Delving into the Latest Updates on Troculeucel with Synapse

Overview

Basic Info

Drug Type

CAR-NK

Synonyms

SNK01 - NKGen Biotech

Target-

Mechanism

Gene transference, Natural killer cell replacements

Therapeutic Areas

NeoplasmsNervous System DiseasesImmune System Diseases+ [2]

Active Indication

Alzheimer DiseaseAdvanced cancerRefractory Cancer+ [2]

Inactive Indication

Advanced Malignant Solid NeoplasmBladder CancerColorectal Cancer+ [14]

Originator Organization

NKGen Biotech, Inc.

Active Organization

NKGen Biotech, Inc.

NKGen Operating Biotech, Inc.Startup

NKMAX Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 1/2

First Approval Date-

Regulation-

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The goal of this clinical trial is to test SNK01 in participants with moderate Alzheimer's Disease. The main questions it aims to answer are:
1. Is SNK01 safe and tolerable when administered every 3 weeks for up to 1 year as an intravenous infusion
2. Can SNK01 administration improve cognitive assessment scores and biomarkers

Start Date21 Nov 2023

Sponsor / Collaborator

NKGen Biotech, Inc.

NCT05099549 / TerminatedPhase 1/2

A Phase 1/2a, Open-Label, Multi-Center Study Evaluating the Safety, Tolerability, and Anti-Tumor Activity of AFM24 in Combination With Ex Vivo Expanded Autologous Natural Killer Cells (SNK01) in Subjects With Advanced/Metastatic EGFR-Expressing Cancers

This is an open-label, multi-center study to evaluate the safety, tolerability, and anti-tumor activity of SNK01 in combination with AFM24 in subjects with advanced or metastatic EGFR-expressing cancers.

Start Date03 Nov 2021

Sponsor / Collaborator

NKGen Operating Biotech, Inc.Startup

[+1]

NCT04872634 / Unknown statusPhase 1/2

A Phase I/IIa, Open, Single-Center Clinical Trial Evaluating the Safety and Anti-Tumor Activity of SNK01 (Natural Killer Cells) Administered in Combination With Gemcitabine/Carboplatin or Gemcitabine/Carboplatin/Cetuximab to Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients Who Have Failed Prior Tyrosine Kinase Inhibitor (TKI) Therapy (SNK_ASTER)

This clinical trial is a Single-Center, Open, Phase I/IIa Clinical Trial conducted to evaluate the safety and anti-tumor activity of SNK01 and GC +/- Cetuximab administered in combination to Locally advanced or Metastatic Non-small Cell Lung Cancer Patients who have failed prior Tyrosine Kinase Inhibitor (TKI) therapy at least once.
After the start of the clinical trial, the first 3 subjects complete the enrollment in Cohort 1 in serial order and then 3 subjects are enrolled in Cohort 2 in serial order. After this, Cohorts 1, 3 and Cohorts 2, 4 are independently processed and subjects are enrolled in serial order when new cohorts start and/or replacement subjects are required. For the subjects who are additionally enrolled after the DLT evaluation and the MTD is determined in each dose cohort, no DLT evaluation is conducted.
The subjects allotted to each cohort are administered with the SNK01 manufactured from peripheral blood mononuclear cells total 8 times over a period of about 10 weeks. Combined administration of SNK01 starts from the Cycle 2 (Week 4) of Cytotoxic Chemotherapy and SNK01 is administered at an interval of 1 week starting from the day after the administration of Cytotoxic Chemotherapy and/or Cetuximab (Visit 5-1, D23).
When no disease progression is confirmed at EOT (End of Treatment), disease progression is checked until the clinical trial is over. The adverse events which have occurred during the study period are monitored until the date when the investigator judges that no monitoring is required as the symptom has disappeared or there is no further change in the symptom or the 30th day (±3 d) from the latest date of the administration among Gemcitabine, Carboplatin and Cetuximab after the EOT, whichever comes first.
For all the subjects enrolled in the present clinical trial, safety is checked in accordance with CTCAE V5.0 and effectiveness is checked in accordance with RECIST V1.1 through the vital signs, laboratory test, adverse events, etc. during the study period.

Start Date08 Jul 2021

Sponsor / Collaborator

NKMAX Co., Ltd.

100 Clinical Results associated with Troculeucel

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100 Translational Medicine associated with Troculeucel

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100 Patents (Medical) associated with Troculeucel

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3

Literatures (Medical) associated with Troculeucel

01 Mar 2024·Journal for ImmunoTherapy of Cancer

Safety and efficacy of SNK01 (autologous natural killer cells) in combination with cytotoxic chemotherapy and/or cetuximab after failure of prior tyrosine kinase inhibitor in non-small cell lung cancer: non-clinical mouse model and phase I/IIa clinical study

Article

Author: Choi, Chang-Min ; Ji, Wonjun ; Choi, Myeong Geun ; Jung, Jae Seob ; Choi, Mi Young ; Kim, Yong Man ; Jo, Jong-Min ; Yoon, Byeong Gon ; Lee, Jae Cheol ; Son, Gun Woo ; Rho, Jin Kyung ; Ko, Dae-Hyun

