{"id":511685,"date":"2021-07-12T08:03:47","date_gmt":"2021-07-12T12:03:47","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/enlivex-initiates-design-and-construction-process-for-a-new-cgmp-allocetra-manufacturing-plant\/"},"modified":"2021-07-12T08:03:47","modified_gmt":"2021-07-12T12:03:47","slug":"enlivex-initiates-design-and-construction-process-for-a-new-cgmp-allocetra-manufacturing-plant","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/enlivex-initiates-design-and-construction-process-for-a-new-cgmp-allocetra-manufacturing-plant\/","title":{"rendered":"Enlivex Initiates Design and Construction Process for a New cGMP Allocetra Manufacturing Plant"},"content":{"rendered":"<h2>\nNew cGMP manufacturing plant designed to support additional clinical- and initial commercial-scale production of Allocetra<br \/>\n<\/h2>\n<div class=\"mw_release\">\n<p align=\"left\">\n        <strong>Nes Ziona, Israel, July  12, 2021  (GLOBE NEWSWIRE) &#8212; <\/strong>Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the \u201cCompany\u201d), a clinical-stage macrophage reprogramming immunotherapy company, today announced that it has initiated the design and construction process for a new wholly owned manufacturing plant in Israel. Upon completion, this cGMP plant will provide additional manufacturing capacity for Allocetra<sup>TM<\/sup>, the Company\u2019s immunotherapy product candidate.<\/p>\n<p>Enlivex intends to use the additional manufacturing capacity to support ongoing clinical trials, future clinical trials and initial commercial production of Allocetra<sup>TM<\/sup> that may occur if Enlivex receives applicable regulatory approvals. The planned new facility will initially be approximately 17,000 square feet, and will have the ability to be expanded to approximately 21,500 square feet in the future.<\/p>\n<p>\u201cThe planned expansion of our manufacturing capacity represents an important milestone that we expect will position Enlivex at a different level of readiness for larger clinical trials and potential initiation of commercial activities,\u201d said Oren Hershkovitz, Ph.D., Chief Executive Officer of Enlivex. \u201cIt will allow us to remain well prepared as we continue to advance Allocetra<sup>TM<\/sup> towards regulatory approval in sepsis and COVID-19 and work to leverage its broadly applicable mechanism of action to expand our planned clinical pipeline into solid tumors. We are very pleased with the progress these programs have been making and look forward to the construction of our new facility, which will be a critical component of the infrastructure needed to support their continued advancement.\u201d\u00a0\u00a0<\/p>\n<p>\n        <strong>ABOUT ALLOCETRA<\/strong><br \/>\n        <sup><br \/>\n          <strong>TM<\/strong><br \/>\n        <\/sup>\n      <\/p>\n<p>Allocetra<sup>TM<\/sup> is being developed as a universal, off-the-shelf cell therapy designed to\u00a0reprogram macrophages into their homeostatic state. Diseases such as solid cancers, sepsis, COVID-19 and many others reprogram macrophages out of their homeostatic state. These non-homeostatic macrophages contribute significantly to the severity of the respective diseases. By restoring macrophage homeostasis, Allocetra<sup>TM<\/sup> has the potential to provide a novel immunotherapeutic mechanism of action\u00a0for life-threatening clinical indications that are defined as \u201cunmet medical needs\u201d, as a stand-alone therapy or in combination with leading therapeutic agents.<\/p>\n<p>\n        <strong>ABOUT <\/strong><br \/>\n        <strong>ENLIVEX<\/strong>\n      <\/p>\n<p>Enlivex is a clinical stage immunotherapy company developing Allocetra<sup>TM<\/sup>, a universal, off-the-shelf cell therapy designed to\u00a0reprogram macrophages into their homeostatic state. Resetting non-homeostatic macrophages into their homeostatic state is critical for immune system rebalancing and resolution of life-threatening conditions. For more information, visit\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=5_KNfK3-2aHQnybmFWG01LguWCYI-QTPVuu0iiO8iDyfc-spWj9cv3LPAgI-KrByN__y9J1f1-Dx7rTPAmsB9kB843s6qVii7bOyjGwBS8Q=\" rel=\"nofollow noopener\" target=\"_blank\">http:\/\/www.enlivex.com.