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HRP20171741T1 - Proteini koji se vežu na ljudski antigen c-fms - Google Patents

Proteini koji se vežu na ljudski antigen c-fms Download PDF

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Publication number
HRP20171741T1
HRP20171741T1 HRP20171741TT HRP20171741T HRP20171741T1 HR P20171741 T1 HRP20171741 T1 HR P20171741T1 HR P20171741T T HRP20171741T T HR P20171741TT HR P20171741 T HRP20171741 T HR P20171741T HR P20171741 T1 HRP20171741 T1 HR P20171741T1
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Croatia
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seq
antibody
full
heavy chain
light chain
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HRP20171741TT
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Kenneth Allan Brasel
Stephen Foster
Douglas Pat Cerretti
Jilin Sun
James F. Smothers
Christopher Mehlin
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Amgen, Inc
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Application filed by Amgen, Inc filed Critical Amgen, Inc
Publication of HRP20171741T1 publication Critical patent/HRP20171741T1/hr

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    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • 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
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • 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
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2866—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for cytokines, lymphokines, interferons
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    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A—HUMAN NECESSITIES
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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/715—Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons
    • C07K14/7153—Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons for colony-stimulating factors [CSF]
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    • C07—ORGANIC CHEMISTRY
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    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
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    • C—CHEMISTRY; METALLURGY
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    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/33—Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
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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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    • C07K2317/40—Immunoglobulins specific features characterized by post-translational modification
    • C07K2317/41—Glycosylation, sialylation, or fucosylation
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    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
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    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]
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    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value

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Claims (29)

1. Protutijelo, naznačeno time što se bira iz skupine koju čine protutijelo koje sadrži područja za određivanje komplementarnosti (CDR) CDRH1, CDRH2, CDRH3, CDRL1, CDRL2, te CDRL3, gdje navedeni CDR-i imaju aminokiselinske sljedove kao što su iznijeti niže: (a) CDRH1 ima SEQ ID NO:147, CDRH2 ima SEQ ID NO:163, CDRH3 ima SEQ ID NO:186, CDRL1 ima SEQ ID NO:193, CDRL2 ima SEQ ID NO:214, a CDRL3 ima SEQ ID NO:228, (b) CDRH1 ima SEQ ID NO:137, CDRH2 ima SEQ ID NO:150, CDRH3 ima SEQ ID NO:166, CDRL1 ima SEQ ID NO:198, CDRL2 ima SEQ ID NO:216, a CDRL3 ima SEQ ID NO:233, (d) CDRH1 ima SEQ ID NO:147, CDRH2 ima SEQ ID NO:163, CDRH3 ima SEQ ID NO:186, CDRL1 ima SEQ ID NO:195, CDRL2 ima SEQ ID NO:214, a CDRL3 ima SEQ ID NO:228, (e) CDRH1 ima SEQ ID NO:137, CDRH2 