BackgroundChoosing treatments for epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) patients with osimertinib resistance is challenging. We evaluated the safety and efficacy of SNK01 (autologous natural killer (NK) cells) in combination with cytotoxic chemotherapy and/or cetuximab (an anti-EGFR monoclonal antibody) in treating EGFR-mutated NSCLC in this non-clinical and phase I/IIa clinical trial.MethodsWe developed a cell line-derived xenograft-humanized mouse model with an osimertinib-resistant lung cancer cell line. The mice were divided into four groups based on treatment (no treatment, cetuximab, SNK01, and combination groups) and treated weekly for 5 weeks. In the clinical study, 12 patients with EGFR-mutated NSCLC who failed prior tyrosine kinase inhibitor (TKI) received SNK01 weekly in combination with gemcitabine/carboplatin (n=6) or cetuximab/gemcitabine/carboplatin (n=6) and dose escalation of SNK01 following the “3+3” design.ResultsIn the non-clinical study, an increase in NK cells in the blood and enhanced NK cell tumor infiltration were observed in the SNK01 group. The volume of tumor extracted after treatment was the smallest in the combination group. In the clinical study, 12 patients (median age, 60.9 years; all adenocarcinoma cases) received SNK01 weekly for 7–8 weeks (4×109cells/dose (n=6); 6×109cells/dose (n=6)). The maximum feasible dose of SNK01 was 6×109cells/dose without dose-limiting toxicity. Efficacy outcomes showed an objective response rate of 25%, disease control rate of 100%, and median progression-free survival of 143 days.ConclusionSNK01 in combination with cytotoxic chemotherapy, including cetuximab, for EGFR-mutated NSCLC with TKI resistance was safe and exerted a potential antitumor effect.Trial registration numberNCT04872634.

15 Oct 2022·Cancer Research and TreatmentQ2 · MEDICINE

A Phase I/IIa Randomized Trial Evaluating the Safety and Efficacy of SNK01 Plus Pembrolizumab in Patients with Stage IV Non-Small Cell Lung Cancer

Q2 · MEDICINE

Article

Author: Kang, Yoonmi ; Ji, Wonjun ; Ko, Dae-Hyun ; Choi, Chang-Min ; Kim, Sang-Yeob ; Choi, Myeong Geun ; Do, Eun-Ju ; Rho, Jin Kyung ; Kim, Eo Jin ; Jung, Jae Seob ; Kim, Dong Ha ; Lee, Jae Cheol ; Kim, Yong Man ; Cho, Yong-Hee

Purpose The aim of this study is to evaluate the safety and efficacy of ex vivo activated and expanded natural killer (NK) cell therapy (SNK01) plus pembrolizumab in a randomized phase I/IIa clinical trial.Materials and Methods Overall, 18 patients with advanced non–small cell lung cancer (NSCLC) and a programmed death ligand 1 tumor proportion score of 1% or greater who had a history of failed frontline platinum-based therapy were randomized (2:1) to receive pembrolizumab every 3 weeks +/– 6 weekly infusions of SNK01 at either 2×109 or 4×109 cells per infusion (pembrolizumab monotherapy vs. SNK01 combination). The primary endpoint was safety, whereas the secondary endpoints were the objective response rate (ORR), progression-free survival (PFS), overall survival, and quality of life.Results Since no dose-limiting toxicity was observed, the maximum tolerated dose was determined as SNK01 4×109 cells/dose. The safety data did not show any new safety signals when SNK01 was combined with pembrolizumab. The ORR and the 1-year survival rate in the NK combination group were higher than those in patients who underwent pembrolizumab monotherapy (ORR, 41.7% vs. 0%; 1-year survival rate, 66.7% vs. 50.0%). Furthermore, the median PFS was higher in the SNK01 combination group (6.2 months vs. 1.6 months, p=0.001).Conclusion Based on the findings of this study, the NK cell combination therapy may consider as a safe treatment method for stage IV NSCLC patients who had a history of failed platinum-based therapy without an increase in adverse events.

01 Jul 2022·Thoracic Cancer

Two‐year efficacy of SNK01 plus pembrolizumab for non‐small cell lung cancer: Expanded observations from a phase I/IIa randomized controlled trial

Article

Author: Lee, Jae Cheol ; Kim, Yong Man ; Ji, Wonjun ; Choi, Chang‐Min ; Park, Hyung Jun ; Jung, Jae Seob

