{"id":56403,"date":"2023-05-01T21:03:16","date_gmt":"2023-05-01T19:03:16","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/sirpant-immunotherapeutics-announces-fda-clearance-of-ind-application-for-sirpant-m-autologous-sirp%ce%b1low-activated-macrophage-immunotherapy\/"},"modified":"2023-05-01T21:03:16","modified_gmt":"2023-05-01T19:03:16","slug":"sirpant-immunotherapeutics-announces-fda-clearance-of-ind-application-for-sirpant-m-autologous-sirp%ce%b1low-activated-macrophage-immunotherapy","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/sirpant-immunotherapeutics-announces-fda-clearance-of-ind-application-for-sirpant-m-autologous-sirp%ce%b1low-activated-macrophage-immunotherapy\/","title":{"rendered":"SIRPant Immunotherapeutics Announces FDA Clearance of IND Application for SIRPant-M\u2122 Autologous SIRP\u03b1low Activated Macrophage Immunotherapy"},"content":{"rendered":"<div>\n<p>HUMMELSTOWN, Pa.&#8211;(BUSINESS WIRE)&#8211;SIRPant Immunotherapeutics, Inc., a clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, today announced that the U.S. Food and Drug Administration (FDA) cleared an investigational new drug (IND) application for the Company\u2019s lead product candidate, SIRPant-M\u2122, an autologous SIRP\u03b1<sup>low<\/sup> activated macrophage therapy for the treatment of aggressive tumors. Under this IND, SIRPant intends to initiate its Phase 1, first-in-human, multi-center study in patients with relapsed refractory non-Hodgkin lymphoma in Q3.<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20230501005615\/en\/1779538\/5\/SIRPantRGB.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20230501005615\/en\/1779538\/21\/SIRPantRGB.jpg\"><\/a><\/p>\n<p>\n\u201cThis is a major accomplishment for the company and an important step forward in the clinical evaluation of SIRPant-M for the treatment of multiple tumor types,\u201d said Robert Towarnicki, President &amp; CEO. \u201cThis initial study will enroll relapsed refractory non-Hodgkin lymphoma patients who are ineligible for or previously failed approved therapeutic regimens. There remains a significant unmet need in this setting, and we are excited to try and fill this need by treating with SIRPant-M.\u201d<\/p>\n<p>\nSIRPant anticipates following this initial IND with a second IND for SIRPant-M focused on solid tumor treatments, initially targeting head &amp; neck cancers. In preclinical testing, SIRPant-M has shown effectiveness against a wide variety of solid tumors <i>in vivo<\/i>, in addition to compelling positive data in hematological tumors.<\/p>\n<p>\n\u201cLeveraging recent findings in macrophage biology, we developed a first-in-class cell therapy, SIRPant-M\u2122, to initiate adaptive immune responses against cancerous cells without requiring prior cancer-associated antigen identification,\u201d notes Nathanael McCurley, PhD, Vice President, R&amp;D. \u201cSIRPant-M\u2122 employs a proprietary cocktail, PhagoAct\u2122, to license macrophages to drive tumor neo-antigen-specific polyclonal T cell and antibody responses, thus targeting cancer cells through multiple avenues simultaneously.\u201d By mobilizing both the cellular and humoral arms of the immune system, SIRPant-M\u2122 yields long-lasting polyclonal immune memory against cancer.<\/p>\n<p>\nThe company anticipates conducting the planned clinical trial at five sites across the United States. Register for company updates regarding initiation and recruiting as the sites come online at <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fsirpantimmunotx.com%2Fcontact%2F&amp;esheet=53390968&amp;newsitemid=20230501005615&amp;lan=en-US&amp;anchor=https%3A%2F%2Fsirpantimmunotx.com%2Fcontact%2F&amp;index=1&amp;md5=a6247c3905aae996597ab1f30266dfc9\" rel=\"nofollow noopener\" shape=\"rect\">https:\/\/sirpantimmunotx.com\/contact\/<\/a>.<\/p>\n<p>\n<b>About SIRPant Immunotherapeutics, Inc.