ima SEQ ID NO:152, CDRH3 ima SEQ ID NO:170, CDRL1 ima SEQ ID NO:198, CDRL2 ima SEQ ID NO:216, a CDRL3 ima SEQ ID NO:233, (f) CDRH1 ima SEQ ID NO:147, CDRH2 ima SEQ ID NO:163, CDRH3 ima SEQ ID NO:186, CDRL1 ima SEQ ID NO:194, CDRL2 ima SEQ ID NO:214, a CDRL3 ima SEQ ID NO:228, (g) CDRH1 ima SEQ ID NO:141, CDRH2 ima SEQ ID NO:156, CDRH3 ima SEQ ID NO:172, CDRL1 ima SEQ ID NO:209, CDRL2 ima SEQ ID NO:223, a CDRL3 ima SEQ ID NO:245, (i) CDRH1 ima SEQ ID NO:140, CDRH2 ima SEQ ID NO:155, CDRH3 ima SEQ ID NO:169, CDRL1 ima SEQ ID NO:202, CDRL2 ima SEQ ID NO:218, a CDRL3 ima SEQ ID NO:236, (j) CDRH1 ima SEQ ID NO:140, CDRH2 ima SEQ ID NO:155, CDRH3 ima SEQ ID NO:169, CDRL1 ima SEQ ID NO:201, CDRL2 ima SEQ ID NO:218, a CDRL3 ima SEQ ID NO:236, (k) CDRH1 ima SEQ ID NO:143, CDRH2 ima SEQ ID NO:158, CDRH3 ima SEQ ID NO:190, CDRL1 ima SEQ ID NO:199, CDRL2 ima SEQ ID NO:219, a CDRL3 ima SEQ ID NO:237, (l) CDRH1 ima SEQ ID NO:137, CDRH2 ima SEQ ID NO:151, CDRH3 ima SEQ ID NO:167, CDRL1 ima SEQ ID NO:199, CDRL2 ima SEQ ID NO:217, a CDRL3 ima SEQ ID NO:233, (m) CDRH1 ima SEQ ID NO:137, CDRH2 ima SEQ ID NO:150, CDRH3 ima SEQ ID NO:173, CDRL1 ima SEQ ID NO:198, CDRL2 ima SEQ ID NO:216, a CDRL3 ima SEQ ID NO:233, (n) CDRH1 ima SEQ ID NO:142, CDRH2 ima SEQ ID NO:157, CDRH3 ima SEQ ID NO:187, CDRL1 ima SEQ ID NO:206, CDRL2 ima SEQ ID NO:221, a CDRL3 ima SEQ ID NO:242, (o) CDRH1 ima SEQ ID NO:143, CDRH2 ima SEQ ID NO:158, CDRH3 ima SEQ ID NO:177, CDRL1 ima SEQ ID NO:200, CDRL2 ima SEQ ID NO:216, a CDRL3 ima SEQ ID NO:235, ili (p) CDRH1 ima SEQ ID NO:142, CDRH2 ima SEQ ID NO:157, CDRH3 ima SEQ ID NO:176, CDRL1 ima SEQ ID NO:207, CDRL2 ima SEQ ID NO:224, a CDRL3 ima SEQ ID NO:243; i gdje se navedeno protutijelo veže na ljudski c-fms s KD manjim od 10–8 M, što je izmjereno kao što je opisano u ovom predmetu.
2. Protutijelo u skladu s patentnim zahtjevom 1, naznačeno time što protutijelo ima varijabilni teški lanac (VH) i varijabilni laki lanac (VL), gdje VH i VL imaju aminokiselinske sljedove iznijete niže: (a) VH ima SEQ ID NO:77, a VL ima SEQ ID NO:109; (b) VH ima SEQ ID NO:77, a VL ima SEQ ID NO:110; (c) VH ima SEQ ID NO:78, a VL ima SEQ ID NO:133; (e) VH ima SEQ ID NO:80, a VL ima SEQ ID NO:112; (f) VH ima SEQ ID NO:84, a VL ima SEQ ID NO:115; (g) VH ima SEQ ID NO:85, a VL ima SEQ ID NO:116; (h) VH ima SEQ ID NO:86, a VL ima SEQ ID NO:117; (j) VH ima SEQ ID NO:70, a VL ima SEQ ID NO:102; (k) VH ima SEQ ID NO:70, a VL ima SEQ ID NO:103; (l) VH ima SEQ ID NO:73, a VL ima SEQ ID NO:105; (m) VH ima SEQ ID NO:74, a VL ima SEQ ID NO:106; (n) VH ima SEQ ID NO:89, a VL ima SEQ ID NO:121; (o) VH ima SEQ ID NO:93, a VL ima SEQ ID NO:123; (p) VH ima SEQ ID NO:94, a VL ima SEQ ID NO:124; (q) VH ima SEQ ID NO:97, a VL ima SEQ ID NO:127; ili (r) VH ima SEQ ID NO:98, a VL ima SEQ ID NO:128.
3. Protutijelo u skladu s patentnim zahtjevom 1 ili patentnim zahtjevom 2, naznačeno time što vezanje između navedenog protutijela i mutantnog ljudskog c-fms-a je manje od 50% od vezanja između navedenog protutijela i ljudskog c-fms-a koji ima aminokiselinski slijed iznijet u SEQ ID NO:1, te gdje navedeni mutantni ljudski c-fms ima aminokiselinski slijed koji se bira između: (a) aminokiselinskog slijeda iznijetog u SEQ ID NO:1, gdje je prisutna najmanje jedna mutacija koju se bira između K102E, R144E, R146E, D174R, te A226R, (b) aminokiselinskog slijeda iznijetog u SEQ ID NO:1, gdje je prisutna najmanje jedna mutacija koju se bira između E29R, Q 121R, T152R, te K185E, (c) aminokiselinskog slijeda iznijetog u SEQ ID NO:1, gdje je prisutna najmanje jedna mutacija koju se bira između E29R, Q121R, S172R, G274R, te Y276R, ili (d) aminokiselinskog slijeda iznijetog u SEQ ID NO:1, gdje je prisutna najmanje jedna mutacija koju se bira između R106E, H151R, T152R, Y154R, S155R, W159R, Q171R, S172R, Q173R, G183R, R184E, K185E, E218R, A220R, S228R, H239R, N240R, K259E, G274R, N275R, Y276R, S277R, te N282R.