AbstractBackgroundA previous trial showed that autologous ex‐vivo expanded NK cell (SNK01) treatment combined with pembrolizumab showed better efficacy than pembrolizumab monotherapy in advanced non‐small cell lung cancer (NSCLC). This study was a 2‐year follow‐up of that previous study to determine the long‐term efficacy of the combination treatment.MethodsThis trial included 20 patients with advanced NSCLC with a PD‐L1 tumor proportion score of 1% or greater who failed prior to front‐line platinum‐based therapy. The patients received pembrolizumab with low‐dose SNK01 (2 × 109 cells/dose) or high‐dose SNK01 (4 × 109 cells/dose), or pembrolizumab monotherapy. The primary study endpoint was overall survival (OS), and the secondary endpoint was progression‐free survival (PFS).ResultsTwo patients were excluded following serious adverse events. Among the 11 patients who died, five were from the NK groups (41.6%, n = 5/12), and six received pembrolizumab monotherapy (100%, n = 6/6). The estimated 2‐year survival rate was 58.3% versus 16.7% (pembrolizumab plus SNK01 vs. pembrolizumab monotherapy). The hazard ratio of pembrolizumab plus SNK01 compared with pembrolizumab monotherapy was 0.32 (95% CI: 0.1, 1.08, p‐value: 0.066). Although the median PFS was significantly higher in the pembrolizumab plus SNK01 group than in the pembrolizumab alone group, OS and PFS did not differ statistically between patients who received low doses of NK cells and those who received high doses of NK cells.ConclusionsAutologous NK cells can enhance the long‐term OS and PFS for NSCLC. A larger study is needed to confirm this result.Clinical Research Information Service number: KCT0003463.

74

News (Medical) associated with Troculeucel

11 Nov 2024

·www.prnewswire.com

NK Cell Therapy Clinical Trial Pipeline Appears Robust With 140+ Key Pharma Companies Actively Working in the Therapeutics Segment | DelveInsight

