{"id":791046,"date":"2024-11-27T03:03:53","date_gmt":"2024-11-27T08:03:53","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/lin-bioscience-receives-u-s-fda-fast-track-designation-for-lbs-007\/"},"modified":"2024-11-27T03:03:53","modified_gmt":"2024-11-27T08:03:53","slug":"lin-bioscience-receives-u-s-fda-fast-track-designation-for-lbs-007","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/lin-bioscience-receives-u-s-fda-fast-track-designation-for-lbs-007\/","title":{"rendered":"Lin BioScience Receives U.S. FDA Fast Track Designation For LBS-007"},"content":{"rendered":"<div class=\"mw_release\">\n<ul type=\"disc\">\n<li style=\"margin-bottom:3.6pt\">\n          <em>Fast Track designation indicates LBS-007\u2019s potential in filling the unmet medical need of acute leukemia<\/em>\n        <\/li>\n<li style=\"margin-bottom:3.6pt\">\n          <em>LBS-007 is the Company\u2019s investigational medicinal product for the treatment of acute leukemia<\/em>\n        <\/li>\n<li style=\"margin-bottom:3.6pt\">\n          <em>A Phase 1\/2 trial in patients with relapsed or resistant acute leukemias is ongoing<\/em>\n        <\/li>\n<li style=\"margin-bottom:3.6pt\">\n          <em>LBS-007, the Company\u2019s lead asset, has been granted orphan drug designations for acute myeloid leukemia and acute lymphocytic leukemia by the U.S. FDA<\/em>\n        <\/li>\n<\/ul>\n<p align=\"justify\">TAIPEI CITY, Taiwan, Nov.  27, 2024  (GLOBE NEWSWIRE) &#8212; Lin BioScience (6696. Taiwan OTC), a clinical-stage biopharmaceutical drug development company focused on\u00a0advancing novel therapeutics targeting acute leukemia that have significant unmet medical needs, today announced that its lead pipeline, LBS-007, has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of acute myeloid leukemia. Lin BioScience is currently conducting a phase 1\/2 trial in patients with relapsed or resistant acute leukemias in the US, Australia, and Taiwan, and has been granted for orphan drug designation (ODD) for acute myeloid leukemia and acute lymphocytic leukemia by the U.S. FDA.<\/p>\n<p align=\"justify\">\u201cWe are thrilled to see LBS-007 showing signs of early treatment response and potential efficacy in addressing this critical unmet medical need,\u201d\u00a0said Dr. Tom Lin, Chairman of Lin BioScience. \u201cReceiving FDA Fast Track Designation is a significant milestone, offering an expedited pathway to advance the development of this promising therapy. We remain deeply committed to delivering transformative solutions for patients in need.\u201d<\/p>\n<p align=\"justify\">\u201cDuring the phase 1 dose escalation, we have not observed any Definitely or Probably Related Adverse Effects in all patients who have received low to high doses, demonstrating the safety profile is very tolerable and promising,\u201d\u00a0said Dr. Irene Wang, President &amp; CSO of Lin BioScience.<\/p>\n<p>\n        <strong>About Fast Track Designation<\/strong><br \/>\n        <br \/>Fast Track is a process designed to facilitate the development, and expedite the review, of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions. Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapies. Once a drug receives Fast Track designation, it is eligible for more frequent meetings with the FDA, more frequent written communication from the FDA, Accelerated Approval and Priority Review if relevant criteria are met, and Rolling Review. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.<\/p>\n<p>\n        <strong>About\u00a0LBS-007<\/strong><br \/>\n        <br \/>LBS-007 is a natural, non-ATP cell cycle inhibitor targeting a broad array of cancers. LBS-007 functions by blocking the kinase activity of CDC7, a key regulator of the cancer cell cycle. Inhibiting CDC7 stops the proliferation of tumor cells and results in cancer cell death. LBS-007 has demonstrated very potent activity against leukemia and multiple solid tumors in preclinical studies.<\/p>\n<p>\n        <strong>Media Contact:<\/strong><br \/>\n        <br \/>Serena Chen <br \/>CFO<br \/>Office: (02) 8780-5008<br \/>Email: <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=3gOgWmpfHsbxku6Wmmpcws_KRzBSf3SKwK4Be9ArTfcaD51EAhK6nunwVfvKCtdOeScost8wsn9KJsPSCZ6uvHtmi2JnPeh3d7_RiS4wb-hr0RWmgydWf-TodsNdFSH6\" rel=\"nofollow\" target=\"_blank\">serenachen@linbioscience.com<\/a><\/p>\n<p>\n        <strong>About Lin BioScience:<\/strong><br \/>\n        <br \/>Lin BioScience (6696. Taiwan OTC), founded in 2016, is a drug development company focused on unmet medical needs through developing first-in-class therapies for cancer, ophthalmology, and metabolic diseases. The Company currently has four primary drug candidates under development, including LBS-008 (for Geographic Atrophy [GA] in advanced dry age-related macular degeneration [AMD] and Stargardt Disease type 1 [STGD1]) and LBS-009 (for non-alcoholic steatohepatitis [NASH]), both developed by its subsidiary Belite Bio (NASDAQ: BLTE), as well as LBS-007 (for acute leukemia and solid tumors) and LBS-002 (for primary and metastatic brain cancers) developed by Lin BioScience.