Lymphoma Tshiab Tshuaj! TG Kev Kho Mob Txuas Ntxiv Tiam Qhov Ncauj PI 3 Kδ Tus Kheej Umbralisib Siv Rau Kev Lag Luam Hauv Tebchaws Asmeskas!

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TG Kev Kho Mob yog lub tuam txhab biopharmaceutical nplooj siab rau kev tsim kho tshiab rau cov neeg mob B-cell mediated kab mob. Tsis ntev los no, lub tuam txhab tau tshaj tawm tias nws tau pib ua cov ntawv thov cov tshuaj tshiab tshiab (NDA) rau Asmeskas Chaw Tswj Xyuas Khoom Noj thiab Tshuaj (FDA), nrhiav kev pom zoo sai sai ntawm cov tuam txhab 0010010 # 39; , txhua hnub, inositol - 3 - kinase δ (PI 3 Kδ) thiab CK1-ε ob-kev ua yeeb yam rau tus mob hnoos qeev (TGR-1202) yog siv rau hauv cov neeg mob marginal tsam lymphoma (MZL) thiab follicular lymphoma (FL) uas twb tau muab tshuaj kho dua los lawm. Lub tuam txhab tau txais FDA kev taw qhia tias ib qho kev xa DNA tsuas yog lees paub rau MZL thiab FL cov cim. Nyuam qhuav pib, FDA tau tso cai rau tsev menyuam cov xwm txheej ntawm cov tshuaj (ODD) thiab cov teeb meem tshuaj txhaum cai (BTD) rau umbralisib rau MZL. Lub tuam txhab xav kom ua tiav cov dov xa ntawm NDAs hauv thawj ib nrab ntawm 2020.

TG Cov Kws Kho Mob Thawj Coj thiab CEO Michael S. Weiss tau hais tias: 0010010 quot; Peb zoo siab los pib ua cov ntawv thov tshuaj tshiab rau umbralisib thiab tau txais kev taw qhia los ntawm FDA kom suav nrog MZL thiab FL rau hauv ib qho NDA. Nov yog qhov tseem ceeb heev rau peb. Ib qho tseem ceeb raws li nws coj peb los ze zog muab qhov kev kho mob tshiab rau kev kho mob yav dhau los MZL thiab FL cov neeg mob. Kuv xav ua tsaug rau cov neeg mob thiab lawv tsev neeg thiab pawg kws tshawb fawb, nrog rau TG, rau koom nrog cov kev sim tseem ceeb no thiab pab ua ntej umbrasib Pab pawg ua haujlwm sib zog ua haujlwm los pib txoj kev xa NDA no. Qhov no yog qhov pib ntawm kev tshaj tawm 2020, raws li peb tos txog rau Ntu III cov ntaub ntawv los ntawm UNITY-CLL mus sib hais thiab ULTIMATE I 0010010 amp; II sim rau ntau tus kab mob sclerosis, thiab raws li muaj peev xwm ua tau raws li cov cai no. 0010010 quot;

Qhov kev thov NDA no yog suav los ntawm cov ntaub ntawv los ntawm MZL pab pawg thiab FL tus neeg ua haujlwm uas tau tshuaj xyuas tus txheejtxheem ntawm tus kab-mob ib leeg-tus neeg sawv cev Ntu IIb Sau npe Kev Qhia Kev Tshuaj Xyuas (UNITY-NHL). Nov yog qhov sij hawm kawm ntau, qhib cov ntawv sau qhia. MZL pab pawg tsim los tshuaj ntsuam xyuas kab mob kev kho mob rau cov neeg mob MZL uas yav tas los tau txais tsawg kawg ib zaug los tiv thaiv CD 20 kiag. FL cohort yog tsim los soj ntsuam kev hloov pauv ntawm cov kab mob rau cov neeg mob FL uas yav tas los tau txais tsawg kawg ob txoj kev kho mob, suav nrog kev tiv thaiv CD 20 cov kev cai thiab kev tsim tshuaj alkylated; thawj qhov xaus rau ob pawg neeg sib koom ua ke raug txiav txim siab tus lej teb tag nrho (ORR) ntsuas los ntawm Independent Central Review Board (IRC).

Lub Plaub Hlis 2019, MZL cov ntaub ntawv tso tawm ntawm Asmeskas Kev Tshawb Nrhiav Cancer Cancer (AACR) lub rooj sib tham txhua xyoo pom tias hauv cov neeg mob uas rov mob lossis rov ua dua tshiab MZL uas tau txais tsawg kawg los tiv thaiv CD 20 kev kho, tag nrho cov nyiaj ntawm tus mob ntsig txog tus mob Lub suab teb (ORR) yog 52%, nrog tus nqi teb tag nrho (CR) ntawm 19%, ib feem ntawm tus lej teb (PR) ntawm 33%, thiab tus kab mob tsis xwm yeem (SD) ntawm 36%. Hauv qhov nruab nrab taug qab ntawm 12. 5 lub hlis, qhov nruab nrab ntawm kev teb (DoR) tsis tau mus txog. Cov ntaub ntawv ua tau ntxiv muaj xws li: 88% tau txais txiaj ntsig kev soj ntsuam, 86% txo cov teeb meem qog, cov sij hawm nruab nrab ntawm kev kho mob mus rau kev kho mob ntawm 2. 7 lub hlis, 12 -month kev kawm-tsis muaj txoj sia nyob ntawm 66%, thiab cov kev vam meej txog kev muaj sia nyob nruab nrab tsis pub muaj kev ua tiav. Hauv kev tshawb fawb, umbralisib tau pom zoo zoo thiab nyab xeeb.

