FDA Yapereka Chithandizo cha IND cha GFH375/VS-7375, choletsa cha KRAS G12D (ON/OFF) choletsa, chomwe chimayambitsa mayeso a Phase I/IIa pochiza KRAS G12D-mutant Advanced Solid Tumors ku United States

Pa Epulo 24, 2025, GenFleet Therapeutics idalengeza kuti US Food and Drug Administration (FDA) yavomereza kugwiritsa ntchito mankhwala atsopano (IND) a GFH375/VS-7375, mankhwala oletsa kumwa a KRAS G12D (ON/OFF), kuti ayesedwe kuchipatala pochiza odwala omwe ali ndi chotupa champhamvu omwe ali ndi kusintha kwa KRAS G12D. Kafukufukuyu akukonzekera kuyambika ndi mnzake wa GenFleet Verastem Oncology ku US chapakati pa chaka cha 2025. Kafukufuku woyamba wa GFH375 mwa anthu womwe unayambitsidwa ndi GenFleet ku China wapita patsogolo mpaka gawo lachiwiri ndipo deta yoyambirira yothandiza komanso yotetezeka ya kafukufukuyu idasankhidwa kuti iperekedwe mwachangu pakamwa pa Msonkhano Wapachaka wa 2025 wa American Society of Clinical Oncology (ASCO).

Mapuloteni a RAS, omwe ali mu mawonekedwe a GTP-bound kapena osagwira ntchito a GDP-bound, ndi ma binary molecular switches omwe amalamulira mayankho a ma cell m'njira zolumikizirana kuphatikizapo RAS-RAF-MEK-ERK ndi PI3K/AKT/mTOR. Majini atatu a RAS amalemba ma isoform a mapuloteni, omwe ndi Kirsten Ras (KRAS), Harvey Ras (HRAS) ndi Neuroblastoma Ras (NRAS), ndipo KRAS ndiye oncogene yomwe imasinthidwa kwambiri mwa anthu. Pakati pa masinthidwe a KRAS, G12D, G12V, ndi G12C ndi ma alleles atatu apamwamba omwe amasinthidwa kwambiri. Kusintha kwa KRAS G12D kumapezeka kwambiri mu pancreatic ductal adenocarcinoma, khansa ya m'matumbo, ndi adenocarcinoma ya m'mapapo.

Odwala ambiri omwe ali ndi kusintha kwa KRAS G12D amapezeka kuti alibe mbiri ya kusuta fodya komanso alibe yankho lolondola ku zoletsa za PD-1. Zoletsa za G12D zomwe zimasankhidwa ndi mutant zili ndi lonjezo lothandiza magulu akuluakulu a odwala PDAC omwe amayendetsedwa ndi KRAS popeza kusintha kwa KRAS G12D ndi komwe kumachitika kawirikawiri mwa odwala PDAC (pafupifupi 40%) omwe akuti ali ndi chiwopsezo cha moyo wazaka 5 chochepera 10%.

GFH375 ndi mankhwala oletsa a KRAS G12D (ON/OFF) omwe amagwira ntchito pakamwa, amphamvu, komanso osankha bwino omwe adapangidwa kuti azitha kusinthana kwa GTP/GDP, motero amasokoneza kuyambika kwa njira zotsikira pansi ndikuletsa kuchulukana kwa maselo a chotupa. Kafukufuku woyambirira adawonetsa kuletsa kutengera mlingo m'mamodeli omwe ali ndi kusintha kwa KRAS G12D; GFH375 idawonetsanso chiopsezo chochepa pakusankha kwa kinase ndi mayeso achitetezo.

Pakadali pano, pali mayesero ambiri azachipatala a ukadaulo watsopano wothana ndi khansa ku China omwe akufuna odwala. Mukafunsira mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region.

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