{"id":403850,"date":"2020-12-21T11:03:37","date_gmt":"2020-12-21T16:03:37","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=403850"},"modified":"2020-12-21T11:03:37","modified_gmt":"2020-12-21T16:03:37","slug":"gt-biopharma-announces-fda-data-gtb-3550-trike-reduces-cancer-cells-by-61-7-for-a-high-risk-myelodysplastic-syndromes-hr-mds-patient","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/gt-biopharma-announces-fda-data-gtb-3550-trike-reduces-cancer-cells-by-61-7-for-a-high-risk-myelodysplastic-syndromes-hr-mds-patient\/","title":{"rendered":"GT BIOPHARMA ANNOUNCES FDA DATA &#8211; GTB-3550 TriKE\u2122 REDUCES CANCER CELLS BY 61.7% FOR A HIGH-RISK MYELODYSPLASTIC SYNDROMES (HR-MDS) PATIENT"},"content":{"rendered":"<div class=\"xn-newslines\">\n<p class=\"xn-distributor\">PR Newswire<\/p>\n<\/p><\/div>\n<div class=\"xn-content\">\n<p>\n        <span class=\"xn-location\">BEVERLY HILLS, Calif<\/span>, <span class=\"xn-chron\">Dec. 21, 2020<\/span> \/PRNewswire\/ &#8212; GT Biopharma, Inc. (OTCQB: GTBP) (GTBP.PA) an immuno-oncology company focused on innovative therapies based on the Company&#8217;s proprietary NK cell engager (TriKE\u2122) technology platform is pleased to announce the presentation of additional interim data results for the Company&#8217;s lead therapeutic candidate, GTB-3550, for the treatment of high-risk myelodysplastic syndromes (HR-MDS).<\/p>\n<p>\n        <span class=\"xn-person\">Erica Warlick<\/span>, M.D, Principal Investigator for the GTB-3550 clinical trial, presented additional clinical data results with the treatment with HR-MDS patient #7 of its TriKE\u2122 GTB-3550 during the Q&amp;A session following her presentation at the 62<sup>nd<\/sup> American Society of Hematology (ASH) Annual Meeting and Exposition.\u00a0 Dr. Warlick&#8217;s HR-MDS patient presentation can be viewed on the GT Biopharma web site at <a target=\"_blank\" href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=3019000-1&amp;h=1704102065&amp;u=https%3A%2F%2Fir.gtbiopharma.com%2Fpresentations&amp;a=https%3A%2F%2Fir.gtbiopharma.com%2Fpresentations\" rel=\"nofollow noopener noreferrer\">https:\/\/ir.gtbiopharma.com\/presentations<\/a>.<\/p>\n<p>Mr. <span class=\"xn-person\">Anthony Cataldo<\/span>, the Chairman and Chief Executive Officer of GT Biopharma commented, &#8220;Our clinical data demonstrates that our proprietary TriKE\u2122 (CD16\/IL15\/CD33), safely activated and harnessed the patient&#8217;s native NK cell&#8217;s cancer killing ability in a target-directed fashion without side effects. Which is not the case with highly expensive and intrusive supplemental NK cell therapies. We look forward to progressing to the next level.&#8221;<\/p>\n<p>\n        <b><br \/>\n          <i>Clinical Benefit Achieved<\/i><br \/>\n        <\/b>\n      <\/p>\n<p>Prior to being treated with TriKE\u2122 GTB-3550, the HR-MDS patient failed hypomethylating agent (HMA) and Luspatercept therapies. \u00a0With TriKE\u2122 GTB-3550 at 50mcg\/kg\/day (three consecutive 96-hour continuous infusions), the patient achieved a successful bone marrow blast level reduction from 12% before GTB-3550 therapy to 4.6% post GTB-3550 therapy determined by morphological assessment, Additionally, the patient achieved stable hematologic parameters including normal platelet counts throughout therapy.\u00a0 Following this single course of GTB-3550 TriKE\u2122 therapy causing significant reduction in bone marrow blast levels, the patient achieved clinical benefit from GTB-3550 therapy, which qualified patient #7 to receive a hematopoietic stem cell transplant (HSCT).\u00a0 <\/p>\n<p>\n        <b><br \/>\n          <i>No Toxicities \/ Potent Native NK Cell Activation and Proliferation achieved without Supplemental NK Cell Therapy<\/i><br \/>\n        <\/b>\n      <\/p>\n<p>The patient exhibited NO SIDE AFFECTS or signs of clinical immune activation, and NO DOSE LIMITING TOXICITY such as cytokine release syndrome (CRS) or serious adverse events (SAEs) or fevers, tachycardia or constitutional symptoms which are synonymous with other NK Cell Therapy and NK Engagers.