HRP20171198T1 - Monoklonsko protutijelo protiv psećeg interleukina-31 - Google Patents
Monoklonsko protutijelo protiv psećeg interleukina-31 Download PDFInfo
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- HRP20171198T1 HRP20171198T1 HRP20171198TT HRP20171198T HRP20171198T1 HR P20171198 T1 HRP20171198 T1 HR P20171198T1 HR P20171198T T HRP20171198T T HR P20171198TT HR P20171198 T HRP20171198 T HR P20171198T HR P20171198 T1 HRP20171198 T1 HR P20171198T1
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- 102100021596 Interleukin-31 Human genes 0.000 title claims 9
- 101710181613 Interleukin-31 Proteins 0.000 title claims 9
- 125000003275 alpha amino acid group Chemical group 0.000 claims 23
- 238000006467 substitution reaction Methods 0.000 claims 7
- 108010047041 Complementarity Determining Regions Proteins 0.000 claims 5
- 241000282465 Canis Species 0.000 claims 4
- 238000000034 method Methods 0.000 claims 4
- 150000007523 nucleic acids Chemical class 0.000 claims 4
- 230000001823 pruritic effect Effects 0.000 claims 4
- FWMNVWWHGCHHJJ-SKKKGAJSSA-N 4-amino-1-[(2r)-6-amino-2-[[(2r)-2-[[(2r)-2-[[(2r)-2-amino-3-phenylpropanoyl]amino]-3-phenylpropanoyl]amino]-4-methylpentanoyl]amino]hexanoyl]piperidine-4-carboxylic acid Chemical compound C([C@H](C(=O)N[C@H](CC(C)C)C(=O)N[C@H](CCCCN)C(=O)N1CCC(N)(CC1)C(O)=O)NC(=O)[C@H](N)CC=1C=CC=CC=1)C1=CC=CC=C1 FWMNVWWHGCHHJJ-SKKKGAJSSA-N 0.000 claims 3
- 201000008937 atopic dermatitis Diseases 0.000 claims 3
- 208000010668 atopic eczema Diseases 0.000 claims 3
- 206010027654 Allergic conditions Diseases 0.000 claims 2
- 201000004624 Dermatitis Diseases 0.000 claims 2
- 206010012438 Dermatitis atopic Diseases 0.000 claims 2
- 108091028043 Nucleic acid sequence Proteins 0.000 claims 2
- 208000003251 Pruritus Diseases 0.000 claims 2
- 125000000539 amino acid group Chemical group 0.000 claims 2
- 239000000427 antigen Substances 0.000 claims 2
- 102000036639 antigens Human genes 0.000 claims 2
- 108091007433 antigens Proteins 0.000 claims 2
- 238000004519 manufacturing process Methods 0.000 claims 2
- 108020004707 nucleic acids Proteins 0.000 claims 2
- 102000039446 nucleic acids Human genes 0.000 claims 2
- 239000000523 sample Substances 0.000 claims 2
- 208000006545 Chronic Obstructive Pulmonary Disease Diseases 0.000 claims 1
- 206010012434 Dermatitis allergic Diseases 0.000 claims 1
- 208000010201 Exanthema Diseases 0.000 claims 1
- 206010020751 Hypersensitivity Diseases 0.000 claims 1
- 201000004681 Psoriasis Diseases 0.000 claims 1
- 206010039710 Scleroderma Diseases 0.000 claims 1
- 208000024780 Urticaria Diseases 0.000 claims 1
- 208000026935 allergic disease Diseases 0.000 claims 1
- 230000005784 autoimmunity Effects 0.000 claims 1
- 239000012472 biological sample Substances 0.000 claims 1
- 230000037396 body weight Effects 0.000 claims 1
- 238000000423 cell based assay Methods 0.000 claims 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 1
- 208000035475 disorder Diseases 0.000 claims 1
- 230000000694 effects Effects 0.000 claims 1
- 201000005884 exanthem Diseases 0.000 claims 1
- 230000009610 hypersensitivity Effects 0.000 claims 1
- 230000016784 immunoglobulin production Effects 0.000 claims 1
- 208000027866 inflammatory disease Diseases 0.000 claims 1
- 230000004054 inflammatory process Effects 0.000 claims 1
- 230000002401 inhibitory effect Effects 0.000 claims 1
- 230000007803 itching Effects 0.000 claims 1
- 230000001404 mediated effect Effects 0.000 claims 1
