Unyango olutsha lweSicelo seChiza seNtuthuko eNgqongileyo

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I-Nuvation Bio Inc. namhlanje ibhengeze ukuba i-US Food and Drug Administration (FDA) iye yacinywa isicelo sayo esitsha sophando (IND) ukuvavanya i-NUV-868, i-BD2-selective oral small molecule bromodomain and extra-terminal (BET) inhibitor, kuba unyango lwamathumba aqinileyo aphezulu, kubandakanya umhlaza we-ovarian, umhlaza wepancreatic, i-metastatic castration resistant cancer prostate (mCRPC), kunye nomhlaza webele ongalunganga kathathu (TNBC).

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"Ukucocwa kwesicelo sethu se-IND se-NUV-868 linyathelo elibalulekileyo kwi-Nuvation Bio njengoko iphawula i-IND yesine kwiinyanga ezili-14 ezidlulileyo kumbhobho wethu onzulu wonyango olutsha olujolise kwiintlobo ezininzi zamathumba," utshilo uDavid Hung, MD, umseki. , umongameli, kunye negosa eliphezulu le-Nuvation Bio. "Siyakhuthazwa kukhetho kunye nokunyamezela okunokuphucula okubonakaliswa yi-NUV-868 kwizifundo zangaphambili, kwaye sijonge phambili ekuqhubeleni phambili inkqubo kwiSigaba 1 sophuhliso phakathi kwe-2022."

I-NUV-868 inqanda i-BRD4, ilungu eliphambili lentsapho ye-BET elawula i-epigenetically iiprotheni ezilawula ukukhula kwe-tumor kunye nokwahlukana. I-NUV-868 yenzelwe ukuba ikhethe ngakumbi i-BD2 kune-BD1 ekuzameni ukuphepha ukuthintela ukunyanzeliswa kwe-toxicities yezinye i-BRD4 inhibitors ezifana ne-gastrointestinal (GI) kunye ne-bone marrow toxicities. Izifundo zangaphambi kweklinikhi zibonise i-NUV-868 iphantse ibe ngama-1,500 amaxesha akhethiweyo ngakumbi kwi-BD2 kune-BD1. I-BD1 / 2 inhibitors engakhethiyo ekuphuhlisweni idibaniswe nemiba yokunyamezela, mhlawumbi ngenxa yokuthintela kakhulu kwe-BD1.

Ngokucocwa kwale IND ye-NUV-868 kwii-tumor eziqinileyo eziphambili, i-Nuvation Bio iya kuqalisa isifundo seSigaba se-1/2 se-NUV-868 njenge-monotherapy kunye nokudibanisa ne-olaparib okanye i- enzalutamide kwiintlobo ezininzi ze-tumor. Le protocol (NUV-868-01) iya kuqalisa ngeSigaba soku-1 sophononongo lokunyuka kwedosi ye-monotherapy kwizigulana zethumba eliqinileyo. Uphononongo lweSigaba 1b luya kuthi emva koko luqaliswe ukuhlola i-NUV-868 ngokudityaniswa ne-olaparib kumhlaza we-ovarian owawunyangwa ngaphambili, umhlaza wepancreatic, i-mCRPC, kunye nezigulana ze-TNBC kunye nokudityaniswa ne- enzalutamide kwizigulana ze-mCRPC ezilandelwa siSigaba se-2b sophononongo lokuphonononga ngakumbi ukhuseleko kunye nokusebenza kakuhle. nje ukuba iSigaba sesi-2 esicetyiswayo sedibaniso simiselwe. Uphononongo lweSigaba sesi-2 sonyango olulodwa nalo luya kuqaliswa kwizigulana ze-mCRPC kunye nokuphonononga ngakumbi ukhuseleko nokusebenza.

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Umhleli oyintloko we-eTurboNew nguLinda Hohnholz. Uzinze kwi-eTN HQ e-Honolulu, eHawaii.

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