{"id":50191,"date":"2022-10-27T21:02:36","date_gmt":"2022-10-27T19:02:36","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/tevogen-bio-ceo-ryan-saadi-and-cso-neal-flomenberg-share-white-house-concerns-about-emerging-covid-19-variants-and-impact-on-immunocompromised-patients-and-express-commitment-to-accelerate-developmen\/"},"modified":"2022-10-27T21:02:36","modified_gmt":"2022-10-27T19:02:36","slug":"tevogen-bio-ceo-ryan-saadi-and-cso-neal-flomenberg-share-white-house-concerns-about-emerging-covid-19-variants-and-impact-on-immunocompromised-patients-and-express-commitment-to-accelerate-developmen","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/tevogen-bio-ceo-ryan-saadi-and-cso-neal-flomenberg-share-white-house-concerns-about-emerging-covid-19-variants-and-impact-on-immunocompromised-patients-and-express-commitment-to-accelerate-developmen\/","title":{"rendered":"Tevogen Bio CEO Ryan Saadi and CSO Neal Flomenberg share White House concerns about emerging COVID-19 variants and impact on immunocompromised patients, and express commitment to accelerate development of company\u2019s investigational COVID-19 therapy"},"content":{"rendered":"<div>\n<ul class=\"bwlistdisc\">\n<li>\nTevogen Bio CEO and CSO share concerns of the White House and President Joe Biden who stated, \u201cNew variants may make some existing protections ineffective for the immunocompromised\u201d and promise to do everything in their power to accelerate development and manufacturing of its investigational therapy, TVGN-489\n<\/li>\n<li>\nA comprehensive review by the company\u2019s R&amp;D team found that TVGN-489 is expected to retain activity against recent variants, including XBB and BQ and its subtypes\n<\/li>\n<li>\nTevogen is exploring all options including Emergency Use Authorization (EUA) for TVGN-489 for the treatment of COVID-19 in immunocompromised patients\n<\/li>\n<li>\nTVGN-489 targets were specifically selected across the entire viral genome to avoid anticipated mutational susceptibility under evolutionary pressure\n<\/li>\n<\/ul>\n<p>WARREN, N.J.&#8211;(BUSINESS WIRE)&#8211;<a href=\"https:\/\/twitter.com\/hashtag\/celltherapies?src=hash\" target=\"_blank\" rel=\"noopener\">#celltherapies<\/a>&#8212;<a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.tevogen.com&amp;esheet=52954782&amp;newsitemid=20221027005988&amp;lan=en-US&amp;anchor=Tevogen+Bio&amp;index=1&amp;md5=5f7cc5daa3796c2871e0dc3546418656\" rel=\"nofollow noopener\" shape=\"rect\">Tevogen Bio<\/a>, a late-stage clinical biotechnology company specializing in the development of cellular immunotherapies in oncology, neurology, and virology today expressed that its CEO Dr. <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.linkedin.com%2Fin%2Fryansaadi%2F&amp;esheet=52954782&amp;newsitemid=20221027005988&amp;lan=en-US&amp;anchor=Ryan+Saadi&amp;index=2&amp;md5=feeee58c1cab1968bf1dc6ca9a985717\" rel=\"nofollow noopener\" shape=\"rect\">Ryan Saadi<\/a> and Chief Scientific Officer Dr. <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.linkedin.com%2Fin%2Fneal-flomenberg-213a74126%2F&amp;esheet=52954782&amp;newsitemid=20221027005988&amp;lan=en-US&amp;anchor=Neal+Flomenberg&amp;index=3&amp;md5=541018266bc3a3a32a0b6f4d08eff367\" rel=\"nofollow noopener\" shape=\"rect\">Neal Flomenberg<\/a> share President Biden\u2019s <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.whitehouse.gov%2Fbriefing-room%2Fspeeches-remarks%2F2022%2F10%2F25%2Fremarks-by-president-biden-on-the-status-of-the-countrys-fight-against-covid-19-2%2F&amp;esheet=52954782&amp;newsitemid=20221027005988&amp;lan=en-US&amp;anchor=concerns&amp;index=4&amp;md5=9d4ae0898e0f3809d7f0460d9c089f62\" rel=\"nofollow noopener\" shape=\"rect\">concerns<\/a> that emerging COVID-19 variants \u201cmay make some existing protections ineffective for the immunocompromised\u201d and reconfirm the company\u2019s commitment to accelerate the development and manufacturing of its investigational COVID-19 treatment, TVGN-489.\n<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20221027005988\/en\/1073275\/5\/Tevogen_Logo_800px.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20221027005988\/en\/1073275\/21\/Tevogen_Logo_800px.jpg\"><\/a><\/p>\n<p>\nA comprehensive review, completed by the company\u2019s Research and Development team, found that TVGN-489 is expected to retain activity against recent variants, including XBB and BQ and its subtypes, which appear to have the ability to evade some existing prophylactic options and immunity.\n<\/p>\n<p>\nTVGN-489 is highly purified cytotoxic CD8+ T lymphocytes (CTLs) designed to detect and kill SARS-CoV-2 infected cells. These allogeneic genetically unmodified CTLs are enriched and expanded in the lab and recognize proteins from across the entire SARS-CoV-2 genome, not just the spike protein.