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HRP20221083T1 - Kombinirana terapija bispecifičnom antigen vezujućom molekulom koja aktivira t stanice i antagonistom vezivanja osi pd-1 - Google Patents

Kombinirana terapija bispecifičnom antigen vezujućom molekulom koja aktivira t stanice i antagonistom vezivanja osi pd-1 Download PDF

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Publication number
HRP20221083T1
HRP20221083T1 HRP20221083TT HRP20221083T HRP20221083T1 HR P20221083 T1 HRP20221083 T1 HR P20221083T1 HR P20221083T T HRP20221083T T HR P20221083TT HR P20221083 T HRP20221083 T HR P20221083T HR P20221083 T1 HRP20221083 T1 HR P20221083T1
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Croatia
Prior art keywords
cells
activates
antigen binding
binding molecule
bispecific antigen
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HRP20221083TT
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Inventor
Christian Klein
Vaios KARANIKAS
Pablo Umaña
Alfred Zippelius
Daniela THOMMEN
Jens Schreiner
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F. Hoffmann - La Roche Ag
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Application filed by F. Hoffmann - La Roche Ag filed Critical F. Hoffmann - La Roche Ag
Publication of HRP20221083T1 publication Critical patent/HRP20221083T1/hr

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Claims (15)

1. Bispecifična antigen vezujuća molekula koja aktivira T stanice, naznačena time, da je za uporabu u liječenju raka, pri čemu se bispecifična antigen vezujuća molekula koja aktivira T stanice upotrebljava u kombinaciji s antagonistom vezivanja osi PD-1, gdje bispecifična antigen vezujuća molekula koja aktivira T stanice sadrži najmanje dva dijela koji se vežu na antigen, od kojih je jedan ukrštena Fab molekula a drugi konvencionalna Fab molekula, pri čemu bispecifična antigen vezujuća molekula koja aktivira T stanice nadalje sadrži Fc domenu sastavljenu od prve i druge podjedinice koje su sposobne za stabilno vezivanje, dok prva antigen vezujuća molekula sadrži prvi antigen vezujući dio sposoban da se veže na CD3 koji sadrži najmanje jedan aminokiselinski slijed regije koja određuje komplementarnost teškog lanca (CDR) odabran iz skupine koju čine SEQ ID NO: 37, SEQ ID NO: 38 i SEQ ID NO:39, i najmanje jedan CDR lakog lanca odabran iz skupine koju čine SEQ ID NO: 32, SEQ ID NO: 33, SEQ ID NO: 34, pri čemu je drugi dio koji veže antigen fuzioniran na C-kraju Fab teškog lanca na N-kraju prve ili druge podjedinice Fc domene, a prvi dio koji veže antigen je fuzioniran na C-kraju Fab teškog lanca na N-kraju Fab teškog lanca drugog dijela za vezivanje antigena, pri čemu antagonist vezivanja osi PD-1 inhibira vezanje PD-1 na njegove partnere za vezivanje liganda, pri čemu je antagonist vezivanja osi PD-1 odabran iz skupine koja se sastoji od anti-PD-1 protutijela, anti-PD-L1 protutijela i anti- PD-L2 protutijela.
2. Bispecifična antigen vezujuća molekula koja aktivira T stanice za uporabu prema patentnom zahtjevu 1, naznačena time, da prva antigen vezujuća molekula sadrži varijabilni teški lanac koji sadrži aminokiselinski slijed SEQ ID NO: 36 i varijabilni laki lanac koji sadrži aminokiselinski slijed SEQ ID NO: 31.
3. Bispecifična antigen vezujuća molekula koja aktivira T stanice za uporabu prema patentnom zahtjevu 1 ili 2, naznačena time, da anti-PD-L1 protutijelo je monoklonsko protutijelo.