4. Protutijelo u skladu s bilo kojim od patentnih zahtjeva 1 do 3, naznačeno time se što navedeno protutijelo može vezati na polipeptid koji ima aminokiselinski slijed SEQ ID NO:326, gdje se navedeno protutijelo ne veže na polipeptid koji sadrži aminokiseline 20-126 iz SEQ ID NO:1 i ne veže se na polipeptid koji sadrži aminokiseline 85-223 iz SEQ ID NO:1.
5. Protutijelo u skladu s patentnim zahtjevom 2, naznačeno time što ima dva istovjetna VH i dva istovjetna VL.
6. Protutijelo u skladu s patentnim zahtjevom 2 ili patentnim zahtjevom 5, naznačeno time što navedeno protutijelo ima puni teški lanac i puni laki lanac, gdje navedeni puni teški lanac i puni laki lanac imaju aminokiselinske sljedove iznijete niže: (a) puni teški lanac ima SEQ ID NO:11, a puni laki lanac ima SEQ ID NO:43; (b) puni teški lanac ima SEQ ID NO:11, a puni laki lanac ima SEQ ID NO:44; (c) puni teški lanac ima SEQ ID NO:12, a puni laki lanac ima SEQ ID NO:67; (e) puni teški lanac ima SEQ ID NO:14, a puni laki lanac ima SEQ ID NO:46; (f) puni teški lanac ima SEQ ID NO:18, a puni laki lanac ima SEQ ID NO:49; (g) puni teški lanac ima SEQ ID NO:19, a puni laki lanac ima SEQ ID NO:50; (h) puni teški lanac ima SEQ ID NO:20, a puni laki lanac ima SEQ ID NO:51; (j) puni teški lanac ima SEQ ID NO:4, a puni laki lanac ima SEQ ID NO:36; (k) puni teški lanac ima SEQ ID NO:4, a puni laki lanac ima SEQ ID NO:37; (l) puni teški lanac ima SEQ ID NO:7, a puni laki lanac ima SEQ ID NO:39; (m) puni teški lanac ima SEQ ID NO:8, a puni laki lanac ima SEQ ID NO:40; (n) puni teški lanac ima SEQ ID NO:23, a puni laki lanac ima SEQ ID NO:55; (o) puni teški lanac ima SEQ ID NO:27, a puni laki lanac ima SEQ ID NO:57; (p) puni teški lanac ima SEQ ID NO:28, a puni laki lanac ima SEQ ID NO:58; (q) puni teški lanac ima SEQ ID NO:31, a puni laki lanac ima SEQ ID NO:61; ili (r) puni teški lanac ima SEQ ID NO:32, a puni laki lanac ima SEQ ID NO:62.
7. Protutijelo u skladu s bilo kojim od patentnih zahtjeva 1, 2, 5, ili 6, naznačeno time što: (a) CDRH1 ima SEQ ID NO:147, CDRH2 ima SEQ ID NO:163, CDRH3 ima SEQ ID NO:186, CDRL1 ima SEQ ID NO:193, CDRL2 ima SEQ ID NO:214, a CDRL3 ima SEQ ID NO:228; (b) CDRH1 ima SEQ ID NO:140, CDRH2 ima SEQ ID NO:155, CDRH3 ima SEQ ID NO:169, CDRL1 ima SEQ ID NO:202, CDRL2 ima SEQ ID NO:218, a CDRL3 ima SEQ ID NO:236; (c) CDRH1 ima SEQ ID NO:140, CDRH2 ima SEQ ID NO:155, CDRH3 ima SEQ ID NO:169, CDRL1 ima SEQ ID NO:201, CDRL2 ima SEQ ID NO:218, a CDRL3 ima SEQ ID NO:236; ili (d) CDRH1 ima SEQ ID NO:142, CDRH2 ima SEQ ID NO:157, CDRH3 ima SEQ ID NO:187, CDRL1 ima SEQ ID NO:206, CDRL2 ima SEQ ID NO:221, a CDRL3 ima SEQ ID NO:242.
