HRP20231280T1 - Anti-her2 biparatopski antitijelo-konjugati lijeka i načini uporabe - Google Patents

Anti-her2 biparatopski antitijelo-konjugati lijeka i načini uporabe Download PDF

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Publication number
HRP20231280T1
HRP20231280T1 HRP20231280TT HRP20231280T HRP20231280T1 HR P20231280 T1 HRP20231280 T1 HR P20231280T1 HR P20231280T T HRP20231280T T HR P20231280TT HR P20231280 T HRP20231280 T HR P20231280T HR P20231280 T1 HRP20231280 T1 HR P20231280T1
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HR
Croatia
Prior art keywords
antibody
her2
drug conjugate
antigen
conjugate according
Prior art date
Application number
HRP20231280TT
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English (en)
Inventor
Kevin HAMBLETT
Rupert H. DAVIES
James R. RICH
Gerald J. ROWSE
Vincent K. C. FUNG
Stuart D. Barnscher
Original Assignee
Zymeworks Bc Inc.
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Application filed by Zymeworks Bc Inc. filed Critical Zymeworks Bc Inc.
Publication of HRP20231280T1 publication Critical patent/HRP20231280T1/hr

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1. Konjugat protutijela i lijeka koji sadrži anti-HER2 biparatopsko protutijelo konjugirano s analogom auristatina preko poveznice (L) pri niskom prosječnom omjeru lijeka prema protutijelu (DAR), pri čemu anti-HER2 biparatopsko protutijelo sadrži prvi polipeptidni konstrukt koji se veže na antigen, koji veže prvi epitop HER2 i drugi konstrukt polipeptida, koji se veže na antigen, koji se veže na drugi epitop HER2, pri čemu su prvi i drugi epitop HER2 na različitim domenama HER2, pri čemu analog auristatina i povezivač imaju opću formulu (X): [image] pri čemu: R1 je odabran između: [image] L je povezivač, i [image] predstavlja točku pričvršćivanja poveznice na anti-HER2 biparatopsko protutijelo, i pri čemu je niski prosječni DAR prosječni DAR između 1,5 i 2,5.
2. Konjugat antitijelo-lijek prema zahtjevu 1, pri čemu R1 je: [image]
3. Konjugat antitijelo-lijek prema zahtjevu 1 ili 2, naznačen time, da je prosječni DAR između 1,8 i 2,5.
4. Konjugat antitijelo-lijek prema zahtjevu 1 ili 2, naznačen time, da je prosječni DAR oko 2,0.
5. Konjugat antitijelo-lijek prema bilo kojem od zahtjeva 1 do 4, naznačen time, da konjugat sadrži između oko 10% i oko 30% DAR0 vrsta.
6. Konjugat antitijelo-lijek prema bilo kojem od zahtjeva 1 do 4, naznačen time, da konjugat sadrži između oko 10% i oko 25% DAR0 vrsta.
7. Konjugat antitijelo-lijek prema bilo kojem od zahtjeva 1 do 4, pri čemu, konjugat sadrži između oko 15% i oko 25% DAR0 vrsta.
8. Konjugat protutijelo-lijek prema bilo kojem od zahtjeva 1 do 7, pri čemu, konjugat sadrži između 0% i oko 15% DAR6 ili više vrsta, ili između oko 0% i oko 10% DAR6 ili više vrsta.
9. Konjugat protutijelo-lijek prema bilo kojem od Zahtjeva 1 do 8, pri čemu, je L linker koji se može cijepati, izborno linker koji se može cijepati proteazom.
10. Konjugat protutijelo-lijek prema bilo kojem od zahtjeva 1 do 9, pri čemu, L ima opću formulu(VI): [image] gdje: Z je funkcionalna skupina sposobna reagirati s ciljnom skupinom na anti-HER2 biparatopnom protutijelu; Str je nosilo; AA1i AA2su svaki neovisno aminokiselina, pri čemu AA1-[AA2]mtvori mjesto cijepanja proteazom; X je samospaljiva skupina; D je točka dodira za analog auristatina; s je 0 ili 1; m je cijeli broj između 1 i 4, i o je 0, 1 ili 2, izborno gdje je s 1 i o je 0.