NK cell therapy is gaining momentum as a promising solution to unmet medical needs in cancer treatment, offering safer, targeted options for patients unresponsive to traditional therapies. Increased R&D investment, regulatory support, and successful clinical trials have bolstered confidence in these therapies, while technological advances in cell production are set to meet growing demand. Rising cancer rates and heightened public awareness further amplify market potential, making NK cell therapy a pivotal area of growth in oncology. LAS VEGAS, Nov. 11, 2024 /PRNewswire/ -- DelveInsight's ' NK Cell Therapy Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline NK cell therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the NK cell therapy pipeline domain. Key Takeaways from the NK Cell Therapy Pipeline Report DelveInsight's NK cell therapy pipeline report depicts a robust space with 140+ active players working to develop 160+ pipeline NK cell therapies. Key NK cell therapy companies such as Amgen, Innate Pharma, Nektar Therapeutics, SMT bio Co., Ltd., Alphageneron Pharmaceuticals, XNK Therapeutics, ImmunityBio, Cellid, Cantargia, Affimed Therapeutics, Takeda, Artiva Biotherapeutics, Sanofi, Dragonfly Therapeutics, INmune Bio, NKGen Biotech, Asclepius Technology Company Group, Glycostem Therapeutics (IPD Therapeutic), Wugen, Celularity, VERAXA, GamidaCell, MiNK Therapeutics, Indapta Therapeutics, ImmunityBio, Inc., Allife Medical Science and Technology, Nkarta, Base Therapeutics, GT Biopharma, Athenex, Ambicion, Biohaven Pharmaceuticals, Acepodia, Bright Path Biotherapeutics, Nkarta Therapeutics, Qihan Biotech, Century Therapeutics, Fate Therapeutics, Chimeric Therapeutics, Senti Biosciences, GICELL, Deverra Therapeutics, Medigen Biotechnology Corporation, GlaxoSmithKline, CytoImmune Therapeutics, Nuwacell Biotechnologies Co., Ltd., and others are evaluating new NK cell therapies to improve the treatment landscape. Promising NK cell therapies in the pipeline such as Bemarituzumab, Monalizumab, NKTR-225, SMT-NK, Enkastim, CellProtect, ALT 803, BVAC-C, PD-L1.t-haNK, Nidanilimab, M ceNK, HER2 t-haNK, AFM-13, TAK-007, IPH4102, AB-101, KDS-1001, AB-201, DF9001, INKmune, IPH65, SNK01, IPH6101 (SAR443579), BCMA CAR-NK 92 cells, DF1001, Allogeneic Natural Killer Cell Therapy (oNKord), WU-NK-101, AFM24, CYNK-001, FLYSYN, GDA-201, AGENT-797, CYNK-101, SAR445514, IDP-023, DF6002, CD19.taNK, Anti-PSMA CAR NK cells, DF2001, NKX101, NK510, GTB-3550, KUR-501, RK-pulsed autologous antigen-presenting cells (APCs), BHV-1100, ACE1702, iPS NKT, Anti-CD19/CD22 CAR NK cell therapy, NKX019, KUR-502, BVAC-P, QN-019a, QN-030a, QN-023a, CNTY-101, FT576, CHM 0201, SENTI-202, AFM28, DF8001, FT522, SNK02, GIC-102, DVX201, Magicell®-NK, GSK4381562, CYTO NK-102, NCR300, and others are under different phases of NK cell therapy clinical trials. In October 2024, Immunitybio announced that the first patients had been dosed in an initial trial studying the potential of the company's CAR-NK cell therapy targeting CD-19 in the treatment of non-Hodgkin's lymphoma (NHL). In July 2024, The U.S. Food and Drug Administration (FDA) gave Nkarta the green light to launch a clinical trial testing its cell therapy candidate NKX019 in people with ANCA-associated vasculitis (AAV) and other autoimmune disorders. In May 2024, KGen Biotech announced that its Safety Review Committee had cleared the Company's cryopreserved autologous, expanded, and enhanced SNK01 to progress into Phase II clinical development. In May 2024, Fate Therapeutics announced that a late-breaking abstract featuring preclinical data from its FT522 program for autoimmune diseases will be featured at the American Society of Gene and Cell Therapy (ASGCT) 27th Annual Meeting. In April 2024, Sanofi moved its natural killer (NK) cell engager candidate SAR443579/IPH6101 to a Phase II trial evaluating the drug's use in treating a range of blood cancers. In April 2024, the FDA granted orphan drug designation to the investigational therapy IGNK001 (Gengleucel) for patients with acute myeloid leukemia (AML). In February 2024, Indapta Therapeutics received FDA Fast Track Designation for its natural killer (NK) cell therapy IDP-023 for patients with multiple myeloma (MM) and non-Hodgkin lymphoma (NHL). Request a sample and discover the recent advances in the NK cell therapy segment @ NK Cell Therapy Pipeline Report The NK cell therapy pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage NK cell therapies, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the NK cell therapy clinical trial landscape. NK Cell Therapy Overview Natural Killer (NK) cell therapy is an innovative approach in immunotherapy that harnesses the power of NK cells, a vital component of the innate immune system. Unlike T cells, which require prior sensitization to target cancer cells, NK cells can recognize and kill abnormal cells without prior exposure. This unique ability makes NK cell therapy a promising option for treating various cancers, including hematologic malignancies like leukemia and lymphoma, as well as solid tumors. By isolating and activating NK cells from a patient's blood or using engineered NK cells from healthy donors, researchers aim to enhance the immune response against tumors, leading to improved patient outcomes. Recent advancements in genetic engineering, such as the introduction of chimeric antigen receptors (CAR) into NK cells, are further enhancing their specificity and efficacy against cancer cells. The clinical applications of NK cell therapy are expanding rapidly, supported by a growing body of research and early-phase clinical trials. These studies have shown promising results, demonstrating the ability