{"id":781988,"date":"2023-09-06T08:57:52","date_gmt":"2023-09-06T12:57:52","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/study-validating-moa-of-intranasal-foralumab-in-alzheimers-disease-published-in-the-prestigious-journal-pnas-following-fda-ind-clearance\/"},"modified":"2023-09-06T08:57:52","modified_gmt":"2023-09-06T12:57:52","slug":"study-validating-moa-of-intranasal-foralumab-in-alzheimers-disease-published-in-the-prestigious-journal-pnas-following-fda-ind-clearance","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/study-validating-moa-of-intranasal-foralumab-in-alzheimers-disease-published-in-the-prestigious-journal-pnas-following-fda-ind-clearance\/","title":{"rendered":"Study Validating MoA of Intranasal Foralumab in Alzheimer\u2019s Disease Published in the Prestigious Journal PNAS, Following FDA IND Clearance"},"content":{"rendered":"<div class=\"mw_release\">\n<ul type=\"disc\">\n<li>\n          <strong>The authors conclude that \u201cnasal anti-CD3 has the potential to be a non-toxic novel immunotherapeutic approach for the treatment of<\/strong><br \/>\n          <strong>Alzheimer\u2019s disease (AD)\u201d<\/strong>\n        <\/li>\n<li>\n          <strong>FDA has cleared the IND for intranasal foralumab, a fully human anti-CD3 monoclonal antibody, for human study in mild to moderate Alzheimer\u2019s Disease<\/strong>\n        <\/li>\n<li>\n          <strong>The publication shows anti-CD3 monoclonal antibody (mAb) administered intranasally, ameliorates disease in a 3xTg model of Alzheimer\u2019s disease by targeting microglial activation in the brain, while expanding regulatory T cells in the periphery<\/strong>\n        <\/li>\n<li>\n          <strong>Remarkably, this reduced microglial activation and improved cognition occurs independent of amyloid beta disposition.<\/strong>\n        <\/li>\n<\/ul>\n<p>NEW YORK, Sept.  06, 2023  (GLOBE NEWSWIRE) &#8212; Tiziana Life Sciences Ltd.\u00a0(Nasdaq: TLSA) (\u201cTiziana\u201d or the \u201cCompany\u201d), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced acceptance of a publication, \u201cNasal Administration of anti-CD3 monoclonal antibody (mAb) ameliorates disease in a mouse model of Alzheimer\u2019s disease\u201d, in the preeminent<sup>1<\/sup> journal, <em>Proceedings of the National Academy of Sciences<\/em> (PNAS), that supports foralumab\u2019s mechanism as a potential treatment for Alzheimer\u2019s disease (AD), a difficult-to-treat neuroinflammatory disease.<sup>2<\/sup>\u00a0\u00a0 This is the second publication pertaining to intranasal administration of anti-CD3 monoclonal antibody this year to be published in PNAS.<sup>3<\/sup><\/p>\n<p>This study shows that intranasal anti-CD3 ameliorates disease in a rodent model of AD by targeting microglial activation in the brain and brain gene expression independent of affecting amyloid beta deposition. These studies identify a novel approach to treat Alzheimer&#8217;s disease.<\/p>\n<p>The publication can be found at : <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=AmBs1bwIKEmHgXS9piYkgEXvqnaq5khIFMYTcBfyrG-GMwWNeGQDBVlLdsF-4IQip6Xf38RSdUhimUKEAYgFipFBOz8rcYQZyPd_bLgMAbcndzJaBrNCvdp5Khi8q-VkNLIYLRCVwE3Typ8hJJu3NdVjguUHUxvbda9qCbXN6kI=\" rel=\"nofollow noopener\" target=\"_blank\">https:\/\/www.pnas.org\/doi\/10.1073\/pnas.2309221120<\/a><\/p>\n<p>Howard L. Weiner, M.D., a Robert L. Kroc Professor of Neurology at the\u00a0Harvard Medical School, Director and Founder of the Partners Multiple Sclerosis Center and Co-Director of the\u00a0Center for Neurologic Diseases\u00a0at Brigham and Women\u2019s Hospital, a