{"id":520715,"date":"2021-07-30T08:04:17","date_gmt":"2021-07-30T12:04:17","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/i-mab-announces-ind-approval-by-fda-to-initiate-phase-1-study-for-protollin-for-the-treatment-of-alzheimers-disease\/"},"modified":"2021-07-30T08:04:17","modified_gmt":"2021-07-30T12:04:17","slug":"i-mab-announces-ind-approval-by-fda-to-initiate-phase-1-study-for-protollin-for-the-treatment-of-alzheimers-disease","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/i-mab-announces-ind-approval-by-fda-to-initiate-phase-1-study-for-protollin-for-the-treatment-of-alzheimers-disease\/","title":{"rendered":"I-Mab Announces IND Approval by FDA to Initiate Phase 1 Study for Protollin for the Treatment of Alzheimer&#8217;s Disease"},"content":{"rendered":"<div class=\"xn-newslines\">\n<p class=\"xn-distributor\">PR Newswire<\/p>\n<\/p><\/div>\n<div class=\"xn-content\">\n<ul type=\"disc\">\n<li>\n          <i>Planning underway for a Phase 1 Trial to assess new immunotherapy aimed at stimulating the innate immune system to clear beta amyloid protein plaques in Alzheimer&#8217;s Disease <\/i>\n        <\/li>\n<\/ul>\n<p>\n        <span><br \/>\n          <span class=\"xn-location\">SHANGHAI<\/span> and <span class=\"xn-location\">GAITHERSBURG, Md.<\/span><\/span>, <span><span class=\"xn-chron\">July 30, 2021<\/span><\/span> \/PRNewswire\/ &#8212; I-Mab (the &#8220;Company&#8221;) (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced that the U.S. Food and Drug Administration\u00a0(FDA) has cleared the Investigational New Drug (IND) submission for Protollin, an investigational drug to treat Alzheimer&#8217;s disease, enabling a Phase 1 clinical trial to be initiated. Worldwide, around 50 million people are living with Alzheimer&#8217;s disease or other dementias, with no cure available.\u00a0<\/p>\n<div class=\"PRN_ImbeddedAssetReference\" id=\"DivAssetPlaceHolder1156\">\n<p>\n          <a href=\"https:\/\/mma.prnewswire.com\/media\/1433981\/logo_Logo.html\" target=\"_blank\" rel=\"nofollow noopener\"><br \/>\n            <img decoding=\"async\" src=\"https:\/\/mma.prnewswire.com\/media\/1433981\/logo_Logo.jpg\" title=\"(PRNewsfoto\/I-Mab)\" alt=\"(PRNewsfoto\/I-Mab)\" \/><br \/>\n          <\/a>\n        <\/p>\n<\/p><\/div>\n<p>&#8220;Advancing Protollin into clinic is a critical milestone in the search to develop novel therapies for this devastating disease, and we are honored to be engaging in a planning process with partners around the globe and contributing our expertise,&#8221; said Dr.\u00a0Jingwu Zang, Founder, Chairman and Director of I-Mab.<\/p>\n<p>Protollin is a new type of immunotherapy aimed at stimulating the innate immune system to activate a response against the build-up of beta amyloid protein plaques and subsequent tau tangles that cause memory loss.<\/p>\n<p>Brigham and Women&#8217;s Hospital and Inspirevax (formerly Biodextris) granted I-Mab and Nhwa global exclusive licenses to develop, manufacture, and commercialize Protollin, and Biodextris will manufacture and supply Protollin for preclinical and clinical studies until the recruitment of the first patient in the Phase <span class=\"xn-money\">1b<\/span> MAD study<sup>[1]<\/sup>. I-Mab will develop and commercialize Protollin outside of the <span class=\"xn-location\">Greater China<\/span> territory, while Nhwa will develop and commercialize the drug in mainland <span class=\"xn-location\">China<\/span>, <span class=\"xn-location\">Hong Kong<\/span>, <span class=\"xn-location\">Macau<\/span>, and <span class=\"xn-location\">Taiwan<\/span>.<\/p>\n<div>\n<table cellspacing=\"0\" cellpadding=\"0\" border=\"0\" class=\"prntblns\">\n<tr>\n<td class=\"prnsbt1 prnsbr1 prnvab prnsbb1 prnpl6 prnsbl1 prnpr6\">\n<p class=\"prnews_p\">\n                <span class=\"prnews_span\"><br \/>\n                  <sup>[1]<\/sup>\u00a0<a target=\"_blank\" href=\"https:\/\/www.i-mabbiopharma.com\/en\/article-304.aspx\" class=\"prnews_a\" rel=\"nofollow noopener\">https:\/\/www.i-mabbiopharma.com\/en\/article-304.aspx<\/a><\/span>\n              <\/p>\n<\/td>\n<\/tr>\n<\/table><\/div>\n<p>\n        <b>About Protollin<br \/><\/b>\n      <\/p>\n<p>Protollin is a novel immunotherapy aimed at stimulating the innate immune system. It is composed of outer membrane proteins of bacteria complexed with lipopolysaccharides (LPS). There are preclinical data indicating that it can modulate immune cells and has the potential to treat disorders with an immune component. Delivery of Protollin through nasal spray will enable the molecule reach brain and stimulate the expected immune response. The initial data support its potential application in neurodegenerative diseases such as Alzheimer&#8217;s disease.