\n<\/p>\n<p>\nIn July 2022, TVGN-489 <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Ftevogen.com%2Fpress_release%2Ftevogen-bio-announces-positive-safety-results-upon-completion-of-patient-enrollment%2F&amp;esheet=52954782&amp;newsitemid=20221027005988&amp;lan=en-US&amp;anchor=completed&amp;index=5&amp;md5=6619b8f868397a3c1a8aac9110f6f850\" rel=\"nofollow noopener\" shape=\"rect\">completed<\/a> proof-of-concept clinical trial with zero treatment-related adverse events. Patients treated were infected with a range of all COVID variants at the time, from Delta through Omicron BA.5. Additionally, each patient had co-morbidities rendering them high risk and 50 percent of those additionally met the definition of being immunocompromised.\n<\/p>\n<p>\n<b>\u201c<\/b>It\u2019s concerning that, so far, all of Omicron\u2019s subvariants have shown increased transmissibility and high immune escape potential,\u201d said Dr. Neal Flomenberg, Tevogen\u2019s Chief Scientific Officer. \u201cEven if the average person gets only a mild case, the risks to the elderly, the infirm, and the immunocompromised subsets of the population remain significant. These are the patient populations on whom we will focus our upcoming trials. However, I\u2019m greatly encouraged by the durability of TVGN-489\u2019s targets from the original COVID strains which reached the U.S. through the Delta and Omicron variants. The fact that TVGN-489 targets are spread across the entire COVID genome, rather than just within the spike protein, helps reduce target loss due to mutation from immunologic pressure. Moreover, TVGN-489 can remain active even if one target should be lost, which is very different from many of the other therapeutic approaches to prevent or treat COVID-19,\u201d added Dr. Flomenberg. \u201cWe are rapidly expanding our capabilities to address the needs of these higher vulnerability groups.\u201d\n<\/p>\n<p>\n\u201cIt is everyone\u2019s responsibly to step up during a moment of crisis, and for those of us in the medical innovation industry, it is our moral obligation. And we will do everything in our power to save as many lives as we can,\u201d said Tevogen CEO and Nobel Peace Prize nominee Ryan Saadi, M.D., M.P.H.\n<\/p>\n<p>\n\u201cWith new variants emerging, especially in the fall and winter months, we need to do everything possible to speed up the process of getting potentially life-saving therapeutics to our most vulnerable populations,\u201d said Victor Sordillo, Mayor of Warren, NJ Township, and a member of Tevogen\u2019s Corporate Advisory Board.\n<\/p>\n<p>\n<b>About Tevogen\u2019s Next Generation Precision T Cell Platform<\/b>\n<\/p>\n<p>\nTevogen\u2019s next generation precision <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Ftevogen.com%2Ftechnology%2F&amp;esheet=52954782&amp;newsitemid=20221027005988&amp;lan=en-US&amp;anchor=T+cell+platform&amp;index=6&amp;md5=8c640f6c49acda61cb566b626f1b4282\" rel=\"nofollow noopener\" shape=\"rect\">T cell platform<\/a> is designed to provide increased immunologic specificity to eliminate malignant and virally infected cells, while allowing healthy cells to remain intact. Multiple targets are selected in advance with the goal of overcoming the mutational capacity of cancer cells and viruses which can otherwise allow for escape from immunologic targeting.\n<\/p>\n<p>\nTevogen is investigating its technology\u2019s potential to overcome the primary barriers to the broad application of personalized T cell therapies: potency, purity, production-at-scale, and patient-pairing, without the limitations of current approaches. Tevogen\u2019s goal is to open the vast and unprecedented potential of developing personalized immunotherapies for large patient populations impacted by common cancers and viral infections.\n<\/p>\n<p>\nTevogen <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Ftevogen.com%2Fpress_release%2Ftevogen-bio-announces-positive-safety-results-upon-completion-of-patient-enrollment%2F&amp;esheet=52954782&amp;newsitemid=20221027005988&amp;lan=en-US&amp;anchor=announced&amp;index=7&amp;md5=aa584d843fa2f007dcaf12b621174be2\" rel=\"nofollow noopener\" shape=\"rect\">announced<\/a> the completion of patient enrollment in the Proof-of-Concept clinical trial of its lead product, TVGN-489, for ambulatory, acute-risk COVID-19 patients, with no dose-limiting toxicities or significant treatment-related adverse events observed for any patient at any dose level.\n<\/p>\n<p>\nTVGN-489 is a genetically unmodified, off-the-shelf, allogeneic cytotoxic CD8+ T lymphocyte (CTL) product with activity against multiple, precise targets across the entire SARS-CoV-2 genome.\n<\/p>\n<p>\n<b>About Tevogen Bio<\/b>\n<\/p>\n<p>\nTevogen Bio is driven by a team of distinguished scientists and highly experienced biopharmaceutical leaders who have successfully developed and commercialized multiple franchises. Tevogen\u2019s leadership believes that accessible personalized immunotherapies are the next frontier of medicine, and that disruptive business models are required to sustain medical innovation in the post-pandemic world.