{"id":812737,"date":"2025-02-13T08:19:17","date_gmt":"2025-02-13T13:19:17","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/nkgen-biotech-announces-publication-of-phase-1-troculeucel-clinical-trial-results-for-the-treatment-of-alzheimers-disease\/"},"modified":"2025-02-13T08:19:17","modified_gmt":"2025-02-13T13:19:17","slug":"nkgen-biotech-announces-publication-of-phase-1-troculeucel-clinical-trial-results-for-the-treatment-of-alzheimers-disease","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/nkgen-biotech-announces-publication-of-phase-1-troculeucel-clinical-trial-results-for-the-treatment-of-alzheimers-disease\/","title":{"rendered":"NKGen Biotech Announces Publication of Phase 1 Troculeucel Clinical Trial Results for the Treatment of Alzheimer\u2019s Disease"},"content":{"rendered":"<div class=\"mw_release\">\n<p align=\"center\">\n        <em>The results from Phase 1 of the Troculeucel Clinical Trial demonstrated stable\/improved outcomes in 90% of subjects, with no drug-related adverse events following troculeucel therapy.<\/em>\n      <\/p>\n<p align=\"center\">\n        <em>Troculeucel therapy was well-tolerated and resulted in beneficial effects on protein aggregate levels and neuroinflammatory biomarkers in the cerebrospinal fluid, with decreases in pTau181 and GFAP appearing to be dose dependent.<\/em>\n      <\/p>\n<p align=\"center\">\n        <em>A larger trial with a higher dosing\/duration has been initiated in the U.S. and is on-going.<\/em>\n      <\/p>\n<p align=\"justify\">SANTA ANA, Calif., Feb.  13, 2025  (GLOBE NEWSWIRE) &#8212; NKGen Biotech, Inc. (Nasdaq: NKGN) (\u201cNKGen\u201d or the \u201cCompany\u201d), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic natural killer (\u201cNK\u201d) cell therapeutics, today announced the publication of results from the Company\u2019s initial dose escalation Phase 1 clinical trial of troculeucel, an expanded autologous NK cell therapy, for the treatment of Alzheimer\u2019s disease (\u201cAD\u201d) in the journal <em>Alzheimer\u2019s Research &amp; Therapy, <\/em>an international peer-reviewed journal with a translational research focus in AD and other neurodegenerative diseases.<\/p>\n<p align=\"justify\">The publication showcases important context and further validation of the findings from the Company\u2019s Phase 1 clinical study, which evaluated its expanded autologous NK cell therapy, troculeucel, in subjects with either mild, moderate, or severe AD (median CDR-SB 10.0). The clinical trial information in this publication includes comprehensive details on troculeucel preparation, preclinical studies elucidating the mechanism of action, clinical trial design, and trial results (safety assessment, efficacy assessment, and biomarkers). <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=j92zoG_Sm_r--LGYargAWHMTqIJgHVGNKC56nOe1FOFNHczQipUrd5P1simPHgZKmYKqAjq6pj9b5e8YlFkMNA0fBJ6x5VJ3S9y3N8OfG7AQAhwamQm-GYU_KfCVJbHJZiTsMGXQ9qtj5taiYx-RR6-cQJdtp6aQfrq8P1MjC2AIs98tszJ606UovcTcm2UKBV98uRoRzzHA5kF9ecL9OGlmF5o6C9ksms07TOkSs0ZRN2EQsPd-wKdaH4li3wYboY4hxR9oa2ekBRwdc1Gxww==\" rel=\"nofollow\" target=\"_blank\">Final Results of the Phase 1 trial<\/a> were previously disclosed at the Alzheimer\u2019s Association International Conference (AAIC 2024).<\/p>\n<p align=\"justify\">\u201cWe are excited to have our Phase 1 clinical trial published in <em>Alzheimer\u2019s Research &amp; Therapy<\/em>,\u201d said Paul Y. Song, MD, Chairman and Chief Executive Officer of NKGen. \u201cPreviously presenting our positive findings at major medical conferences has been a great way to share our progress with the medical community, but having these data published in such a respected, peer-reviewed journal certainly elevates the credibility of our work and the importance of having a therapy such as troculeucel. The rigorous peer-review process gives our research further validation, as it has been thoroughly evaluated by experts in the field, which not only strengthens the foundation of our early research but also highlights our potential to shape the future of AD treatment. Additionally, this is an important step towards advancing the scientific understanding of troculeucel as a potential treatment option for AD and other neurodegenerative diseases.