{"id":88668,"date":"2023-10-05T12:58:10","date_gmt":"2023-10-05T10:58:10","guid":{"rendered":"https:\/\/www.pcb.ub.edu\/la-fda-designa-medicamento-huerfano-el-oc-1-de-onechain-immunotherapeutics\/"},"modified":"2025-10-13T15:24:51","modified_gmt":"2025-10-13T13:24:51","slug":"la-fda-designa-medicamento-huerfano-el-oc-1-de-onechain-immunotherapeutics","status":"publish","type":"post","link":"https:\/\/www.pcb.ub.edu\/es\/la-fda-designa-medicamento-huerfano-el-oc-1-de-onechain-immunotherapeutics\/","title":{"rendered":"La FDA designa medicamento hu\u00e9rfano el OC-1 de OneChain Immunotherapeutics"},"content":{"rendered":"<p><strong><a href=\"https:\/\/www.pcb.ub.edu\/es\/empresa\/onechain-immunotherapeutics-s-l\/\" target=\"_blank\" rel=\"noopener\">OneChain\u00a0Immunotherapeutics<\/a>, con sede en el Parque Cient\u00edfico de Barcelona, ha obtenido la designaci\u00f3n de medicamento hu\u00e9rfano de la U.S. Food and Drug Administration (FDA) para el OC-1, una terapia CAR T para el tratamiento de la leucemia linfobl\u00e1stica aguda. La compa\u00f1\u00eda, que forma parte de la primera generaci\u00f3n de empresas aceleradas en la <a href=\"https:\/\/www.pcb.ub.edu\/es\/bcn-health-booster\/\" target=\"_blank\" rel=\"noopener\">BCN Health Booster<\/a>, ya ha iniciado el ensayo cl\u00ednico CARxALL para evaluar la seguridad y eficacia del compuesto en humanos.<\/strong><\/p>\n<p>La <a href=\"https:\/\/www.fda.gov\/industry\/medical-products-rare-diseases-and-conditions\/designating-orphan-product-drugs-and-biological-products\" target=\"_blank\" rel=\"noopener\"><span class=\"css-901oao css-16my406 r-poiln3 r-b88u0q r-bcqeeo r-qvutc0\">Orphan<\/span><\/a><span class=\"css-901oao css-16my406 r-poiln3 r-bcqeeo r-qvutc0\"> Drug Designation\u00a0<\/span>de la FDA, concedida a f\u00e1rmacos y productos biol\u00f3gicos destinados a tratar, diagnosticar o prevenir enfermedades que afectan a menos de 200.000 personas en los Estados Unidos, brindar\u00e1 a la compa\u00f1\u00eda una serie de beneficios como cr\u00e9ditos fiscales, exenci\u00f3n de ciertas tasas regulatorias, exclusividad de mercado y asesoramiento durante el desarrollo cl\u00ednico.<\/p>\n<p>\u201cLa designaci\u00f3n de medicamento hu\u00e9rfano es un reconocimiento significativo que subraya la urgencia y la necesidad de tratamientos innovadores para esta patolog\u00eda. Este es un paso crucial en nuestro camino para brindar esperanza a los pacientes que no cuentan con otras opciones terap\u00e9uticas\u201d,\u00a0se\u00f1ala la <strong>Dra. Wilmar Castillo<\/strong>, directora de OneChain Immunotherapeutics (OCI).<\/p>\n<p>La leucemia linfobl\u00e1stica aguda es un tipo de c\u00e1ncer hematol\u00f3gico caracterizado por la producci\u00f3n excesiva de linfocitos inmaduros, que invaden la sangre, la m\u00e9dula \u00f3sea y los tejidos linf\u00e1ticos, con la capacidad de propagarse a otras partes del cuerpo en pocos meses. Este c\u00e1ncer, agresivo y poco com\u00fan, representa menos de la mitad del 1% de todos los c\u00e1nceres en Estados Unidos, y puede clasificarse en varios subtipos, cada uno con prevalencias a\u00fan menores, dependiendo de factores como el tipo de linfocito afectado y el estadio de desarrollo celular. La terapia de OCI est\u00e1 enfocada en uno de estos subtipos.