{"id":46368,"date":"2022-07-20T13:01:47","date_gmt":"2022-07-20T11:01:47","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/immunomic-therapeutics-announces-first-patient-dosed-in-phase-i-clinical-trial-of-iti-3000-pdna-vaccine-for-the-treatment-of-merkel-cell-carcinoma\/"},"modified":"2022-07-20T13:01:47","modified_gmt":"2022-07-20T11:01:47","slug":"immunomic-therapeutics-announces-first-patient-dosed-in-phase-i-clinical-trial-of-iti-3000-pdna-vaccine-for-the-treatment-of-merkel-cell-carcinoma","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/immunomic-therapeutics-announces-first-patient-dosed-in-phase-i-clinical-trial-of-iti-3000-pdna-vaccine-for-the-treatment-of-merkel-cell-carcinoma\/","title":{"rendered":"Immunomic Therapeutics Announces First Patient Dosed in Phase I Clinical Trial of ITI-3000 pDNA Vaccine for the Treatment of Merkel Cell Carcinoma"},"content":{"rendered":"<div>\n<p class=\"bwalignc\">\n<i>-Top line data expected in second half of 2023-<\/i>\n<\/p>\n<p>ROCKVILLE, Md.&#8211;(BUSINESS WIRE)&#8211;<a href=\"https:\/\/twitter.com\/hashtag\/MCC?src=hash\" target=\"_blank\" rel=\"noopener\">#MCC<\/a>&#8211;Immunomic Therapeutics, Inc., (\u201cITI\u201d), a privately-held clinical-stage biotechnology company pioneering the study of LAMP (Lysosome Associated Membrane Protein)-mediated nucleic acid-based immunotherapy, today announced dosing of the first patient in the company\u2019s Phase 1 study evaluating ITI-3000, a plasmid DNA (pDNA) vaccine targeting patients with Merkel cell carcinoma (MCC), a rare but aggressive form of skin cancer that is typically caused by the Merkel cell polyomavirus (MCPyV). The single-center study is being conducted at the University of Washington School of Medicine and the Fred Hutchinson Cancer Center in Seattle, Washington and is being led by Drs. Paul Nghiem, Song Park and David M. Koelle.\n<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20220630005827\/en\/1502659\/4\/ITI_logo_h_color.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20220630005827\/en\/1502659\/21\/ITI_logo_h_color.jpg\"><\/a><\/p>\n<p>\nThe eight-patient, open label, first-in-humans (FIH) study is designed to evaluate the safety, tolerability, and immunogenicity of 4 mg of ITI-3000 in patients with MCC who have undergone surgery. The study\u2019s primary endpoints include the number of participants experiencing dose limiting toxicities (DLTs), the number of occurrences of adverse events\/serious adverse reactions, (AEs\/SARs), as well as other standard clinical assessments and safety laboratory parameters.\n<\/p>\n<p>\nITI-3000 leverages the company\u2019s investigational UNiversal Intracellular Targeted Expression (UNITE\u00ae) platform, powered by LAMP, which fuses sequences from the mutated form of the large T antigen (LT) of the MCPyV into the sequence of the LAMP-1 gene. This lysosomal targeting technology has been shown to result in enhanced antigen presentation and a balanced immune response, including, of note, ITI-3000 activated antigen-specific CD4+ T cells <i>in vivo<\/i>.\n<\/p>\n<p>\n\u201cDespite recent advances in cancer immunotherapy, there remains a need for therapies to treat this rather rare, but aggressive form of skin cancer, and we believe that our proprietary approach, utilizing nucleic acid vaccines with the power to leverage the body\u2019s natural biochemistry to develop a broad immune response, holds tremendous potential in this indication,\u201d said Dr. William Hearl, Chief Executive Officer of Immunomic Therapeutics. \u201cWe look forward to reporting top-line results from the Phase 1 trial in the second quarter of next year.\u201d\n<\/p>\n<p>\nAdditional information regarding the Phase 1 trial may be found at <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fclinicaltrials.gov%2F&amp;esheet=52767759&amp;newsitemid=20220630005827&amp;lan=en-US&amp;anchor=clinicaltrials.gov&amp;index=1&amp;md5=57e3c88bb76a415ccefbf8ae215688a9\" rel=\"nofollow noopener\" shape=\"rect\">clinicaltrials.gov<\/a>, using identifier: NCT05422781.