\u201d<\/p>\n<p align=\"justify\">Publication Highlights:<\/p>\n<ul type=\"disc\">\n<li style=\"text-align:justify\">11 subjects (5 males and 6 females) enrolled.\n<ul type=\"circle\">\n<li style=\"text-align:justify\">10 subjects were evaluable.<\/li>\n<li style=\"text-align:justify\">Median age was 79 years (56 to 85 years).<\/li>\n<\/ul>\n<\/li>\n<li style=\"text-align:justify\">Using a 3 + 3 design to identify the maximum tolerated dose (\u201cMTD\u201d) and\/or the recommended phase 2 dose (\u201cRP2D\u201d), three dose cohorts (1 \u00d7 10<sup>9<\/sup> cells, 2 \u00d7 10<sup>9<\/sup> cells, and 4 \u00d7 10<sup>9<\/sup> cells) were enrolled, each receiving a total of four doses at three-week intervals.<\/li>\n<li style=\"text-align:justify\">Despite 70% of subjects being treated at relatively low doses of troculeucel, 90% of all evaluable subjects had either stable or improved (\u00b10.1) composite ADCOMS scores at week 11 (one-week after the final dose), as previously disclosed.<\/li>\n<li style=\"text-align:justify\">The study demonstrated that adoptive NK cell therapy was well-tolerated.<\/li>\n<li style=\"text-align:justify\">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.<\/li>\n<li style=\"text-align:justify\">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-A\u03b2 antibodies.<\/li>\n<li style=\"text-align:justify\">Since AD is a complex disease, it stands to reason that a multi-pronged approach to treatment, which includes NK cell adoptive therapy, and potentially other anti-inflammatory therapeutic agents, may be able to stabilize or even improve this disease beyond the effect on slowing progression seen with the anti-A\u03b2 antibodies.<\/li>\n<li style=\"text-align:justify\">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.<\/li>\n<\/ul>\n<p align=\"justify\">The full publication entitled \u201cTreatment of Alzheimer&#8217;s Disease subjects with expanded non-genetically modified autologous natural killer cells (SNK01): a phase I study\u201d is available at the following link:<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=yChJJ1CkQd93A8JH7QTNj0AsYRwtad60SOvM8LZrvNgYlplL9GTe3omtVU7CkEG5G2Y1OgM2txAYdEptBWG8jBJFYuJdJr0agjUjazHFtBL0KMDotL1ez_5-CbRTyAiYdIr75vxDuafj2SAl0E-zWAODzqRyqXwISuLPW4kVsiikiN2qc49dgvXlShMBudXbSGuV5Rkqx2_l9k-VMQsEhQ==\" rel=\"nofollow\" target=\"_blank\">https:\/\/alzres.biomedcentral.com\/articles\/10.1186\/s13195-025-01681-2<\/a><\/p>\n<p align=\"justify\">NKGen\u2019s follow-up Phase 1\/2a trial on troculeucel in moderate AD is currently enrolling patients for the Phase 2 cohort. For more information, please visit the ClinicalTrials.gov website at <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=yChJJ1CkQd93A8JH7QTNj9-nrcJs7tYfLD1jftF7KHHv_UgUc6NDEhkMQtaobkQqApW5jzwlgD29q4DhUvmpK2xl8IaqgclWWELAT1OGvyXQ7LZG0QhPRCUeE5gn00lUOSyc79FvTpgV76chh6fhuQ==\" rel=\"nofollow\" target=\"_blank\">https:\/\/clinicaltrials.gov\/study\/NCT06189963<\/a>.<\/p>\n<p align=\"justify\">\n        <strong>About Troculeucel<\/strong>\n      <\/p>\n<p align=\"justify\">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 (\u201cINN\u201d) for SNK01 assigned by the World Health Organization (\u201cWHO\u201d). The WHO INN approval of troculeucel establishes a universally recognized nonproprietary drug name for SNK01 and marks a significant step on NKGen\u2019s journey toward bringing this therapy to market.<\/p>\n<p align=\"justify\">\n        <strong>About NKGen Biotech<\/strong>\n      <\/p>\n<p align=\"justify\">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\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=ZdvD7Ru0fR4KEQY30xABUPtf82Mnz3LAn47VKRjVEkeXbbhc_XQSaRjXwj7tXpulIiZ4HsRtWjA1Ete-Aem3tdhPjJ8BeeVaQHQJNpwdY5E=\" rel=\"nofollow\" target=\"_blank\">www.nkgenbiotech.com<\/a>.