Ukwelashwa Kwezidakamizwa Okusha Kwezimila Eziqinile Ezithuthukile

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I-Nuvation Bio Inc. namuhla imemezele ukuthi i-US Food and Drug Administration (FDA) isisusile isicelo sayo esisha somuthi (IND) sokuhlola i-NUV-868, i-BD2-selective oral small molecule bromodomain and extra-terminal (BET) inhibitor, for ukwelashwa kwezimila eziqinile ezithuthukisiwe, okuhlanganisa umdlavuza we-ovarian, umdlavuza we-pancreatic, umdlavuza we-prostate resistant metastatic castration (mCRPC), kanye nomdlavuza webele ongemuhle kathathu (TNBC).

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"Ukugunyazwa kwesicelo sethu se-IND se-NUV-868 kuyingqopha-mlando ebalulekile ku-Nuvation Bio njengoba kuphawula i-IND yesine ezinyangeni eziyi-14 ezedlule epayipini lethu elijulile lokwelapha umdlavuza okuhloswe ngazo izinhlobo eziningi zesimila," kusho uDavid Hung, MD, umsunguli. , umongameli, kanye nesikhulu esiphezulu se-Nuvation Bio. "Sikhuthazwa ukukhetha kanye nokubekezelelana okuthuthukisiwe okukhonjiswe yi-NUV-868 ezifundweni zangaphambi komtholampilo, futhi sibheke ngabomvu ukuqhubekisela phambili lolu hlelo ekuthuthukisweni kweSigaba 1 maphakathi no-2022."

I-NUV-868 ivimbela i-BRD4, eyilungu eliyinhloko lomndeni we-BET olawula i-epigenetically amaprotheni alawula ukukhula nokuhlukaniswa kwesimila. I-NUV-868 yakhelwe ukuthi ikhethe kakhulu i-BD2 kune-BD1 emzamweni wokugwema ubuthi obukhawula bokwelapha bamanye ama-BRD4 inhibitor afana nobuthi besisu (GI) nomnkantsha. Ucwaningo lwangaphambi komtholampilo lubonise ukuthi i-NUV-868 ikhetha cishe izikhathi ezingu-1,500 ku-BD2 kune-BD1. Ama-BD1/2 inhibitors angakhethi ekuthuthukisweni ahlotshaniswe nezinkinga zokubekezelelana, okungenzeka ngenxa yokuvinjelwa kwe-BD1 kakhulu.

Ngokusulwa kwale IND ye-NUV-868 kumathumba aqinile athuthukile, i-Nuvation Bio izobe iqala ucwaningo lweSigaba 1/2 se-NUV-868 njenge-monotherapy futhi ihlanganiswe ne-olaparib noma i- enzalutamide ezinhlotsheni eziningi zesimila. Le phrothokholi (NUV-868-01) izoqala ngocwaningo lokwenyuka komthamo we-monotherapy weSigaba 1 ezigulini ezithuthukisiwe zesimila esiqinile. Kuzobe sekuqalwa ucwaningo lweSigaba 1b oluhlola i-NUV-868 ngokuhlangana ne-olaparib ekulapheni umdlavuza wesibeletho, umdlavuza we-pancreatic, i-mCRPC, neziguli ze-TNBC futhi kuhlanganiswe ne- enzalutamide yeziguli ze-mCRPC okulandelwa ucwaningo lweSigaba 2b ukuze kuqhutshekwe nokuhlola ukuphepha nokusebenza ngempumelelo. uma umthamo wenhlanganisela weSigaba 2 onconywayo usunqunyiwe. Ucwaningo lweSigaba 2 lwe-monotherapy luzophinda luqalwe ezigulini ze-mCRPC ukuze kuqhutshekwe nokuhlola ukuphepha nokusebenza ngempumelelo.

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Umhleli omkhulu we-eTurboNew nguLinda Hohnholz. Uzinze e-eTN HQ e-Honolulu, e-Hawaii.

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