\n<\/p>\n<p>\n<b>About Immunomic Therapeutics, Inc.<\/b>\n<\/p>\n<p>\nImmunomic Therapeutics, Inc. (ITI) is a privately held, clinical stage biotechnology company pioneering the development of vaccines through its proprietary technology platform, UNiversal Intracellular Targeted Expression (UNITE\u00ae), which is designed to utilize the body\u2019s natural biochemistry to develop vaccines that generate broad immune responses. UNITE\u00ae has a robust history of applications in various therapeutic areas, including infectious diseases, oncology, allergy, and autoimmune diseases. ITI is primarily focused on applying the UNITE\u00ae platform to oncology, where it could potentially have broad applications, including antigen-derived antibodies as biologics. The Company has built a pipeline leveraging UNITE\u00ae with programs in oncology, animal health, infectious disease, and allergy. ITI maintains its headquarters in Rockville, Maryland. For more information, please visit <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.immunomix.com&amp;esheet=52767759&amp;newsitemid=20220630005827&amp;lan=en-US&amp;anchor=www.immunomix.com&amp;index=2&amp;md5=1f0e217a2c22d5493ce508c2c756d97f\" rel=\"nofollow noopener\" shape=\"rect\">www.immunomix.com<\/a>.\n<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\n<b>ITI Company Contact:<\/b><br \/>Melissa Kemp<br \/>\n<br \/><a target=\"_blank\" href=\"&#109;&#x61;&#105;&#x6c;&#116;&#x6f;:&#x6d;k&#x65;m&#112;&#x40;&#105;&#x6d;&#109;&#x75;&#110;&#x6f;m&#x69;x&#x2e;c&#111;&#x6d;\" rel=\"nofollow noopener\" shape=\"rect\">&#109;&#x6b;&#x65;m&#112;&#x40;i&#109;&#x6d;&#x75;n&#111;&#x6d;i&#120;&#x2e;&#x63;o&#109;<\/a><br \/>301-968-3501<\/p>\n<p><b>ITI Media Contact:<\/b><br \/>Melody Carey<br \/>\n<br \/><a target=\"_blank\" href=\"m&#97;&#x69;&#x6c;t&#111;&#58;&#x6d;&#x63;a&#114;&#101;&#x79;&#x40;r&#120;&#x69;&#x72;&#x2e;c&#111;&#x6d;\" rel=\"nofollow noopener\" shape=\"rect\">mcarey&#64;&#114;&#120;&#105;&#114;&#46;&#99;&#x6f;&#x6d;<\/a><br \/>917-322-2571\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>-Top line data expected in second half of 2023- ROCKVILLE, Md.&#8211;(BUSINESS WIRE)&#8211;#MCC&#8211;Immunomic Therapeutics, Inc., (\u201cITI\u201d), a privately-held clinical-stage biotechnology company pioneering the study of LAMP (Lysosome Associated Membrane Protein)-mediated nucleic acid-based immunotherapy, today announced dosing of the first patient in the company\u2019s Phase 1 study evaluating ITI-3000, a plasmid DNA (pDNA) vaccine targeting patients with &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/immunomic-therapeutics-announces-first-patient-dosed-in-phase-i-clinical-trial-of-iti-3000-pdna-vaccine-for-the-treatment-of-merkel-cell-carcinoma\/\">[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-46368","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Immunomic Therapeutics Announces First Patient Dosed in Phase I Clinical Trial of ITI-3000 pDNA Vaccine for the Treatment of Merkel Cell Carcinoma - 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\/immunomic-therapeutics-announces-first-patient-dosed-in-phase-i-clinical-trial-of-iti-3000-pdna-vaccine-for-the-treatment-of-merkel-cell-carcinoma\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Immunomic Therapeutics Announces First Patient Dosed in Phase I Clinical Trial of ITI-3000 pDNA Vaccine for the Treatment of Merkel Cell Carcinoma - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"-Top line data expected in second half of 2023- ROCKVILLE, Md.&#8211;(BUSINESS WIRE)&#8211;#MCC&#8211;Immunomic Therapeutics, Inc., (\u201cITI\u201d), a privately-held clinical-stage biotechnology company pioneering the study of LAMP (Lysosome Associated Membrane Protein)-mediated nucleic acid-based immunotherapy, today announced dosing of the first patient in the company\u2019s Phase 1 study evaluating ITI-3000, a plasmid DNA (pDNA) vaccine targeting patients with ... 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