{"id":755943,"date":"2023-05-08T09:25:55","date_gmt":"2023-05-08T13:25:55","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/promis-neurosciences-announces-fda-clearance-of-investigational-new-drug-ind-application-for-pmn310-in-alzheimers-disease\/"},"modified":"2023-05-08T09:25:55","modified_gmt":"2023-05-08T13:25:55","slug":"promis-neurosciences-announces-fda-clearance-of-investigational-new-drug-ind-application-for-pmn310-in-alzheimers-disease","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/promis-neurosciences-announces-fda-clearance-of-investigational-new-drug-ind-application-for-pmn310-in-alzheimers-disease\/","title":{"rendered":"ProMIS Neurosciences Announces FDA Clearance of Investigational New Drug (IND) Application for PMN310 in Alzheimer\u2019s Disease"},"content":{"rendered":"<div class=\"mw_release\">\n<p>TORONTO, Ontario and CAMBRIDGE, Massachusetts, May  08, 2023  (GLOBE NEWSWIRE) &#8212; <\/p>\n<ul type=\"disc\">\n<li>\n          <em>In pre<\/em><br \/>\n          <em>clinical studies, PMN310 demonstrated <\/em><br \/>\n          <em>the<\/em><br \/>\n          <em>abilit<\/em><br \/>\n          <em>y<\/em><br \/>\n          <em> to selectively target<\/em><br \/>\n          <em> and protect against<\/em><br \/>\n          <em> pathogenic <\/em><br \/>\n          <em>A\u03b2 oligomers<\/em>\n        <\/li>\n<li>\n          <em>The IND clearance of PMN310 <\/em><br \/>\n          <em>in the<\/em><br \/>\n          <em> Alzheimer\u2019s <\/em><br \/>\n          <em>disease indication <\/em><br \/>\n          <em>paves the way for <\/em><br \/>\n          <em>initiation<\/em><br \/>\n          <em> of <\/em><br \/>\n          <em>clinical evaluation<\/em>\n        <\/li>\n<\/ul>\n<p align=\"left\">ProMIS Neurosciences Inc. (TSX: PMN) (Nasdaq: PMN), a biotechnology company focused on the generation and development of antibody therapeutics targeting toxic misfolded proteins in neurodegenerative diseases such as Alzheimer\u2019s disease (AD), amyotrophic lateral sclerosis (ALS) and multiple system atrophy (MSA), today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for PMN310 for the treatment of AD. PMN310 is a novel monoclonal antibody which is designed to be highly selective for toxic oligomers of amyloid-beta (A\u03b2) that are believed to be a major driver of AD.<\/p>\n<p>\u201cReceiving IND clearance for PMN310 marks an important corporate milestone as we continue towards our goal of delivering next-generation therapy to patients with Alzheimer\u2019s disease who have limited options to slow cognitive decline,\u201d said Gail Farfel, Ph.D., Chief Executive Officer of ProMIS Neurosciences. \u201cOur preclinical data demonstrated PMN310\u2019s greater selective binding to toxic oligomers compared to other A\u03b2-directed antibodies, which we believe supports the potential clinical profile of PMN310. We look forward to advancing PMN310 into clinical development and sharing what we learn from this innovative work.\u201d<\/p>\n<p>In preclinical studies, PMN310 showed strong <em>ex vivo<\/em> target engagement of toxic oligomers in brain samples from patients with AD, with little or no diversion by A\u03b2 monomers or plaque. In a recent presentation of <em>in vitro<\/em> data at the AD\/PD 2023 conference, PMN310 was the least impacted by monomer competition, compared to other A\u03b2-directed antibodies, resulting in an overall greater ability to target toxic oligomers. In addition, PMN310 was not observed to bind to plaque, potentially reducing the risk of A\u03b2-related imaging abnormalities (ARIA) observed with plaque-binding antibodies. The Company believes these data support a potentially differentiated clinical profile when compared to other antibody therapeutic candidates in AD.<\/p>\n<p>With the IND clearance for PMN310, the Company plans to initiate a Phase 1a clinical trial designed to evaluate the pharmacokinetics, safety and tolerability of a range of PMN310 doses in healthy adult volunteers.<\/p>\n<p align=\"justify\">\n        <strong>About ProMIS Neurosciences Inc.<\/strong>\n      <\/p>\n<p>ProMIS Neurosciences Inc. is a development stage biotechnology company focused on generating and developing antibody therapeutics selectively targeting toxic misfolded proteins in neurodegenerative diseases such as Alzheimer\u2019s disease (AD), amyotrophic lateral sclerosis (ALS) and multiple system atrophy (MSA). The Company\u2019s proprietary target discovery engine is based on the use of two complementary techniques. The Company applies its thermodynamic, computational discovery platform &#8211; ProMIS\u2122 and Collective Coordinates &#8211; to predict novel targets known as Disease Specific Epitopes on the molecular surface of misfolded proteins. Using this unique approach, the Company is developing novel antibody therapeutics for AD, ALS and MSA. ProMIS has offices in Toronto, Ontario and Cambridge, Massachusetts. ProMIS is listed on Nasdaq and the Toronto Stock Exchange under the symbol PMN.