<\/p>\n<p>Significantly, LBS-008 has been granted Orphan Drug Designation (ODD) for the treatment of STGD1 from the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. It has also received Fast Track Designation and Rare Pediatric Disease (RPD) designation from the U.S. FDA, along with Sakigake Designation from the Ministry of Health, Labour and Welfare (MHLW) in Japan. Additionally, LBS-007 has been granted ODD for the treatment of acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML), as well as Fast Track Designation for the treatment of AML, from the U.S. FDA.<\/p>\n<p>For more information, follow us on\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=s7Np_rz1W1TCcXwDbpuMMlV99XNV49EKHMzzNCgurU10TPymadDCH-_VLqXIXUF_C83h8DS3ZU1F1a1PRNU2oXfG78QXb3wHNqJO5l3vJRexNJC2u7mPQO8B2ISWwrNsZxe10-jz7igF2MEFbNRsSw==\" rel=\"nofollow\" target=\"_blank\">LinkedIn<\/a>,<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=dKjLln86WbpjtzVgcHVpNPXVUBvHTeWf-oPUi1Ujp_TXk-L4dYmFaDj84AbqszU0KYA-Nh_khKyTxJMWtzw81a_zCDNayak8p7IFmHSJmy4=\" rel=\"nofollow\" target=\"_blank\">\u00a0Facebook<\/a>\u00a0or visit us at <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=7kbd9mIITJM9EJUA56gUSphopBtFNuTKH8ZkyjTeJSbopU3SRIclhU-nzwsIEh1bQ-A8baXBNNDZ2JYmy8-_rITvIj_WxxdzelqW_DHlavg=\" rel=\"nofollow\" target=\"_blank\">www.linbioscience.com<\/a>.<\/p>\n<p>\n        <strong>Disclaimer:<\/strong><br \/>\n        <br \/>This press release and the concurrently released related information contain forward-looking statements, based on existing risks and potential uncertainties, including market factors and other causes beyond the control of Lin BioScience (referred to hereafter as the Company). These forward-looking statements rely on current forecasts and assessments, and the Company undertakes no obligation to update the information, except as required by law.<\/p>\n<p>      <img decoding=\"async\" alt=\"\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTI5MDc0MiM2NjEyOTgwIzIyOTYxODk=\" \/><br \/>\n      <br \/>\n      <img decoding=\"async\" alt=\"\" src=\"https:\/\/ml.globenewswire.com\/media\/OGM2NTQwNjMtNzJjMC00Y2M4LThjNTgtNjdkZjkxYzU2MThkLTEzMDc3Mzk=\/tiny\/Lin-BioScience-Inc-.png\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Fast Track designation indicates LBS-007\u2019s potential in filling the unmet medical need of acute leukemia LBS-007 is the Company\u2019s investigational medicinal product for the treatment of acute leukemia A Phase 1\/2 trial in patients with relapsed or resistant acute leukemias is ongoing LBS-007, the Company\u2019s lead asset, has been granted orphan drug designations for acute myeloid leukemia and acute lymphocytic leukemia by the U.S. FDA TAIPEI CITY, Taiwan, Nov. 27, 2024 (GLOBE NEWSWIRE) &#8212; Lin BioScience (6696. Taiwan OTC), a clinical-stage biopharmaceutical drug development company focused on\u00a0advancing novel therapeutics targeting acute leukemia that have significant unmet medical needs, today announced that its lead pipeline, LBS-007, has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/lin-bioscience-receives-u-s-fda-fast-track-designation-for-lbs-007\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Lin BioScience Receives U.S. FDA Fast Track Designation For LBS-007&#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-791046","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Lin BioScience Receives U.S. FDA Fast Track Designation For LBS-007 - 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\/lin-bioscience-receives-u-s-fda-fast-track-designation-for-lbs-007\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Lin BioScience Receives U.S. FDA Fast Track Designation For LBS-007 - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Fast Track designation indicates LBS-007\u2019s potential in filling the unmet medical need of acute leukemia LBS-007 is the Company\u2019s investigational medicinal product for the treatment of acute leukemia A Phase 1\/2 trial in patients with relapsed or resistant acute leukemias is ongoing LBS-007, the Company\u2019s lead asset, has been granted orphan drug designations for acute myeloid leukemia and acute lymphocytic leukemia by the U.S. FDA TAIPEI CITY, Taiwan, Nov. 