of NK cell therapy to induce durable remissions in patients with refractory cancers. Furthermore, the off-the-shelf nature of certain NK cell therapies allows for quicker treatment deployment compared to traditional CAR-T cell therapies, which require a personalized approach. Challenges remain, including optimizing NK cell expansion, persistence, and overcoming the immunosuppressive tumor microenvironment. However, ongoing research into combination therapies, such as pairing NK cell therapy with checkpoint inhibitors or monoclonal antibodies, is expected to enhance the therapeutic potential of NK cells and provide new hope for cancer patients. Find out more about NK cell therapy @ Novel NK Cell Therapies A snapshot of the Pipeline NK Cell Therapies mentioned in the report: Learn more about the emerging NK cell therapies @ NK Cell Therapy Clinical Trials NK Cell Therapy Therapeutics Assessment The NK cell therapy pipeline report proffers an integral view of the emerging NK cell therapies segmented by stage, product type, molecule type, and route of administration. Scope of the NK Cell Therapy Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous, Parenteral, Topical Therapeutics Assessment By Molecule Type: Vaccines, Monoclonal antibody, Peptides, Polymer, Small molecule Key NK Cell Therapy Companies: Amgen, Innate Pharma, Nektar Therapeutics, SMT bio Co., Ltd., Alphageneron Pharmaceuticals, XNK Therapeutics, ImmunityBio, Cellid, Cantargia, Affimed Therapeutics, Takeda, Artiva Biotherapeutics, Sanofi, Dragonfly Therapeutics, INmune Bio, NKGen Biotech, Asclepius Technology Company Group, Glycostem Therapeutics (IPD Therapeutic), Wugen, Celularity, VERAXA, GamidaCell, MiNK Therapeutics, Indapta Therapeutics, ImmunityBio, Inc., Allife Medical Science and Technology, Nkarta, Base Therapeutics, GT Biopharma, Athenex, Ambicion, Biohaven Pharmaceuticals, Acepodia, Bright Path Biotherapeutics, Nkarta Therapeutics, Qihan Biotech, Century Therapeutics, Fate Therapeutics, Chimeric Therapeutics, Senti Biosciences, GICELL, Deverra Therapeutics, Medigen Biotechnology Corporation, GlaxoSmithKline, CytoImmune Therapeutics, Nuwacell Biotechnologies Co., Ltd., and others. Key Pipeline NK Cell Therapies: Bemarituzumab, Monalizumab, NKTR-225, SMT-NK, Enkastim, CellProtect, ALT 803, BVAC-C, PD-L1.t-haNK, Nidanilimab, M ceNK, HER2 t-haNK, AFM-13, TAK-007, IPH4102, AB-101, KDS-1001, AB-201, DF9001, INKmune, IPH65, SNK01, IPH6101 (SAR443579), BCMA CAR-NK 92 cells, DF1001, Allogeneic Natural Killer Cell Therapy (oNKord), WU-NK-101, AFM24, CYNK-001, FLYSYN, GDA-201, AGENT-797, CYNK-101, SAR445514, IDP-023, DF6002, CD19.taNK, Anti-PSMA CAR NK cells, DF2001, NKX101, NK510, GTB-3550, KUR-501, RK-pulsed autologous antigen-presenting cells (APCs), BHV-1100, ACE1702, iPS NKT, Anti-CD19/CD22 CAR NK cell therapy, NKX019, KUR-502, BVAC-P, QN-019a, QN-030a, QN-023a, CNTY-101, FT576, CHM 0201, SENTI-202, AFM28, DF8001, FT522, SNK02, GIC-102, DVX201, Magicell®-NK, GSK4381562, CYTO NK-102, NCR300, and others. Dive deep into rich insights for new NK cell therapies, visit @ NK Cell Therapy Drugs Table of Contents For further information on the NK cell therapy pipeline therapeutics, reach out @ NK Cell Therapy Treatment Drugs Related Reports NK Cell Therapy Market NK Cell Therapy Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key NK cell therapy companies including Sanofi, Dragonfly Therapeutics, INmune Bio, NKGen Biotech, Asclepius Technology Company Group, Glycostem Therapeutics (IPD Therapeutic), Wugen, Celularity, VERAXA, GamidaCell, MiNK Therapeutics, Indapta Therapeutics, among others. Non-small Cell Lung Cancer Market Non-small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key NSCLC companies, including EMD Serono, Merck, Cellular Biomedicine Group, Inc., Celgene, CellSight Technologies, Inc., BeyondSpring Pharmaceuticals Inc., J Ints Bio, Forward Pharmaceuticals Co., Ltd., AstraZeneca, Bristol-Myers Squibb, Teligene US, Rain Oncology Inc, ReHeva Biosciences, Inc., Amgen, Novartis, RedCloud Bio, Parexel, Vitrac Therapeutics, LLC, Mythic Therapeutics, Instil Bio, Mirati Therapeutics Inc., Daiichi Sankyo, Inc., AstraZeneca, Precision Biologics, Inc, Promontory Therapeutics Inc., Palobiofarma SL, Regeneron Pharmaceuticals, Revolution Medicines, Inc., Cullinan Oncology, LLC, Iovance Biotherapeutics, Inc., Innate Pharma, among others. Non-small Cell Lung Cancer Pipeline Non-small Cell Lung Cancer Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key non-small cell lung cancer companies, including BridgeBio Pharma, Daiichi Sankyo, EMD Serono, Merck, BridgeBio Pharma, Abbvie, Pfizer, Eli Lilly and Company BioNTech SE, Shenzhen TargetRx, Taiho Pharmaceutical, Chong Kun Dang, Bristol Myers Squibb, Innovent Biologics, Xuanzhu Biopharmaceutical, Bayer, GeneScience Pharmaceuticals, InventisBio, Apollomics, Imugene, Ono Pharmaceutical, Pierre Fabre, Jiangsu Hengrui Medicine Co., Bristol-Myers Squibb, Surface Oncology, Inhibrx, Sinocelltech, Mirati Therapeutics, REVOLUTION Medicines, Yong Shun Technology Development, Iovance Biotherapeutics, Galecto Biotech, among others. Multiple Myeloma Market Multiple Myeloma Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key multiple myeloma companies, including Johnson & Johnson (Janssen), Pfizer, AbbVie and Roche (Genentech), Regeneron Pharmaceuticals, Bristol-Myers Squibb, Celgene, Roche (Genentech), Arcellx, Novartis, Regeneron Pharmaceuticals, BeiGene, CARsgen Therapeutics, Cartesian Therapeutics, C4 Therapeutics, Heidelberg Pharma, Bristol-Myers Squibb, RAPA Therapeutics, AbbVie (TeneoOne), Takeda , among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Cell TherapyOrphan DrugFast TrackImmunotherapyPhase 2

