Teb Chaws Asmeskas FDA Tau Txais Kev Kho Tus Kheej Kev Tsim Kho Rau Kev Tsim Kho Tshuaj Tiv Thaiv ASP3772

Tsis ntev los no Affinivax thiab Astellas tshaj tawm cov txiaj ntsig ntawm theem 2 kev sim tshuaj ntawm ASP3772, tus tshuaj tiv thaiv tshiab tiv thaiv Streptococcus pneumoniae. Cov ntaub ntawv qhia tau tias ASP3772 tau ua siab ntev thiab tuaj yeem tsim cov tshuaj tiv thaiv kab mob tiv thaiv txhua tus ntawm 24 polysaccharides, ntxiv rau cov tshuaj tiv thaiv kab mob ntxiv rau tiv thaiv cov kab mob ntsws pneumococcal. The Phase 2 cov ntaub ntawv kho mob ntawm ASP3772 tau tshaj tawm ntawm 31th European Conference on Clinical Microbiology and Infectious Diseases (ECCMID) thaum Lub Xya Hli 9-12, 2021.

Affinivax thiab Astellas tseem tshaj tawm tias US FDA tau tso cai rau ASP3772 Kev Kho Kom Zoo Dua (BTD) rau cov neeg laus hnub nyoog 50 thiab tshaj saud los tiv thaiv kev mob ntsws thiab kab mob kis los ntawm Streptococcus pneumonia serotype npog los ntawm ASP3772. ASP3772 yog tsim los siv Affinivax' tus tswv MAPS (Ntau Yam Antigen Qhia Txog Txheej Txheem) platform thev naus laus zis, uas lub hom phiaj muab B cell (tshuaj tiv thaiv) thiab T cell tiv thaiv kab mob Streptococcus pneumoniae. ASP3772 muaj 24 hom pneumococcal polysaccharides thiab 2 hom kev tiv thaiv kab mob ntsws pneumococcal.

Thaum Lub Ob Hlis 2017, Affinivax thiab Astellas tau txais daim ntawv tso cai thoob ntiaj teb tshwj xeeb los tsim thiab ua lag luam ASP3772 siv MAPS thev naus laus zis. Cov tshuaj tiv thaiv' phiaj xwm txhim kho kev kho mob suav nrog kev tiv thaiv tus kab mob Streptococcus pneumoniae rau cov neeg laus thiab menyuam mos. Qhov tseem ceeb theem 3 kev sim tshuaj rau cov neeg laus yog nyob hauv kev npaj. Txoj kev tshawb fawb kho mob theem 1 tau ua tiav tiav rau cov menyuam mos noj qab nyob zoo hnub nyoog 12-15 hlis, thiab theem 2 kev tshawb fawb kho mob tau npaj yuav pib.

FDA tau tso cai ASP3772 BTD raws cov ntaub ntawv los ntawm Phase 2 kev sim tshuaj. BTD yog ib txoj kev tshuaj xyuas tshuaj tshiab ntawm FDA, uas muaj lub hom phiaj txhawm rau txhawm rau txhim kho thiab tshuaj xyuas cov tshuaj tshiab rau kev kho mob hnyav lossis muaj kev phom sij rau lub neej, thiab muaj cov ntaub ntawv pov thawj ua ntej sib piv nrog cov tshuaj kho mob tam sim no, cov tshuaj tshiab uas tuaj yeem ua tau muaj peev xwm txhim kho qhov xwm txheej ntawm tus kab mob. BTD-tau txais cov tshuaj tuaj yeem tau txais cov lus qhia ze rau suav nrog cov kws lis haujlwm laus hauv FDA thaum tshawb fawb thiab kev txhim kho, thiab tsim nyog rau kev tshuaj xyuas thiab muaj peev xwm tshuaj xyuas thawj zaug thaum tshuaj xyuas kom ntseeg tau tias cov neeg mob tau txais kev kho mob tshiab hauv lub sijhawm luv tshaj.

Steven B. Brugger, CEO ntawm Affinivax, tau hais tias:" Los ntawm kev nthuav dav cov tshuaj tiv thaiv mus rau 24 pneumococcal serotypes, peb ntseeg tias ASP3772 muaj peev xwm muab kev tiv thaiv dav dua li cov tshuaj tiv thaiv kab mob pneumococcal tam sim no hauv khw lossis hauv kev sim tshuaj. Peb cia siab tias yuav txuas ntxiv mus rau qhov kev xaiv tshuaj tiv thaiv tseem ceeb no los ntawm kev sim tshuaj hauv cov neeg laus thiab menyuam mos. Cov tshuaj tiv thaiv ASP3772 qhia tau tias muaj zog tiv thaiv kab mob tiv thaiv kab mob polysaccharides thiab cov protein, thiab tseem sawv cev rau kev txheeb xyuas qhov tseeb ntawm peb lub tshuab MAPS thev naus laus zis. Nov yog kauj ruam tseem ceeb rau yav tom ntej, qhia txog lub peev xwm ntawm MAPS cov tshuaj tiv thaiv yav tom ntej hauv peb cov raj xa dej."