8. Protutijelo u skladu s bilo kojim od patentnih zahtjeva 1, 2, 5, 6 ili 7, naznačeno time što se protutijelo bira iz skupine koju čine protutijelo gdje: (a) VH ima SEQ ID NO:77, a VL ima SEQ ID NO:109, (b) VH ima SEQ ID NO:77, a VL ima SEQ ID NO:110, (c) VH ima SEQ ID NO:70, a VL ima SEQ ID NO:102, (d) VH ima SEQ ID NO:70, a VL ima SEQ ID NO:103, (e) VH ima SEQ ID NO:93, a VL ima SEQ ID NO:123, ili (f) VH ima SEQ ID NO:94, a VL ima SEQ ID NO:124.
9. Protutijelo u skladu s bilo kojim od patentnih zahtjeva 1, 2, 5, 6, 7 ili 8, naznačeno time što se protutijelo bira iz skupine koju čine protutijelo gdje: (a) puni teški lanac ima SEQ ID NO:11, a puni laki lanac ima SEQ ID NO:43, (b) puni teški lanac ima SEQ ID NO:11, a puni laki lanac ima SEQ ID NO:44, (c) puni teški lanac ima SEQ ID NO:4, a puni laki lanac ima SEQ ID NO:36, (d) puni teški lanac ima SEQ ID NO:4, a puni laki lanac ima SEQ ID NO:37, (e) puni teški lanac ima SEQ ID NO:27, a puni laki lanac ima SEQ ID NO:57, ili (f) puni teški lanac ima SEQ ID NO:28, a puni laki lanac ima SEQ ID NO:58.
10. Protutijelo u skladu s bilo kojim od patentnih zahtjeva 1 do 9, naznačeno time što: (a) je monoklonsko protutijelo, rekombinantno protutijelo, ljudsko protutijelo, kimerno protutijelo, bispecifično protutijelo, multispecifično protutijelo, ili njegov fragment; (b) je podtipa IgG1, IgG2, IgG3 ili IgG4; (c) je ljudsko protutijelo podtipa IgG1, IgG2, IgG3 ili IgG4; (d) je Fab fragment, Fab’ fragment, F(ab’)2 fragment, Fv fragment, dijatijelo, domensko protutijelo, ili jednolančana molekula protutijela; ili (e) je imunološki funkcionalni fragment imunoglobulina i dobiven iz ljudskog izvora.
11. Nukleinska kiselina, naznačena time što kodira protutijelo u skladu s bilo kojim od patentnih zahtjeva 1 do 10, gdje navedena nukleinska kiselina može biti operabilno povezana s kontrolnim slijedom.
12. Vektor, naznačen time što sadrži nukleinsku kiselinu u skladu s patentnim zahtjevom 11.
13. Stanica domaćin, naznačena time što sadrži vektor u skladu s patentnim zahtjevom 12 i/ili nukleinsku kiselinu u skladu s patentnim zahtjevom 11.
14. Farmaceutski pripravak, naznačen time što sadrži najmanje jedno protutijelo u skladu s bilo kojim od patentnih zahtjeva 1 do 10, kao i farmaceutski prihvatljivu pomoćnu tvar.
15. Farmaceutski pripravak u skladu s patentnim zahtjevom 14, naznačen time što dodatno sadrži: (a) dodatno aktivno sredstvo; ili (b) dodatno aktivno sredstvo koje se bira iz skupine koju čine radioizotop, radionuklid, toksin, terapijska i kemoterapijska skupina.
16. Protutijelo u skladu s bilo kojim od patentnih zahtjeva 1 do 10, naznačeno time što je namijenjeno upotrebi u terapiji.
17. Protutijelo u skladu s bilo kojim od patentnih zahtjeva 1 do 10, naznačeno time što je namijenjeno upotrebi u liječenju ili sprječavanju stanja povezanog s c-fms-om kod pacijenta, gdje se stanje bira između raka, bolesti kostiju, te upalne bolesti.
18. Protutijelo namijenjeno upotrebi u skladu s patentnim zahtjevom 17, naznačeno time što se upalnu bolest bira iz skupine koju čine upalni artritis, ateroskleroza, multipla skleroza, upalna crijevna bolest, Crohnova bolest, ulcerozni colitis, reumatoidni spondilitis, ankilozantni spondilitis, artritis, psorijatični artritis, reumatoidni artritis, osteoartritis, egzem, kontaktni dermatitis, psorijaza, sindrom toksičnog šoka, sepsa, septični šok, endotoksični šok, astma, kronična plućna upalna bolest, silikoza, plućna sarkoidoza, restenoza, reperfuzijska ozljeda srca i bubrega, tromboza, glomerularonefritis, dijabetes, reakcija presatka prema domaćinu, odbacivanje alogeničnog presatka, multipla skleroza, mišićna degeneracija, mišićna distrofija, Alzheimerova bolest, inzult, te kaheksija.