27, 2024 (GLOBE NEWSWIRE) &#8212; Lin BioScience (6696. Taiwan OTC), a clinical-stage biopharmaceutical drug development company focused on\u00a0advancing novel therapeutics targeting acute leukemia that have significant unmet medical needs, today announced that its lead pipeline, LBS-007, has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for &hellip; Continue reading &quot;Lin BioScience Receives U.S. FDA Fast Track Designation For LBS-007&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/lin-bioscience-receives-u-s-fda-fast-track-designation-for-lbs-007\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2024-11-27T08:03:53+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTI5MDc0MiM2NjEyOTgwIzIyOTYxODk=\" \/>\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=\"4 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\\\/lin-bioscience-receives-u-s-fda-fast-track-designation-for-lbs-007\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/lin-bioscience-receives-u-s-fda-fast-track-designation-for-lbs-007\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Lin BioScience Receives U.S. FDA Fast Track Designation For LBS-007\",\"datePublished\":\"2024-11-27T08:03:53+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/lin-bioscience-receives-u-s-fda-fast-track-designation-for-lbs-007\\\/\"},\"wordCount\":776,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/lin-bioscience-receives-u-s-fda-fast-track-designation-for-lbs-007\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=OTI5MDc0MiM2NjEyOTgwIzIyOTYxODk=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/lin-bioscience-receives-u-s-fda-fast-track-designation-for-lbs-007\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/lin-bioscience-receives-u-s-fda-fast-track-designation-for-lbs-007\\\/\",\"name\":\"Lin BioScience Receives U.S. FDA Fast Track Designation For LBS-007 - 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Market Newsdesk","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.marketnewsdesk.com\/index.php\/lin-bioscience-receives-u-s-fda-fast-track-designation-for-lbs-007\/","og_locale":"en_US","og_type":"article","og_title":"Lin BioScience Receives U.S. FDA Fast Track Designation For LBS-007 - Market Newsdesk","og_description":"Fast Track designation indicates LBS-007\u2019s potential in filling the unmet medical need of acute leukemia LBS-007 is the Company\u2019s investigational medicinal product for the treatment of acute leukemia A Phase 1\/2 trial in patients with relapsed or resistant acute leukemias is ongoing LBS-007, the Company\u2019s lead asset, has been granted orphan drug designations for acute myeloid leukemia and acute lymphocytic leukemia by the U.S. FDA TAIPEI CITY, Taiwan, Nov. 27, 2024 (GLOBE NEWSWIRE) &#8212; Lin BioScience (6696. Taiwan OTC), a clinical-stage biopharmaceutical drug development company focused on\u00a0advancing novel therapeutics targeting acute leukemia that have significant unmet medical needs, today announced that its lead pipeline, LBS-007, has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for &hellip; Continue reading \"Lin BioScience Receives U.S. FDA Fast Track Designation For LBS-007\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/lin-bioscience-receives-u-s-fda-fast-track-designation-for-lbs-007\/","og_site_name":"Market Newsdesk","article_published_time":"2024-11-27T08:03:53+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTI5MDc0MiM2NjEyOTgwIzIyOTYxODk=","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"4 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/lin-bioscience-receives-u-s-fda-fast-track-designation-for-lbs-007\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/lin-bioscience-receives-u-s-fda-fast-track-designation-for-lbs-007\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Lin BioScience Receives U.S. FDA Fast Track Designation For LBS-007","datePublished":"2024-11-27T08:03:53+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/lin-bioscience-receives-u-s-fda-fast-track-designation-for-lbs-007\/"},"wordCount":776,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/lin-bioscience-receives-u-s-fda-fast-track-designation-for-lbs-007\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTI5MDc0MiM2NjEyOTgwIzIyOTYxODk=","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/lin-bioscience-receives-u-s-fda-fast-track-designation-for-lbs-007\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/lin-bioscience-receives-u-s-fda-fast-track-designation-for-lbs-007\/","name":"Lin BioScience Receives U.S. FDA Fast Track Designation For LBS-007 - 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