<\/p>\n<p>\n        <strong>Forward-Looking Statements <\/strong>\n      <\/p>\n<p align=\"justify\">Statements contained in this press release may contain \u201cforward-looking statements\u201d 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 \u201canticipate\u201d, \u201cbelieve\u201d, \u201ccould\u201d, \u201ccontinue\u201d, \u201cexpect\u201d, \u201cestimate\u201d, \u201cmay\u201d, \u201cplan\u201d, \u201coutlook\u201d, \u201cfuture\u201d and \u201cproject\u201d 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\u2019s 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\u2019s 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\u2019s 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\u2019s 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\u2019s 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 \u201cRisk Factors\u201d and elsewhere in the Company\u2019s filings and reports, which may be accessed for free by visiting the Securities and Exchange Commission\u2019s website at www.sec.gov and on the Company\u2019s website under the subheading \u201cInvestors\u2014Financial and Filings\u201d. 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.<\/p>\n<p align=\"justify\">\n        <strong>Internal Contact:<\/strong><br \/>\n        <br \/>Denise Chua, MBA, CLS, MLS (ASCP)<br \/>SVP, Corporate Affairs<br \/>949-396-6830<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=GfaOLTQyRMRdy7FafmWzE1XvSMfBgLyC2Y58bs_BTOcv3LXDHmZ_MnWE9NfpXIkf4n0-CPgxeTWhwWEMZ6CorftKasXplGYYOIoEX4mvXVc=\" rel=\"nofollow\" target=\"_blank\">dchua@nkgenbiotech.com<\/a><\/p>\n<p align=\"justify\">\n        <strong>External Contacts:<\/strong><br \/>\n        <br \/>Chris Calabrese<br \/>Managing Director<br \/>LifeSci Advisors, LLC<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=NoIA8DggR6PXV1xmEc9WgJxODHk9Bx2h9lBRmiMt-lwQBeRmZD4c9qO4DfVBmCoHWFcuhNYeoCMFvYFslujfZqrm9dNBW92cXpKWOFBLDQSuvSgMLk1ctpQuJTteuXOn\" rel=\"nofollow\" target=\"_blank\">ccalabrese@lifesciadvisors.com<\/a><\/p>\n<p align=\"justify\">Kevin Gardner<br \/>Managing Director<br \/>LifeSci Advisors, LLC<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=zywRQBcc9eSleJesNWn1_i6XP5r21DZqu5Nw5l4j8EA-br1HY-vlWC_Ufnf_kOzwcnW9UuKgcy-_I7sOJFR2zazXer4HKdFGap5-gmuo8GsqRO1Ddk3uQ3m-dNg091zp\" rel=\"nofollow\" target=\"_blank\">kgardner@lifesciadvisors.com<\/a><\/p>\n<p>      <img decoding=\"async\" alt=\"\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTM1NzUzMiM2NzQ4NTk0IzIyNDc3NTk=\" \/><br \/>\n      <br \/>\n      <img decoding=\"async\" alt=\"\" src=\"https:\/\/ml.globenewswire.com\/media\/ZGM3Zjc2NjktZTdhMC00NjEwLTkyOGQtODFjNWNkOWQ0NDc3LTEyNTkzMTI=\/tiny\/NKGen-Biotech.png\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>The results from Phase 1 of the Troculeucel Clinical Trial demonstrated stable\/improved outcomes in 90% of subjects, with no drug-related adverse events following troculeucel therapy. Troculeucel therapy was well-tolerated and resulted in beneficial effects on protein aggregate levels and neuroinflammatory biomarkers in the cerebrospinal fluid, with decreases in pTau181 and GFAP appearing to be dose dependent. A larger trial with a higher dosing\/duration has been initiated in the U.S. and is on-going. SANTA ANA, Calif., Feb. 13, 2025 (GLOBE NEWSWIRE) &#8212; NKGen Biotech, Inc. (Nasdaq: NKGN) (\u201cNKGen\u201d or the \u201cCompany\u201d), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic natural killer (\u201cNK\u201d) cell therapeutics, today announced the publication of results from the Company\u2019s initial &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/nkgen-biotech-announces-publication-of-phase-1-troculeucel-clinical-trial-results-for-the-treatment-of-alzheimers-disease\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;NKGen Biotech Announces Publication of Phase 1 Troculeucel Clinical Trial Results for the Treatment of Alzheimer\u2019s Disease&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-812737","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>NKGen