- 230000000414 obstructive effect Effects 0.000 claims 1
- 206010037844 rash Diseases 0.000 claims 1
- 230000000306 recurrent effect Effects 0.000 claims 1
- 210000002345 respiratory system Anatomy 0.000 claims 1
- 230000011664 signaling Effects 0.000 claims 1
- 238000002560 therapeutic procedure Methods 0.000 claims 1
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- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
- C07K16/244—Interleukins [IL]
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- G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
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- A61K2039/55511—Organic adjuvants
- A61K2039/55522—Cytokines; Lymphokines; Interferons
- A61K2039/55527—Interleukins
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- C07K2317/00—Immunoglobulins specific features
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- C07K2317/34—Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
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- C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
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Claims (28)
1. Izolirano protutijelo koje se specifično veže na pseći IL-31, naznačeno time što navedeno protutijelo smanjuje, inhibira ili neutralizira pSTAT signaliziranje posredovano psećim IL-31 u ispitivanju baziranom na stanicama.
2. Protutijelo u skladu s patentnim zahtjevom 1, naznačeno time što je navedeno protutijelo monoklonsko protutijelo.
3. Protutijelo u skladu s patentnim zahtjevom 2, naznačeno time što je protutijelo kimerno.
4. Protutijelo u skladu s patentnim zahtjevom 2, naznačeno time što je protutijelo kaninizirano.
5. Izolirano protutijelo u skladu s bilo kojim od patentnih zahtjeva 1 do 4, ili njegov antigenski vežući dio, naznačeno time što sadrži najmanje jedno iz skupine koju čine:
područje za određivanje komplementarnosti (CDR)1 varijabilnog teškog (VH) lanca, s aminokiselinskim slijedom YYDIN (SEQ ID NO: 1; 11E12-VH-CDR1), SYDMS (SEQ ID NO: 2; 19D07-VH-CDR1) ili NYGMS (SEQ ID NO: 3; 34D03-VH-CDR1);
CDR2 varijabilnog teškog lanca, s aminokiselinskim slijedom WIFPGDGGTKYNETFKG (SEQ ID NO: 4; 11E12-VH-CDR2), TITSGGGYTYSADSVKG (SEQ ID NO: 5; 19D07-VH-CDR2) ili TISYGGSYTYYPDNIKG (SEQ ID NO: 6; 34D03-VH-CDR2);
CDR3 varijabilnog teškog lanca, s aminokiselinskim slijedom ARGGTSVIRDAMDY (SEQ ID NO: 7; 11E12-VH-CDR3), ARQNWVVGLAY (SEQ ID NO: 8; 19D07-VH-CDR3) ili VRGYGYDTMDY (SEQ ID NO: 9; 34D03-VH-CDR3); i
njegova varijanta s jednom ili više konzervativnih aminokiselinskih supstitucija u najmanje jednom od CDR1, CDR2 ili CDR3.
6. Izolirano protutijelo u skladu s bilo kojim od patentnih zahtjeva 1 do 4, ili njegov antigenski vežući dio, naznačeno time što sadrži najmanje jedno iz skupine koju čine:
varijabilni laki (VL) lanac koji sadrži područje za određivanje komplementarnosti (CDR)1, s aminokiselinskim slijedom RASESVDNYGISFMH (SEQ ID NO: 10; 11E12-VL-CDR1), KSSQSLLNSGNOKNYLA (SEQ ID NO: 11; 19D07-VL-CDR1) ili KASQSVSFAGTGLMH (SEQ ID NO: 12; 34D03-VL-CDR1);
CDR2 varijabilnog lakog lanca, s aminokiselinskim slijedom RASNLES (SEQ ID NO: 13; 11E12-VL-CDR2), GASTRES (SEQ ID NO: 14; 19D07-VL-CDR2) ili RASNLEA (SEQ ID NO: 15; 34D03-VL-CDR2);
CDR3 varijabilnog lakog lanca, s aminokiselinskim slijedom QQSNKDPLT (SEQ ID NO: 16; 11E12-VL-CDR3), QNDYSYPYT (SEQ ID NO: 17; 19D07-VL-CDR3) ili QQSREYPWT (SEQ ID NO: 18; 34D03-VL-CDR3); i
njegova varijanta s jednom ili više konzervativnih aminokiselinskih supstitucija u najmanje jednom od CDR1, CDR2 ili CDR3.
