Tebchaws Asmeskas FDA tau tso cai FolRα tsom cov tshuaj tiv thaiv kab mob sib txuas tshuaj STRO-002 kev tsim nyog nrawm nrawm!

Sutro Biopharma yog lub chaw kho mob-qib American biopharmaceutical tuam txhab uas tsom mus rau kev siv cov cuab yeej ua kom muaj protein ntau thiab tsim nyog tsim los tsim lub cim tom ntej ntawm kev mob qog noj ntshav thiab kho tus mob autoimmune. Tsis ntev los no, lub tuam txhab tshaj tawm tias Asmeskas Cov Khoom Noj thiab Tshuaj Yeeb Tshuaj (FDA) tau tso cai rau STRO-002 Fast Track Qualification (FTD) rau kev kho mob qog noj ntshav ntawm zes qe menyuam, tshwj xeeb: yav dhau los 1-3 kab kev kho, platinum-resistant epithelial Cov neeg mob nrog zes qe menyuam, lub raj xa menyuam, thiab thawj tus mob qog noj ntshav peritoneal.

Kev Tuav Pov Hwm Tiav (FTD) lub hom phiaj txhawm rau txhawm rau txhim kho tshuaj thiab tshuaj xyuas sai sai rau cov kab mob hnyav txhawm rau hais daws qhov tsis xav tau kev kho mob hnyav hauv thaj chaw tseem ceeb. Tau txais cov txheej txheem nrawm rau cov tshuaj hauv kev txhim kho txhais tau tias cov tuam txhab lag luam tshuaj tuaj yeem cuam tshuam nrog FDA ntau zaus thaum tshawb fawb thiab txhim kho theem. Tom qab xa daim ntawv thov kev lag luam, lawv tsim nyog tau txais kev pom zoo nrawm dua thiab rov xyuas dua yog tias lawv ua tau raws cov qauv tsim nyog. Ib qho ntxiv, lawv kuj tseem tsim nyog rau kev tshuaj xyuas.

STRO-002 yog cov tshuaj tiv thaiv kab mob tiv thaiv kab mob (ADC) tsom mus rau folate receptor α (FolRα), tsim los ntawm Sutro cov tswv lag luam uas tsis muaj cov protein sib xyaw ua ke sib xyaw ua ke platform XpressCF thiab qhov chaw tshwj xeeb sib koom ua ke XpressCF +. Tam sim no, STR0-002 tab tom tsim kho kev kho mob qog noj ntshav ntawm zes qe menyuam thiab mob qog noj ntshav hauv tsev, thiab theem 1 kev sim tshuaj kho mob tseem tab tom pib. Cov kev kho mob rau cov poj niam uas muaj mob qog noj ntshav zes qe menyuam muaj tsawg. Tau txais FTD yog qhov kev lees paub tseem ceeb ntawm STRO-002 raws li qhov muaj peev xwm zoo tshaj FolRα ADC rau cov poj niam uas muaj mob qog noj ntshav zes qe menyuam.

STRO-002 tau tsim los tsom mus rau FolRα, cov protein ntawm cov xovtooj ntawm tes uas tau qhia ntau hauv kev mob qog noj ntshav ntawm zes qe menyuam. Hauv kev tshawb fawb ua ntej, STRO-002 tau qhia pom muaj zog hauv vitro cytotoxicity hauv kab mob qog noj ntshav ntawm zes qe menyuam, thiab cuam tshuam qhov cuam tshuam loj hlob ntawm cov qog hauv ntau yam qauv qog noj ntshav qog noj ntshav. Hauv kev tshawb fawb txog kev nyab xeeb tau ua hauv cov neeg tsis yog neeg, cov tshuaj muaj feem cuam tshuam ntawm STRO-002 tau raug zam zoo."

STRO-002 tus yam ntxwv yam ntxwv

Dr. Arturo Molina, Tus Thawj Saib Xyuas Kev Noj Qab Haus Huv ntawm Sutro Biopharma, hais tias:" Peb zoo siab heev uas FDA tau tso cai rau STRO-002 cov xwm txheej nrawm, uas yuav muab sijhawm rau peb los cuam tshuam nrog FDA ntau dua. Peb tseem muaj kev ntseeg siab rau lub peev xwm ntawm txoj haujlwm STRO-002. Txoj haujlwm tau qhia pom kev txhawb nqa thawj zaug ua haujlwm thiab ua siab ntev hauv Phase 1 Dose Escalation Study of Ovarian Cancer. Peb npaj yuav txuas ntxiv ua haujlwm nrog FDA txhawm rau txhawm rau ua kom nrawm rau peb cov chaw kho mob thiab cov cai tswj hwm."

Sutro tau tsim ob lub ADCs siv cov tswv lag luam uas tsis muaj cov protein sib xyaw ua ke sib xyaw ua ke XpressCF thiab lub vev xaib tshwj xeeb kev sib koom ua ke XpressCF +. Ntxiv rau STRO-002, lwm yam tshuaj, STRO-001, yog ADC uas tsom mus rau CD47. Qhov tom kawg yog tam sim no nyob rau theem kuv txoj kev tshawb fawb soj ntsuam kev kho mob siab B-cell malignancies, suav nrog ntau yam myeloma thiab tsis-Hodgé Gold lymphoma. Thaum Lub Kaum Hli 2018, FDA tau tso cai rau STRO-001 cov menyuam ntsuag tsim cov tshuaj rau kev kho mob ntau yam myeloma.

Sutro tuam txhab xa khoom

Sutro's XpressCF + thev naus laus zis platform ua kom muaj kev tsim meej thiab kev paub zoo dua ntawm ADCs thiab lwm yam khoom sib tw. Txog tam sim no, Sutro tau tsim cov txheej txheem cytokine-based immuno-oncology kho, ADCs, tshuaj tiv thaiv thiab tshuaj tiv thaiv kab mob tshwj xeeb, feem ntau yog rau cov hom phiaj uas tau txheeb xyuas hauv tsev kho mob tab sis tam sim no tsis zoo rau kev saib xyuas tus qauv. Ntxiv rau kev txhim kho nws tus kheej oncology pipeline, Sutro kuj tseem tau koom tes nrog kev koom tes nrog ntau lub tuam txhab biotechnology thiab cov tuam txhab tshuaj los tshawb nrhiav thiab txhim kho kev tsim kho tshiab.

Tam sim no, Sutro tau tsom mus rau kev koom tes nrog Bristol-Myers Squibb (BMS) txhawm rau txhim kho CC-99712, uas yog ADC tsom rau BCMA. Theem 1 kev sim tshuaj rau kev kho mob ntau yam myeloma (MM) tab tom nrhiav cov neeg mob. Tau Txais Me Nyuam Yeeb Tshuaj Tsim los ntawm FDA.

Ib qho ntxiv, Sutro tseem koom tes nrog Merck KGaA txhawm rau txhim kho M1231, thawj-hauv-chav kawm tshwj xeeb ADC tsom mus rau MUC1-EGFR los kho cov tsis yog cov qog ntshav me me hauv cov qog nqaij hlav loj Phase 1 kev kuaj mob qog noj ntshav hauv lub ntsws (NSCLL) thiab cov hlab pas ntawm cov leeg nqaij. carcinoma (ESCC) tab tom nrhiav cov neeg mob.

BMS thiab Merck yog tus tsim txoj cai thoob ntiaj teb thiab kev ua lag luam ntawm CC-99712 thiab M1231 feem, thiab Sutro tsim nyog tau txais cov txiaj ntsig tseem ceeb cuam tshuam nrog kev them nqi thiab cov nqi sib luag.