{"id":816704,"date":"2025-02-24T10:32:33","date_gmt":"2025-02-24T15:32:33","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/calidi-biotherapeutics-announces-commencement-of-recruitment-for-multiple-dose-cld-101-trial-in-patients-with-newly-diagnosed-high-grade-glioma-at-northwestern-university-hospital\/"},"modified":"2025-02-24T10:32:33","modified_gmt":"2025-02-24T15:32:33","slug":"calidi-biotherapeutics-announces-commencement-of-recruitment-for-multiple-dose-cld-101-trial-in-patients-with-newly-diagnosed-high-grade-glioma-at-northwestern-university-hospital","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/calidi-biotherapeutics-announces-commencement-of-recruitment-for-multiple-dose-cld-101-trial-in-patients-with-newly-diagnosed-high-grade-glioma-at-northwestern-university-hospital\/","title":{"rendered":"Calidi Biotherapeutics Announces Commencement of Recruitment for Multiple Dose CLD-101 Trial in Patients with Newly Diagnosed High Grade Glioma at Northwestern University Hospital"},"content":{"rendered":"<div class=\"mw_release\">\n<p align=\"left\">SAN DIEGO, Feb.  24, 2025  (GLOBE NEWSWIRE) &#8212; Calidi Biotherapeutics Inc. (NYSE American: CLDI) (\u201cCalidi\u201d), a clinical-stage biotechnology company developing a new generation of targeted antitumor virotherapies, today announced that Northwestern University\/Northwestern Memorial Hospital is starting recruitment for the CLD-101 clinical trial of its immunotherapy product.<\/p>\n<p>Calidi Biotherapeutics has completed the shipment of the first batch of CLD-101, which comprises allogeneic neural stem cells loaded with the oncolytic adenovirus CRAd-S-pk7. This batch will support a new clinical trial in patients with newly diagnosed high-grade glioma, an aggressive and often fatal form of brain cancer.<\/p>\n<p>This physician-led and NCI sponsored clinical trial, led by prominent experts Dr. Maciej Lesniak and Dr. Roger Stupp, represents a major step forward in cancer therapy. Building on the promising results from a prior Phase 1 trial involving 12 patients treated with a single dose of CLD-101 published in the prestigious journal <em>The Lancet Oncology,<\/em> the upcoming Phase 1B\/2 trial introduces multiple doses of CLD-101 regime in newly diagnosed patients, aiming to enhance therapeutic efficacy and improve patient outcomes.<\/p>\n<p>\u201cI am extremely excited about the commencement of recruitment for the multiple dose CLD-101 trial in newly diagnosed HGG patients. This increases the probability of success due to the improved treatment regimen initiated as early as possible in this devastating disease,\u201d said Dr. Lesniak, chairman of the Department of Neurological Surgery at Northwestern University\u2019s Feinberg School of Medicine. The trial has been granted funding by the NIH\/NCI SPORE to support this pioneering study.<\/p>\n<p>Both Dr. Lesniak and Dr. Stupp bring a wealth of experience in treating brain tumors. Dr. Stupp is globally recognized for developing the FDA-approved Stupp Protocol, a treatment that transformed Glioblastoma care.<\/p>\n<p>\u201cWe are proud to have assembled a world-class team of surgeons and neuro-oncologists to lead this trial,\u201d said Allan Camaisa, Chief Executive Officer and Chairman at Calidi Biotherapeutics. \u201cShould the results of this trial demonstrate treatment outcomes consistent with the previous study, now in a larger patient group and with multiple doses of CLD-101, the implications could be transformative for the treatment of brain tumors. Together with our systemic, enveloped virus platform, I believe we are developing a portfolio of products to address glioblastoma, solid tumors and metastatic cancer.\u201d<\/p>\n<p>\n        <strong>About Calidi Biotherapeutics<\/strong>\n      <\/p>\n<p>Calidi Biotherapeutics (NYSE American: CLDI) is a clinical-stage immuno-oncology company with proprietary technology designed to arm the immune system to fight cancer. Calidi\u2019s novel stem cell-based platforms are utilizing potent allogeneic stem cells capable of carrying payloads of oncolytic viruses for use in multiple oncology indications, including high-grade gliomas and solid tumors. Calidi\u2019s clinical stage off-the-shelf, universal cell-based delivery platforms are designed to protect, amplify, and potentiate oncolytic viruses leading to enhanced efficacy and improved patient safety. Calidi\u2019s