FDA waxay IND ku bixisay ogolaanshaha GFH375/VS-7375, oo ah joojiye afka ah oo KRAS G12D ah (ON/OFF), taasoo awood u siinaysa tijaabada wejiga I/IIa ee lagu daaweynayo KRAS G12D-mutant Burooyinka adag ee horumarsan ee Mareykanka

Abriil 24, 2025, GenFleet Therapeutics waxay ku dhawaaqday in Maamulka Cuntada iyo Dawooyinka ee Mareykanka (FDA) uu oggolaaday isticmaalka cusub ee daawada (IND) ee GFH375/VS-7375, oo ah daawo afka laga qaato oo ka hortagta KRAS G12D (ON/OFF), si loogu sameeyo tijaabo caafimaad oo lagu daaweynayo bukaanada burooyinka adag ee horumarsan ee qaba isbeddelka KRAS G12D. Daraasaddan waxaa qorsheynaya in ay bilowdo Verastem Oncology oo ay wada shaqeeyaan GenFleet oo ku taal Mareykanka qiyaastii bartamihii 2025. Daraasaddii ugu horreysay ee aadanaha ee GFH375 oo ay bilowday GenFleet ee Shiinaha ayaa u gudubtay wejiga II, xogta waxtarka iyo badbaadada hordhaca ah ee daraasaddanna waxaa lagu soo bandhigay bandhigga degdegga ah ee afka ah ee Shirka Sannadlaha ah ee Bulshada Mareykanka ee Cudurrada Kiliinikada (ASCO) ee soo socda 2025.

Borotiinnada RAS, oo ku jira qaab firfircoon oo ku xiran GTP ama aan firfircoonayn oo ku xiran GDP, waa isbeddello molecular ah oo laba-geesood ah oo xakameeya jawaabaha unugyada ee waddooyinka calaamadaha oo ay ku jiraan RAS-RAF-MEK-ERK iyo PI3K/AKT/mTOR. Saddex hiddo-side oo RAS ah ayaa u codeeya isoforms-ka borotiinka, kuwaas oo kala ah Kirsten Ras (KRAS), Harvey Ras (HRAS) iyo Neuroblastoma Ras (NRAS), KRAS-na waa oncogene-ka ugu badan ee isbeddela ee aadanaha. Isbeddellada KRAS, G12D, G12V, iyo G12C waxay matalaan saddexda alleles ee ugu badan ee isbeddela. Isbeddelka KRAS G12D waxaa badanaa laga helaa adenocarcinoma-ka ganaca, kansarka mindhicirka, iyo adenocarcinoma sambabada.

Boqolkiiba badan oo bukaanada qaba isbeddelka KRAS G12D ayaa la helaa iyagoon lahayn taariikh sigaar cabis ah iyo jawaab celin liidata oo ku saabsan daawooyinka joojiya PD-1. Daawooyinka joojiya G12D ee doorta mutant-ka ayaa ballanqaadyo u leh inay ka faa'iidaystaan ​​​​qaybo badan oo ka mid ah bukaanada PDAC ee KRAS-ku wado maadaama isbeddellada KRAS G12D ay yihiin kuwa ugu badan ee ka dhaca bukaanada PDAC (qiyaastii 40%) kuwaas oo la sheegay inay leeyihiin heer badbaado oo 5 sano ah oo ka hooseeya 10%.

GFH375 waa daawo afka laga qaato oo awood leh, oo aad u xulasho badan oo molecule yar oo KRAS G12D (ON/OFF) ah oo loogu talagalay in lagu beegsado is-weydaarsiga GTP/GDP, taasoo carqaladeynaysa dhaqdhaqaaqa waddooyinka hoose iyo si wax ku ool ah u joojinaysa faafitaanka unugyada burooyinka. Daraasadaha kahor-kiliinikada waxay muujiyeen xannibaad ku tiirsan qiyaasta moodooyinka wata isbeddelka KRAS G12D; GFH375 waxay sidoo kale muujisay khatar yar oo ka baxsan bartilmaameedka ee xulashada kinase iyo baaritaannada bartilmaameedka badbaadada.

Waqtigan xaadirka ah, waxaa weli jira tijaabooyin caafimaad oo badan oo ku saabsan teknoolojiyada cusub ee ka hortagga kansarka ee Shiinaha oo raadinaya bukaanno. La-tashi ku saabsan daawooyinka cusub iyo teknoolojiyada, waxaad la xiriiri kartaa Waaxda Caalamiga ah ee Isbitaalka Oncology ee Gobolka Koonfureed ee Beijing.

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