CDE Yapereka Chilolezo cha IND ku Chithandizo cha Immunofoco cha EpCAM CAR-T kuti Chiwonetsedwe Kachiwiri

Pa 21 Marichi, 2025, Immunofoco idalengeza kuti chithandizo cha maselo a CAR-T chodziyimira pawokha cha EpCAM, IMC001, chaperekedwa chilolezo ndi Center for Drug Evaluation (CDE) pansi pa National Medical Products Administration (NMPA) ku China kuti chigwiritsidwe ntchito kachiwiri ndi Investigational New Drug (IND), yokhala ndi nambala yovomerezeka ya CXSL2400901. Pulogalamu iyi ya IND cholinga chake ndi kuchiza zotupa zolimba za epithelial za EpCAM. M'mbuyomu, IMC001 idalandira chilolezo cha IND ku China ndi ku United States mu February 2024 kuti ichite zotupa zam'mimba za EpCAM.

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Molekyulu yolumikizira maselo a epithelial (EpCAM) imapezeka kwambiri pa minofu yosiyanasiyana ya chotupa yomwe imachokera ku epithelial, kuphatikizapo khansa ya m'mero, khansa ya m'matumbo, khansa ya kapamba, khansa ya m'chiberekero, khansa ya m'mapapo, khansa ya m'mimba, ndi khansa ya m'mawere. Mosiyana ndi zimenezi, mawonekedwe ake ndi ochepa m'minofu yachibadwa. Ngakhale kuti pali zovuta monga zovuta za malo ozungulira chotupa cholimba komanso kusiyana kwa cholinga, IMC001 yawonetsa chitetezo chabwino komanso mphamvu yoyambirira m'mayesero am'mbuyomu azachipatala a zotupa zam'mimba, chifukwa cha kusankha kwake kwapadera komwe kumayang'aniridwa komanso kapangidwe kake katsopano. Chizindikiro chowonjezerachi chikufuna kufufuza bwino kuthekera kwake kwachipatala.

Mu ma poster omwe adawonetsedwa pamisonkhano ya 2024 ASCO ndi CSCO, deta ya kafukufuku wa zachipatala wa IIT ya IMC001 idawonetsa kuti pakati pa odwala 10 omwe adayesedwa omwe ali ndi khansa ya m'mimba yoopsa, kuchuluka kwa matenda kunali 90%, pomwe wodwala m'modzi m'gulu la odwala ochepa anali 33.3% ndipo awiri m'gulu la odwala apakati anali 40% adapeza yankho la gawo (PR). Kupulumuka kwapakati (OS) m'gulu la odwala apakati kunapitilira masabata 55. Wodwala m'modzi m'gulu la odwala apakati adapeza PR yotsimikizika pofika Sabata 24, zomwe zidapangitsa kuti achotsedwe m'mimba kwambiri pa Sabata 27, ndipo wodwalayo adapulumuka kwa miyezi yoposa 22 pofika tsiku lomaliza.

Kuchotsedwa kwa IND yowonjezerayi kukuyimira gawo lofunika kwambiri pakukulitsa kuchuluka kwa kafukufuku wa IMC001 kuchokera ku zotupa zam'mimba kupita ku mitundu yosiyanasiyana ya zotupa zolimba za epithelial, kuphatikizapo khansa ya m'mapapo ya maselo ang'onoang'ono (SCLC), khansa ya m'mawere ya triple-negative (TNBC), ndi matenda ena a khansa.

Pakadali pano, pali mayesero ambiri azachipatala a ukadaulo watsopano wothana ndi khansa ku China omwe akufuna odwala. Mukafunsira mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region.

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Nthawi yotumizira: Epulo-03-2025