FDA Inopa IND Clearance yeGFH375/VS-7375, mushonga weKRAS G12D (ON/OFF) Inhibitor, Unogonesa Kuedza kwePhase I/IIa Kurapa KRAS G12D-mutant Advanced Solid Tumors muUnited States

Musi wa24 Kubvumbi, 2025, GenFleet Therapeutics yakazivisa kuti US Food and Drug Administration (FDA) yakabvumidza kushandiswa kwemushonga mutsva (IND) weGFH375/VS-7375, mushonga unodzivisa KRAS G12D (ON/OFF) wekuyedzwa kwekiriniki kurapa varwere vane bundu rakasimba vane KRAS G12D mutations. Chidzidzo ichi chakarongwa kutanga nemushandi weGenFleet Verastem Oncology muUS pakati pa2025. Chidzidzo chekutanga cheGFH375 chakatangwa neGenFleet muChina chaenderera mberi kusvika muchikamu chechipiri uye data rekutanga rekushanda nekuchengetedza kwechidzidzo ichi rakasarudzwa kuti riitwe nekukurumidza pamusangano wegore negore weAmerican Society of Clinical Oncology (ASCO) wegore ra2025.

Mapuroteni eRAS, ari muchimiro cheGTP-bound kana kuti asina kushanda muGDP-bound, mabhinari molecular switches anodzora mhinduro dzemasero munzira dzekutumira zviratidzo dzinosanganisira RAS-RAF-MEK-ERK uye PI3K/AKT/mTOR. Majini matatu eRAS anoumba mapuroteni isoforms, anoti Kirsten Ras (KRAS), Harvey Ras (HRAS) uye Neuroblastoma Ras (NRAS), uye KRAS ndiyo oncogene inowanzo shanduka muvanhu. Pakati peKRAS mutations, G12D, G12V, uye G12C ndiwo matatu epamusoro anowanzo shanduka. KRAS G12D mutation inowanzo kuwanikwa mupancreatic ductal adenocarcinoma, colorectal cancer, uye lung adenocarcinoma.

Huwandu hukuru hwevarwere vane shanduko yeKRAS G12D vanowanikwa vasina nhoroondo yekuputa uye vasina mhinduro yakanaka kune PD-1 inhibitors. Mishonga inosarudza G12D ine zvipikirwa zvinobatsira zvikamu zvikuru zvevarwere vane PDAC inotungamirirwa neKRAS sezvo shanduko dzeKRAS G12D dziridzo dzinonyanya kuitika muvarwere vePDAC (vanenge 40%) vanonzi vane mwero wekurarama kwemakore mashanu wakaderera pane 10%.

GFH375 mushonga unoshanda nemuromo, une simba, uye unosarudza zvakanyanya KRAS G12D (ON/OFF) inhibitor yakagadzirirwa kunanga kuchinjana kweGTP/GDP, nokudaro ichikanganisa kushanda kwenzira dziri pasi pemvura uye ichidzivirira kukura kwemasero egomarara. Zvidzidzo zvepamberi pekiriniki zvakaratidza kudziviswa kunoenderana nedosi mumamodeli ane KRAS G12D mutation; GFH375 yakaratidzawo njodzi yakaderera yekusarudzwa kwekinase uye kuyedzwa kwekuchengetedza.

Parizvino, kuchine miedzo yakawanda yekiriniki yehunyanzvi hutsva hwekurwisa gomarara muChina huri kutsvaga varwere. Kana muchida kubvunzana nezvemishonga mitsva netekinoroji, munogona kubata Dhipatimendi reBeijing South Region Oncology Hospital International.

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Nguva yekutumira: Kubvumbi-25-2025