical Trial of Troculeucel in Moderate Alzheimer’s Disease at the International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD 2025) (GlobeNewswire) - P1/2a | N=36 | NCT06189963 | Sponsor: NKGen Biotech, Inc. | "NKGen Biotech, Inc...announced the oral presentation of updated Phase 1 clinical data from the Phase 1/2a trial evaluating troculeucel, cryopreserved expanded autologous NK cell therapy, in patients with moderate AD at the International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders (AD/PD 2025) in Vienna, Austria....After up to 12 months of treatment, with a dose of 6 x 109 cells every three weeks, the three patients had no drug-related adverse reactions. At 3 months, preliminary efficacy analyses for the three patients showed stable or improved cognitive scores on CDR-SB and ADCOMS; two of the three patients improved on all cognitive scales and ADCOMS score and downgraded their AD stage from moderate to mild (based on CDR-SB score)."

P1 data • Alzheimer's Disease

PRELIMINARY COGNITIVE IMPROVEMENT IN PHASE I COHORT OF MODERATE ALZHEIMER'S DISEASE SUBJECTS TREATED WITH AUTOLOGOUS NATURAL KILLER CELLS (TROCULEUCEL; SNK01) (ADPD 2025) - P1/2 | "Conclusions Troculeucel at the highest dose given to moderate AD subjects was well tolerated and in 2/3 subjects showed clinical benefits after only 3 months on therapy. Troculeucel will be evaluated for safety and efficacy in the randomized, placebo-controlled Phase IIa part of the study."

Clinical • P1 data • Alzheimer's Disease • CNS Disorders • Inflammation

NKGen Biotech To Present Updated Troculeucel Data at the International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD 2025) (GlobeNewswire) - "NKGen Biotech, Inc...today announced that Paul Y. Song, M.D., Chairman and Chief Executive Officer of NKGen, will present at the International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders ('AD/PD 2025') taking place online and in Vienna, Austria from April 1 – 5, 2025....Dr. Song’s presentation will focus on the three-month cognitive and biomarker results from the Phase 1 cohort of the Phase 1/2a clinical trial for troculeucel NK cell therapy in moderate Alzheimer’s disease, as well as new data from the six-month analysis of this cohort."

P1 data • Alzheimer's Disease

NKGen Biotech To Present on Potential of Troculeucel for the Treatment of Neurodegenerative Diseases at the 13th Annual Alzheimer’s & Parkinson’s Drug Development Summit (GlobeNewswire) - "NKGen Biotech, Inc...today announced that Paul Y. Song...will present at the 13th Annual Alzheimer’s & Parkinson’s Drug Development Summit (the 'Summit') to be held in Boston, MA, from March 18–20, 2025. Dr. Song’s presentation will highlight troculeucel, the Company’s autologous, non-genetically modified NK cell therapy, as a potential treatment for neurodegenerative diseases...Dr. Song will outline the mechanism of troculeucel, the Company’s novel, autologous NK cell therapy, for treating neurodegeneration. He will also present promising data from the Company’s Phase 1 clinical trial, demonstrating early signs of clinical benefit...for moderate Alzheimer’s Disease and a new Investigational New Drug for Parkinson’s Disease."

P1 data • Alzheimer's Disease • CNS Disorders • Parkinson's Disease

NKGen Biotech Announces Administration of First Dose of Troculeucel to Stroke Patient Under FDA-Cleared Compassionate Use Program (GlobeNewswire) - "NKGen Biotech, Inc...today announced the administration of troculeucel, an expanded autologous NK cell therapy, in a stroke patient under a single compassionate use, Investigational New Drug ('IND') cleared by the U.S. Food and Drug Administration ('FDA')."

Trial status • Cardiovascular

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 (GlobeNewswire) - "NKGen Biotech, Inc...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...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."

Trial status • Alzheimer's Disease

NKGen Biotech Announces Administration of First Dose of Troculeucel to Frontotemporal Dementia Patient Under FDA-Cleared Compassionate Use Program (GlobeNewswire) - "KGen Biotech, Inc...today announced the administration of troculeucel, an expanded autologous NK cell therapy, in an FTD patient under a single compassionate use, Investigational New Drug ('IND') cleared by the U.S. Food and Drug Administration ('FDA')....The patient will be routinely assessed independently by Dr. Mendez at UCLA while receiving troculeucel infusions at the Sarcoma Oncology Center under the guidance of Dr. Sant Chawla and Dr. Erlinda Gordon."

Clinical • Dementia

NKGen Biotech Announces Publication of Phase 1 Troculeucel Clinical Trial Results for the Treatment of Alzheimer’s Disease (GlobeNewswire) - P1 | N=36 | NCT06189963 | Sponsor: NKGen Biotech, Inc. | "Despite 70% of subjects being treated at relatively low doses of troculeucel, 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. The study demonstrated that adoptive NK cell therapy was well-tolerated. Treatment with troculeucel reduced neuroinflammation and had a positive effect on brain protein aggregates (as suggested by CSF biomarker levels), which appeared to translate into a stabilization or even an improvement in cognitive function. Given the role of the innate immune system in AD pathology, a reduction in neuroinflammation as a therapeutic strategy may complement the current available anti-Aβ antibodies...The additional ability of NK cell therapy to potentially cause degradation of protein aggregates suggests that this treatment on its own may have therapeutic and/or disease-modifying benefits."

P1 data • Alzheimer's Disease