\u00a0 Correlative studies showed no shedding of CD16 from patient&#8217;s NK cells, and potent NK cell activation, proliferation and target cell killing without the need for supplemental autologous NK cell therapy.\u00a0 <\/p>\n<p>Targeted delivery of IL-15 to NK cells via GTB-3550 TriKE\u2122 therapy showed preferential proliferation of NK cells, significantly less effect on CD8+ T-cells, and no observed toxicity at 25x the previous reported MTD for continuous infusion of recombinant human IL-15.\u00a0 GTB-3550 TriKE\u2122 is a single-chain, tri-specific scFv recombinant fusion protein conjugate composed of the variable regions of the heavy and light chains of anti-CD16 and anti-CD33 antibodies, and a modified form of IL-15.<\/p>\n<p>\n        <b><br \/>\n          <i>GTB-3550 Therapy Prior to Hematopoietic Stem Cell Transplant (HSCT)<\/i><br \/>\n        <\/b>\n      <\/p>\n<p>The only treatment with curative intent for a majority of elderly HR-MDS or relapsed\/refractory AML patients is allogeneic hematopoietic stem cell transplant (HSCT).\u00a0 Age is one of the strongest risk factors associated with poor outcome.\u00a0 Difficulties in treating elderly patients include comorbidities, reduced performance status, and a disease biology with more frequent aberrant cytogenetics and multidrug resistance.\u00a0 There is a significant gap between elderly patients in need of HSCT, and those actually receiving HSCT due to their failure to meet the eligibility requirements.\u00a0 TriKE\u2122GTB-3550 represents a novel, low intensity therapeutic option which has the potential to increase HSCT eligibility for elderly HR-MDS and relapsed\/refractory AML patients. <\/p>\n<p>Mr. <span class=\"xn-person\">Anthony Cataldo<\/span>, the Chairman and Chief Executive Officer of GT Biopharma commented &#8220;we are gratified that GTB-3550 TriKE\u2122 achieved the threshold of clinical benefit, and the HR-MDS patient became eligible for HSCT.&#8221;\u00a0 Mr. Cataldo further stated &#8220;we believe our clinical data demonstrates that our proprietary CD16 and IL-15 incorporated in TriKE\u2122 safely activates and harnesses the patient&#8217;s native NK cell&#8217;s cancer killing ability in a target-directed fashion without the need for highly expensive and intrusive supplemental NK cell therapies.\u00a0 The TriKE\u2122 platform biologic technology is demonstrating its capabilities as a first in class drug never before done technology.&#8221;<\/p>\n<p>\n        <b><br \/>\n          <i>About High-Risk Myelodysplastic Syndromes (MDS)<\/i><br \/>\n        <\/b>\n      <\/p>\n<p>MDS is a rare form of bone marrow-related cancer caused by irregular blood cell production within the bone marrow. As a result of this irregular production, MDS patients do not have sufficient normal red blood cells, white blood cells and\/or platelets in circulation. \u00a0High-risk MDS is associated with poor prognosis, diminished quality of life, and a higher chance of transformation to acute myeloid leukemia.\u00a0 Approximately 40% of patients with High-Risk MDS transform to acute myeloid leukemia (AML), another aggressive cancer with poor outcomes.<\/p>\n<p>\n        <b><br \/>\n          <i>About GTB-3550 TriKE\u2122 Clinical Trial<\/i><br \/>\n        <\/b>\n      <\/p>\n<p>Patients with CD33+ malignancies (primary induction failure or relapsed AML with failure of one reinduction attempt or high-risk MDS progressed on two lines of therapy) age 18 and older are eligible (<a target=\"_blank\" href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=3019000-1&amp;h=3050197085&amp;u=https%3A%2F%2Fclinicaltrials.gov%2Fct2%2Fshow%2FNCT03214666&amp;a=NCT03214666\" rel=\"nofollow noopener noreferrer\">NCT03214666<\/a>).\u00a0 The primary endpoint is to identify the maximum tolerated dose (MTD) of GTB-3550 TriKE.\u00a0 Correlative objectives include the number, phenotype, activation status and function of NK cells and T cells.