<\/p>\n<p align=\"justify\">\n        <strong>Forward-Looking Statements<\/strong>\n      <\/p>\n<p>Neither the TSX nor Nasdaq has reviewed and neither accepts responsibility for the adequacy or accuracy of this release.\u00a0Certain information in this news release constitutes forward-looking statements and forward-looking information (collectively, \u200e\u200e\u201cforward-looking information\u201d) within the meaning of applicable securities laws. In some cases, but not necessarily in all cases, forward-looking information can be identified by the \u200euse of forward-looking terminology such as \u201cplans\u201d, \u201cexcited to\u201d, \u201ctargets\u201d, \u201cexpects\u201d or \u201cdoes not expect\u201d, \u201cis expected\u201d, \u201can opportunity exists\u201d, \u200e\u200e\u201cis positioned\u201d, \u201cestimates\u201d, \u201cintends\u201d, \u201cassumes\u201d, \u201canticipates\u201d or \u201cdoes not anticipate\u201d or \u201cbelieves\u201d, or variations of such words and \u200ephrases or state that certain actions, events or results \u201cmay\u201d, \u201ccould\u201d, \u201cwould\u201d, \u201cmight\u201d, \u201cwill\u201d or \u201cwill be taken\u201d, \u201coccur\u201d or \u201cbe \u200eachieved\u201d. In addition, any statements that refer to expectations, projections or other characterizations of future events or \u200ecircumstances contain forward-looking information. Specifically, this news release contains forward-looking information relating to targeting of toxic misfolded proteins that the Company believes may directly address fundamental AD pathology (including the belief and understanding that toxic oligomers of amyloid-beta are a major driver of AD) and have greater therapeutic potential due to reduction of off-target activity, the initiation of the Company\u2019s first-in-human study, and its ability to enroll the requisite number of patients, dose each patient in the intended manner and progress the study, statements related to the presentation of data and the significance of such data, ProMIS\u2019 pipeline, management\u2019s belief that its patented platform technology has created an antibody candidate specific to toxic misfolded oligomers known to be present in Alzheimer\u2019s disease, and management\u2019s belief that this specificity may indicate greater therapeutic potential due to lower off-target activity. Statements containing forward-looking\u00a0information are not historical facts but instead represent management&#8217;s current \u200eexpectations, estimates and projections regarding the future of our business, future plans, strategies, projections, anticipated events \u200eand trends, the economy and other future conditions. Forward-looking information is necessarily based on a number of opinions, assumptions and estimates that, while considered reasonable by the Company as of the date of this news release, are subject to \u200eknown and unknown risks, uncertainties and assumptions and other factors that may cause the actual results, level of activity, \u200eperformance or achievements to be materially different from those expressed or implied by such forward-looking information, including, but not limited to, the Company\u2019s ability to fund its operations and continue as a going concern, its accumulated deficit and the expectation for continued losses and future financial results. Important factors that could cause actual results to differ materially from those indicated in the forward-looking information include, among others, the factors discussed throughout the \u201cRisk Factors\u201d section of the Company&#8217;s most recently filed annual information form available on www.SEDAR.com, in Item 1A of its Annual Report on Form 10-K for the year ended December 31, 2022 and the section entitled \u201cRisk Factors\u201d in its Post-Effective Amendment No. 1 to Form S-1, filed March 17, 2023, each as filed with the Securities and Exchange\u00a0Commission. Except as required by applicable securities laws, the Company undertakes no obligation to publicly update any forward-looking information, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.