7. Protutijelo u skladu s patentnim zahtjevom 6, naznačeno time što dodatno sadrži najmanje jedno iz skupine koju čine:
područje za određivanje komplementarnosti (CDR)1 varijabilnog teškog lanca, s aminokiselinskim slijedom YYDIN (SEQ ID NO: 1; 11E12-VH-CDR1), SYDMS (SEQ ID NO: 2; 19D07-VH-CDR1) ili NYGMS (SEQ ID NO: 3; 34D03-VH-CDR1);
CDR2 varijabilnog teškog lanca, s aminokiselinskim slijedom WIFPGDGGTKYNETFKG (SEQ ID NO: 4; 11E12-VH-CDR2), TITSGGGYTYSADSVKG (SEQ ID NO: 5; 19D07-VH-CDR2) ili TISYGGSYTYYPDNIKG (SEQ ID NO: 6; 34D03-VH-CDR2);
CDR3 varijabilnog teškog lanca, s aminokiselinskim slijedom ARGGTSVIRDAMDY (SEQ ID NO: 7; 11E12-VH-CDR3), ARQNWVVGLAY (SEQ ID NO: 8; 19D07-VH-CDR3) ili VRGYGYDTMDY (SEQ ID NO: 9; 34D03-VH-CDR3); i
njegova varijanta s jednom ili više konzervativnih aminokiselinskih supstitucija u najmanje jednom od CDR1, CDR2 ili CDR3.
8. Protutijelo u skladu s patentnim zahtjevom 7, naznačeno time što sadrži najmanje jedno iz skupine koju čine:
a) varijabilni laki lanac, koji sadrži
DIVLTQSPASLAVSLGQRATISCRASESVDNYGISFMHWYQQKPGQPPKLLIYRASNLESGIPARFSGSGSRTDFTLTINPVETDDVATYYCQQSNKDPLTFGAGTKLELK (SEQ ID NO: 19; MU-11E12-VL), DIVMTQTPLSLSVSPGEPASISCRASESVDNYGISFMHWYQQKPGQPPKLLIYRASNLESGVPDRFSGSGSGTDFTLRISRVEADDAGVYYCQQSNKDPLTFGAGTKLEIK (SEQ ID NO: 20; CAN-11E12-VL-cUn-FW2), DIVMTQTPLSLSVSPGEPASISCRASESVDNYGISFMHWFQQKPGQSPQLLIYRASNLESGVPDRFSGSGSGTDFTLRISRVEADDAGVYYCQQSNKDPLTFGAGTKLEIK (SEQ ID NO: 21; CAN-11E12-VL-cUn-13), DIVMSQSPSSLSVSAGDKVTMSCKSSQSLLNSGNQKNYLAWYQQKPWQPPKLLIYGASTRESGVPDRFTGSGSGTDFTLTISSVQAEDLAVYYCQNDYSYPYTFGGGTKLEIK (SEQ ID NO: 22; MU-19D07-VL), EIVMTQSPASLSLSQEEKVTITCKSSQSLLNSGNQKNYLAWYQQKPGQAPKLLIYGASTRESGVPSRFSGSGSGTDFSFTISSLEPEDVAVYYCQNDYSYPYTFGQGTKLEIK (SEQ ID NO: 23; CAN-19D07-VL-998-1), DILLTQSPASLAVSLGQRAIISCKASQSVSFAGTGLMHWYQQKPGQQPKLLIYRASNLEAGVPTRFSGSGSRTDFTLNIHPVEEEDAATYFCQQSREYPWTFGGGTKLEIK (SEQ ID NO: 24; MU-34D03-VL) ili EIVMTQSPASLSLSQEEKVTITCKASQSVSFAGTGLMHWYQQKPGQAPKLLIYRASNLEAGVPSRFSGSGSGTDFSFTISSLEPEDVAVYYCQQSREYPWTFGQGTKLEIK (SEQ ID NO: 25; CAN-34D03-VL-998-1);
