FDA enyela IND ikike iwepụ GFH375/VS-7375, ihe mgbochi ọgwụ KRAS G12D (ON/OFF), na-eme ka nnwale Phase I/IIa gwọọ KRAS G12D-mutant Advanced Solid Tumors na United States.

Na Eprel 24, 2025, GenFleet Therapeutics kwupụtara na US Food and Drug Administration (FDA) kwadoro ojiji ọgwụ ọhụrụ (IND) nke GFH375/VS-7375, ọgwụ mgbochi KRAS G12D (ON/OFF) nke a na-aṅụ, maka nnwale ahụike na-agwọ ndị ọrịa kansa siri ike nwere mgbanwe KRAS G12D. A na-eme atụmatụ ka onye mmekọ GenFleet bụ Verastem Oncology malite ọmụmụ ihe a na US n'ihe dị ka etiti afọ 2025. Ọmụmụ ihe mbụ n'ime mmadụ nke GFH375 nke GenFleet malitere na China abanyela na nkebi nke abụọ, a họrọkwara data mmalite na nchekwa nke ọmụmụ a n'ime ngosipụta ọnụ ngwa ngwa na Nzukọ Kwa Afọ nke American Society of Clinical Oncology (ASCO) nke 2025 na-abịa.

Protein RAS, n'ụdị GDP na-ejikọta ma ọ bụ na-anaghị arụ ọrụ, bụ swiitị molekul abụọ na-achịkwa nzaghachi sel na ụzọ mgbaàmà gụnyere RAS-RAF-MEK-ERK na PI3K/AKT/mTOR. Mkpụrụ ndụ ihe nketa RAS atọ na-akọwapụta isoforms protein, ya bụ Kirsten Ras (KRAS), Harvey Ras (HRAS) na Neuroblastoma Ras (NRAS), na KRAS bụ oncogene a na-agbanwekarị n'ime mmadụ. N'ime mgbanwe KRAS, G12D, G12V, na G12C na-anọchite anya alleles atọ kachasị elu a na-agbanwekarị. A na-ahụkarị mgbanwe KRAS G12D na adenocarcinoma pancreatic ductal, kansa colorectal, na adenocarcinoma akpa ume.

A na-ahụ nnukwu pasentị nke ndị ọrịa nwere mgbanwe KRAS G12D na-enweghị akụkọ ihe mere eme nke ise siga ma na-enwe mmeghachi omume na-adịghị mma na ndị na-egbochi PD-1. Ndị na-egbochi G12D nke nwere nhọrọ nwere nkwa ga-abara nnukwu akụkụ nke ndị ọrịa PDAC nke KRAS na-achịkwa uru ebe ọ bụ na mgbanwe KRAS G12D bụ mgbanwe somatic kachasị na-eme na ndị ọrịa PDAC (ihe dị ka 40%) bụ ndị a kọrọ na ha nwere ọnụego ndụ afọ ise dị ala karịa 10%.

GFH375 bụ ihe mgbochi obere molekul KRAS G12D (ON/OFF) nke na-arụ ọrụ n'ọnụ, nke nwere ike, nke a na-ahọrọ nke ọma iji lekwasị anya na mgbanwe GTP/GDP, si otú a na-egbochi mmegharị nke ụzọ ndị dị n'okpuru ala ma na-egbochi mmụba nke mkpụrụ ndụ tumor nke ọma. Ọmụmụ ihe tupu oge ahụike gosiri mgbochi dabere na dose na ụdị ndị nwere mgbanwe KRAS G12D; GFH375 gosikwara obere ihe egwu na-apụ na ebumnuche kinase na nnwale nchekwa.

Ugbu a, enwere ọtụtụ nnwale ahụike nke teknụzụ ọhụrụ na-egbochi kansa na China na-achọ ndị ọrịa. Maka ndụmọdụ gbasara ọgwụ na teknụzụ ọhụrụ, ị nwere ike ịkpọtụrụ Ngalaba Mba Nile nke Ụlọ Ọgwụ Oncology nke Beijing South Region.

Nọmba ekwentị: 4008803716

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