<\/p>\n<p align=\"justify\">For further information:<\/p>\n<p align=\"justify\">Visit us at <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=gOCm7YJzjJj0lc2M-pz7CgVO62emX45MAYJqqBCTZpi9mh_p9QbaMFQZjfyeogKp3kz5uqfrmV-PlaiyjAX-kIFt1nHI5CzWTMb9XMEpW_WWMgCkrcTX2dh6WehR6HlN\" rel=\"nofollow noopener\" target=\"_blank\">www.promisneurosciences.com<\/a><\/p>\n<p align=\"justify\">Please submit media inquiries to <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=pA1QUKyDIcSYWeM8iUp6FjpE4mJBazVPAm32NrwGH42EcuaOEMdMkEuFpf2zEpACIhEtNeEAgUCejQFXDUm8gcLBT1iuAtnGYTx84-BU09Ut0z3IxgrIdcZ7EhMzHGLM\" rel=\"nofollow noopener\" target=\"_blank\">info@promisneurosciences.com<\/a>.<\/p>\n<p align=\"justify\">For Investor Relations, please contact: <br \/>Stern Investor Relations<br \/>Suzanne Messere, Managing Director<br \/>suzanne.messere@sternir.com<br \/>Tel. 212 698-8801<\/p>\n<p \/>\n      <img decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODgzMzg5NyM1NTgwNDY0IzIwODQ1ODk=\" \/><br \/>\n      <br \/>\n      <img decoding=\"async\" src=\"https:\/\/ml.globenewswire.com\/media\/MzU4NzVkZjgtM2UwZS00NGY0LTkzMzQtZWZhNTJlZmI3MDIyLTEwOTYxNjA=\/tiny\/ProMIS-Neurosciences-Inc-.png\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>TORONTO, Ontario and CAMBRIDGE, Massachusetts, May 08, 2023 (GLOBE NEWSWIRE) &#8212; In pre clinical studies, PMN310 demonstrated the abilit y to selectively target and protect against pathogenic A\u03b2 oligomers The IND clearance of PMN310 in the Alzheimer\u2019s disease indication paves the way for initiation of clinical evaluation ProMIS Neurosciences Inc. (TSX: PMN) (Nasdaq: PMN), a biotechnology company focused on the generation and development of antibody therapeutics targeting toxic misfolded proteins in neurodegenerative diseases such as Alzheimer\u2019s disease (AD), amyotrophic lateral sclerosis (ALS) and multiple system atrophy (MSA), today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for PMN310 for the treatment of AD. PMN310 is a novel &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/promis-neurosciences-announces-fda-clearance-of-investigational-new-drug-ind-application-for-pmn310-in-alzheimers-disease\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;ProMIS Neurosciences Announces FDA Clearance of Investigational New Drug (IND) Application for PMN310 in 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-755943","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>ProMIS Neurosciences Announces FDA Clearance of Investigational New Drug (IND) Application for PMN310 in 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\/promis-neurosciences-announces-fda-clearance-of-investigational-new-drug-ind-application-for-pmn310-in-alzheimers-disease\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ProMIS Neurosciences Announces FDA Clearance of Investigational New Drug (IND) Application for PMN310 in Alzheimer\u2019s Disease - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"TORONTO, Ontario and CAMBRIDGE, Massachusetts, May 08, 2023 (GLOBE NEWSWIRE) &#8212; In pre clinical studies, PMN310 demonstrated the abilit y to selectively target and protect against pathogenic A\u03b2 oligomers The IND clearance of PMN310 in the Alzheimer\u2019s disease indication paves the way for initiation of clinical evaluation ProMIS Neurosciences Inc. (TSX: PMN) (Nasdaq: PMN), a biotechnology company focused on the generation and development of antibody therapeutics targeting toxic misfolded proteins in neurodegenerative diseases such as Alzheimer\u2019s disease (AD), amyotrophic lateral sclerosis (ALS) and multiple system atrophy (MSA), today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for PMN310 for the treatment of AD. PMN310 is a novel &hellip; Continue reading &quot;ProMIS Neurosciences Announces FDA Clearance of Investigational New Drug (IND) Application for PMN310 in Alzheimer\u2019s Disease&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/promis-neurosciences-announces-fda-clearance-of-investigational-new-drug-ind-application-for-pmn310-in-alzheimers-disease\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2023-05-08T13:25:55+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODgzMzg5NyM1NTgwNDY0IzIwODQ1ODk=\" \/>\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=\"5 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\\\/promis-neurosciences-announces-fda-clearance-of-investigational-new-drug-ind-application-for-pmn310-in-alzheimers-disease\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/promis-neurosciences-announces-fda-clearance-of-investigational-new-drug-ind-application-for-pmn310-in-alzheimers-disease\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"ProMIS