CDE enyela ikike IND maka ọgwụgwọ EpCAM CAR-T nke Immunofoco maka ihe ngosi nke abụọ

Na Machị 21, 2025, Immunofoco kwupụtara na Center for Drug Evaluation (CDE) nke mepụtara n'onwe ya enyela ikike site na Center for Drug Evaluation (NMPA) na China maka ngwa Investigational New Drug (IND) nke abụọ ya, yana nọmba nnabata CXSL2400901. Ngwa IND a bụ maka ịgwọ ọrịa EpCAM-positive epithelial siri ike. Na mbụ, IMC001 enwetala nkwenye IND na China na United States na Febụwarị 2024 maka ọgwụgwọ nke ọrịa EpCAM-positive intestinal intestinal intestinal intestinal intestinal intestinal intestinal intestinal intestinal index.

A na-egosipụta molekul njikọ mkpụrụ ndụ epithelial (EpCAM) nke ọma n'ọtụtụ anụ ahụ epithelial sitere na epithelial, gụnyere kansa esophageal, kansa eriri afọ, kansa pancreas, kansa ovarian, kansa akpa ume, kansa afọ, na kansa ara. N'ụzọ dị iche, ngosipụta ya dị obere na anụ ahụ nkịtị. N'agbanyeghị ihe ịma aka dịka mgbagwoju anya nke gburugburu ebe obibi tumor siri ike na ọdịiche dị iche iche, IMC001 egosila nchekwa dị mma na irè mbụ na nnwale ahụike mbụ maka etuto afọ, n'ihi nhọrọ pụrụ iche ya na imewe ọhụrụ. Ihe ngosi ọzọ a na-achọ inyochakwu ike ọgwụgwọ ya.

N'ihe ngosi posta na ogbako ASCO na CSCO nke afọ 2024, data ọmụmụ ahụike IIT nke IMC001 gosiri na n'ime ndị ọrịa iri a na-enyocha nwere ọrịa kansa afọ dị elu, ọnụego njikwa ọrịa ahụ bụ 90%, otu onye ọrịa nọ na otu obere dose 33.3% na abụọ nọ na otu etiti dose 40% nwetara nzaghachi akụkụ (PR). Ọnụọgụ ndụ zuru oke (OS) n'ime otu ọkara dose gafere izu 55. Otu onye ọrịa nọ na otu etiti dose nwetara PR akwadoro site na Izu 24, nke butere ịwa ahụ dị egwu na Izu 27, onye ọrịa ahụ lanarịrị ihe karịrị ọnwa 22 tupu ụbọchị njedebe.

Nwepu nke IND ọzọ a na-anọchite anya ihe dị mkpa n'ịgbasa oke nyocha ahụike nke IMC001 site na etuto afọ ruo na ụdị etuto siri ike nke epithelial, gụnyere kansa akpa ume obere mkpụrụ ndụ (SCLC), kansa ara atọ na-adịghị mma (TNBC), na ọrịa ndị ọzọ.

Ugbu a, enwere ọtụtụ nnwale ahụike nke teknụzụ ọhụrụ na-egbochi kansa na China na-achọ ndị ọrịa. Maka ndụmọdụ gbasara ọgwụ na teknụzụ ọhụrụ, ị nwere ike ịkpọtụrụ Ngalaba Mba Nile nke Ụlọ Ọgwụ Oncology nke Beijing South Region.

Nọmba ekwentị: 4008803716

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