HRP20201928T1 - Kombinirana terapija bispecifičnom antigen vezujućom molekulom koja aktivira t-stanice, za cd3 i folatni receptor 1 (folr1), i antagonistom vezivanja osi pd-1 - Google Patents
Kombinirana terapija bispecifičnom antigen vezujućom molekulom koja aktivira t-stanice, za cd3 i folatni receptor 1 (folr1), i antagonistom vezivanja osi pd-1 Download PDFInfo
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- HRP20201928T1 HRP20201928T1 HRP20201928TT HRP20201928T HRP20201928T1 HR P20201928 T1 HRP20201928 T1 HR P20201928T1 HR P20201928T T HRP20201928T T HR P20201928TT HR P20201928 T HRP20201928 T HR P20201928T HR P20201928 T1 HRP20201928 T1 HR P20201928T1
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- 230000027455 binding Effects 0.000 title claims 63
- 239000005557 antagonist Substances 0.000 title claims 33
- 239000000427 antigen Substances 0.000 title claims 29
- 102000036639 antigens Human genes 0.000 title claims 29
- 108091007433 antigens Proteins 0.000 title claims 29
- 102000010451 Folate receptor alpha Human genes 0.000 title claims 24
- 108050001931 Folate receptor alpha Proteins 0.000 title claims 24
- 230000003213 activating effect Effects 0.000 title claims 21
- 238000002648 combination therapy Methods 0.000 title 1
- 102100040678 Programmed cell death protein 1 Human genes 0.000 claims 31
- 101710089372 Programmed cell death protein 1 Proteins 0.000 claims 31
- 210000001744 T-lymphocyte Anatomy 0.000 claims 27
- 125000003275 alpha amino acid group Chemical group 0.000 claims 20
- 108010054477 Immunoglobulin Fab Fragments Proteins 0.000 claims 16
- 102000001706 Immunoglobulin Fab Fragments Human genes 0.000 claims 16
- 108010047041 Complementarity Determining Regions Proteins 0.000 claims 15
- 230000009870 specific binding Effects 0.000 claims 11
- 206010028980 Neoplasm Diseases 0.000 claims 5
- 201000011510 cancer Diseases 0.000 claims 5
- 229940123803 TIM3 antagonist Drugs 0.000 claims 4
- 102000008394 Immunoglobulin Fragments Human genes 0.000 claims 2
- 108010021625 Immunoglobulin Fragments Proteins 0.000 claims 2
- 108010074708 B7-H1 Antigen Proteins 0.000 claims 1
- 206010009944 Colon cancer Diseases 0.000 claims 1
- 208000001333 Colorectal Neoplasms Diseases 0.000 claims 1
- 206010014733 Endometrial cancer Diseases 0.000 claims 1
- 206010014759 Endometrial neoplasm Diseases 0.000 claims 1
- 108060003951 Immunoglobulin Proteins 0.000 claims 1
- 208000008839 Kidney Neoplasms Diseases 0.000 claims 1
- 206010058467 Lung neoplasm malignant Diseases 0.000 claims 1
- 102000007295 Mucin-3 Human genes 0.000 claims 1
- 108010008701 Mucin-3 Proteins 0.000 claims 1
- 206010033128 Ovarian cancer Diseases 0.000 claims 1
- 206010061535 Ovarian neoplasm Diseases 0.000 claims 1
- 102100024216 Programmed cell death 1 ligand 1 Human genes 0.000 claims 1
- 206010038389 Renal cancer Diseases 0.000 claims 1
- 210000000481 breast Anatomy 0.000 claims 1
- 239000012634 fragment Substances 0.000 claims 1
- 102000018358 immunoglobulin Human genes 0.000 claims 1
- 238000002513 implantation Methods 0.000 claims 1
- 201000010982 kidney cancer Diseases 0.000 claims 1
- 239000003446 ligand Substances 0.000 claims 1
- 201000005202 lung cancer Diseases 0.000 claims 1
- 208000020816 lung neoplasm Diseases 0.000 claims 1
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Claims (24)
1. Bispecifična antigen vezujuća molekula koja aktivira T-stanice i antagonist vezivanja osi PD-1, naznačeni time, da se upotrebljavaju za kombiniranu primjenu u liječenju raka, pri čemu bispecifična antigen vezujuća molekula koja aktivira T-stanice sadrži prvi Fab fragment sposoban za specifično vezivanje na CD3, drugi Fab fragment sposoban za specifično vezivanje na folatni receptor 1 (FolR1) i Fc domenu, gdje antagonist vezivanja osi PD-1 inhibira vezivanje PD-1 na njegove partnere za vezivanje liganda, te gdje 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 i antagonist vezivanja osi PD-1 za uporabu prema patentnom zahtjevu 1, naznačeni time, da prvi Fab fragment sadrži najmanje jedan aminokiselinski slijed regije koja određuje komplementarnost (CDR) teškog lanca odabran iz skupine koju čine SEQ ID NO: 37, SEQ ID NO: 38 i SEQ ID NO: 39 te najmanje jedan CDR lakog lanca odabran iz skupine koju čine SEQ ID NO: 32, SEQ ID NO: 33, SEQ ID NO: 34.
