US FDA tau tso cai rau ZN-c3 ceev-khiav kev tsim nyog los tiv thaiv DNA kev puas tsuaj rau cov protein los rhuav tshem cov qog nqaij hlav cancer!

Zentalis Pharmaceuticals yog lub tuam txhab kho mob-theem biopharmaceutical tuam txhab uas tsom mus rau kev tshawb pom thiab kev txhim kho ntawm cov tshuaj kho me me uas tsom rau txoj hauv kev lom neeg mob qog noj ntshav. Tsis ntev los no, lub tuam txhab tshaj tawm tias US Food and Drug Administration (FDA) tau tso cai ZN-c3 Fast Track Designation (FTD) rau kev kho mob ntawm cov poj niam laus cov neeg mob uas rov muaj dua los yog refractory uterine serous carcinoma (USC).

ZN-c3 yog qhov muaj peev xwm ua ntej thiab zoo tshaj plaws hauv chav kawm qhov ncauj WEE1 inhibitor tsim los ntawm Zentalis. Nws yog ib qho tseem ceeb ntawm kev kho mob hauv kev puas tsuaj DNA teb thiab hluavtaws lethality. Tam sim no nws tab tom raug tshuaj xyuas hauv qhov muaj peev xwm sau npe theem 2 kev sim tshuaj. Cov ntaub ntawv raws li lub Tsib Hlis 15 xyoo no qhia tau hais tias tag nrho cov lus teb tus nqi (ORR) ntawm ZN-c3 kev kho mob ntawm USC tau mus txog 43% (n=3/7, raws li kev ntsuam xyuas hluav taws xob teb).

Fast Track Qualification (FTD) lub hom phiaj txhawm rau txhawm rau txhawm rau txhim kho tshuaj thiab tshuaj xyuas sai rau cov kab mob loj los daws cov kev xav tau kev kho mob hnyav hauv cov chaw tseem ceeb. Tau txais kev tsim nyog tau txais txiaj ntsig sai rau cov tshuaj hauv kev txhim kho txhais tau tias cov tuam txhab tshuaj tuaj yeem cuam tshuam nrog FDA ntau dua thaum lub sijhawm tshawb fawb thiab txhim kho. Tom qab xa daim ntawv thov kev lag luam, lawv tsim nyog tau txais kev pom zoo nrawm dua thiab kev tshuaj xyuas ua ntej yog tias lawv ua tau raws li cov qauv tsim nyog. Tsis tas li ntawd, lawv kuj tsim nyog rau kev tshuaj xyuas dov.

Dr. Anthony Sun, Thawj Tswj Hwm thiab CEO ntawm Zentalis, tau hais tias: “USC yog ib qho mob qog noj ntshav uas ua rau mob qog noj ntshav uas tshwm sim los ntawm qhov muaj sia nyob tsawg thiab tus nqi rov qab siab dua. Qhov khoom plig ntawm ZN-c3 rau FTD yog qhov tseem ceeb tshaj plaws vim tias nws hais txog qhov xav tau kev kho tshiab thiab muaj txiaj ntsig zoo rau cov kab mob hnyav thiab feem ntau tuag taus. Peb zoo siab heev rau lub sijhawm los cuam tshuam ntau zaus nrog FDA raws li peb txuas ntxiv mus sai sai rau qhov kev cog lus no rau cov neeg mob xav tau kev txhim kho kev sib tw."

ZN-c3 mechanism ntawm kev txiav txim

Uterine serous carcinoma (USC) yog ib qho kev sib txawv ntawm cov qog nqaij hlav endometrial, uas muaj tsawg dua 10% ntawm tag nrho cov qog nqaij hlav endometrial, tab sis suav txog 80% ntawm cov neeg mob qog nqaij hlav endometrial. Hauv Tebchaws Meskas, kwv yees li 6,500 tus poj niam tau kuaj pom USC txhua xyoo, thiab kwv yees li 70% ntawm lawv muaj tus kabmob III lossis IV thaum lub sijhawm kuaj mob. Tam sim no, tus qauv rau kev kho USC yog staged phais ntxiv rau chemotherapy lossis radiotherapy; Txawm li cas los xij, qhov rov tshwm sim tom qab phais yog qhov siab heev, ua rau cov neeg mob muaj sia nyob tsawg. Kev hloov pauv kev kho mob rau USC' txoj hauv kev lom neeg tseem ceeb tseem yog qhov xav tau kev kho mob ceev.

ZN-c3 yog qhov muaj peev xwm ua ntej-hauv-chav kawm thiab zoo tshaj plaws-hauv-chav qhov ncauj WEE1 inhibitor, tam sim no tau tsim los rau kev kho cov qog nqaij hlav siab heev. WEE1 yog DNA kev puas tsuaj rau cov protein uas nws cov nyhuv inhibitory yog tsim los ua rau DNA puas txaus rau cov qog nqaij hlav cancer, ua rau cov cell tuag, yog li tiv thaiv qog loj hlob thiab tej zaum yuav ua rau qog regression.

ZN-c3 muaj peev xwm dav raws li kev kho mob monotherapy thiab kev kho ua ke. Tam sim no, Zentals tab tom ntsuas ZN-c3 nyob rau hauv ntau qhov kev tshawb fawb tsis tu ncua thiab npaj kho mob, suav nrog ob lub peev xwm sau npe kev kho mob monotherapy ntawm University of Southern California, kev sim biomarker-tsav, thiab kev tshawb fawb ua ke, suav nrog kev siv tshuaj khomob ua ke los kho cov neeg mob. mob cancer ntawm zes qe menyuam.

Yav dhau los, US FDA tau tso cai ZN-c3 Orphan Drug Designation (ODD) thiab Rare Pediatric Disease Designation (RPDD) rau kev kho mob ntawm cov menyuam yaus osteosarcoma, thiab tau pib ua Phase 1/2 sim ntawm kev sib xyaw ua ke.