b) varijabilni teški lanac, koji sadrži
QVQLQQSGAELVKPGASVKLSCKASGYTFKYYDINWVRQRPEQGLEWIGWIFPGDGG TKYNETFKGKATLTTDKSSSTAYMQLSRLTSEDSAVYFCARGGTSVIRDAMDYWGQGT SVTVSS (SEQ ID NO: 26; MU-11E12-VH), EVQLVQSGAEVKKPGASVKVSCKTSGYTFKYYDINWVRQAPGAGLDWMGWIFPGDG GTKYNETFKGRVTLTADTSTSTAYMELSSLRAGDIAVYYCARGGTSVIRDAMDYWGQG TLVTVSS (SEQ ID NO: 27; CAN-11E12-VH-415-1), EVKLVESGGGLVKPGGSLKLSCAASGFAFSSYDMSWVRQIPEKRLEWVATITSGGGYTYSADSVKGRFTISRDNARNTLYLQMSSLRSEDTAVYYCARQWVVGLAYWGQGTLVT VSA (SEQ ID NO: 28; MU-19D07-VH), EVQLVESGGDLVKPGGSLRLSCVASGFTFSSYDMSWVRQAPGKGLQWVATITSGGGYTYSADSVKGRFTISRDNARNTLYLQMNSLRSEDTAVYYCARQNWVVGLAYWGQGTLV TVSS (SEQ ID NO: 29; CAN-19D07-VH-400-1), EVQLVESGGDLVKPGGSLKLSCAASGFSFSNYGMSWVRQTPDKRLEWVATISYGGSYTYYPDNIKGRFTISRDNAKNTLYLQMSSLKSEDTAMYYCVRGYGYDTMDYWGQGTSV TVSS (SEQ ID NO: 30; MU-34D03-VH), ili EVQLVESGGDLVKPGGSLRLSCVASGFTFSNYGMSWVRQAPGKGLQWVATISYGGSYTYYPDNIKGRFTISRDNAKNTLYLQMNSLRAEDTAMYYCVRGYGYDTMDYWGQGTL VTVSS (SEQ ID NO: 31; CAN-34D03-VH-568-1); i
c) njihove varijante s jednom ili više konzervativnih aminokiselinskih supstitucija.
9. Protutijelo u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačeno time što protutijelo sadrži najmanje jedno iz skupine koju čine:
a) varijabilni laki lanac, koji sadrži
DILLTQSPASLAVSLGQRAIISCKASQSVSFAGTGLMHWYQQKPGQQPKLLIYRASNLEAGVPTRFSGSGSRTDFTLNIHPVEEEDAATYFCQQSREYPWTFGGGTKLEIK (SEQ ID NO: 24; MU-34D03-VL) ili EIVMTQSPASLSLSQEEKVTITCKASQSVSFAGTGLMHWYQQKPGQAPKLLIYRASNLEAGVPSRFSGSGSGTDFSFTISSLEPEDVAVYYCQQSREYPWTFGQGTKLEIK (SEQ ID NO: 25; CAN-34D03-VL-998-1);
b) varijabilni teški lanac, koji sadrži
EVQLVESGGDLVKPGGSLRLSCVASGFTFSNYGMSWVRQAPGKGLQWVATISYGGS YTYYPDNIKGRFTISRDNAKNTLYLQMNSLRAEDTAMYYCVRGYGYDTMDYWGQGTLVTVSS (SEQ ID NO: 31; CAN-34D03-VH-568-1); i EVQLVESGGDLVKPGGSLKLSCAASGFSFSNYGMSWVRQTPDKRLEWVATISYGGSYTYYPDNIKGRFTISRDNAKNTLYLQMSSLKSEDTAMYYCVRGYGYDTMDYWGQGTSVTVSS (SEQ ID NO: 30; MU-34D03-VH), ili
c) njihove varijante s jednom ili više konzervativnih aminokiselinskih supstitucija.