<\/p>\n<p>\n        <b><br \/>\n          <i>About GTB-3550 TriKE\u2122<\/i><br \/>\n        <\/b>\n      <\/p>\n<p>GTB-3550 is the Company&#8217;s first TriKE\u2122 product candidate being initially developed for the treatment or relapsed\/refractory acute myeloid leukemia (AML), high-risk myelodysplastic syndrome (HR-MDS).\u00a0 GTB-3550 is a single-chain, tri-specific scFv recombinant fusion protein conjugate composed of the variable regions of the heavy and light chains of anti-CD16 and anti-CD33 antibodies and a modified form of IL-15.\u00a0 The natural killer (NK) cell stimulating cytokine human IL-15 portion of the molecule provides a self-sustaining signal that activates NK cells and enhances their ability to kill cancer cells.<\/p>\n<p>\n        <b><br \/>\n          <i>About GT Biopharma, Inc.<\/i><br \/>\n        <\/b>\n      <\/p>\n<p>GT Biopharma, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of immuno-oncology therapeutic products based our proprietary TriKE\u2122 NK cell engager platform.\u00a0 Our TriKE\u2122 platform is designed to harness and enhance the cancer killing abilities of a patient&#8217;s immune system natural killer cells (NK cells).\u00a0 GT Biopharma has an exclusive worldwide license agreement with the <span class=\"xn-org\">University of Minnesota<\/span> to further develop and commercialize therapies using TriKE\u2122 technology.<\/p>\n<p>\n        <b><br \/>\n          <i>Forward-Looking Statements<\/i><br \/>\n        <\/b>\n      <\/p>\n<p>This press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict, including statements regarding the potential acquisition, the likelihood of closing the potential transaction, our clinical focus, and our current and proposed trials. \u00a0Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as &#8220;believes&#8221;, &#8220;hopes&#8221;, &#8220;intends&#8221;, &#8220;estimates&#8221;, &#8220;expects&#8221;, &#8220;projects&#8221;, &#8220;plans&#8221;, &#8220;anticipates&#8221; and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. \u00a0Our forward-looking statements are not a guarantee of performance, and actual results could differ materially from those contained in or expressed by such statements. \u00a0In evaluating all such statements, we urge you to specifically consider the various risk factors identified in our Form 10-K for the fiscal year ended December\u00a031, 2019 in the section titled &#8220;Risk Factors&#8221; in Part I, Item 1A and in our subsequent Form 10Q Quarterly filings with the Securities and Exchange Commission, any of which could cause actual results to differ materially from those indicated by our forward-looking statements.<\/p>\n<p>Our forward-looking statements reflect our current views with respect to future events and are based on currently available financial, economic, scientific, and competitive data and information on current business plans. \u00a0You should not place undue reliance on our forward-looking statements, which are subject to risks and uncertainties relating to, among other things: \u00a0(i)\u00a0the sufficiency of our cash position and our ongoing ability to raise additional capital to fund our operations, (ii)\u00a0our ability to complete our contemplated clinical trials, or to meet the FDA&#8217;s requirements with respect to safety and efficacy, (iii) our ability to identify patients to enroll in our clinical trials in a timely fashion, (iv)\u00a0our ability to achieve approval of a marketable product, (v)\u00a0design, implementation and conduct of clinical trials, (vii)\u00a0the results of our clinical trials, including the possibility of unfavorable clinical trial results, (vii)\u00a0the market for, and marketability of, any product that is approved, (viii)\u00a0the existence or development of treatments that are viewed by medical professionals or patients as superior to our products, (ix)\u00a0regulatory initiatives, compliance with governmental regulations and the regulatory approval process, and social conditions, and (x)\u00a0various other matters, many of which are beyond our control. \u00a0Should one or more of these risks or uncertainties develop, or should underlying assumptions prove to be incorrect, actual results may vary materially and adversely from those anticipated, believed, estimated, or otherwise indicated by our forward-looking statements.