founding member of\u00a0Mass General Brigham Healthcare System and Chairman of Tiziana&#8217;s\u00a0Scientific Advisory Board, stated, \u201cI am proud to be the senior author on this seminal publication showing that anti-CD3 mAb mitigates Alzheimer\u2019s disease in a rodent model. Remarkably, we found this benefit occurred independent of reduction of amyloid beta plaque in the brain. This finding demonstrates a unique mechanism of action that can now be tested in humans using foralumab, a fully human anti-CD3 mAb, foralumab, in which we modulate microglia by inducing T cells in the periphery that migrate to the brain. This represents a unique approach to treating Alzheimer\u2019s disease that could also potentially be employed in combination with anti-amyloid therapy. The neuromodulation of the T cell inflammatory response we observed in the brains of Alzheimer\u2019s mice is consistent with multiple sclerosis research we have conducted at the Ann Romney Center and validates our scientific rationale for testing foralumab in Alzheimer\u2019s patients after the recent IND clearance by the United States Food and Drug Administration.\u201d<\/p>\n<p>\u201cWe\u2019ve now have had two seminal publications in the esteemed journal <em>PNAS<\/em> related to novel and significant research on intranasal anti-CD3. It has been established through both publications that intranasal anti-CD3 positively modulates the immune system allowing Tiziana to explore foralumab in multiple neuro-inflammatory disease indications in addition to our ongoing research in non-active secondary progressive multiple sclerosis. We believe this scientific publication, along with the groundbreaking research continuously being conducted by our partners at Brigham and Women\u2019s Hospital led by Dr. Weiner, greatly increases the utilization potential of our foralumab portfolio,\u201d commented Gabriele Cerrone, Executive Chairman, founder and acting Chief Executive Officer of Tiziana.<\/p>\n<p>\n        <strong>Study Rationale<\/strong>\n      <\/p>\n<p>Alzheimer&#8217;s disease is a neurodegenerative disease characterized by amyloid beta (A\u03b2) plaques, neurofibrillary tangles, and microglial activation. Neuroinflammation is a major component of AD. Microglia are the primary immune cells of the brain that help both maintain homeostasis and react to injury. Studies showing activated microglia and astrocytes surrounding A\u03b2 plaques suggest significant involvement of inflammatory pathways in Alzheimer\u2019s disease. Therapies targeting A\u03b2 have shown positive effects in subjects with AD. Nasal anti-CD3 has been shown to treat animals with a progressive form of experimental autoimmune encephalomyelitis (EAE), a model for multiple sclerosis, by inducing regulatory T cells that dampen microglial inflammation in the brain.<\/p>\n<p>\n        <strong>Study Design<\/strong>\n      <\/p>\n<p>In this study, mice were treated three times a week with intranasal anti-CD3 for five months and compared against isotype control or saline. In the treated mice, the study found modulation of the activated microglia phenotype, changes in gene expression patterns in the brain and improved cognition, which all occurred independent of affecting amyloid beta deposition. Modulation of activated microglia was measured in treated mice by sorting the microglia using microglia-specific markers and performing a gene expression analysis using the Nanostring mouse myeloid panel and comparing treated mice versus control. Changes in gene expression were measured in the cortex and hippocampus. Cognition was measured including spatial learning and long- and short- term memories as assessed by the Morris water maze and the novel arm Y-maze behavioral test. Amyloid beta accumulation was measured by immunofluorescence in the hippocampus and prefrontal cortex areas of the brain.