\n<\/p>\n<p>\n<b>Forward-Looking Statements<\/b>\n<\/p>\n<p>\nThis press release contains certain forward-looking statements relating to Tevogen Bio\u2122 Inc (the \u201cCompany\u201d) and its business. These statements are based on management\u2019s current expectations and beliefs as of the date of this release and are subject to several factors which involve known and unknown risks, delays, uncertainties, and other factors not under the Company\u2019s control that may cause actual results, performance or achievements to be materially different from the results, performance or other expectations implied by these forward-looking statements. Forward-looking statements can sometimes be identified by terminology such as \u201cmay,\u201d \u201cwill,\u201d \u201cshould,\u201d \u201cintend,\u201d \u201cexpect,\u201d \u201cbelieve,\u201d \u201cpotential,\u201d and \u201cpossible,\u201d or their negatives or comparable terminology, as well as other words and expressions referencing future events, conditions, or circumstances. In any forward-looking statement in which the Company expresses an expectation or belief as to future results, there can be no assurance that the statement or expectation or belief will be achieved. Various factors may cause differences between the Company\u2019s expectations and actual results, including, among others: the Company\u2019s limited operating history; uncertainties inherent in the execution, cost, and completion of preclinical studies and clinical trials; risks related to regulatory review, and approval and commercial development; risks associated with intellectual property protection; and risks related to matters that could affect the Company\u2019s future financial results, including the commercial potential, sales, and pricing of the Company\u2019s products. Except as required by law, the Company undertakes no obligation to update the forward-looking statements or any of the information in this release, or provide additional information, and expressly disclaims any and all liability and makes no representations or warranties in connection herewith or with respect to any omissions therefrom.\n<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\n<b>Media:<\/b><br \/>Katelyn Joyce<br \/>\n<br \/>Corporate Communications Lead<br \/>\n<br \/>T: 1 877 TEVOGEN, Ext 709<br \/>\n<br \/><a target=\"_blank\" href=\"&#109;&#97;&#x69;&#x6c;&#116;&#111;&#x3a;&#x4b;&#97;&#116;&#x65;&#x6c;&#121;&#110;&#x2e;&#x6a;&#111;&#121;&#x63;&#x65;&#64;&#116;&#x65;&#x76;&#111;&#103;&#x65;&#x6e;&#46;&#99;&#x6f;&#x6d;\" rel=\"nofollow noopener\" shape=\"rect\">&#75;&#x61;t&#x65;&#x6c;&#121;&#x6e;&#46;&#106;&#x6f;&#121;&#x63;e&#64;&#x74;e&#x76;o&#103;&#x65;n&#x2e;&#x63;&#111;&#x6d;<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Tevogen Bio CEO and CSO share concerns of the White House and President Joe Biden who stated, \u201cNew variants may make some existing protections ineffective for the immunocompromised\u201d and promise to do everything in their power to accelerate development and manufacturing of its investigational therapy, TVGN-489 A comprehensive review by the company\u2019s R&amp;D team found &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/tevogen-bio-ceo-ryan-saadi-and-cso-neal-flomenberg-share-white-house-concerns-about-emerging-covid-19-variants-and-impact-on-immunocompromised-patients-and-express-commitment-to-accelerate-developmen\/\">[Read more&#8230;]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-50191","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Tevogen Bio CEO Ryan Saadi and CSO Neal Flomenberg share White House concerns about emerging COVID-19 variants and impact on immunocompromised patients, and express commitment to accelerate development of company\u2019s investigational COVID-19 therapy - Pharma Trend<\/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:\/\/pharma-trend.com\/en\/tevogen-bio-ceo-ryan-saadi-and-cso-neal-flomenberg-share-white-house-concerns-about-emerging-covid-19-variants-and-impact-on-immunocompromised-patients-and-express-commitment-to-accelerate-developmen\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Tevogen Bio CEO Ryan Saadi and CSO Neal Flomenberg share White House concerns about emerging COVID-19 variants and impact on immunocompromised patients, and express commitment to accelerate development of company\u2019s investigational COVID-19 therapy - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"Tevogen Bio CEO and CSO share concerns of the White House and President Joe Biden who stated, \u201cNew variants may make some existing protections ineffective for the immunocompromised\u201d and promise to do everything in their power to accelerate development and manufacturing of its investigational therapy, TVGN-489 A comprehensive review by the company\u2019s R&amp;D team found ... 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