<\/p>\n<p>We intend that all forward-looking statements made in this press release will be subject to the safe harbor protection of the federal securities laws pursuant to Section\u00a027A of the Securities Act, to the extent applicable. \u00a0Except as required by law, we do not undertake any responsibility to update these forward-looking statements to take into account events or circumstances that occur after the date of this press release.\u00a0 Additionally, we do not undertake any responsibility to update you on the occurrence of any unanticipated events which may cause actual results to differ from those expressed or implied by these forward-looking statements.<\/p>\n<p>For more information, please visit <a target=\"_blank\" href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=3019000-1&amp;h=336515515&amp;u=http%3A%2F%2Fwww.gtbiopharma.com%2F&amp;a=www.gtbiopharma.com\" rel=\"nofollow noopener noreferrer\">www.gtbiopharma.com<\/a>. <\/p>\n<p id=\"PURL\">\n        <img loading=\"lazy\" decoding=\"async\" title=\"Cision\" width=\"12\" height=\"12\" alt=\"Cision\" src=\"https:\/\/c212.net\/c\/img\/favicon.png?sn=NY30146&amp;sd=2020-12-21\" \/> View original content:<a id=\"PRNURL\" rel=\"nofollow\" href=\"http:\/\/www.prnewswire.com\/news-releases\/gt-biopharma-announces-fda-data---gtb-3550-trike-reduces-cancer-cells-by-61-7-for-a-high-risk-myelodysplastic-syndromes-hr-mds-patient-301196659.html\">http:\/\/www.prnewswire.com\/news-releases\/gt-biopharma-announces-fda-data&#8212;gtb-3550-trike-reduces-cancer-cells-by-61-7-for-a-high-risk-myelodysplastic-syndromes-hr-mds-patient-301196659.html<\/a><\/p>\n<p>SOURCE  GT Biopharma, Inc.<\/p>\n<\/p><\/div>\n<p>    <img decoding=\"async\" alt=\"\" src=\"https:\/\/rt.prnewswire.com\/rt.gif?NewsItemId=NY30146&amp;Transmission_Id=202012211100PR_NEWS_USPR_____NY30146&amp;DateId=20201221\" style=\"border:0px;width:1px;height:1px\" \/><\/p>\n","protected":false},"excerpt":{"rendered":"<p>PR Newswire BEVERLY HILLS, Calif, Dec. 21, 2020 \/PRNewswire\/ &#8212; GT Biopharma, Inc. (OTCQB: GTBP) (GTBP.PA) an immuno-oncology company focused on innovative therapies based on the Company&#8217;s proprietary NK cell engager (TriKE\u2122) technology platform is pleased to announce the presentation of additional interim data results for the Company&#8217;s lead therapeutic candidate, GTB-3550, for the treatment of high-risk myelodysplastic syndromes (HR-MDS). Erica Warlick, M.D, Principal Investigator for the GTB-3550 clinical trial, presented additional clinical data results with the treatment with HR-MDS patient #7 of its TriKE\u2122 GTB-3550 during the Q&amp;A session following her presentation at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition.\u00a0 Dr. Warlick&#8217;s HR-MDS patient presentation can be viewed on the GT Biopharma web site at &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/gt-biopharma-announces-fda-data-gtb-3550-trike-reduces-cancer-cells-by-61-7-for-a-high-risk-myelodysplastic-syndromes-hr-mds-patient\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;GT BIOPHARMA ANNOUNCES FDA DATA &#8211; GTB-3550 TriKE\u2122 REDUCES CANCER CELLS BY 61.7% FOR A HIGH-RISK MYELODYSPLASTIC SYNDROMES (HR-MDS) PATIENT&#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-403850","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>GT BIOPHARMA ANNOUNCES FDA DATA - GTB-3550 TriKE\u2122 REDUCES CANCER CELLS BY 61.7% FOR A HIGH-RISK MYELODYSPLASTIC SYNDROMES (HR-MDS) PATIENT - 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\/gt-biopharma-announces-fda-data-gtb-3550-trike-reduces-cancer-cells-by-61-7-for-a-high-risk-myelodysplastic-syndromes-hr-mds-patient\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"GT BIOPHARMA ANNOUNCES FDA DATA - GTB-3550 TriKE\u2122 REDUCES CANCER CELLS