Lub Kaum Hli 2019, TG tshaj tawm tias FL tus neeg ua haujlwm mus txog ORR thawj qhov kawg rau txhua tus neeg mob (n= 118) raws li tau txiav txim siab los ntawm IRC kev ntsuas, thiab lub tuam txhab ua tiav nws lub hom phiaj ORR ntawm 40-50 %. Qhov tseem ceeb, kev kho mob hnyuv ntxwm tau zoo rau kev nyab xeeb thiab kev nyab xeeb zoo ib yam nrog cov lus ceeb toom dhau los. Cov ntaub ntawv ntxaws yuav raug tshaj tawm ntawm kev sib tham txog kev kho mob yav tom ntej.

Umbralisib yog qhov ncauj, ib zaug-txhua hnub PI 3 Kδ thiab CK1-ε dual-acting inhibitor, uas yuav ua rau nws kov yeej qee qhov teeb meem thev taus cuam tshuam nrog thawj tiam PI 3 Kδ inhibitors. Phosphatidylinositol - 3 kinase (PI 3 K) yog cov chav kawm ntawm cov enzymes koom nrog ntau yam haujlwm ntawm tes xws li kev loj hlob ntawm tes thiab kev ciaj sia, kev hloov ntawm tes, kev thauj mus los, thiab kev tiv thaiv kab mob. Muaj plaub qhov me me ntawm PI 3 K (α, β, and, thiab γ). Ty subtype yog qhia tau hais tawm nyob rau hauv cov hlwb hematopoietic keeb kwm thiab feem ntau cuam tshuam nrog B-cell-txuam lymphoma.

Umbrasib muaj nanomolar potency rau raws isoform ntawm PI 3 K, thiab muaj kev xaiv siab ntawm alpha, beta, thiab gamma isoforms. Umbralisib kuj tseem ceeb tshwj xeeb cov tshuaj tiv thaiv casein kinase 1-ε (CK1-ε), uas tej zaum yuav muaj qhov cuam tshuam los tiv thaiv tus mob cancer thiab tseem yuav tswj T cell ua si cuam tshuam nrog kev tiv thaiv kab mob rau cov xwm txheej tsis zoo uas tau pom yav dhau los hauv PI 3 K inhibitors.

Tam sim no tau pom zoo PI 3 Kδ inhibitors yog txuam nrog autoimmune-mediated toxicity, xws li daim siab ua kom lub siab, lub ntsws tsis muaj mob, thiab mob plab. Piv nrog kev txhim kho PI 3 K inhibitors, qhov sib txawv tshwj xeeb ntawm umbralisib, nws cov nyhuv tshwj xeeb ntawm CK1-ε, thiab nws cov cim tshwj xeeb thiab cov qauv tshuaj lom neeg yuav muaj cov yam ntxwv sib txawv ntawm PI 3 K inhibitors.

Umbralisib tau ua kom pom nws cov haujlwm hauv cov qauv preclinical thiab cov kev tshawb fawb soj ntsuam ntawm hematological malignancies. Tam sim no, Theem IIb thiab Theem III sim hauv CLL thiab NHL cov neeg mob tseem niaj hnub tshuaj xyuas qhov muaj peev xwm kho tau ntawm tus mob umbralisib.

Ntxiv nrog rau umbralisib, TG tseem tab tom txhim kho cov tshuaj monoclonal antibody ublituximab (TG-1101), glycoengineered chimeric IgG 1 monoclonal antibody uas tsom lub CD 20. Nws tam sim no nyob rau theem III kev soj ntsuam kev loj hlob thiab ntsuas kev kho mob qog noj ntshav. (Mob ntsws lymphocytic ntev [CLL], tsis-Hodgkin 0010010 # 39; s lymphoma [NHL]) thiab tsis mob cancer (ntau myeloma [MM]). Ntxiv rau, TG muaj ntau lub cuab tam uas tau nkag mus rau theem I kev soj ntsuam, nrog rau PD-L 1 monoclonal antibody TG-1501, covalently khi Bruton tyrosine kinase (BTK) inhibitor TG-1701, thiab lwm yam. (los ntawm Bioon.com, sau hsppharma.com)

qhov chaw qub: 0010010 nbsp;TG Cov Tshuaj Kho Kom Zoo Luv Tawm Qiv Cov Ntawv Thov Tshiab Tshuaj (NDA) rau Asmeskas Cov Khoom Siv thiab Tshuaj Noj rau Umbralisib ua Kev Kho Mob rau Cov Neeg Mob Nrog Kev Kho Tus Mob Marginal Zone Lymphoma lossis Follicular Lymphoma.