Hāʻawi ʻo CDE i ka ʻae ʻana o IND i ka lāʻau lapaʻau EpCAM CAR-T a Immunofoco no ka lua o ka hōʻailona

Ma Malaki 21, 2025, ua hoʻolaha ʻo Immunofoco ua ʻae ʻia kāna hana lapaʻau cell CAR-T autologous i hoʻomohala kūʻokoʻa ʻia ʻo EpCAM, ʻo IMC001, e ke Center for Drug Evaluation (CDE) ma lalo o ka National Medical Products Administration (NMPA) ma Kina no kāna noi ʻelua no ka Investigational New Drug (IND), me ka helu ʻae ʻia ʻo CXSL2400901. Ua kuhikuhi ʻia kēia noi IND no ka mālama ʻana i nā ʻōpū paʻa epithelial holomua EpCAM-positive. Ma mua, ua loaʻa iā IMC001 nā ʻae IND ma Kina a me ʻAmelika Hui Pū ʻIa i Pepeluali 2024 no ka mālama ʻana i nā ʻōpū gastrointestinal holomua EpCAM-positive.

Ua hōʻike nui ʻia ka molekole hoʻopili cell Epithelial (EpCAM) ma nā ʻiʻo tumor i loaʻa mai ka epithelial, me ke kanesa esophageal, ke kanesa colorectal, ke kanesa pancreatic, ke kanesa ovarian, ke kanesa māmā, ke kanesa ʻōpū, a me ke kanesa umauma. I ka hoʻohālikelike ʻana, ua haʻahaʻa kona hōʻike ʻana i nā ʻiʻo maʻamau. ʻOiai nā pilikia e like me ka paʻakikī o ka microenvironment tumor paʻa a me ka heterogeneity target, ua hōʻike ʻo IMC001 i ka palekana maikaʻi a me ka pono mua i nā hoʻokolohua lapaʻau mua no nā tumors gastrointestinal, ma muli o kāna koho pahuhopu kū hoʻokahi a me ka hoʻolālā hou. Manaʻo kēia hōʻailona hou e ʻimi hou aku i kona hiki ke lapaʻau.

Ma nā hōʻikeʻike pepa hoʻolaha ma nā ʻaha kūkā ASCO a me CSCO 2024, ua hōʻike ka ʻikepili noiʻi lapaʻau IIT o IMC001 ma waena o 10 mau maʻi loiloi me ka maʻi ʻōpū holomua, ʻo ka helu kaohi maʻi he 90%, me hoʻokahi maʻi ma ka hui haʻahaʻa 33.3% a ʻelua ma ka hui waena 40% i loaʻa kahi pane hapa (PR). ʻOi aku ka awelika o ke ola holoʻokoʻa (OS) ma ka hui waena ma mua o 55 mau pule. Hoʻokahi maʻi ma ka hui waena i loaʻa kahi PR i hōʻoia ʻia ma ka Pule 24, e alakaʻi ana i kahi gastrectomy radical ma ka Pule 27, a ua ola ka mea maʻi no nā mahina he 22 a ʻoi ma ka lā palena.

ʻO ka hoʻomaʻemaʻe ʻana o kēia IND hou e hōʻike ana i kahi hanana koʻikoʻi i ka hoʻonui ʻana i ka laulā noiʻi lapaʻau o IMC001 mai nā ʻōpū gastrointestinal a i kahi ākea ākea o nā ʻōpū paʻa epithelial, me ka maʻi kanesa māmā liʻiliʻi (SCLC), ka maʻi kanesa umauma triple-negative (TNBC), a me nā maʻi ʻino ʻē aʻe.

I kēia manawa, nui nā hoʻokolohua lapaʻau o nā ʻenehana anti-cancer hou ma Kina e ʻimi nei i nā maʻi. I ke kūkākūkā ʻana i nā lāʻau lapaʻau a me nā ʻenehana hou, hiki iā ʻoe ke hoʻokaʻaʻike aku i ka Beijing South Region Oncology Hospital International Department.

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