preclinical off-the-shelf enveloped virotherapies, are designed to target disseminated solid tumors. This dual approach can potentially treat, or even prevent, metastatic disease. Calidi Biotherapeutics is headquartered in San Diego, California. For more information, please visit\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=3kq8zvmc2nzgypri9TyxTsvj64CYSJ9utYE6Q-K9LX4ScX7LaMylAcCZA0FMymb2ByGVWunS3Lyr-cwuk-yFw_jr46a3t2EVcaYXIVxF4UeOVsmuTo_XftFHdU_3_2-_z0ujDIt1-ZicUn9RYTCN8gymkjo6hO666BqLEyZXuo8bDA5YpqypGvUwJWA3oeBK0M8VH8o7rAe7gMyLq4hGPst1wrApOKznZ1u0AgrSUIO9uJGSuYTCcjv95piN9SsZ\" rel=\"nofollow\" target=\"_blank\"><strong>www.calidibio.com<\/strong><\/a>.<\/p>\n<p>\n        <strong>Forward-Looking Statements<\/strong>\n      <\/p>\n<p>This press release may contain forward-looking statements for purposes of the \u201csafe harbor\u201d provisions under the United States Private Securities Litigation Reform Act of 1995. Terms such as \u201canticipates,\u201d \u201cbelieve,\u201d \u201ccontinue,\u201d \u201ccould,\u201d \u201cestimate,\u201d \u201cexpect,\u201d \u201cintends,\u201d \u201cmay,\u201d \u201cmight,\u201d \u201cplan,\u201d \u201cpossible,\u201d \u201cpotential,\u201d \u201cpredicts,\u201d \u201cproject,\u201d \u201cshould,\u201d \u201ctowards,\u201d \u201cwould\u201d as well as similar terms, are forward-looking in nature, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements include, but are not limited to, statements concerning upcoming key milestones (including the reporting of interim clinical results and the dosing of patients), planned clinical trials, and statements relating to the safety and efficacy of Calidi\u2019s therapeutic candidates in development. Any forward-looking statements contained in this discussion are based on Calidi\u2019s current expectations and beliefs concerning future developments and their potential effects and are subject to multiple risks and uncertainties that could cause actual results to differ materially and adversely from those set forth or implied in such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that Calidi is not able to raise sufficient capital to support its current and anticipated clinical trials, the risk that early results of clinical trials do not necessarily predict final results and that one or more of the clinical outcomes may materially change following more comprehensive review of the data, and as more patient data becomes available, the risk that Calidi may not receive FDA approval for some or all of its therapeutic candidates. Other risks and uncertainties are set forth in the section entitled \u201cRisk Factors\u201d and \u201cCautionary Note Regarding Forward-Looking Statements\u201d in the Company\u2019s Registration Statements filed with the SEC on (i) Form S-4 filed on August 2, 2023 and the corresponding prospectus filed on August 4, 2023, and (ii) on Form S-1 filed on April 15, 2024, and the Company\u2019s periodic reports filed with the SEC on (i) Form 10-K filed on March 15, 2024, (ii) Form 10-Q filed on May 14, 2024, (iii) Form 10-Q filed on August 13, 2024, and (iv) Form 10-Q filed on November 12, 2024. These reports may be amended or supplemented by other reports we file with the SEC from time to time.<\/p>\n<p>\n        <strong>Corporate Communications:<\/strong>\n      <\/p>\n<p>Dave Gentry, CEO<br \/>RedChip Companies, Inc.<br \/>1-407-644-4256<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=6EHOPka0JQYE9KBb1k3sJZYY7ofEThJjdvZWdlCX6dIWhTHm8tMzrt6Abq3XsldcBNhLOcxZyeEEdFLSKgc8cA==\" rel=\"nofollow\" target=\"_blank\"><strong>CLDI@redchip.com<\/strong><\/a><\/p>\n<p>Source: Calidi Biotherapeutics, Inc.<\/p>\n<p>      <img decoding=\"async\" alt=\"\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTM4MzE1OSM2Nzc0MzI4IzIxOTM4NTQ=\" \/><br \/>\n      <br \/>\n      <img decoding=\"async\" alt=\"\" src=\"https:\/\/ml.globenewswire.com\/media\/M2UwNDJkZjEtOGFmNy00ZWU0LWFiYmQtMjYyZTU1YWJmMTRkLTEyMDU0MDc=\/tiny\/Calidi-Biotherapeutics-Inc.png\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>SAN DIEGO, Feb. 24, 2025 (GLOBE NEWSWIRE) &#8212; Calidi Biotherapeutics Inc. (NYSE American: CLDI) (\u201cCalidi\u201d), a clinical-stage biotechnology company developing a new generation of targeted antitumor virotherapies, today announced that Northwestern University\/Northwestern Memorial Hospital is starting recruitment for