3. Bispecifična antigen vezujuća molekula koja aktivira T-stanice i antagonist vezivanja osi PD-1 za upoprabu prema bilo kojem od patentnih zahtjeva 1 ili 2, naznačeni time, da prvi Fab fragment sadrži varijabilni teški lanac koji sadrži aminokiselinski slijed SEQ ID NO: 36 i varijabilni laki lanac koji sadrži aminokiselinski slijed SEQ ID NO: 31.
4. Bispecifična antigen vezujuća molekula koja aktivira T-stanice i antagonist vezivanja osi PD-1 za uporabu prema bilo kojem od patentnih zahtjeva 1 do 3, naznačeni time, da bispecifična antigen vezujuća molekula koja aktivira T-stanice dodatno sadrži treći Fab fragment sposoban za specifično vezivanje na FolR1.
5. Bispecifična antigen vezujuća molekula koja aktivira T-stanice i antagonist vezivanja osi PD-1 za uporabu prema patentnom zahtjevu 4, naznačeni time, da drugi i treći Fab fragment koji su sposobni za specifično vezivanje na FolR1 sadrže identične slijedove regije koja određuje komplementarnost (CDR) teškog lanca i CDR lakog lanca.
6. Bispecifična antigen vezujuća molekula koja aktivira T-stanice i antagonist vezivanja osi PD-1 za uporabu prema patentnom zahtjevu 5, naznačeni time, da je treći Fab fragment identičan drugom Fab fragmentu.
7. Bispecifična antigen vezujuća molekula koja aktivira T-stanice i antagonist vezivanja osi PD-1 za uporabu prema bilo kojem od prethodnih patentnih zahtjeva, naznačeni time, da Fab fragment sposoban za specifično vezanje na folatni receptor 1 (FolR1) sadrži najmanje jedan aminokiselinski slijed regije koja određuje komplementarnost (CDR) teškog lanca odabran iz skupine koju čine SEQ ID NO: 16, SEQ ID NO: 17 i SEQ ID NO: 18 te najmanje jedan CDR lakog lanca odabran iz skupine koju čine SEQ ID NO: 32, SEQ ID NO: 33, SEQ ID NO: 34.
8. Bispecifična antigen vezujuća molekula koja aktivira T-stanice i antagonist vezivanja osi PD-1 za uporabu prema patentnom zahtjevu 7, naznačeni time, da Fab fragment sposoban za specifično vezivanje na folatni receptor 1 (FolR1) sadrži varijabilni teški lanac koji sadrži aminokiselinski slijed SEQ ID NO: 15 i varijabilni laki lanac koji sadrži aminokiselinski slijed SEQ ID NO: 31.