11. Konjugat antitijelo-lijek prema bilo kojem od zahtjeva 1 do 9, pri čemu, L ima opću formulu(VI): [image] gdje: AS- je točka pričvršćivanja za anti-HER2 biparatopsko protutijelo; Y je jedna ili više dodatnih komponenata povezivača, ili je odsutan, i D je točka pričvršćivanja za analog auristatina;
12. Konjugat antitijelo-lijek prema bilo kojem od Zahtjeva 1 do 8, naznačen time, da analog auristatina i linker imaju strukturu: [image] gdje je AS- točka vezanja na anti-HER2 biparatopsko protutijelo.
13. Konjugat antitijelo-lijek u skladu s bilo kojim od patentnih zahtjeva 1 do 12, naznačen time, da se anti-HER2 biparatopsko antitijelo veže na HER2 s višim afinitetom u usporedbi s odgovarajućim bivalentnim monospecifičnim antitijelom, i/ili pri čemu anti-HER2 biparatopno antitijelo pokazuje veća internalizacija u stanice koje eksprimiraju HER2 u usporedbi s odgovarajućim dvovalentnim monospecifičnim antitijelom.
14. Konjugat antitijelo-lijek prema bilo kojem od Zahtjeva 1 do 13, naznačen time, da je prvi polipeptidni konstrukt koji se veže na antigen scFv, a drugi polipeptidni konstrukt koji se veže na antigen je Fab.
15. Konjugat antitijelo-lijek prema bilo kojem od Zahtjeva 1 do 14, naznačen time, da je prvi HER2 epitop na ECD4 od HER2, a drugi HER2 epitop je na ECD2 od HER2, izborno gdje se prvi polipeptidni konstrukt koji veže antigen natječe s trastuzumabom. za vezanje na HER2, i/ili gdje se drugi polipeptidni konstrukt koji veže antigen natječe s pertuzumabom za vezanje na HER2.
16. Konjugat antitijela i lijeka prema bilo kojem od zahtjeva 1 do 15, naznačen time što: (a) prvi polipeptidni konstrukt koji se veže na antigen sadrži CDR sekvence iz kraka za vezanje ECD4 bilo kojeg od v5019, v5020, v7091, v10000, v6902, v6903 ili v6717, a drugi polipeptidni konstrukt koji se veže na antigen sadrži CDR sekvence iz ECD2-veznog kraka bilo kojeg od v5019, v5020, v7091, v10000, v6902, v6903, v6717, v7133, v15079, v15080, v15081, v15082, v15083, v15084 ili v15085, ili (b) prvi polipeptidni konstrukt koji se veže na antigen sadrži CDR sekvence iz ECD4-vezujućeg kraka v10000, a drugi polipeptidni konstrukt koji se veže na antigen sadrži CDR sekvence iz ECD2-vezujućeg kraka v10000.
17. Konjugat antitijelo-lijek prema bilo kojem od Zahtjeva 1 do 15, naznačen time, da prvi polipeptidni konstrukt koji veže antigen sadrži CDR sekvence navedene u SEQ ID NO: 67, 68, 69, 70, 71 i 72, i drugi polipeptidni konstrukt koji veže antigen sadrži CDR sekvence navedene u SEQ ID NO: 27, 28, 29, 39, 40 i 41.
18. Konjugat antitijelo-lijek u skladu s bilo kojim od patentnih zahtjeva 1 do 15, naznačen time, da prvi polipeptidni konstrukt koji se veže na antigen sadrži VH sekvencu kako je navedeno u SEQ ID NO: 66 i VL sekvencu kako je navedeno u SEQ ID NO: 65, a drugi polipeptidni konstrukt koji veže antigen sadrži VH sekvencu kako je prikazano u SEQ ID NO: 38 i VL slijed kako je navedeno u SEQ ID NO: 26.