<br \/>\n<br \/><\/b>SIRPant, a clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, is initially addressing the development of novel autologous macrophage cell therapy for treatment of aggressive cancers of unmet medical need. The company believes its proprietary technologies for empowering patient innate and adaptive immune responses against cancer will play a leading role in the next generation of successful treatments. For more information, please visit <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.sirpantimmunotx.com&amp;esheet=53390968&amp;newsitemid=20230501005615&amp;lan=en-US&amp;anchor=www.sirpantimmunotx.com&amp;index=2&amp;md5=b1baa236ec0009fda796a4f1f2c8d595\" rel=\"nofollow noopener\" shape=\"rect\">www.sirpantimmunotx.com<\/a>.<\/p>\n<p>\n<b>Forward-looking statements<br \/>\n<br \/><\/b>This press release contains certain \u201cforward-looking statements\u201d concerning the development of SIRPant Immunotherapeutics products, the potential benefits and attributes of those products, and the company\u2019s expectations regarding its prospects. Forward-looking statements are subject to risks, assumptions and uncertainties that could cause actual future events or results to differ materially from such statements. These statements are made as of the date of this press release. Actual results may vary. SIRPant Immunotherapeutics undertakes no obligation to update any forward-looking statements for any reason.<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\n<b>Media Inquiries:<\/b><br \/>Robert Towarnicki<br \/>\n<br \/>President &amp; CEO<br \/>\n<br \/>(215) 630-1110<br \/>\n<br \/><a target=\"_blank\" href=\"&#x6d;&#x61;&#105;l&#x74;&#x6f;&#58;&#114;t&#x6f;&#x77;&#97;&#114;n&#x69;&#x63;&#107;i&#64;&#x73;&#x69;&#114;p&#x61;&#x6e;&#116;&#105;m&#x6d;&#x75;&#110;&#111;t&#x78;&#x2e;&#99;om\" rel=\"nofollow noopener\" shape=\"rect\">&#x72;&#116;o&#x77;&#97;r&#x6e;&#x69;&#99;&#x6b;&#x69;&#64;s&#x69;&#114;p&#x61;&#x6e;&#116;&#x69;&#x6d;&#109;u&#x6e;&#111;t&#x78;&#x2e;&#99;&#x6f;&#x6d;<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>HUMMELSTOWN, Pa.&#8211;(BUSINESS WIRE)&#8211;SIRPant Immunotherapeutics, Inc., a clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, today announced that the U.S. Food and Drug Administration (FDA) cleared an investigational new drug (IND) application for the Company\u2019s lead product candidate, SIRPant-M\u2122, an autologous SIRP\u03b1low activated macrophage therapy for the treatment of aggressive tumors. Under this &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/sirpant-immunotherapeutics-announces-fda-clearance-of-ind-application-for-sirpant-m-autologous-sirp%ce%b1low-activated-macrophage-immunotherapy\/\">[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-56403","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>SIRPant Immunotherapeutics Announces FDA Clearance of IND Application for SIRPant-M\u2122 Autologous SIRP\u03b1low Activated Macrophage Immunotherapy - 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\/sirpant-immunotherapeutics-announces-fda-clearance-of-ind-application-for-sirpant-m-autologous-sirp\u03b1low-activated-macrophage-immunotherapy\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"SIRPant Immunotherapeutics Announces FDA Clearance of IND Application for SIRPant-M\u2122 Autologous SIRP\u03b1low Activated Macrophage Immunotherapy - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"HUMMELSTOWN, Pa.&#8211;(BUSINESS WIRE)&#8211;SIRPant Immunotherapeutics, Inc., a clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, today announced that the U.S. Food and Drug Administration (FDA) cleared an investigational new drug (IND) application for the Company\u2019s lead product candidate, SIRPant-M\u2122, an autologous SIRP\u03b1low activated macrophage therapy for the treatment of aggressive tumors. 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