9. Bispecifična antigen vezujuća molekula koja aktivira T-stanice i antagonist vezivanja osi PD-1 za uporabu prema bilo kojem od patentnih zahtjeva 1 do 6, naznačeni time, da Fab fragment sposoban za specifično vezivanje na folatni receptor 1 (FolR1) sadrži najmanje jedan aminokiselinski slijed regije koja određuje komplementarnost (CDR) teškog lanca odabran iz skupine koju čine SEQ ID NO: 8, SEQ ID NO: 56 i SEQ ID NO: 57 te barem jedan CDR lakog lanca odabran iz skupine koju čine SEQ ID NO: 59, SEQ ID NO: 60, SEQ ID NO: 65.
10. Bispecifična antigen vezujuća molekula koja aktivira T-stanice i antagonist vezivanja osi PD-1 za uporabu prema patentnom zahtjevu 9, naznačeni time, da Fab fragment sposoban za specifično vezivanje na folatni receptor 1 (FolR1) sadrži varijabilni teški lanac koji sadrži aminokiselinski slijed SEQ ID NO: 55 i varijabilni laki lanac koji sadrži aminokiselinski slijed SEQ ID NO: 64.
11. Bispecifična antigen vezujuća molekula koja aktivira T-stanice i antagonist vezivanja osi PD-1 za uporabu prema bilo kojem od patentnih zahtjeva 1 do 6, naznačeni time, da Fab fragment sposoban za specifično vezivanje na folatni receptor 1 (FolR1) sadrži najmanje jedan aminokiselinski slijed regije koja određuje komplementarnost (CDR) teškog lanca odabran iz skupine koja sadrži SEQ ID NO: 16, SEQ ID NO: 402 i SEQ ID NO: 400 te barem jedan CDR lakog lanca odabran iz skupine koju čine SEQ ID NO: 32, SEQ ID NO: 33, SEQ ID NO: 34.
12. Bispecifična antigen vezujuća molekula koja aktivira T-stanice i antagonist vezivanja osi PD-1 za primjenu prema patentnom zahtjevu 11, naznačeni time, da Fab fragment sposoban za specifično vezivanje na FolR1 sadrži:
a) aminokiselinski slijed regije koja određuje komplementarnost teškog lanca 1 (CDR-H1) SEQ ID NO: 16;
b) aminokiselinski slijed regije CDR-H2 SEQ ID NO: 402;
c) aminokiselinski slijed regije CDR-H3 SEQ ID NO: 400;
d) aminokiselinski slijed regije koja određuje komplementarnost lakog lanca 1 (CDR-L1) SEQ ID NO: 32;
e) aminokiselinski slijed regije CDR-L2 SEQ ID NO: 33, i
f) aminokiselinski slijed regije CDR-L3 SEQ ID NO: 34.
13. Bispecifična antigen vezujuća molekula koja aktivira T-stanice i antagonist vezivanja osi PD-1 za uporabu prema patentnom zahtjevu 12, naznačeni time, da Fab fragment sposoban za specifično vezanje na FolR1 sadrži varijabilni teški lanac koji sadrži aminokiselinski slijed SEQ ID NO: 401 i varijabilni laki lanac koji sadrži aminokiselinski slijed SEQ ID NO: 31.
14. Bispecifična antigen vezujuća molekula koja aktivira T-stanice i antagonist vezivanja osi PD-1 za uporabu prema bilo kojem od prethodnih patentnih zahtjeva, naznačeni time, da (i) anti-PD-L1 protutijelo je monoklonsko protutijelo, ili (ii) anti-PD-L1 protutijelo je fragment protutijela odabran iz skupine koja se sastoji od fragmenata Fab, Fab’-SH, Fv, scFv i (Fab’)2, ili (iii) anti-PD-L1 protutijelo je humanizirano protutijelo ili humano protutijelo.
15. Bispecifična antigen vezujuća molekula koja aktivira T-stanice i antagonist vezivanja osi PD-1 za uporabu prema bilo kojem od prethodnih patentnih zahtjeva, naznačeni time, da (i) 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; te 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, ili (ii) 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.