10. Veterinarski pripravak, naznačen time što sadrži terapijski djelotvornu količinu protutijela u skladu s bilo kojim od patentnih zahtjeva 1 do 9.
11. Stanica domaćin, naznačena time što proizvodi protutijelo u skladu s bilo kojim od patentnih zahtjeva 1 do 9.
12. Izolirana nukleinska kiselina koja kodira protutijelo u skladu s bilo kojim od patentnih zahtjeva 1 do 9, naznačena time što sadrži nukleinskokiselinski slijed koji kodira najmanje jedno iz skupine koju čine:
područje za određivanje komplementarnosti (CDR)1 varijabilnog teškog (VH) lanca, s aminokiselinskim slijedom YYDIN (SEQ ID NO: 1; 11E12-VH-CDR1), SYDMS (SEQ ID NO: 2; 19D07-VH-CDR1) ili NYGMS (SEQ ID NO: 3; 34D03-VH-CDR1);
CDR2 varijabilnog teškog lanca, s aminokiselinskim slijedom WIFPGDGGTKYNETFKG (SEQ ID NO: 4; 11E12-VH-CDR2), TITSGGGYTYSADSVKG (SEQ ID NO: 5; 19D07-VH-CDR2) ili TISYGGSYTYYPDNIKG (SEQ ID NO: 6; 34D03-VH-CDR2);
CDR3 varijabilnog teškog lanca, s aminokiselinskim slijedom ARGGTSVIRDAMDY (SEQ ID NO: 7; 11E12-VH-CDR3), ARQNWVVGLAY (SEQ ID NO: 8; 19D07-VH-CDR3) ili VRGYGYDTMDY (SEQ ID NO: 9; 34D03-VH-CDR3); i
njegova varijanta s jednom ili više konzervativnih aminokiselinskih supstitucija u najmanje jednom od CDR1, CDR2 ili CDR3, te koja dodatno sadrži nukleinskokiselinski slijed koji kodira najmanje jedno iz skupine koju čine:
varijabilni laki (VL) lanac koji sadrži područje za određivanje komplementarnosti (CDR)1, s aminokiselinskim slijedom RASESVDNYGISFMH (SEQ ID NO: 10; 11E12-VL-CDR1), KSSQSLLNSGNQKNYLA (SEQ ID NO: 11; 19D07-VL-CDR1) ili KASQSVSFAGTGLMH (SEQ ID NO: 12; 34D03-VL-CDR1);
CDR2 varijabilnog lakog lanca, s aminokiselinskim slijedom RASNLES (SEQ ID NO: 13; 11E12-VL-CDR2), GASTRES (SEQ ID NO: 14; 19D07-VL-CDR2) ili RASNLEA (SEQ ID NO: 15; 34D03-VL-CDR2);
CDR3 varijabilnog lakog lanca, s aminokiselinskim slijedom QQSNKDPLT (SEQ ID NO: 16; 11E12-VL-CDR3), QNDYSYPYT (SEQ ID NO: 17; 19D07-VL-CDR3) ili QQSREYPWT (SEQ ID NO: 18; 34D03-VL-CDR3); i
njegova varijanta s jednom ili više konzervativnih aminokiselinskih supstitucija u najmanje jednom od CDR1, CDR2 ili CDR3.
13. Vektor, naznačen time što sadrži nukleinsku kiselinu u skladu s patentnim zahtjevom 12.
14. Postupak proizvodnje protutijela, naznačen time što se sastoji u uzgoju stanice domaćina u skladu s patentnim zahtjevom 11 u uvjetima koji dovode do proizvodnje protutijela, te izoliranju protutijela iz stanice domaćina ili medija za uzgoj stanice domaćina.
15. Protutijelo u skladu s bilo kojim od patentnih zahtjeva 1 do 9, naznačeno time što je namijenjeno upotrebi u terapiji.
16. Protutijelo u skladu s bilo kojim od patentnih zahtjeva 1 do 9, naznačeno time što je namijenjeno upotrebi u liječenju stanja ili poremećaja koji se bira između pruritičnog stanja ili alergijskog stanja, gdje se liječenje sastoji u primjeni terapijski djelotvorne količine protutijela u skladu s bilo kojim od patentnih zahtjeva 1 do 9.