19. Konjugat protutijelo-lijek prema bilo kojem od Zahtjeva 1 do 18, naznačen time, da anti-HER2 biparatopsko protutijelo dalje sadrži skelu koja je IgGFc regija, pri čemu su prvi i drugi polipeptidni konstrukti koji vežu antigen operativno povezani na skelu, i pri čemu je IgG Fc regija heterodimerna Fc regija koja sadrži modificiranu CH3 domenu.
20. Konjugat antitijelo-lijek prema zahtjevu 19, naznačen time što modificirana CH3 domena sadrži prvu polipeptidnu sekvencu i drugu polipeptidnu sekvencu, i gdje: (a) prva polipeptidna sekvenca modificirane CH3 domene sadrži aminokiselinske modifikacije L351Y, F405A i Y407V, a druga polipeptidna sekvenca modificirane CH3 domene sadrži aminokiselinske modifikacije T366L, K392M i T394W; ili (b) prva polipeptidna sekvenca modificirane CH3 domene sadrži aminokiselinske modifikacije L351Y, F405A i Y407V, a druga polipeptidna sekvenca modificirane CH3 domene sadrži aminokiselinske modifikacije T366L, K392L i T394W; ili (c) prva polipeptidna sekvenca modificirane CH3 domene sadrži aminokiselinske modifikacije T350V, L351Y, F405A i Y407V, a druga polipeptidna sekvenca modificirane CH3 domene sadrži aminokiselinske modifikacije T350V, T366L, K392M i T394W; ili (d) prva polipeptidna sekvenca modificirane CH3 domene sadrži aminokiselinske modifikacije T350V, L351Y, F405A i Y407V, a druga polipeptidna sekvenca modificirane CH3 domene sadrži aminokiselinske modifikacije T350V, T366L, K392L i T394W; ili (e) prva polipeptidna sekvenca modificirane CH3 domene sadrži aminokiselinske modifikacije T350V, L351Y, S400E, F405A i Y407V, a druga polipeptidna sekvenca modificirane CH3 domene sadrži aminokiselinske modifikacije T350V, T366L, N390R, K392M i T394W.
21. Konjugat antitijelo-lijek prema zahtjevu 1, pri čemu R1 je : (a) prvi polipeptidni konstrukt anti-HER2 biparatopnog antitijela koji se veže na antigen je scFv koji sadrži VH sekvencu kako je navedeno u SEQ ID NO: 66 i VL sekvencu kako je navedeno u SEQ ID NO: 65, i drugi antigen-vezujući polipeptidni konstrukt anti-HER2 biparatopnog protutijela je Fab koji sadrži VH sekvencu kako je prikazano u SEQ ID NO: 38 i VL sekvencu kako je navedeno u SEQ ID NO: 26; (b) anti-HER2 biparatopsko protutijelo nadalje sadrži skelu koja je heterodimerna IgG Fc regija koja sadrži modificiranu CH3 domenu, pri čemu su prvi i drugi polipeptidni konstrukt koji veže antigen operativno povezani na skelu, pri čemu modificirana CH3 domena sadrži prvi polipeptidni slijed i drugi polipeptidni slijed, prvi polipeptidni slijed koji sadrži aminokiselinske modifikacije T350V, L351Y, F405A i Y407V, i drugi polipeptidni slijed koji sadrži aminokiselinske modifikacije T350V, T366L, K392L i T394W; (c) analog auristatina i poveznica imaju strukturu: [image] gdje je AS- točka vezanja za anti-HER2 biparatopsko protutijelo; (d) prosječni DAR je između 1,8 i 2,5, i (e) konjugat sadrži između oko 10% i oko 25% DAR0 vrsta.
22. Farmaceutski pripravak, naznačen time, da sadrži konjugat antitijelo-lijek prema bilo kojem od zahtjeva 1 do 21 i farmaceutski prihvatljiv nosač ili razrjeđivač.
23. Konjugat antitijelo-lijek prema bilo kojem od Zahtjeva 1 do 21, naznačen time, da se koristi za liječenje raka koji eksprimira HER2 kod subjekta kojem je to potrebno.
24. Konjugat antitijelo-lijek za upotrebu prema Zahtjevu 23, naznačen time što je rak koji eksprimira HER2 rak dojke, rak jajnika, rak pluća ili rak želuca.
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