Neurosciences Announces FDA Clearance of Investigational New Drug (IND) Application for PMN310 in Alzheimer\u2019s Disease\",\"datePublished\":\"2023-05-08T13:25:55+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/promis-neurosciences-announces-fda-clearance-of-investigational-new-drug-ind-application-for-pmn310-in-alzheimers-disease\\\/\"},\"wordCount\":1094,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/promis-neurosciences-announces-fda-clearance-of-investigational-new-drug-ind-application-for-pmn310-in-alzheimers-disease\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=ODgzMzg5NyM1NTgwNDY0IzIwODQ1ODk=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/promis-neurosciences-announces-fda-clearance-of-investigational-new-drug-ind-application-for-pmn310-in-alzheimers-disease\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/promis-neurosciences-announces-fda-clearance-of-investigational-new-drug-ind-application-for-pmn310-in-alzheimers-disease\\\/\",\"name\":\"ProMIS Neurosciences Announces FDA Clearance of Investigational New Drug (IND) Application for PMN310 in Alzheimer\u2019s 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\/promis-neurosciences-announces-fda-clearance-of-investigational-new-drug-ind-application-for-pmn310-in-alzheimers-disease\/","og_locale":"en_US","og_type":"article","og_title":"ProMIS Neurosciences Announces FDA Clearance of Investigational New Drug (IND) Application for PMN310 in Alzheimer\u2019s Disease - Market Newsdesk","og_description":"TORONTO, Ontario and CAMBRIDGE, Massachusetts, May 08, 2023 (GLOBE NEWSWIRE) &#8212; In pre clinical studies, PMN310 demonstrated the abilit y to selectively target and protect against pathogenic A\u03b2 oligomers The IND clearance of PMN310 in the Alzheimer\u2019s disease indication paves the way for initiation of clinical evaluation ProMIS Neurosciences Inc. (TSX: PMN) (Nasdaq: PMN), a biotechnology company focused on the generation and development of antibody therapeutics targeting toxic misfolded proteins in neurodegenerative diseases such as Alzheimer\u2019s disease (AD), amyotrophic lateral sclerosis (ALS) and multiple system atrophy (MSA), today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for PMN310 for the treatment of AD. PMN310 is a novel &hellip; Continue reading \"ProMIS Neurosciences Announces FDA Clearance of Investigational New Drug (IND) Application for PMN310 in Alzheimer\u2019s Disease\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/promis-neurosciences-announces-fda-clearance-of-investigational-new-drug-ind-application-for-pmn310-in-alzheimers-disease\/","og_site_name":"Market Newsdesk","article_published_time":"2023-05-08T13:25:55+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODgzMzg5NyM1NTgwNDY0IzIwODQ1ODk=","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"5 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/promis-neurosciences-announces-fda-clearance-of-investigational-new-drug-ind-application-for-pmn310-in-alzheimers-disease\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/promis-neurosciences-announces-fda-clearance-of-investigational-new-drug-ind-application-for-pmn310-in-alzheimers-disease\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"ProMIS Neurosciences Announces FDA Clearance of Investigational New Drug (IND) Application for PMN310 in Alzheimer\u2019s Disease","datePublished":"2023-05-08T13:25:55+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/promis-neurosciences-announces-fda-clearance-of-investigational-new-drug-ind-application-for-pmn310-in-alzheimers-disease\/"},"wordCount":1094,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/promis-neurosciences-announces-fda-clearance-of-investigational-new-drug-ind-application-for-pmn310-in-alzheimers-disease\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODgzMzg5NyM1NTgwNDY0IzIwODQ1ODk=","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/promis-neurosciences-announces-fda-clearance-of-investigational-new-drug-ind-application-for-pmn310-in-alzheimers-disease\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/promis-neurosciences-announces-fda-clearance-of-investigational-new-drug-ind-application-for-pmn310-in-alzheimers-disease\/","name":"ProMIS Neurosciences Announces FDA Clearance of Investigational New Drug (IND) Application for PMN310 in Alzheimer\u2019s Disease - 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