<\/a><\/p>\n<p>\n        <em>Safe Harbor Statement:\u00a0 This press release contains forward-looking statements, which may be identified by words such as \u201cexpects,\u201d \u201cplans,\u201d \u201cprojects,\u201d \u201cwill,\u201d \u201cmay,\u201d \u201canticipates,\u201d \u201cbelieves,\u201d \u201cshould,\u201d \u201cwould\u201d, \u201ccould,\u201d \u201cintends,\u201d \u201cestimates,\u201d \u201csuggests,\u201d \u201chas the potential to\u201d and other words of similar meaning, including statements regarding expected cash balances, market opportunities for the results of current clinical studies and preclinical experiments, the effectiveness of, and market opportunities for, ALLOCETRA<\/em><br \/>\n        <sup><br \/>\n          <em>TM<\/em><br \/>\n        <\/sup><br \/>\n        <em>\u00a0programs. All such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.\u00a0 Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect Enlivex\u2019s business and prospects, including the risks that Enlivex may not succeed in generating any revenues or developing any commercial products; that the products in development may fail, may not achieve the expected results or effectiveness and\/or may not generate data that would support the approval or marketing of these products for the indications being studied or for other indications; that ongoing studies may not continue to show substantial or any activity; and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-looking statements. The results of clinical trials in humans may produce results that differ significantly from the results of clinical and other trials in animals. The results of early-stage trials may differ significantly from the results of more developed, later-stage trials. The development of any products using the ALLOCETRA<\/em><br \/>\n        <sup><br \/>\n          <em>TM<\/em><br \/>\n        <\/sup><br \/>\n        <em>\u00a0product line could also be affected by a number of other factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision making, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing and the impact of patents and other proprietary rights held by competitors and other third parties.\u00a0 In addition to the risk factors described above, investors should consider the economic, competitive, governmental, technological and other factors discussed in Enlivex\u2019s filings with the Securities and Exchange Commission, including in the Company\u2019s most recent Annual Report on Form 20-F filed with the Securities and Exchange Commission.\u00a0 The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements, except as required under applicable law.<\/em>\n      <\/p>\n<p>\n        <strong>ENLIVEX CONTACT<\/strong><br \/>\n        <br \/>Shachar Shlosberger, CFO<br \/>Enlivex Therapeutics, Ltd.<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=0nt4Lj9T_yKv3kxixeIqOjji5gy3qg6qO8hHuKLbUGcM1O72stt_mweAA6O507mUWNUkCbiv3iW0ajuxMwtj7f0rSbhCDaVKhsqaLg_MnfA=\" rel=\"nofollow noopener\" target=\"_blank\">shachar@enlivexpharm.com<\/a><\/p>\n<p>\n        <strong>INVESTOR RELATIONS CONTACT<\/strong><br \/>\n        <br \/>Eric Ribner<br \/>LifeSci Advisors<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=c-zc72pP1h6ROEmRN8ObE9ogHwF4hHZ0aPErD1Ed0O4iaA_FB0nb10iqseYDSko3IstgaMf1gFktRsrxFH7T1yqJ6ErZsbNKHg4__wVYK88=\" rel=\"nofollow noopener\" target=\"_blank\">eric@lifesciadvisors.com<\/a><\/p>\n<\/p>\n<p>      <img loading=\"lazy\" decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODI3ODM2OCM0MjkxNDIwIzUwMDA2NTE3NA==\" width=\"1\" height=\"1\" \/><br \/>\n      <br \/>\n      <img loading=\"lazy\" decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/ml.globenewswire.com\/release\/track\/88d6f49a-527d-4d03-a900-389ee6c36972\" width=\"1\" height=\"1\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>New cGMP manufacturing plant designed to support additional clinical- and initial commercial-scale production of Allocetra Nes Ziona, Israel, July 12, 2021 (GLOBE NEWSWIRE) &#8212; Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the \u201cCompany\u201d), a clinical-stage macrophage reprogramming immunotherapy company, today announced that it has initiated the design and construction process for a new wholly owned manufacturing plant in Israel. Upon completion, this cGMP plant will provide additional manufacturing capacity for AllocetraTM, the Company\u2019s immunotherapy product candidate. Enlivex intends to use the additional manufacturing capacity to support ongoing clinical trials, future clinical trials and initial commercial production of AllocetraTM