<\/p>\n<p>\u201cLa realidad es que nuestro producto va dirigido a una diana muy concreta, el ant\u00edgeno CD1a, que se expresa casi exclusivamente en las c\u00e9lulas tumorales de los pacientes con leucemia linfobl\u00e1stica aguda de c\u00e9lulas T cortical\u201d, explica <strong>Castillo<\/strong>. \u201cPara estos pacientes, la primera l\u00ednea de tratamiento suele ser efectiva, pero el pron\u00f3stico para aquellos que no responden a las terapias existentes es muy desfavorable\u201d.<\/p>\n<p>Este reconocimiento a OC-1 se suma a la designaci\u00f3n que ya recibi\u00f3 por parte de la Agencia Europea de Medicamentos (EMA) en 2021, ambas otorgadas en base a s\u00f3lidos datos precl\u00ednicos que respaldan la eficacia y seguridad del tratamiento. \u201cLa concesi\u00f3n de estas designaciones refleja la confianza y el potencial que ven las agencias reguladoras en nuestro producto. Es una muestra de la robustez de nuestros datos y del valor que OC-1 puede aportar en la lucha contra esta patolog\u00eda\u201d, a\u00f1ade.<\/p>\n<p>La compa\u00f1\u00eda inici\u00f3 el ensayo cl\u00ednico <a href=\"https:\/\/www.onechaintx.com\/carxall\" target=\"_blank\" rel=\"noopener\">CARxALL<\/a>\u00a0en enero de 2023 para evaluar la seguridad y eficacia del producto en pacientes con leucemia linfobl\u00e1stica aguda de c\u00e9lulas T cortical sin alternativa terap\u00e9utica. \u00abEstos logros son un testimonio del avance de la compa\u00f1\u00eda y del potencial de su enfoque para tratar neoplasias malignas\u201d, concluye la directora de Operacions Cl\u00edniques de la companyia.<\/p>\n<p><a href=\"https:\/\/www.onechaintx.com\/\" target=\"_blank\" rel=\"noopener\">OneChain Immunotherapeutics (OCI)<\/a> fue fundada por el Instituto de Investigaci\u00f3n contra la Leucemia Josep Carreras, ICREA y el Dr. Pablo Men\u00e9ndez en Barcelona en junio de 2020, con una primera ronda de financiaci\u00f3n liderada por Invivo Ventures con el CDTI-Innvierte (Ministerio de Industria) y la Fundaci\u00f3n Josep Carreras.<\/p>\n<p>La compa\u00f1\u00eda tiene como objetivo desarrollar tratamientos basados en inmunoterapias para neoplasias malignas, a partir de los resultados de las investigaciones del grupo liderado por el Dr. Pablo Men\u00e9ndez, profesor de investigaci\u00f3n ICREA e investigador del Instituto de Investigaci\u00f3n contra la Leucemia Josep Carreras.<\/p>\n<p>OCI ha cerrado recientemente una ronda de inversi\u00f3n pre-serie A de 6,7 millones de euros.\u00a0 En la operaci\u00f3n han participado la gestora de capital riesgo Invivo Capital, el Centro para el Desarrollo Tecnol\u00f3gico y la Innovaci\u00f3n, las gestoras de capital de riesgo Nara Capital y Clave Capital, y la Fundaci\u00f3n Josep Carreras contra la Leucemia.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>OneChain\u00a0Immunotherapeutics, con sede en el Parque Cient\u00edfico de Barcelona, ha obtenido la designaci\u00f3n de medicamento hu\u00e9rfano de la U.S. Food and Drug Administration (FDA) para el OC-1, una terapia CAR&#8230;<\/p>\n","protected":false},"author":14,"featured_media":88646,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[24,356],"tags":[],"class_list":["post-88668","post","type-post","status-publish","format-standard","has-post-thumbnail","category-ciencia","category-empresas"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.4 - 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