{"id":104850,"date":"2025-06-17T10:36:03","date_gmt":"2025-06-17T08:36:03","guid":{"rendered":"https:\/\/www.pcb.ub.edu\/gate2brain-obtiene-la-designacion-de-medicamento-huerfano-de-la-fda-para-su-farmaco-g2b-002\/"},"modified":"2025-10-13T15:11:11","modified_gmt":"2025-10-13T13:11:11","slug":"gate2brain-obtiene-la-designacion-de-medicamento-huerfano-de-la-fda-para-su-farmaco-g2b-002","status":"publish","type":"post","link":"https:\/\/www.pcb.ub.edu\/es\/gate2brain-obtiene-la-designacion-de-medicamento-huerfano-de-la-fda-para-su-farmaco-g2b-002\/","title":{"rendered":"Gate2Brain obtiene la designaci\u00f3n de medicamento hu\u00e9rfano de la FDA para su f\u00e1rmaco G2B-002"},"content":{"rendered":"<p><strong>La biotecnol\u00f3gica <a href=\"https:\/\/www.pcb.ub.edu\/es\/empresa\/gate2brain-s-l\/\" target=\"_blank\" rel=\"noopener\">Gate2Brain<\/a>, con sede en el Parque Cient\u00edfico de Barcelona, ha obtenido la designaci\u00f3n de medicamento hu\u00e9rfano (ODD) por parte de la Administraci\u00f3n de Alimentos y Medicamentos de los Estados Unidos (FDA) para su candidato principal, G2B-002, una innovadora terapia para combatir el glioma pontino intr\u00ednseco difuso (DIPG) y el glioblastoma pedi\u00e1trico (pGBM), dos de los tumores cerebrales pedi\u00e1tricos m\u00e1s letales y con escasas opciones terap\u00e9uticas. Esta concesi\u00f3n se suma a la otorgada por la Agencia Europea del Medicamento (EMA) a finales de 2024 y destaca el gran potencial de esta terapia tanto en Europa como en Estados Unidos.<br \/>\n<\/strong><\/p>\n<p>La compa\u00f1\u00eda, spinoff de la Universidad de Barcelona (<a href=\"https:\/\/web.ub.edu\/es\/\" target=\"_blank\" rel=\"noopener\">UB<\/a>), el Instituto de Investigaci\u00f3n Biom\u00e9dica (IRB Barcelona), y el Instituto de Investigaci\u00f3n Sant Joan de D\u00e9u (<a href=\"https:\/\/www.irsjd.org\/es\/\" target=\"_blank\" rel=\"noopener\">IRSJD<\/a>) \u2013 Hospital Sant Joan de D\u00e9u (<a href=\"https:\/\/www.sjdhospitalbarcelona.org\/es\" target=\"_blank\" rel=\"noopener\">SJD<\/a>), se especializa en el desarrollo de sistemas de administraci\u00f3n de f\u00e1rmacos a trav\u00e9s de barreras biol\u00f3gicas. En esta l\u00ednea, <a href=\"https:\/\/www.pcb.ub.edu\/es\/gate2brain-valida-su-tecnologia-para-el-transporte-de-anticuerpos-al-cerebro-un-avance-decisivo-hacia-una-nueva-generacion-de-terapias-para-el-sistema-nervioso-central\/\" target=\"_blank\" rel=\"noopener\">su principal candidato G2B-002<\/a> optimiza el transporte y la penetraci\u00f3n del f\u00e1rmaco a trav\u00e9s de la barrera hematoencef\u00e1lica, incrementando su eficacia y minimizando los efectos secundarios sist\u00e9micos.<\/p>\n<p>Gracias a esta designaci\u00f3n de la FDA, G2B-002 se beneficiar\u00e1 de un respaldo regulatorio reforzado y un impulso estrat\u00e9gico que facilitar\u00e1 su transici\u00f3n de la fase precl\u00ednica avanzada a los ensayos cl\u00ednicos.<\/p>\n<p>\u00abLa designaci\u00f3n de medicamento hu\u00e9rfano por parte de la EMA y la FDA refuerza nuestra confianza en el potencial de G2B-002 para cubrir necesidades cr\u00edticas en oncolog\u00eda pedi\u00e1trica\u00bb, afirma <strong>Meritxell Teixid\u00f3<\/strong>, CEO y CSO de Gate2Brain. \u00abEste doble reconocimiento nos acerca un paso m\u00e1s a los ensayos cl\u00ednicos y, en \u00faltima instancia, a ofrecer una nueva esperanza a los pacientes j\u00f3venes y a sus familias\u00bb.<\/p>\n<p>Gate2Brain mantiene su prop\u00f3sito de transformar el panorama terap\u00e9utico de los tumores cerebrales pedi\u00e1tricos mediante soluciones innovadoras en la administraci\u00f3n de f\u00e1rmacos. La compa\u00f1\u00eda ha contado con el respaldo de instituciones como Fundaci\u00f3n Bot\u00edn (Mind the Gap), Banco Sabadell (BStartup Health), CDTI (Neotec, Multipa\u00eds), el Consejo Europeo de Innovaci\u00f3n (EIC Accelerator), Startup Capital de ACCI\u00d3 y CaixaResearch Consolidate de la \u201cFundaci\u00f3 la Caixa\u201d.<\/p>\n<p><strong>\u00bb Enlace a la noticia: <\/strong><a href=\"https:\/\/gate2brain.com\/gate2brain-obtains-fda-orphan-drug-designation-for-g2b-002\/\" target=\"_blank\" rel=\"noopener\">web de Gate2Brain [+]<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>La biotecnol\u00f3gica Gate2Brain, con sede en el Parque Cient\u00edfico de Barcelona, ha obtenido la designaci\u00f3n de medicamento hu\u00e9rfano (ODD) por parte de la Administraci\u00f3n de Alimentos y Medicamentos de los&#8230;<\/p>\n","protected":false},"author":14,"featured_media":104847,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[356],"tags":[305],"class_list":["post-104850","post","type-post","status-publish","format-standard","has-post-thumbnail","category-empresas","tag-gate2brain-es"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - 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