Biotech Announces Publication of Phase 1 Troculeucel Clinical Trial Results for the Treatment of Alzheimer\u2019s Disease - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/nkgen-biotech-announces-publication-of-phase-1-troculeucel-clinical-trial-results-for-the-treatment-of-alzheimers-disease\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"NKGen Biotech Announces Publication of Phase 1 Troculeucel Clinical Trial Results for the Treatment of Alzheimer\u2019s Disease - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"The results from Phase 1 of the Troculeucel Clinical Trial demonstrated stable\/improved outcomes in 90% of subjects, with no drug-related adverse events following troculeucel therapy. Troculeucel therapy was well-tolerated and resulted in beneficial effects on protein aggregate levels and neuroinflammatory biomarkers in the cerebrospinal fluid, with decreases in pTau181 and GFAP appearing to be dose dependent. A larger trial with a higher dosing\/duration has been initiated in the U.S. and is on-going. SANTA ANA, Calif., Feb. 13, 2025 (GLOBE NEWSWIRE) &#8212; NKGen Biotech, Inc. (Nasdaq: NKGN) (\u201cNKGen\u201d or the \u201cCompany\u201d), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic natural killer (\u201cNK\u201d) cell therapeutics, today announced the publication of results from the Company\u2019s initial &hellip; Continue reading &quot;NKGen Biotech Announces Publication of Phase 1 Troculeucel Clinical Trial Results for the Treatment of Alzheimer\u2019s Disease&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/nkgen-biotech-announces-publication-of-phase-1-troculeucel-clinical-trial-results-for-the-treatment-of-alzheimers-disease\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2025-02-13T13:19:17+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTM1NzUzMiM2NzQ4NTk0IzIyNDc3NTk=\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"6 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/nkgen-biotech-announces-publication-of-phase-1-troculeucel-clinical-trial-results-for-the-treatment-of-alzheimers-disease\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/nkgen-biotech-announces-publication-of-phase-1-troculeucel-clinical-trial-results-for-the-treatment-of-alzheimers-disease\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"NKGen Biotech Announces Publication of Phase 1 Troculeucel Clinical Trial Results for the Treatment of Alzheimer\u2019s Disease\",\"datePublished\":\"2025-02-13T13:19:17+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/nkgen-biotech-announces-publication-of-phase-1-troculeucel-clinical-trial-results-for-the-treatment-of-alzheimers-disease\\\/\"},\"wordCount\":1294,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/nkgen-biotech-announces-publication-of-phase-1-troculeucel-clinical-trial-results-for-the-treatment-of-alzheimers-disease\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=OTM1NzUzMiM2NzQ4NTk0IzIyNDc3NTk=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/nkgen-biotech-announces-publication-of-phase-1-troculeucel-clinical-trial-results-for-the-treatment-of-alzheimers-disease\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/nkgen-biotech-announces-publication-of-phase-1-troculeucel-clinical-trial-results-for-the-treatment-of-alzheimers-disease\\\/\",\"name\":\"NKGen Biotech Announces Publication of Phase 1 Troculeucel Clinical Trial Results for the Treatment of Alzheimer\u2019s Disease - 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Troculeucel therapy was well-tolerated and resulted in beneficial effects on protein aggregate levels and neuroinflammatory biomarkers in the cerebrospinal fluid, with decreases in pTau181 and GFAP appearing to be dose dependent. A larger trial with a higher dosing\/duration has been initiated in the U.S. and is on-going. SANTA ANA, Calif., Feb. 13, 2025 (GLOBE NEWSWIRE) &#8212; NKGen Biotech, Inc. 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