<\/p>\n<p>\n        <b>About I-Mab<\/b>\n      <\/p>\n<p>I-Mab (Nasdaq: IMAB) is a dynamic, global biotech company exclusively focused on discovery, development and soon, commercialization of novel or highly differentiated biologics in the therapeutic areas of immuno-oncology and autoimmune diseases. The Company&#8217;s mission is to bring transformational medicines to patients around the world through innovation. I-Mab&#8217;s innovative pipeline of more than 10 clinical and pre-clinical stage drug candidates is driven by the Company&#8217;s Fast-to-PoC (Proof-of-Concept) and Fast-to-Market development strategies through internal R&amp;D and global partnerships. The Company is on track to transition from a clinical stage biotech company toward a fully integrated global biopharmaceutical company with cutting-edge R&amp;D capabilities, world-class GMP manufacturing facilities and commercial capability. I-Mab has offices in <span class=\"xn-location\">Beijing<\/span>, <span class=\"xn-location\">Shanghai<\/span>, <span class=\"xn-location\">Hangzhou<\/span>, <span class=\"xn-location\">Hong Kong<\/span> and <span class=\"xn-location\">Maryland<\/span>, <span class=\"xn-location\">United States<\/span>. For more information, please visit <a target=\"_blank\" href=\"http:\/\/ir.i-mabbiopharma.com\/\" rel=\"nofollow noopener\">http:\/\/ir.i-mabbiopharma.com<\/a>\u00a0and follow I-Mab on <a target=\"_blank\" href=\"https:\/\/www.linkedin.com\/company\/i-mab\/\" rel=\"nofollow noopener\">LinkedIn<\/a>, <a target=\"_blank\" href=\"https:\/\/twitter.com\/IMabBiopharma\" rel=\"nofollow noopener\">Twitter<\/a>\u00a0and <a target=\"_blank\" href=\"https:\/\/mp.weixin.qq.com\/s\/_s634aizyQPuq1Vgf-hLGA\" rel=\"nofollow noopener\">WeChat<\/a>.<\/p>\n<p>\n        <b>Special Note Regarding Forward-Looking Statements<br \/><\/b>\n      <\/p>\n<p>This press release includes certain disclosures which contain &#8220;forward-looking statements.&#8221; You can identify forward-looking statements because they contain words such as &#8220;anticipate&#8221; and &#8220;expected.&#8221; Forward-looking statements are based on I-Mab, Jiangsu Nhwa, and Inspirevax&#8217;s (formerly Biodextris) current expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance. Important factors that could cause actual results to differ materially from those in the forward-looking statements are set forth in filings with the U.S. Securities and Exchange Commission. I-Mab, Jiangsu Nhwa, and Inspirevax (formerly Biodextris) undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.<\/p>\n<p>\n        <b>For more information, please contact:<\/b>\n      <\/p>\n<p>\n        <b>I-Mab<\/b>\n      <\/p>\n<p>Jielun Zhu, Chief Financial Officer<br \/>E-mail: <a target=\"_blank\" href=\"mailto:jielun.zhu@i-mabbiopharma.com\" rel=\"nofollow noopener\">jielun.zhu@i-mabbiopharma.com<\/a>\u00a0<br \/>Office line: +86 21 6057 8000<\/p>\n<p>\n        <span class=\"xn-person\">Gigi Feng<\/span>, Chief Communications Officer<br \/>E-mail: <a target=\"_blank\" href=\"mailto:gigi.feng@i-mabbiopharma.com\" rel=\"nofollow noopener\">gigi.feng@i-mabbiopharma.com<\/a>\u00a0<br \/>Office line: +86 21 6057 5709<\/p>\n<p>\n        <b>Investor Inquiries:<\/b>\n      <\/p>\n<p>The Piacente Group, Inc.