the CLD-101 clinical trial of its immunotherapy product. Calidi Biotherapeutics has completed the shipment of the first batch of CLD-101, which comprises allogeneic neural stem cells loaded with the oncolytic adenovirus CRAd-S-pk7. This batch will support a new clinical trial in patients with newly diagnosed high-grade glioma, an aggressive and often fatal form of brain cancer. This physician-led and NCI sponsored clinical trial, led by prominent experts Dr. Maciej Lesniak and Dr. Roger Stupp, represents a major step forward in cancer therapy. &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/calidi-biotherapeutics-announces-commencement-of-recruitment-for-multiple-dose-cld-101-trial-in-patients-with-newly-diagnosed-high-grade-glioma-at-northwestern-university-hospital\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Calidi Biotherapeutics Announces Commencement of Recruitment for Multiple Dose CLD-101 Trial in Patients with Newly Diagnosed High Grade Glioma at Northwestern University Hospital&#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-816704","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>Calidi Biotherapeutics Announces Commencement of Recruitment for Multiple Dose CLD-101 Trial in Patients with Newly Diagnosed High Grade Glioma at Northwestern University Hospital - 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\/calidi-biotherapeutics-announces-commencement-of-recruitment-for-multiple-dose-cld-101-trial-in-patients-with-newly-diagnosed-high-grade-glioma-at-northwestern-university-hospital\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Calidi Biotherapeutics Announces Commencement of Recruitment for Multiple Dose CLD-101 Trial in Patients with Newly Diagnosed High Grade Glioma at Northwestern University Hospital - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"SAN DIEGO, Feb. 24, 2025 (GLOBE NEWSWIRE) &#8212; Calidi Biotherapeutics Inc. (NYSE American: CLDI) (\u201cCalidi\u201d), a clinical-stage biotechnology company developing a new generation of targeted antitumor virotherapies, today announced that Northwestern University\/Northwestern Memorial Hospital is starting recruitment for the CLD-101 clinical trial of its immunotherapy product. Calidi Biotherapeutics has completed the shipment of the first batch of CLD-101, which comprises allogeneic neural stem cells loaded with the oncolytic adenovirus CRAd-S-pk7. This batch will support a new clinical trial in patients with newly diagnosed high-grade glioma, an aggressive and often fatal form of brain cancer. This physician-led and NCI sponsored clinical trial, led by prominent experts Dr. Maciej Lesniak and Dr. Roger Stupp, represents a major step forward in cancer therapy. &hellip; Continue reading &quot;Calidi Biotherapeutics Announces Commencement of Recruitment for Multiple Dose CLD-101 Trial in Patients with Newly Diagnosed High Grade Glioma at Northwestern University Hospital&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/calidi-biotherapeutics-announces-commencement-of-recruitment-for-multiple-dose-cld-101-trial-in-patients-with-newly-diagnosed-high-grade-glioma-at-northwestern-university-hospital\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2025-02-24T15:32:33+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTM4MzE1OSM2Nzc0MzI4IzIxOTM4NTQ=\" \/>\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\\\/calidi-biotherapeutics-announces-commencement-of-recruitment-for-multiple-dose-cld-101-trial-in-patients-with-newly-diagnosed-high-grade-glioma-at-northwestern-university-hospital\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/calidi-biotherapeutics-announces-commencement-of-recruitment-for-multiple-dose-cld-101-trial-in-patients-with-newly-diagnosed-high-grade-glioma-at-northwestern-university-hospital\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Calidi Biotherapeutics Announces Commencement of Recruitment for Multiple Dose CLD-101 Trial in Patients with Newly Diagnosed High Grade Glioma at Northwestern University