BY 61.7% FOR A HIGH-RISK MYELODYSPLASTIC SYNDROMES (HR-MDS) PATIENT - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"PR Newswire BEVERLY HILLS, Calif, Dec. 21, 2020 \/PRNewswire\/ &#8212; GT Biopharma, Inc. (OTCQB: GTBP) (GTBP.PA) an immuno-oncology company focused on innovative therapies based on the Company&#8217;s proprietary NK cell engager (TriKE\u2122) technology platform is pleased to announce the presentation of additional interim data results for the Company&#8217;s lead therapeutic candidate, GTB-3550, for the treatment of high-risk myelodysplastic syndromes (HR-MDS). Erica Warlick, M.D, Principal Investigator for the GTB-3550 clinical trial, presented additional clinical data results with the treatment with HR-MDS patient #7 of its TriKE\u2122 GTB-3550 during the Q&amp;A session following her presentation at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition.\u00a0 Dr. Warlick&#8217;s HR-MDS patient presentation can be viewed on the GT Biopharma web site at &hellip; Continue reading &quot;GT BIOPHARMA ANNOUNCES FDA DATA &#8211; GTB-3550 TriKE\u2122 REDUCES CANCER CELLS BY 61.7% FOR A HIGH-RISK MYELODYSPLASTIC SYNDROMES (HR-MDS) PATIENT&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/gt-biopharma-announces-fda-data-gtb-3550-trike-reduces-cancer-cells-by-61-7-for-a-high-risk-myelodysplastic-syndromes-hr-mds-patient\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2020-12-21T16:03:37+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/c212.net\/c\/img\/favicon.png?sn=NY30146&amp;sd=2020-12-21\" \/>\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=\"8 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\\\/gt-biopharma-announces-fda-data-gtb-3550-trike-reduces-cancer-cells-by-61-7-for-a-high-risk-myelodysplastic-syndromes-hr-mds-patient\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/gt-biopharma-announces-fda-data-gtb-3550-trike-reduces-cancer-cells-by-61-7-for-a-high-risk-myelodysplastic-syndromes-hr-mds-patient\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"GT BIOPHARMA ANNOUNCES FDA DATA &#8211; 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GT Biopharma, Inc. (OTCQB: GTBP) (GTBP.PA) an immuno-oncology company focused on innovative therapies based on the Company&#8217;s proprietary NK cell engager (TriKE\u2122) technology platform is pleased to announce the presentation of additional interim data results for the Company&#8217;s lead therapeutic candidate, GTB-3550, for the treatment of high-risk myelodysplastic syndromes (HR-MDS). Erica Warlick, M.D, Principal Investigator for the GTB-3550 clinical trial, presented additional clinical data results with the treatment with HR-MDS patient #7 of its TriKE\u2122 GTB-3550 during the Q&amp;A session following her presentation at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition.\u00a0 Dr. Warlick&#8217;s HR-MDS patient presentation can be viewed on the GT Biopharma web site at &hellip; Continue reading \"GT BIOPHARMA ANNOUNCES FDA DATA &#8211; GTB-3550 TriKE\u2122 REDUCES CANCER CELLS BY 61.7% FOR A HIGH-RISK MYELODYSPLASTIC SYNDROMES (HR-MDS) PATIENT\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/gt-biopharma-announces-fda-data-gtb-3550-trike-reduces-cancer-cells-by-61-7-for-a-high-risk-myelodysplastic-syndromes-hr-mds-patient\/","og_site_name":"Market Newsdesk","article_published_time":"2020-12-21T16:03:37+00:00","og_image":[{"url":"https:\/\/c212.net\/c\/img\/favicon.png?sn=NY30146&amp;sd=2020-12-21","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"8 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/gt-biopharma-announces-fda-data-gtb-3550-trike-reduces-cancer-cells-by-61-7-for-a-high-risk-myelodysplastic-syndromes-hr-mds-patient\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/gt-biopharma-announces-fda-data-gtb-3550-trike-reduces-cancer-cells-by-61-7-for-a-high-risk-myelodysplastic-syndromes-hr-mds-patient\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"GT BIOPHARMA ANNOUNCES FDA DATA &#8211; 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