that may occur if Enlivex receives applicable regulatory approvals. The planned new facility will initially be approximately 17,000 square feet, and will have the &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/enlivex-initiates-design-and-construction-process-for-a-new-cgmp-allocetra-manufacturing-plant\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Enlivex Initiates Design and Construction Process for a New cGMP Allocetra Manufacturing Plant&#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-511685","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>Enlivex Initiates Design and Construction Process for a New cGMP Allocetra Manufacturing Plant - 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\/enlivex-initiates-design-and-construction-process-for-a-new-cgmp-allocetra-manufacturing-plant\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Enlivex Initiates Design and Construction Process for a New cGMP Allocetra Manufacturing Plant - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"New cGMP manufacturing plant designed to support additional clinical- and initial commercial-scale production of Allocetra Nes Ziona, Israel, July 12, 2021 (GLOBE NEWSWIRE) &#8212; Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the \u201cCompany\u201d), a clinical-stage macrophage reprogramming immunotherapy company, today announced that it has initiated the design and construction process for a new wholly owned manufacturing plant in Israel. Upon completion, this cGMP plant will provide additional manufacturing capacity for AllocetraTM, the Company\u2019s immunotherapy product candidate. Enlivex intends to use the additional manufacturing capacity to support ongoing clinical trials, future clinical trials and initial commercial production of AllocetraTM that may occur if Enlivex receives applicable regulatory approvals. 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(Nasdaq: ENLV, the \u201cCompany\u201d), a clinical-stage macrophage reprogramming immunotherapy company, today announced that it has initiated the design and construction process for a new wholly owned manufacturing plant in Israel. Upon completion, this cGMP plant will provide additional manufacturing capacity for AllocetraTM, the Company\u2019s immunotherapy product candidate. Enlivex intends to use the additional manufacturing capacity to support ongoing clinical trials, future clinical trials and initial commercial production of AllocetraTM that may occur if Enlivex receives applicable regulatory approvals. The planned new facility will initially be approximately 17,000 square feet, and will have the &hellip; Continue reading \"Enlivex Initiates Design and Construction Process for a New cGMP Allocetra Manufacturing Plant\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/enlivex-initiates-design-and-construction-process-for-a-new-cgmp-allocetra-manufacturing-plant\/","og_site_name":"Market Newsdesk","article_published_time":"2021-07-12T12:03:47+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODI3ODM2OCM0MjkxNDIwIzUwMDA2NTE3NA==","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\/enlivex-initiates-design-and-construction-process-for-a-new-cgmp-allocetra-manufacturing-plant\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/enlivex-initiates-design-and-construction-process-for-a-new-cgmp-allocetra-manufacturing-plant\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Enlivex Initiates Design and Construction Process for a New cGMP Allocetra Manufacturing Plant","datePublished":"2021-07-12T12:03:47+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/enlivex-initiates-design-and-construction-process-for-a-new-cgmp-allocetra-manufacturing-plant\/"},"wordCount":803,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/enlivex-initiates-design-and-construction-process-for-a-new-cgmp-allocetra-manufacturing-plant\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODI3ODM2OCM0MjkxNDIwIzUwMDA2NTE3NA==","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/enlivex-initiates-design-and-construction-process-for-a-new-cgmp-allocetra-manufacturing-plant\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/enlivex-initiates-design-and-construction-process-for-a-new-cgmp-allocetra-manufacturing-plant\/","name":"Enlivex Initiates Design and Construction Process for a New cGMP Allocetra Manufacturing Plant - 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