Hospital\",\"datePublished\":\"2025-02-24T15:32:33+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/calidi-biotherapeutics-announces-commencement-of-recruitment-for-multiple-dose-cld-101-trial-in-patients-with-newly-diagnosed-high-grade-glioma-at-northwestern-university-hospital\\\/\"},\"wordCount\":885,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/calidi-biotherapeutics-announces-commencement-of-recruitment-for-multiple-dose-cld-101-trial-in-patients-with-newly-diagnosed-high-grade-glioma-at-northwestern-university-hospital\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=OTM4MzE1OSM2Nzc0MzI4IzIxOTM4NTQ=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/calidi-biotherapeutics-announces-commencement-of-recruitment-for-multiple-dose-cld-101-trial-in-patients-with-newly-diagnosed-high-grade-glioma-at-northwestern-university-hospital\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/calidi-biotherapeutics-announces-commencement-of-recruitment-for-multiple-dose-cld-101-trial-in-patients-with-newly-diagnosed-high-grade-glioma-at-northwestern-university-hospital\\\/\",\"name\":\"Calidi Biotherapeutics Announces Commencement of Recruitment for Multiple Dose CLD-101 Trial in Patients with Newly Diagnosed High Grade Glioma at Northwestern University Hospital - 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(NYSE American: CLDI) (\u201cCalidi\u201d), a clinical-stage biotechnology company developing a new generation of targeted antitumor virotherapies, today announced that Northwestern University\/Northwestern Memorial Hospital is starting recruitment for the CLD-101 clinical trial of its immunotherapy product. Calidi Biotherapeutics has completed the shipment of the first batch of CLD-101, which comprises allogeneic neural stem cells loaded with the oncolytic adenovirus CRAd-S-pk7. This batch will support a new clinical trial in patients with newly diagnosed high-grade glioma, an aggressive and often fatal form of brain cancer. This physician-led and NCI sponsored clinical trial, led by prominent experts Dr. Maciej Lesniak and Dr. Roger Stupp, represents a major step forward in cancer therapy. &hellip; Continue reading \"Calidi Biotherapeutics Announces Commencement of Recruitment for Multiple Dose CLD-101 Trial in Patients with Newly Diagnosed High Grade Glioma at Northwestern University Hospital\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/calidi-biotherapeutics-announces-commencement-of-recruitment-for-multiple-dose-cld-101-trial-in-patients-with-newly-diagnosed-high-grade-glioma-at-northwestern-university-hospital\/","og_site_name":"Market Newsdesk","article_published_time":"2025-02-24T15:32:33+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTM4MzE1OSM2Nzc0MzI4IzIxOTM4NTQ=","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\/calidi-biotherapeutics-announces-commencement-of-recruitment-for-multiple-dose-cld-101-trial-in-patients-with-newly-diagnosed-high-grade-glioma-at-northwestern-university-hospital\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/calidi-biotherapeutics-announces-commencement-of-recruitment-for-multiple-dose-cld-101-trial-in-patients-with-newly-diagnosed-high-grade-glioma-at-northwestern-university-hospital\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Calidi Biotherapeutics Announces Commencement of Recruitment for Multiple Dose CLD-101 Trial in Patients with Newly Diagnosed High Grade Glioma at Northwestern University Hospital","datePublished":"2025-02-24T15:32:33+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/calidi-biotherapeutics-announces-commencement-of-recruitment-for-multiple-dose-cld-101-trial-in-patients-with-newly-diagnosed-high-grade-glioma-at-northwestern-university-hospital\/"},"wordCount":885,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/calidi-biotherapeutics-announces-commencement-of-recruitment-for-multiple-dose-cld-101-trial-in-patients-with-newly-diagnosed-high-grade-glioma-at-northwestern-university-hospital\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTM4MzE1OSM2Nzc0MzI4IzIxOTM4NTQ=","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/calidi-biotherapeutics-announces-commencement-of-recruitment-for-multiple-dose-cld-101-trial-in-patients-with-newly-diagnosed-high-grade-glioma-at-northwestern-university-hospital\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/calidi-biotherapeutics-announces-commencement-of-recruitment-for-multiple-dose-cld-101-trial-in-patients-with-newly-diagnosed-high-grade-glioma-at-northwestern-university-hospital\/","name":"Calidi Biotherapeutics Announces Commencement of Recruitment for Multiple Dose CLD-101 Trial in Patients with Newly Diagnosed High Grade Glioma at Northwestern University Hospital - 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