{"id":52704,"date":"2023-01-09T17:02:20","date_gmt":"2023-01-09T16:02:20","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/minerva-biotechnologies-gets-fda-approval-of-ind-for-a-muc1-car-1xx-with-increased-persistence-and-ability-to-kill-low-antigen-expressing-cells-for-treatment-of-solid-tumor-cancers\/"},"modified":"2023-01-09T17:02:20","modified_gmt":"2023-01-09T16:02:20","slug":"minerva-biotechnologies-gets-fda-approval-of-ind-for-a-muc1-car-1xx-with-increased-persistence-and-ability-to-kill-low-antigen-expressing-cells-for-treatment-of-solid-tumor-cancers","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/minerva-biotechnologies-gets-fda-approval-of-ind-for-a-muc1-car-1xx-with-increased-persistence-and-ability-to-kill-low-antigen-expressing-cells-for-treatment-of-solid-tumor-cancers\/","title":{"rendered":"Minerva Biotechnologies Gets FDA Approval of IND for a MUC1*-CAR-1XX with Increased Persistence and Ability to Kill Low Antigen Expressing Cells for Treatment of Solid Tumor Cancers"},"content":{"rendered":"<div>\n<p>WALTHAM, Mass.&#8211;(BUSINESS WIRE)&#8211;Minerva Biotechnologies, a private company developing 1<sup>st<\/sup>-in-human therapies for the treatment of solid tumor cancers, announced today that the FDA has approved their IND (Investigational New Drug) application to conduct clinical trials with huMNC2-CAR22, aka MUC1*-CAR-1XX, for the treatment of metastatic breast cancers. huMNC2-CAR22 targets MUC1* (muk 1 star), the growth factor receptor that drives the growth and metastasis of most solid tumor cancers.\n<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20230109005010\/en\/1676966\/5\/logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20230109005010\/en\/1676966\/21\/logo.jpg\"><\/a><\/p>\n<p>\nMinerva\u2019s first CAR T that targets MUC1*, huMNC2-CAR44, is already in a clinical trial for metastatic breast cancers. Initial results show CAR T cell expansion, patients going from Progressive Disease to Stable Disease and Partial Response. However, for a durable response, we needed to overcome CAR T cell exhaustion, which is common to CAR T cell treatment of solid tumor cancers. This second MUC1* CAR T, huMNC2-CAR22, bears the \u201c1XX\u201d mutations in the T cell\u2019s CD3-z signaling domain. These four Tyrosine to Phenylalanine mutations block tyrosine phosphorylation in two of the three signaling domains of CD3-z, which slow signaling and dramatically increase persistence. Unexpectedly, the 1XX mutations give the CAR T cells the added benefit of being able to recognize and kill the low antigen expressing cancer cells that lead to cancer recurrence.\n<\/p>\n<p>\n\u201cThese 1XX mutations solve the two hurdles that have thus far stood in the way of an effective CAR T treatment for solid tumor cancers: 1) CAR T cell exhaustion; and 2) failure to kill the low antigen expressing cells,\u201d said Minerva\u2019s CEO Dr. Cynthia Bamdad, \u201cTogether with our MUC1* antibodies that recognize an epitope only available on cancer cells, huMNC2-CAR22 promises to be a big leap ahead in our fight against cancers.\u201d\n<\/p>\n<p>\nWe thank our scientists, collaborators, and the patients and their families for their courage.\n<\/p>\n<p>\nMinerva holds a license from Memorial Sloan Kettering for use of the 1XX technology.\n<\/p>\n<p>\nAbout the trial\n<\/p>\n<p>\nNCT04020575 is a first-in-human trial of huMNC2-CAR22 and huMNC2-CAR44, autologous CAR T cells targeting MUC1* in metastatic breast cancer in patients with MUC1* positive tumors.\n<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\nRon Axelrod (617-785-9491); <a target=\"_blank\" href=\"&#109;&#x61;&#x69;l&#116;&#x6f;:&#114;&#x61;&#x78;e&#108;&#x72;o&#100;&#x40;&#x6d;i&#110;&#x65;r&#118;&#x61;&#x62;&#105;&#111;&#x2e;c&#111;&#x6d;\" rel=\"nofollow noopener\" shape=\"rect\">&#x72;&#x61;&#120;e&#x6c;&#x72;&#111;d&#64;&#x6d;&#x69;&#110;e&#x72;&#x76;&#97;&#98;i&#x6f;&#x2e;&#99;o&#x6d;<\/a>; <a target=\"_blank\" href=\"m&#97;&#x69;&#x6c;t&#111;&#x3a;&#x69;n&#102;&#111;&#x40;&#x6d;i&#110;&#x65;&#x72;v&#97;&#x62;&#x69;o&#46;&#99;&#x6f;&#x6d;\" rel=\"nofollow noopener\" shape=\"rect\">&#x69;&#110;f&#x6f;&#64;&#109;&#x69;&#x6e;&#101;r&#x76;&#97;b&#x69;&#x6f;&#46;c&#x6f;&#109;<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>WALTHAM, Mass.&#8211;(BUSINESS WIRE)&#8211;Minerva Biotechnologies, a private company developing 1st-in-human therapies for the treatment of solid tumor cancers, announced today that the FDA has approved their IND (Investigational New Drug) application to conduct clinical trials with huMNC2-CAR22, aka MUC1*-CAR-1XX, for the treatment of metastatic breast cancers. huMNC2-CAR22 targets MUC1* (muk 1 star), the growth factor receptor &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/minerva-biotechnologies-gets-fda-approval-of-ind-for-a-muc1-car-1xx-with-increased-persistence-and-ability-to-kill-low-antigen-expressing-cells-for-treatment-of-solid-tumor-cancers\/\">[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-52704","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>Minerva Biotechnologies Gets FDA Approval of IND for a MUC1*-CAR-1XX with Increased Persistence and Ability to Kill Low Antigen Expressing Cells for Treatment of Solid Tumor Cancers - 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\/minerva-biotechnologies-gets-fda-approval-of-ind-for-a-muc1-car-1xx-with-increased-persistence-and-ability-to-kill-low-antigen-expressing-cells-for-treatment-of-solid-tumor-cancers\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Minerva Biotechnologies Gets FDA Approval of IND for a MUC1*-CAR-1XX with Increased Persistence and Ability to Kill Low Antigen Expressing Cells for Treatment of Solid Tumor Cancers - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"WALTHAM, Mass.&#8211;(BUSINESS WIRE)&#8211;Minerva Biotechnologies, a private company developing 1st-in-human therapies for the treatment of solid tumor cancers, announced today that the FDA has approved their IND (Investigational New Drug) application to conduct clinical trials with huMNC2-CAR22, aka MUC1*-CAR-1XX, for the treatment of metastatic breast cancers. huMNC2-CAR22 targets MUC1* (muk 1 star), the growth factor receptor ... 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