FDA Pom Zoo Rau IND Txog GFH375/VS-7375, Ib Yam Tshuaj KRAS G12D (ON/OFF) Uas Haus Tau, Pab Kom Muaj Kev Sim Theem I/IIa Kho Cov Mob Qog Siab KRAS G12D-mutant Hauv Tebchaws Meskas

Thaum Lub Plaub Hlis 24, 2025, GenFleet Therapeutics tau tshaj tawm tias US Food and Drug Administration (FDA) tau pom zoo rau kev siv tshuaj tshiab (IND) ntawm GFH375/VS-7375, uas yog ib yam tshuaj uas noj los ntawm KRAS G12D (ON/OFF) inhibitor, rau kev sim tshuaj kho cov neeg mob qog nqaij hlav uas muaj KRAS G12D mutation. Txoj kev tshawb fawb no tau npaj yuav pib los ntawm GenFleet tus khub Verastem Oncology hauv Tebchaws Meskas thaum nruab nrab xyoo 2025. Txoj kev tshawb fawb thawj zaug hauv tib neeg ntawm GFH375 uas GenFleet tau pib hauv Suav teb tau nce mus rau theem II thiab cov ntaub ntawv ua tau zoo thiab kev nyab xeeb ntawm txoj kev tshawb fawb no tau raug xaiv rau hauv kev nthuav qhia sai ntawm 2025 American Society of Clinical Oncology (ASCO) Lub Rooj Sib Tham Txhua Xyoo.

Cov protein RAS, nyob rau hauv daim ntawv GTP-bound lossis tsis ua haujlwm GDP-bound, yog cov binary molecular switches tswj cov lus teb ntawm lub cellular hauv cov signaling pathways suav nrog RAS-RAF-MEK-ERK thiab PI3K/AKT/mTOR. Peb lub RAS genes encode rau protein isoforms, uas yog Kirsten Ras (KRAS), Harvey Ras (HRAS) thiab Neuroblastoma Ras (NRAS), thiab KRAS yog cov oncogene mutated feem ntau hauv tib neeg. Ntawm KRAS mutations, G12D, G12V, thiab G12C sawv cev rau peb sab saum toj feem ntau mutated alleles. KRAS G12D mutation feem ntau pom muaj nyob rau hauv pancreatic ductal adenocarcinoma, colorectal cancer, thiab lub ntsws adenocarcinoma.

Feem pua ​​loj ntawm cov neeg mob uas muaj kev hloov pauv KRAS G12D pom tias tsis muaj keeb kwm haus luam yeeb thiab tsis teb zoo rau PD-1 inhibitors. Cov tshuaj G12D inhibitors xaiv kev hloov pauv muaj kev cia siab tias yuav pab tau rau cov neeg mob PDAC uas tsav los ntawm KRAS vim tias kev hloov pauv KRAS G12D yog qhov kev hloov pauv somatic feem ntau tshwm sim hauv cov neeg mob PDAC (kwv yees li 40%) uas tau tshaj tawm tias muaj feem pua ​​​​​​ntawm kev ciaj sia nyob 5 xyoos qis dua 10%.

GFH375 yog ib qho tshuaj uas siv thaum noj, muaj zog, thiab xaiv tau cov tshuaj me me KRAS G12D (ON/OFF) inhibitor uas tsim los tsom rau kev sib pauv GTP/GDP, ua rau tsis ua haujlwm ntawm cov txoj hauv kev qis thiab tiv thaiv cov hlwb qog kom loj hlob zoo. Cov kev tshawb fawb ua ntej kuaj mob tau qhia txog kev txwv tsis pub noj tshuaj hauv cov qauv uas muaj kev hloov pauv KRAS G12D; GFH375 kuj tau qhia txog kev pheej hmoo tsawg hauv kev xaiv kinase thiab kev ntsuam xyuas kev nyab xeeb.

Tam sim no, tseem muaj ntau qhov kev sim tshuaj kho mob qog noj ntshav tshiab hauv Suav teb nrhiav cov neeg mob. Kev sab laj txog cov tshuaj tshiab thiab cov thev naus laus zis, koj tuaj yeem tiv tauj Beijing South Region Oncology Hospital International Department.

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Lub sijhawm tshaj tawm: Plaub Hlis-25-2025