16. Bispecifična antigen vezujuća molekula koja aktivira T-stanice i antagonist vezivanja osi PD-1 za uporabu prema bilo kojem od patentnih zahtjeva 1 do 15, naznačeni time, da nadalje obuhvaća davanje pojedincu antagonista T-staničnog imunoglobulina i mucina-3 (TIM3), pri čemu TIM3 antagonist je anti-TIM3 protutijelo.
17. Bispecifična antigen vezujuća molekula koja aktivira T-stanice i antagonist vezivanja osi PD-1 za uporabu prema patentnom zahtjevu 16, naznačeni time, da (i) anti-TIM3 protutijelo je monoklonsko protutijelo, ili (ii) anti-TIM3 protutijelo je humano, humanizirano ili kimerno protutijelo, ili (iii) anti-TIM3 protutijelo je fragment protutijela koji se veže na TIM3, ili (iv) anti-TIM3 protutijelo je Fab fragment.
18. Bispecifična antigen vezujuća molekula koja aktivira T-stanice i antagonist vezivanja osi PD-1 za uporabu prema bilo kojem od patentnih zahtjeva 1 do 17, naznačeni time, da se (i) antagonist vezivanja osi PD-1 primjenjuje prije FolR1 TCB, ili (ii) antagonist vezivanja osi PD-1 se primjenjuje istovremeno s FolR1 TCB, ili (iii) antagonist vezivanja osi PD-1 se primjenjuje nakon FolR1 TCB.
19. Bispecifična antigen vezujuća molekula koja aktivira T-stanice i antagonist vezivanja osi PD-1 za uporabu prema bilo kojem od patentnih zahtjeva 1 do 18, naznačeni time, da je rak odabran iz skupine koja se sastoji od raka jajnika, raka pluća, raka dojke, raka bubrega, kolorektalnog raka, raka endometrija.
20. Bispecifična antigen vezujuća molekula koja aktivira T-stanice i antagonist vezivanja osi PD-1 za uporabu prema bilo kojem od patentnih zahtjeva 1 do 19, naznačeni time, da se ili bispecifična antigen vezujuća molekula koja aktivira T-stanice ili antagonist vezivanja osi PD-1 primjenjuje intravenozno, intramuskularno, supkutano, topikalno, oralno, transdermalno, intraperitonealno, intraorbitalno, implantacijom, inhalacijom, intratekalno, intraventrikularno ili intranazalno.
21. Komplet, naznačen time, da sadrži bispecifičnu antigen vezujuću molekulu koja aktivira T-stanice, specifičnu za folatni receptor 1 (FolR1) i CD3, za uporabu bispecifične antigen vezujuće molekule koja aktivira T-stanice s antagonistom vezivanja osi PD-1, pri čemu se primjenjuju u liječenju ili odgađanju progresije raka kod pojedinca, gdje antagonist vezivanja osi PD-1 je anti-PD-1 protutijelo ili anti-PD-L1 protutijelo.
22. Komplet za uporabu prema patentnom zahtjevu 21, naznačen time, da služi za primjenu bispecifične antigen vezujuće molekule koja aktivira T-stanice s TIM3 antagonistom.
23. Komplet, naznačen time, da sadrži bispecifičnu antigen vezujuću molekulu koja aktivira T-stanice, specifičnu za folatni receptor1 (FolR1) i CD3, i antagonist vezivanja osi PD-1, za uporabu bispecifične antigen vezujuće molekule koja aktivira T-stanice i antagonista vezivanja osi PD-1, pri čemu se primjenjuju u liječenju ili odgađanju progresije raka kod pojedinca, s time da antagonist vezivanja osi PD-1 je anti-PD-1 protutijelo ili anti-PD-L1 protutijelo.
24. Komplet za uporabu prema patentnom zahtjevu 23, naznačen time, da nadalje sadrži TIM3 antagonist, te time, da TIM3 antagonist je anti-TIM3 protutijelo.
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EP15797954.3A EP3221355B1 (en) | 2014-11-20 | 2015-11-16 | Combination therapy of t cell activating bispecific antigen binding molecules cd3 and folate receptor 1 (folr1) and pd-1 axis binding antagonists |
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