19. Protutijelo namijenjeno upotrebi u skladu s patentnim zahtjevom 17, naznačeno time što se rak bira iz skupine koju čine rak dojke, rak prostate, kolorektalni rak, adenokarcinom endometrija, leukemija, limfom, melanom, rak pločastih stanica jednjaka, rak želuca, astrocitni rak, rak endometrija, rak vrata maternice, rak mokraćnog mjehura, rak bubrega, rak pluća i rak jajnika.
20. Protutijelo namijenjeno upotrebi u skladu s patentnim zahtjevom 17, naznačeno time što se bolest kostiju bira iz skupine koju čine: (a) medicinski poremećaji koji uključuju prekomjerni gubitak kostiju; (b) medicinski poremećaji koji zahtijevaju formiranje nove kosti; (c) osteopenični poremećaji koji uključuju prekomjernu aktivnost osteoklasta; (d) sistemni gubitak kostiju povezan s artritisom; i (e) bolest kostiju povezana s bubrežnom insuficijencijom.
21. Protutijelo namijenjeno upotrebi u skladu s patentnim zahtjevom 20, naznačeno time što: (a) protutijelo je namijenjeno upotrebi u skladu s patentnim zahtjevom 20(a), te gdje se medicinski poremećaj bira između raka dojke, raka prostate, multiplog mijeloma i osteosarkoma; ili (b) protutijelo je namijenjeno upotrebi u skladu s patentnim zahtjevom 20(c), gdje se osteopenični poremećaj bira iz skupine koju čine osteopenija, osteoporoza, periodontitis, Pagetova bolest, gubitak kostiju zbog imobilizacije, litičke metastaze u kostima, te artritis.
22. Protutijelo namijenjeno upotrebi u skladu s patentnim zahtjevom 20(d) ili patentnim zahtjevom 21(b), naznačen time što se artritis bira iz skupine koju čine osteoartritis, reumatoidni artritis, psorijatični artritis, te upalni artritis.
23. Protutijelo namijenjeno upotrebi u skladu s patentnim zahtjevom 17, naznačeno time što je stanje bolest kostiju, te gdje je bolest kostiju poremećaj kostiju; gdje se protutijelo primijenjuje u kombinaciji s: (a) dodatnim terapijskim sredstvom; ili (b) dodatnim terapijskim sredstvom koje se bira između sredstva za terapiju raka, sredstva koje inhibira aktivnost osteoklasta, te sredstva koje pojačava aktivnost osteoblasta.
24. Protutijelo namijenjeno upotrebi u skladu s patentnim zahtjevom 23, naznačeno time što je pacijent pacijent s rakom koji prolazi radioterapiju ili kemoterapiju.
25. Protutijelo namijenjeno upotrebi u skladu s bilo kojim od patentnih zahtjeva 17 i 19-23, naznačeno time što je stanje rak ili bolest kostiju; gdje se protutijelo primijenjuje u kombinaciji sa sredstvom za terapiju raka.
26. Protutijelo namijenjeno upotrebi u skladu s bilo kojim od patentnih zahtjeva 17, 20 i 21, naznačeno time što je stanje bolest kostiju, koja ima za posljedicu gubitak koštane mase, te gdje se protutijelo primijenjuje u kombinaciji s dodatno terapijsko sredstvo, koje se bira između sredstva koje potiče rast kostiju (anaboličkog) i sredstva protiv resorpcije kostiju.
27. Protutijelo namijenjeno upotrebi u skladu s bilo kojim od patentnih zahtjeva 17, 18 i 22, naznačeno time što je stanje upalna bolest; te gdje se protutijelo primijenjuje u kombinaciji s protuupalnim sredstvom.
28. Farmaceutski pripravak u skladu s patentnim zahtjevom 14 ili patentnim zahtjevom 15, naznačen time što je namijenjen upotrebi u liječenju pacijenta, gdje se farmaceutski prihvatljivu pomoćna tvar bira između farmaceutski prihvatljivog razrjeđivača, nosača, solubilizatora, emulgatora, konzervansa i/ili adjuvansa; te gdje je pacijent ljudski pacijent.
29. Postupak dobivanja protutijela u skladu s bilo kojim od patentnih zahtjeva 1 do 10, naznačen time što se sastoji u koraku dobivanja navedenog protutijela iz stanice domaćina koja izlučuje navedeno protutijelo.
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