<\/p>\n<p>\n        <strong>About Foralumab<\/strong>\n      <\/p>\n<p>Activated T cells play an important role in the inflammatory process. Foralumab, the only fully human anti-CD3 monoclonal antibody (mAb), binds to the T cell receptor and dampens inflammation by modulating T cell function, thereby suppressing effector features in multiple immune cell subsets, an effect demonstrated in patients with COVID and with multiple sclerosis, as well as in healthy normal subjects. Intranasal foralumab Phase 2 trials are expected to start in Q3 2023 in patients with non-active SPMS immunomodulation by nasal anti-CD3 mAb represents a novel avenue for treatment of inflammatory human diseases that affects the brain and other organs.<sup>2<\/sup><sup>,<\/sup><sup>3<\/sup><\/p>\n<p>\n        <strong>About\u00a0Tiziana Life Sciences<\/strong>\n      <\/p>\n<p>Tiziana Life Sciences\u00a0is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana\u2019s innovative nasal, oral and inhalation approaches in development have the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana\u2019s lead candidate, intranasal foralumab, the only fully human anti-CD3 mAb, has demonstrated a favorable safety profile and clinical response in patients in studies to date. Tiziana\u2019s technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications.<\/p>\n<p>For further inquiries:<\/p>\n<p>\n        <strong>Tiziana Life Sciences Ltd<\/strong>\n      <\/p>\n<p>Paul Spencer, Business Development and Investor Relations <br \/>+44 (0) 207 495 2379<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=64qX6I85D3hv4nCyTtauyAQg3EeE2jHIJXfRTZLAwXRR5humrXyFhzxWwsMXlA1PSoXZiuLLO1n5k8NF-WdKqS9mFPlE7c8ysHiRHRXgKdeWgueMPn3LkRn6dGCGSfS4\" rel=\"nofollow noopener\" target=\"_blank\">info@tizianalifesciences.com<\/a><\/p>\n<p>\n        <strong>Investors:<\/strong><br \/>\n        <br \/>Irina Koffler<br \/>LifeSci Advisors, LLC<br \/>646.970.4681<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=dzjvJ9wnMnjNiIJOpFBGXX0rpEhJm6GmQms5AAXZNFHil15jMxx5sjVa9Ox5wudOItFHYXP9OOO5mI0EjNd6_A3F-hIwVqG_T6h3fwIff1J3DleXVo6vLROBxGUIcmtsJAivYc78kvci3kN55ASTgnouqpx1ZT7O90dMyga5y3-LE95pyWkgcGQzN5wlKEdV6itYUmQrDnoNV8fEfbomyAECIP78wgAFTU4st3M0cmeAmiqRVb1l8W4WNox9M9ey8sNmUoK1hrDqv9gWP87DEsxVfm4ICqgeVCo3OYPT0rCt3sK-WZ7oHNqKffkZm-DowIcdcJAExFry89594JDACd2C4N3cq0e2lB7-usFuoVaaH-OD2MpAdBbBLHAIzeWXu25pd4-rdLG9YDmfUMB1YZ_AU_tBm7RR2Ur8kVoyo-NfGj1Qq_7XUID5-fWbUoauaFK3ikgr7_CyXWMd_RHRIlk5L4TynefPdlyvtc7jj9PYOCXDWqTYoNEM8qyevuUx79pcWlJZaR4Qiyi9CxSjlw==\" rel=\"nofollow noopener\" target=\"_blank\"><u>ikoffler@lifesciadvisors.com<\/u><\/a><\/p>\n<hr \/>\n<p>\n        <sup>1<\/sup><br \/>\n        <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=AmBs1bwIKEmHgXS9piYkgEXvqnaq5khIFMYTcBfyrG_NJfj8f9QKQa8MojwzYOaVnGmtenGNSwo3SomyQ47dkf_wDf2GjRkZLWNZQdP6NY5fWBAl_0OF4_1eMYx1giGkJ49oOZBOvp1TX_ZLYinsQyiuel28mmQ2Mzqo_d76WYk=\" rel=\"nofollow noopener\" target=\"_blank\">https:\/\/www.pnas.org\/about\/article-journal-metrics<\/a><br \/>\n        <br \/>\n        <sup>2<\/sup><br \/>\n        <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=AmBs1bwIKEmHgXS9piYkgEXvqnaq5khIFMYTcBfyrG-GMwWNeGQDBVlLdsF-4IQivuWnULo8ku8SsFg1KyXt73_OmG7C9QlvIHVHrZPyIZVguMi0nJCd_ip1N8Ue5v1hOZShsTHJVq7OigUPMsvnND8yRV-Q92vs92TQO4gWCDQ=\" rel=\"nofollow