30 Oct 2024

·pipelinereview.com

NKGen Biotech Presents Phase 1/2a Troculeucel Data in Alzheimer’s Disease at the 17th Annual Clinical Trials on Alzheimer’s Disease (CTAD) Conference

Newly analyzed biomarker data from the initial dose-escalation Phase 1 AD trial found that troculeucel reduces GFAP, NfL, p-tau181, GDF-15, and LTBP2 levels, which are detectable up to 10 years before dementia symptoms appear according to recent reports. This suggests a potential role for the use of troculeucel in delaying or preventing dementia onset in asymptomatic individuals with detectable biomarkers. Preliminary analysis from the Phase 1/2a AD trial administering the highest dose of cryopreserved troculeucel given to date (6 billion cells) showed troculeucel to be very safe with no adverse reactions. Of the first three subjects treated at this highest dose, 100% had stable or improved cognitive function, and two of the three showed significant improvement from moderate stage disease to mild cognitive impairment after only three months of treatment. SANTA ANA, CA, USA I October 29, 2024 I 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 cell therapeutics, today announced the presentation of two posters, on its first-in-kind, autologous, non-genetically modified NK cell product, troculeucel, in Alzheimer’s Disease (“AD”). The posters entitled, “Use of Non-genetically Modified Natural Killer Cells (SNK01) With Enhanced Activity in Subjects with Active Alzheimer’s Disease. Further Biomarker Analysis and Implications for Use in Prevention” and “Treatment of Moderate Alzheimer’s Disease Subjects with Expanded Non-genetically Modified Natural Killer Cells (troculeucel; SNK01) with Enhanced Activity – Report of the Phase 1 results of the Phase 1/2a Study” were presented at the 17th Clinical Trials on Alzheimer’s Disease Annual Meeting (“CTAD”) on October 29, 2024. NKGen previously showed, in a dose-escalation Phase 1 pilot trial, that four treatments with suboptimal doses of troculeucel in AD subjects were well-tolerated and had preliminary ability to impact cognition and improve protein and neuroinflammation biomarkers. Based on recent publications by Guo et. al., and Johansson et. al., which both reported the detection of several biomarkers a full decade before patients developed clinical symptoms of dementia, NKGen reanalyzed its biobank to determine if troculeucel effected specific biomarkers (e.g., GFAP, NfL, p-tau181, GDF-15, and LTBP2) implicated with increased AD risk. “Despite the majority of subjects receiving suboptimal dosing and only four total doses in the Phase 1 pilot trial, we found that our autologous NK cell treatment was safe and that 90% of evaluable subjects experienced stable or improved cognitive function,” said Paul Y. Song, MD, Chairman and CEO of NKGen. “We also revealed that several subjects demonstrated reductions in several neuroinflammation biomarkers, such as GFAP, NfL, p-tau181, GDF-15, and LTBP2. We believe that increased screening for these biomarkers in asymptomatic individuals may reveal that troculeucel, which potentially reduces the associated biomarkers, could be a safe intervention to either delay, or prevent the onset of, dementia. However, further studies are needed to confirm these initial findings.” For the follow-up Phase 1/2a trial on moderate Alzheimer’s patients, the Company hypothesized that troculeucel, given at the highest dose to date of 6 billion cells, could be safely infused and hopes to confirm an even greater impact on cognition and biomarkers. Dr. Song added, “While 35% of all Alzheimer’s patients have moderate-stage disease, there is currently no approved therapy to improve cognitive function, let alone stop and/or slow cognitive decline, in this patient population. We have since initiated a Phase 1/2a trial using our highest dose of cryopreserved troculeucel in moderate AD subjects. We observed stable or improved cognitive function and no treatment-related adverse events after just three months of treatment. Notably, two of the three enrolled subjects in the Phase 1 cohort showed clinical improvement from moderate to mild AD based on ADCOMS and CDR-SB scores. Based on our promising data to date , we have already dosed the first two subjects in our double-blind, randomized Phase 2 cohort; and, look forward to sharing data updates when available. We are excited about the potential of troculeucel as a treatment for AD as well as the potential utility for it across other tau- and synuclein-related neurodegenerative diseases.” Data Highlights from the Poster Presentations: Poster entitled “Use of Non-genetically Modified Natural Killer Cells (SNK01) With Enhanced Activity in Subjects with Active Alzheimer’s Disease. Further Biomarker Analysis and Implications for Use in Prevention”: Poster entitled “Treatment of Moderate Alzheimer’s Disease Subjects with Expanded Non-genetically Modified Natural Killer Cells (troculeucel; SNK01) with Enhanced Activity – Report of the Phase 1 results of the Phase 1/2a Study”: Copies of the posters are available on the Scientific Publications page of the Company’s website at https://nkgenbiotech.com/ . Previously disclosed Phase 1 data on the positive effects of troculeucel on amyloid, tau, and neuroinflammation biomarkers in Alzheimer’s patients can also be found on the Scientific Publications webpage. About Troculeucel Troculeucel is a novel cell-based, patient specific ex vivo expanded autologous natural killer (“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 our journey toward bringing this therapy to market. 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 . SOURCE: NKGen Biotech

Phase 1Clinical ResultPhase 2Cell TherapyImmunotherapy

29 Oct 2024

·www.globenewswire.com

NKGen Biotech Presents Phase 1/2a Troculeucel Data in Alzheimer’s Disease at the 17th Annual Clinical Trials on Alzheimer’s Disease (CTAD) Conference