4. Bispecifična antigen vezujuća molekula koja aktivira T stanice za uporabu prema bilo kojem od patentnih zahtjeva 1 do 3, naznačena time, da anti-PD-L1 protutijelo je fragment protutijela odabran iz skupine koju čine fragmenti Fab, Fab'-SH, Fv, scFv i (Fab')2.
5. Bispecifična antigen vezujuća molekula koja aktivira T stanice za uporabu prema bilo kojem od patentnih zahtjeva 1 do 4, naznačena time, da anti-PD-L1 protutijelo je humanizirano protutijelo ili ljudsko protutijelo.
6. Bispecifična antigen vezujuća molekula koja aktivira T stanice za uporabu prema bilo kojem od patentnih zahtjeva 1 do 5, naznačena time, da anti-PD-L1 protutijelo sadrži teški lanac koji sadrži HVR-H1 slijed SEQ ID NO: 289, HVR-H2 slijed SEQ ID NO: 290 i HVR-H3 slijed SEQ ID NO: 291; i laki lanac koji sadrži HVR-L1 slijed SEQ ID NO: 292, HVR-L2 slijed SEQ ID NO: 293 i HVR-L3 slijed SEQ ID NO: 294.
7. Bispecifična antigen vezujuća molekula koja aktivira T stanice za uporabu prema bilo kojem od patentnih zahtjeva 1 do 6, naznačena time, da protutijelo sadrži varijabilnu regiju teškog lanca koja sadrži aminokiselinski slijed SEQ ID NO: 280 ili SEQ ID NO: 281 i varijabilnu regiju lakog lanca koja sadrži aminokiselinski slijed SEQ ID NO: 383.
8. Bispecifična antigen vezujuća molekula koja aktivira T stanice za uporabu prema bilo kojem od patentnih zahtjeva 1 do 7, naznačena time, da nadalje obuhvaća davanje pojedincu antagonista T-staničnog imunoglobulina mucina 3 (TIM3), pri čemu TIM3 antagonist je anti-TIM3 protutijelo.
9. Bispecifična antigen vezujuća molekula koja aktivira T stanice za uporabu prema patentnom zahtjevu 8, naznačena time, da anti-TIM3 protutijelo je monoklonsko protutijelo.
10. Bispecifična antigen vezujuća molekula koja aktivira T stanice za uporabu prema patentnom zahtjevu 8 ili 9, naznačena time, da anti-TIM3 protutijelo je ljudsko, humanizirano ili kimerno protutijelo.
11. Bispecifična antigen vezujuća molekula koja aktivira T stanice za uporabu prema bilo kojem od patentnih zahtjeva 8 do 10, naznačena time, da anti-TIM3 protutijelo je fragment protutijela koji se veže na TIM3.
12. Bispecifična antigen vezujuća molekula koja aktivira T stanice za uporabu prema bilo kojem od patentnih zahtjeva 8 do 11, naznačena time, da anti-TIM3 protutijelo je Fab fragment.
13. Bispecifična antigen vezujuća molekula koja aktivira T stanice za uporabu prema bilo kojem od patentnih zahtjeva 1 do 12, naznačena time, da je rak odabran iz skupine koju čine rak jajnika, rak pluća, rak dojke, rak bubrega, kolorektalni rak, rak endometrija.
14. Bispecifična antigen vezujuća molekula koja aktivira T stanice za uporabu prema bilo kojem od patentnih zahtjeva 1 do 13, naznačena time, da se najmanje jedna bispecifična antigen vezujuća molekula koja aktivira T stanice ili najmanje jedan antagonist vezivanja osi PD-1 primjenjuje intravenozno, intramuskularno, supkutano, topikalno, oralno, transdermalno, intraperitonealno, intraorbitalno, implantacijom, inhalacijom, intratekalno, intraventrikularno ili intranazalno.
15. Bispecifična antigen vezujuća molekula koja aktivira T stanice za uporabu prema bilo kojem od patentnih zahtjeva 1 do 14, naznačena time, da T stanice kod pojedinca imaju pojačanu aktivaciju, proliferaciju i/ili efektorsku funkciju u odnosu na stanje prije primjene kombinacije.
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