noopener\" target=\"_blank\">https:\/\/www.pnas.org\/doi\/10.1073\/pnas.2309221120<\/a><br \/>\n        <br \/>\n        <sup>3<\/sup><br \/>\n        <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=AmBs1bwIKEmHgXS9piYkgEXvqnaq5khIFMYTcBfyrG-GMwWNeGQDBVlLdsF-4IQibUAb6ILNbdQfieMDcZqc7Vb2mBJTxwQj1a8rUcoNK3v-nyRb0zQqrYDkQ2VBCnRYaae5kKIRyowFC0w_vhdHT_Vg2dY0ENp1MYgtJwOqX98=\" rel=\"nofollow noopener\" target=\"_blank\">https:\/\/www.pnas.org\/doi\/10.1073\/pnas.2220272120<\/a>\n      <\/p>\n<p>\u00a0<\/p>\n<p>      <img decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODkxNzMwMSM1ODAwNTQzIzIxMjM4ODU=\" \/><br \/>\n      <br \/>\n      <img decoding=\"async\" src=\"https:\/\/ml.globenewswire.com\/media\/NDViZmRhMDMtYmY2MS00M2U3LWI1MDQtNWQwNTNiOGMzMTg0LTExMzU0NTY=\/tiny\/Tiziana-Life-Sciences-Plc.png\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>The authors conclude that \u201cnasal anti-CD3 has the potential to be a non-toxic novel immunotherapeutic approach for the treatment of Alzheimer\u2019s disease (AD)\u201d FDA has cleared the IND for intranasal foralumab, a fully human anti-CD3 monoclonal antibody, for human study in mild to moderate Alzheimer\u2019s Disease The publication shows anti-CD3 monoclonal antibody (mAb) administered intranasally, ameliorates disease in a 3xTg model of Alzheimer\u2019s disease by targeting microglial activation in the brain, while expanding regulatory T cells in the periphery Remarkably, this reduced microglial activation and improved cognition occurs independent of amyloid beta disposition. NEW YORK, Sept. 06, 2023 (GLOBE NEWSWIRE) &#8212; Tiziana Life Sciences Ltd.\u00a0(Nasdaq: TLSA) (\u201cTiziana\u201d or the \u201cCompany\u201d), a biotechnology company developing breakthrough immunomodulation therapies via novel routes &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/study-validating-moa-of-intranasal-foralumab-in-alzheimers-disease-published-in-the-prestigious-journal-pnas-following-fda-ind-clearance\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Study Validating MoA of Intranasal Foralumab in Alzheimer\u2019s Disease Published in the Prestigious Journal PNAS, Following FDA IND Clearance&#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-781988","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Study Validating MoA of Intranasal Foralumab in Alzheimer\u2019s Disease Published in the Prestigious Journal PNAS, Following FDA IND Clearance - 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\/study-validating-moa-of-intranasal-foralumab-in-alzheimers-disease-published-in-the-prestigious-journal-pnas-following-fda-ind-clearance\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Study Validating MoA of Intranasal Foralumab in Alzheimer\u2019s Disease Published in the Prestigious Journal PNAS, Following FDA IND Clearance - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"The authors conclude that \u201cnasal anti-CD3 has the potential to be a non-toxic novel immunotherapeutic approach for the treatment of Alzheimer\u2019s disease (AD)\u201d FDA has cleared the IND for intranasal foralumab, a fully human anti-CD3 monoclonal antibody, for human study in mild to moderate Alzheimer\u2019s Disease The publication shows anti-CD3 monoclonal antibody (mAb) administered intranasally, ameliorates disease in a 3xTg model of Alzheimer\u2019s disease by targeting microglial activation in the brain, while expanding regulatory T cells in the periphery Remarkably, this reduced microglial activation and improved cognition occurs independent of amyloid beta disposition. NEW YORK, Sept. 06, 2023 (GLOBE NEWSWIRE) &#8212; Tiziana Life Sciences Ltd.