<br \/><span class=\"xn-person\">Emilie Wu<\/span><br \/>E-mail: <a target=\"_blank\" href=\"mailto:emilie@thepiacentegroup.com\" rel=\"nofollow noopener\">emilie@thepiacentegroup.com<\/a>\u00a0<br \/>Office line: + 86 21 6039 8363<\/p>\n<div class=\"PRN_ImbeddedAssetReference\" id=\"DivAssetPlaceHolder0\"><\/div>\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=CN60034&amp;sd=2021-07-30\" \/> View original content to download multimedia:<a id=\"PRNURL\" rel=\"nofollow\" href=\"https:\/\/www.prnewswire.com\/news-releases\/i-mab-announces-ind-approval-by-fda-to-initiate-phase-1-study-for-protollin-for-the-treatment-of-alzheimers-disease-301345030.html\">https:\/\/www.prnewswire.com\/news-releases\/i-mab-announces-ind-approval-by-fda-to-initiate-phase-1-study-for-protollin-for-the-treatment-of-alzheimers-disease-301345030.html<\/a><\/p>\n<p>SOURCE  I-Mab<\/p>\n<\/p><\/div>\n<p>    <img decoding=\"async\" alt=\"\" src=\"https:\/\/rt.prnewswire.com\/rt.gif?NewsItemId=CN60034&amp;Transmission_Id=202107300800PR_NEWS_USPR_____CN60034&amp;DateId=20210730\" style=\"border:0px;width:1px;height:1px\" \/><\/p>\n","protected":false},"excerpt":{"rendered":"<p>PR Newswire Planning underway for a Phase 1 Trial to assess new immunotherapy aimed at stimulating the innate immune system to clear beta amyloid protein plaques in Alzheimer&#8217;s Disease SHANGHAI and GAITHERSBURG, Md., July 30, 2021 \/PRNewswire\/ &#8212; I-Mab (the &#8220;Company&#8221;) (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced that the U.S. Food and Drug Administration\u00a0(FDA) has cleared the Investigational New Drug (IND) submission for Protollin, an investigational drug to treat Alzheimer&#8217;s disease, enabling a Phase 1 clinical trial to be initiated. Worldwide, around 50 million people are living with Alzheimer&#8217;s disease or other dementias, with no cure available.\u00a0 &#8220;Advancing Protollin into clinic is a critical milestone in the search &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/i-mab-announces-ind-approval-by-fda-to-initiate-phase-1-study-for-protollin-for-the-treatment-of-alzheimers-disease\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;I-Mab Announces IND Approval by FDA to Initiate Phase 1 Study for Protollin for the Treatment of Alzheimer&#8217;s 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-520715","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>I-Mab Announces IND Approval by FDA to Initiate Phase 1 Study for Protollin for the Treatment of Alzheimer&#039;s 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\/i-mab-announces-ind-approval-by-fda-to-initiate-phase-1-study-for-protollin-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=\"I-Mab Announces IND Approval by FDA to Initiate Phase 1 Study for Protollin for the Treatment of Alzheimer&#039;s Disease - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"PR Newswire Planning underway for a Phase 1 Trial to assess new immunotherapy aimed at stimulating the innate immune system to clear beta amyloid protein plaques in Alzheimer&#8217;s Disease SHANGHAI and GAITHERSBURG, Md., July 30, 2021 \/PRNewswire\/ &#8212; I-Mab (the &#8220;Company&#8221;) (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced that the U.S. Food and Drug Administration\u00a0(FDA) has cleared the Investigational New Drug (IND) submission for Protollin, an investigational drug to treat Alzheimer&#8217;s disease, enabling a Phase 1 clinical trial to be initiated. Worldwide, around 50 million people are living with Alzheimer&#8217;s disease or other dementias, with no cure available.\u00a0 &#8220;Advancing Protollin into clinic is a critical milestone in the search &hellip; Continue reading &quot;I-Mab Announces IND Approval by FDA to Initiate Phase 1 Study for Protollin for the Treatment of Alzheimer&#8217;s Disease&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/i-mab-announces-ind-approval-by-fda-to-initiate-phase-1-study-for-protollin-for-the-treatment-of-alzheimers-disease\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2021-07-30T12:04:17+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/mma.prnewswire.com\/media\/1433981\/logo_Logo.jpg\" \/>\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\\\/i-mab-announces-ind-approval-by-fda-to-initiate-phase-1-study-for-protollin-for-the-treatment-of-alzheimers-disease\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/i-mab-announces-ind-approval-by-fda-to-initiate-phase-1-study-for-protollin-for-the-treatment-of-alzheimers-disease\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"I-Mab Announces IND Approval by FDA to Initiate Phase 1 Study for Protollin for the Treatment of Alzheimer&#8217;s