NgoMashi 21, 2025, i-Immunofoco yamemezela ukuthi ukwelashwa kwayo kweseli ye-CAR-T okuqondiswe ku-EpCAM, i-IMC001, okuthuthukiswe ngokuzimela, kunikezwe imvume yi-Center for Drug Evaluation (CDE) ngaphansi kwe-National Medical Products Administration (NMPA) eShayina ngesicelo sayo sesibili se-Investigational New Drug (IND), enenombolo yokwamukelwa i-CXSL2400901. Lolu hlelo lokusebenza lwe-IND luhlose ukwelapha izimila eziqinile ze-EpCAM-positive epithelial. Ngaphambilini, i-IMC001 yayithole imvume ye-IND kokubili eShayina nase-United States ngoFebhuwari 2024 yokwelapha izimila ezithuthukile ze-EpCAM-positive gastrointestinal.
I-Epithelial cell adhesion molecule (i-EpCAM) ivezwa kakhulu ezicutshini ezahlukahlukene zesimila esitholakala e-epithelial, okuhlanganisa umdlavuza womphimbo, umdlavuza we-colorectal, umdlavuza we-pancreatic, umdlavuza we-ovarian, umdlavuza wamaphaphu, umdlavuza wesisu, kanye nomdlavuza webele. Ngokuphambene nalokho, ukuvezwa kwayo kuphansi kakhulu ezicutshini ezivamile. Naphezu kwezinselele ezifana nobunzima be-microenvironment yesimila esiqinile kanye nokungafani okuqondiwe, i-IMC001 ibonise ukuphepha okuhle kanye nokusebenza kahle kokuqala ezivivinyweni zomtholampilo zangaphambilini zezimila zesisu, ngenxa yokukhetha kwayo okuqondiwe okuhlukile kanye nomklamo wayo omusha. Lesi sibonakaliso esengeziwe sihlose ukuhlola kabanzi amandla ayo okwelapha.
Ezethulweni zephosta emihlanganweni ye-ASCO ne-CSCO ka-2024, idatha yocwaningo lwezokwelapha lwe-IIT ye-IMC001 ibonise ukuthi phakathi kweziguli eziyi-10 ezihlolwe ezinomdlavuza wesisu othuthukile, izinga lokulawula isifo lalingu-90%, kanti isiguli esisodwa eqenjini ledosi ephansi singu-33.3% kanti ezimbili eqenjini ledosi ephakathi zingu-40% zithole impendulo engaphelele (PR). Ukusinda okujwayelekile okumaphakathi (OS) eqenjini ledosi ephakathi kudlule amasonto angu-55. Isiguli esisodwa eqenjini ledosi ephakathi sithole i-PR eqinisekisiwe ngeviki lama-24, okwaholela ekususweni kwesisu okunamandla ngeviki lama-27, kanti isiguli sase sisinde izinyanga ezingaphezu kuka-22 ngosuku lokugcina.
Ukusulwa kwale IND eyengeziwe kumelela ingqophamlando ebalulekile ekwandiseni ububanzi bokuhlola imitholampilo be-IMC001 kusukela ezimila zesisu kuya ezinhlobonhlobo eziningi zezimila eziqinile ze-epithelial, okuhlanganisa umdlavuza wamaphaphu wamangqamuzana amancane (i-SCLC), umdlavuza webele one-triple-negative (i-TNBC), kanye nezinye izifo zomdlavuza.
Njengamanje, kusenezivivinyo eziningi zemitholampilo zobuchwepheshe obusha bokulwa nomdlavuza eShayina ezifuna iziguli. Ukubonisana ngemithi emisha kanye nobuchwepheshe, ungaxhumana noMnyango Wezizwe Ngezizwe Wesibhedlela iBeijing South Region Oncology.
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Email：myimmnet@163.com
Isikhathi sokuthunyelwe: Ephreli-03-2025