Newly analyzed biomarker data from the initial dose-escalation Phase 1 AD trial found that troculeucel reduces GFAP, NfL, p-tau181, GDF-15, and LTBP2 levels, which are detectable up to 10 years before dementia symptoms appear according to recent reports. This suggests a potential role for the use of troculeucel in delaying or preventing dementia onset in asymptomatic individuals with detectable biomarkers. Preliminary analysis from the Phase 1/2a AD trial administering the highest dose of cryopreserved troculeucel given to date (6 billion cells) showed troculeucel to be very safe with no adverse reactions. Of the first three subjects treated at this highest dose, 100% had stable or improved cognitive function, and two of the three showed significant improvement from moderate stage disease to mild cognitive impairment after only three months of treatment. SANTA ANA, Calif., Oct. 29, 2024 (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 cell therapeutics, today announced the presentation of two posters, on its first-in-kind, autologous, non-genetically modified NK cell product, troculeucel, in Alzheimer’s Disease (“AD”). The posters entitled, “Use of Non-genetically Modified Natural Killer Cells (SNK01) With Enhanced Activity in Subjects with Active Alzheimer’s Disease. Further Biomarker Analysis and Implications for Use in Prevention” and “Treatment of Moderate Alzheimer’s Disease Subjects with Expanded Non-genetically Modified Natural Killer Cells (troculeucel; SNK01) with Enhanced Activity – Report of the Phase 1 results of the Phase 1/2a Study” were presented at the 17th Clinical Trials on Alzheimer’s Disease Annual Meeting (“CTAD”) on October 29, 2024. NKGen previously showed, in a dose-escalation Phase 1 pilot trial, that four treatments with suboptimal doses of troculeucel in AD subjects were well-tolerated and had preliminary ability to impact cognition and improve protein and neuroinflammation biomarkers. Based on recent publications by Guo et. al., and Johansson et. al., which both reported the detection of several biomarkers a full decade before patients developed clinical symptoms of dementia, NKGen reanalyzed its biobank to determine if troculeucel effected specific biomarkers (e.g., GFAP, NfL, p-tau181, GDF-15, and LTBP2) implicated with increased AD risk. “Despite the majority of subjects receiving suboptimal dosing and only four total doses in the Phase 1 pilot trial, we found that our autologous NK cell treatment was safe and that 90% of evaluable subjects experienced stable or improved cognitive function,” said Paul Y. Song, MD, Chairman and CEO of NKGen. “We also revealed that several subjects demonstrated reductions in several neuroinflammation biomarkers, such as GFAP, NfL, p-tau181, GDF-15, and LTBP2. We believe that increased screening for these biomarkers in asymptomatic individuals may reveal that troculeucel, which potentially reduces the associated biomarkers, could be a safe intervention to either delay, or prevent the onset of, dementia. However, further studies are needed to confirm these initial findings.” For the follow-up Phase 1/2a trial on moderate Alzheimer’s patients, the Company hypothesized that troculeucel, given at the highest dose to date of 6 billion cells, could be safely infused and hopes to confirm an even greater impact on cognition and biomarkers. Dr. Song added, “While 35% of all Alzheimer’s patients have moderate-stage disease, there is currently no approved therapy to improve cognitive function, let alone stop and/or slow cognitive decline, in this patient population. We have since initiated a Phase 1/2a trial using our highest dose of cryopreserved troculeucel in moderate AD subjects. We observed stable or improved cognitive function and no treatment-related adverse events after just three months of treatment. Notably, two of the three enrolled subjects in the Phase 1 cohort showed clinical improvement from moderate to mild AD based on ADCOMS and CDR-SB scores. Based on our promising data to date, we have already dosed the first two subjects in our double-blind, randomized Phase 2 cohort; and, look forward to sharing data updates when available. We are excited about the potential of troculeucel as a treatment for AD as well as the potential utility for it across other tau- and synuclein-related neurodegenerative diseases.” Data Highlights from the Poster Presentations: Poster entitled “Use of Non-genetically Modified Natural Killer Cells (SNK01) With Enhanced Activity in Subjects with Active Alzheimer’s Disease. Further Biomarker Analysis and Implications for Use in Prevention”: Eleven subjects (5 males and 6 females) enrolled. 10 subjects were evaluable.Median age was 79 years (56 to 85 years). 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.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, and 30% 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.Results from this study suggest troculeucel could potentially be a safe preventative intervention for individuals at high-risk for AD.Further evaluation of neuroinflammation biomarkers related to predicting risk of AD and dementia would be beneficial to support the investigation. Poster entitled “Treatment of Moderate Alzheimer’s Disease Subjects with Expanded Non-genetically Modified Natural Killer Cells (troculeucel; SNK01) with Enhanced Activity – Report of the Phase 1 results of the Phase 1/2a Study”: Three (3) subjects were enrolled in the Phase 1 cohort.Early review of the data shows that after three months’ treatment with a dose of 6 x 109 cells every 3 weeks: Clinical improvement was seen in two/thirds of the subjects, who went from a moderate to a mild AD rating on the CDR-SB scale.All three subjects had either a stable or improved ADCOMS score. No treatment-related clinical or laboratory adverse reactions were seen; and, well tolerated in moderate AD subjects. Findings are similar to the SNK01-MX04 Phase 1 AD study (NCT04678453), where troculeucel was well-tolerated, and the one moderate AD subject who received a dose of 4 x 109 cells also went from a moderate to a mild rating on the CDR-SB.This study aims to confirm previous preliminary efficacy seen on both cognitive and biomarker changes in AD subjects.Troculeucel will be evaluated for safety and efficacy in the randomized, placebo-controlled Phase 2a part of the study. Copies of the posters are available on the Scientific Publications page of the Company’s website at https://nkgenbiotech.com/. Previously disclosed Phase 1 data on the positive effects of troculeucel on amyloid, tau, and neuroinflammation biomarkers in Alzheimer’s patients can also be found on the Scientific Publications webpage. About Troculeucel Troculeucel is a novel cell-based, patient specific ex vivo expanded autologous natural killer (“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 our journey toward bringing this therapy to market. 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)Vice President, Investor Relations and Corporate Communications949-396-6830dchua@nkgenbiotech.com External Contacts:Chris CalabreseManaging DirectorLifeSci Advisors, LLCccalabrese@lifesciadvisors.com Kevin GardnerManaging DirectorLifeSci Advisors, LLCkgardner@lifesciadvisors.com