Disease\",\"datePublished\":\"2021-07-30T12:04:17+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/i-mab-announces-ind-approval-by-fda-to-initiate-phase-1-study-for-protollin-for-the-treatment-of-alzheimers-disease\\\/\"},\"wordCount\":723,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/i-mab-announces-ind-approval-by-fda-to-initiate-phase-1-study-for-protollin-for-the-treatment-of-alzheimers-disease\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/mma.prnewswire.com\\\/media\\\/1433981\\\/logo_Logo.jpg\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/i-mab-announces-ind-approval-by-fda-to-initiate-phase-1-study-for-protollin-for-the-treatment-of-alzheimers-disease\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/i-mab-announces-ind-approval-by-fda-to-initiate-phase-1-study-for-protollin-for-the-treatment-of-alzheimers-disease\\\/\",\"name\":\"I-Mab Announces IND Approval by FDA to Initiate Phase 1 Study for Protollin for the Treatment of Alzheimer's Disease - 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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\/i-mab-announces-ind-approval-by-fda-to-initiate-phase-1-study-for-protollin-for-the-treatment-of-alzheimers-disease\/","og_locale":"en_US","og_type":"article","og_title":"I-Mab Announces IND Approval by FDA to Initiate Phase 1 Study for Protollin for the Treatment of Alzheimer's Disease - Market Newsdesk","og_description":"PR Newswire Planning underway for a Phase 1 Trial to assess new immunotherapy aimed at stimulating the innate immune system to clear beta amyloid protein plaques in Alzheimer&#8217;s Disease SHANGHAI and GAITHERSBURG, Md., July 30, 2021 \/PRNewswire\/ &#8212; I-Mab (the &#8220;Company&#8221;) (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced that the U.S. Food and Drug Administration\u00a0(FDA) has cleared the Investigational New Drug (IND) submission for Protollin, an investigational drug to treat Alzheimer&#8217;s disease, enabling a Phase 1 clinical trial to be initiated. Worldwide, around 50 million people are living with Alzheimer&#8217;s disease or other dementias, with no cure available.\u00a0 &#8220;Advancing Protollin into clinic is a critical milestone in the search &hellip; Continue reading \"I-Mab Announces IND Approval by FDA to Initiate Phase 1 Study for Protollin for the Treatment of Alzheimer&#8217;s Disease\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/i-mab-announces-ind-approval-by-fda-to-initiate-phase-1-study-for-protollin-for-the-treatment-of-alzheimers-disease\/","og_site_name":"Market Newsdesk","article_published_time":"2021-07-30T12:04:17+00:00","og_image":[{"url":"https:\/\/mma.prnewswire.com\/media\/1433981\/logo_Logo.jpg","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\/i-mab-announces-ind-approval-by-fda-to-initiate-phase-1-study-for-protollin-for-the-treatment-of-alzheimers-disease\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/i-mab-announces-ind-approval-by-fda-to-initiate-phase-1-study-for-protollin-for-the-treatment-of-alzheimers-disease\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"I-Mab Announces IND Approval by FDA to Initiate Phase 1 Study for Protollin for the Treatment of Alzheimer&#8217;s Disease","datePublished":"2021-07-30T12:04:17+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/i-mab-announces-ind-approval-by-fda-to-initiate-phase-1-study-for-protollin-for-the-treatment-of-alzheimers-disease\/"},"wordCount":723,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/i-mab-announces-ind-approval-by-fda-to-initiate-phase-1-study-for-protollin-for-the-treatment-of-alzheimers-disease\/#primaryimage"},"thumbnailUrl":"https:\/\/mma.prnewswire.com\/media\/1433981\/logo_Logo.jpg","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/i-mab-announces-ind-approval-by-fda-to-initiate-phase-1-study-for-protollin-for-the-treatment-of-alzheimers-disease\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/i-mab-announces-ind-approval-by-fda-to-initiate-phase-1-study-for-protollin-for-the-treatment-of-alzheimers-disease\/","name":"I-Mab Announces IND Approval by FDA to Initiate Phase 1 Study for Protollin for the Treatment of Alzheimer's Disease - 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