17. Protutijelo u skladu s bilo kojim od patentnih zahtjeva 1 do 9, namijenjeno upotrebi u skladu s patentnim zahtjevom 16, naznačeno time što se pruritično stanje bira iz skupine koju čine atopični dermatitis, egzem, psorijaza, skleroderma i pruritis.
18. Protutijelo u skladu s bilo kojim od patentnih zahtjeva 1 do 9, namijenjeno upotrebi u skladu s patentnim zahtjevom 17, naznačeno time što je pruritično stanje atopični dermatitis.
19. Protutijelo u skladu s bilo kojim od patentnih zahtjeva 1 do 9, namijenjeno upotrebi u skladu s patentnim zahtjevom 18, naznačeno time što je za pruritično stanje karakterističan svrbež.
20. Protutijelo u skladu s bilo kojim od patentnih zahtjeva 1 do 9, namijenjeno upotrebi u skladu s patentnim zahtjevom 16, naznačeno time što se alergijsko stanje bira iz skupine koju čine alergijsko dermatitis, ljetni egzem, koprivnjača, sipljivost, upalna bolest dišnih puteva, ponavljajuća opstrukcijska dišnih puteva, preosjetljivost dišnih puteva, kronična opstrukcijska plućna bolest i upalni procesi do kojih dolazi zbog autoimunosti.
21. Protutijelo u skladu s bilo kojim od patentnih zahtjeva 1 do 9, naznačeno time što je namijenjeno upotrebi u liječenju psa kojem je to potrebno inhibiranjem aktivnosti IL-31.
22. Protutijelo u skladu s bilo kojim od patentnih zahtjeva 1 do 9, naznačeno time što je namijenjeno upotrebi u skladu s bilo kojim od patentnih zahtjeva 16 do 20, gdje se terapijski djelotvorna količina protutijela primjenjuje u rasponu doza od 0,1-10 mg protutijela po kg tjelesne težine svaka dva tjedna ili mjesečno.
23. Protutijelo namijenjeno upotrebi u skladu s bilo kojim od patentnih zahtjeva 16 do 22, naznačeno time što se protutijelo označeno ovdje kao CAN34D03-65 primjenjuje supkutano u dozi od 1,0 mg/kg, gdje CAN34D03-65 je predstavljeno s SEQ ID NO:31 (VH) u paru s SEQ ID NO: 25 (VL) na SEQ ID NO: 42 (HC-65) i SEQ ID NO: 44 (LC-κ).
24. Postupak detektiranja ili kvantificiranja IL-31 u uzorku, naznačen time što se postupak sastoji u:
(a) inkubiranju kliničkog ili biološkog uzorka koji sadrži IL-31 u prisutnosti protutijela u skladu s bilo kojim od patentnih zahtjeva 1 do 9; i
(b) detektiranju protutijela vezanog na IL-31 u uzorku.
25. Postupak u skladu s patentnim zahtjevom 24, naznačen time što je protutijelo obilježeno na detektibilan način.
26. Postupak u skladu s patentnim zahtjevom 25, naznačen time što protutijelo nije obilježeno i upotrebljava se u kombinaciji s drugim protutijelom, obilježenim na detektibilan način.
27. Protutijelo u skladu s bilo kojim od patentnih zahtjeva 1 do 9, naznačeno time što se specifično veže na područje između aminokiselinskih ostataka 95 i 125 psećeg IL-31 s aminokiselinskim slijedom SEQ ID NO: 32.
28. Protutijelo u skladu s patentnim zahtjevom 27, naznačeno time što se protutijelo specifično veže na područje između aminokiselinskih ostataka 102 i 122 psećeg IL-31 sa slijedom SEQ ID NO: 32.
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EP12748547.2A EP2734549B1 (en) | 2011-07-21 | 2012-07-05 | Monoclonal antibody against dog interleukin-31 |
PCT/IB2012/053450 WO2013011407A1 (en) | 2011-07-21 | 2012-07-05 | Interleukin-31 monoclonal antibody |
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