\u00a0(Nasdaq: TLSA) (\u201cTiziana\u201d or the \u201cCompany\u201d), a biotechnology company developing breakthrough immunomodulation therapies via novel routes &hellip; Continue reading &quot;Study Validating MoA of Intranasal Foralumab in Alzheimer\u2019s Disease Published in the Prestigious Journal PNAS, Following FDA IND Clearance&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/study-validating-moa-of-intranasal-foralumab-in-alzheimers-disease-published-in-the-prestigious-journal-pnas-following-fda-ind-clearance\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2023-09-06T12:57:52+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODkxNzMwMSM1ODAwNTQzIzIxMjM4ODU=\" \/>\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\\\/study-validating-moa-of-intranasal-foralumab-in-alzheimers-disease-published-in-the-prestigious-journal-pnas-following-fda-ind-clearance\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/study-validating-moa-of-intranasal-foralumab-in-alzheimers-disease-published-in-the-prestigious-journal-pnas-following-fda-ind-clearance\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Study Validating MoA of Intranasal Foralumab in Alzheimer\u2019s Disease Published in the Prestigious Journal PNAS, Following FDA IND Clearance\",\"datePublished\":\"2023-09-06T12:57:52+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/study-validating-moa-of-intranasal-foralumab-in-alzheimers-disease-published-in-the-prestigious-journal-pnas-following-fda-ind-clearance\\\/\"},\"wordCount\":1096,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/study-validating-moa-of-intranasal-foralumab-in-alzheimers-disease-published-in-the-prestigious-journal-pnas-following-fda-ind-clearance\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=ODkxNzMwMSM1ODAwNTQzIzIxMjM4ODU=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/study-validating-moa-of-intranasal-foralumab-in-alzheimers-disease-published-in-the-prestigious-journal-pnas-following-fda-ind-clearance\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/study-validating-moa-of-intranasal-foralumab-in-alzheimers-disease-published-in-the-prestigious-journal-pnas-following-fda-ind-clearance\\\/\",\"name\":\"Study Validating MoA of Intranasal Foralumab in Alzheimer\u2019s Disease Published in the Prestigious Journal PNAS, Following FDA IND Clearance - 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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\/study-validating-moa-of-intranasal-foralumab-in-alzheimers-disease-published-in-the-prestigious-journal-pnas-following-fda-ind-clearance\/","og_locale":"en_US","og_type":"article","og_title":"Study Validating MoA of Intranasal Foralumab in Alzheimer\u2019s Disease Published in the Prestigious Journal PNAS, Following FDA IND Clearance - Market Newsdesk","og_description":"The authors conclude that \u201cnasal anti-CD3 has the potential to be a non-toxic novel immunotherapeutic approach for the treatment of Alzheimer\u2019s disease (AD)\u201d FDA has cleared the IND for intranasal foralumab, a fully human anti-CD3 monoclonal antibody, for human study in mild to moderate Alzheimer\u2019s Disease The publication shows anti-CD3 monoclonal antibody (mAb) administered intranasally, ameliorates disease in a 3xTg model of Alzheimer\u2019s disease by targeting microglial activation in the brain, while expanding regulatory T cells in the periphery Remarkably, this reduced microglial activation and improved cognition occurs independent of amyloid beta disposition. 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