Ngomhla wama-21 kuMatshi 2025, i-Immunofoco yabhengeza ukuba unyango lwayo oluzimeleyo lwe-EpCAM-targeting autologous CAR-T cell therapy, i-IMC001, lunikwe imvume yiZiko loVavanyo lwaMayeza (CDE) phantsi koLawulo lweMveliso yezonyango yeSizwe (i-NMPA) eTshayina kwisicelo sayo sesibini se-Investigational New Drug (IND), kunye nenombolo yokwamkelwa ye-CXSL2400901. Esi sicelo se-IND sijolise ekunyangeni ii-epithelial advanced solid tumors ze-EpCAM-positive epithelial. Ngaphambili, i-IMC001 yayifumene imvume ye-IND eTshayina nase-United States ngoFebruwari 2024 kunyango lwee-epithelial advanced tumors ze-EpCAM-positive.
Imolekyuli yokunamathela kweseli ye-Epithelial (i-EpCAM) ibonakaliswa kakhulu kwiithishu ezahlukeneyo zethumba ezivela kwi-epithelial, kubandakanya umhlaza womqala, umhlaza we-colorectal, umhlaza we-pancreatic, umhlaza we-ovarian, umhlaza wemiphunga, umhlaza wesisu, kunye nomhlaza webele. Ngokwahlukileyo koko, ukubonakaliswa kwayo kuphantsi kakhulu kwiithishu eziqhelekileyo. Nangona kukho imingeni efana nobunzima be-microenvironment ye-tumor eqinileyo kunye nokungafani kweethagethi, i-IMC001 ibonakalise ukhuseleko olufanelekileyo kunye nokusebenza kwangaphambili kwizilingo zangaphambili zeklinikhi zeethumbu zesisu, ngenxa yokukhethwa kwayo okukhethekileyo kunye noyilo olutsha. Olu phawu longezelelweyo lujolise ekuhlolisiseni ngakumbi amandla ayo eklinikhi.
Kwimiboniso yeposta kwinkomfa ze-ASCO kunye ne-CSCO zika-2024, idatha yophando lweklinikhi lwe-IIT ye-IMC001 ibonise ukuba phakathi kwezigulane ezili-10 ezivavanyiweyo ezinomhlaza wesisu oqhubele phambili, izinga lokulawula isifo yayiyi-90%, apho isigulane esinye kwiqela ledosi ephantsi singama-33.3% kwaye ezimbini kwiqela ledosi ephakathi zingama-40% zifumene impendulo engaphelelanga (PR). Ukusinda okuphakathi (OS) kwiqela ledosi ephakathi kudlule iiveki ezingama-55. Isigulane esinye kwiqela ledosi ephakathi sifumene i-PR eqinisekisiweyo kwiVeki yama-24, nto leyo ekhokelele ekususweni kwesisu okugqithisileyo kwiVeki yama-27, kwaye isigulane sasiphile iinyanga ezingaphezu kwama-22 ngomhla wokugqibela.
Ukususwa kwale IND eyongezelelweyo kubonisa inqanaba elibalulekileyo ekwandiseni ububanzi bokuhlolwa kweklinikhi kwe-IMC001 ukusuka kwiithumba zesisu ukuya kwiintlobo ezibanzi zeethumba eziqinileyo ze-epithelial, kubandakanya umhlaza wemiphunga weeseli ezincinci (i-SCLC), umhlaza webele one-triple-negative (i-TNBC), kunye nezinye izifo ezinobungozi.
Okwangoku, kusekho iimvavanyo ezininzi zeklinikhi zobuchwepheshe obutsha bokulwa nomhlaza eTshayina obufuna izigulane. Iingcebiso ngamayeza amatsha kunye nobuchwepheshe, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region.
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Ixesha leposi: Epreli-03-2025