Phase 1Clinical ResultPhase 2Cell TherapyASCO

100 Deals associated with Troculeucel

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Malignant Solid Neoplasm	Phase 2	-	NKGen Operating Biotech, Inc.Startup	01 Mar 2021
Colorectal Cancer	Phase 2	-	NKGen Operating Biotech, Inc.Startup	01 Mar 2021
EGFR positive non-small cell lung cancer	Phase 2	-	NKGen Operating Biotech, Inc.Startup	01 Mar 2021
Esophageal Carcinoma	Phase 2	-	NKGen Operating Biotech, Inc.Startup	01 Mar 2021
HER2-positive gastric cancer	Phase 2	-	NKGen Operating Biotech, Inc.Startup	01 Mar 2021
Neoplasm Metastasis	Phase 2	-	NKGen Operating Biotech, Inc.Startup	01 Mar 2021
Ovarian Cancer	Phase 2	-	NKGen Operating Biotech, Inc.Startup	01 Mar 2021
Sarcoma	Phase 2	-	NKGen Operating Biotech, Inc.Startup	01 Mar 2021
Squamous Cell Carcinoma of Head and Neck	Phase 2	-	NKGen Operating Biotech, Inc.Startup	01 Mar 2021
Uterine Cervical Cancer	Phase 2	-	NKGen Operating Biotech, Inc.Startup	01 Mar 2021

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06189963 (GlobeNewswire) Manual	Phase 1/2	Alzheimer Disease	3	SNK01	(vtqzpfnpua) = xghmbefuwc qckxjkkkea (smsnjnmfhq ) View more	Positive	29 Oct 2024
NCT04678453 (GlobeNewswire) Manual	Phase 1	Alzheimer Disease	11	Troculeucel	(qgiltccnvo) = 90% of all evaluable subjects had either stable or improved (±0.1). envbwpzwax (xraqqfwqze ) View more	Positive	29 Oct 2024
NCT04872634 (Pubmed) Manual	Phase 1/2	EGFR-mutated non-small Cell Lung Cancer	12	SNK01 + gemcitabine + carboplatin±cetuximab	(dyhryqfpux) = ubdvtcprpn lvjzeoumkr (rjxzgmhwpd ) View more	Positive	27 Mar 2024
NCT04678453 (GlobeNewswire \| Corporate Publications) Manual	Phase 1	Alzheimer Disease cerebral spinal fluid (“CSF”) and plasma Tau proteins	11	SNK01	(mnexzmqyeo) = ceneyfvwsn geyymjdwjk (ilwmnkyzdt ) View more	Positive	25 Mar 2024
Corporate Publications Manual	Phase 1	Alzheimer Disease	10	SNK01	(mlypgevmcf) = udqpnbhivs sapddpcnad (hkycjiilxk ) View more	Positive	26 Oct 2023
NCT05099549 (ASCO_Breakthrough2023) Manual	Phase 1	EGFR mutation Solid Tumors EGFR Expressing	6	AFM24+SNK01	(vmkwuzqzry) = bvesjgqitp ekabalyyoz (bbjpdezfsp )	Positive	03 Aug 2023
ESMO2022	Not Applicable	Sarcoma	8	SNK01 + Pembrolizumab	(xuwjtazfyf) = ssrfnbnluj gmoeolbtdk (savszgzzsp )	-	10 Sep 2022
WCLC2022	Phase 1/2	Non-Small Cell Lung Cancer	20	Pembrolizumab + SNK01 (2 x 10^9 cells/dose)	(xrtuppbjcd): HR = 0.32 (95% CI, 0.1 - 1.08), P-Value = 0.066 View more	-	06 Aug 2022
WCLC2022	Phase 1/2	Non-Small Cell Lung Cancer	20	Pembrolizumab monotherapy		-	06 Aug 2022
NCT03941262 (ASCO2022) Manual	Phase 1	HR-positive/HER2-low Solid Tumors	10	SNK01	(wiycmobmak) = vcnmzlcuoe cntafpwgfw (qpbmakmbyj ) View more	Positive	02 Jun 2022
NCT03941262 (ASCO2022)	Phase 1	Refractory Soft Tissue Sarcoma	15	SNK01 + Avelumab	(apvsywpxpx) = scsyifixnr xwwtwhljzv (vmcwznwxzn ) View more	-	02 Jun 2022