ME00519B - Antitijela visokog afiniteta prema humanom il-6 receptoru - Google Patents

Antitijela visokog afiniteta prema humanom il-6 receptoru

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Publication number
ME00519B
ME00519B MEP-2008-853A MEP85308A ME00519B ME 00519 B ME00519 B ME 00519B ME P85308 A MEP85308 A ME P85308A ME 00519 B ME00519 B ME 00519B
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Montenegro
Prior art keywords
seq
antibody
binding fragment
antigen
heavy chain
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MEP-2008-853A
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English (en)
French (fr)
Inventor
Nicholas J Papadopoulos
Joel H Martin
Sean Stevens
Tammy T Huang
Jeanette L Fairhurst
James P Fandl
Gang Chen
Margaret Karow
Ashique Rafique
Eric Smith
Kevin J Pobursky
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Regeneron Pharma
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Application filed by Regeneron Pharma filed Critical Regeneron Pharma
Publication of ME00519B publication Critical patent/ME00519B/me

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    • 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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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • 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
    • C07K16/26—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against hormones ; against hormone releasing or inhibiting factors
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09—Recombinant DNA-technology
    • C12N15/11—DNA or RNA fragments; Modified forms thereof; Non-coding nucleic acids having a biological activity
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/10—Immunoglobulins specific features characterized by their source of isolation or production
    • C07K2317/14—Specific host cells or culture conditions, e.g. components, pH or temperature
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
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    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • 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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    • C07—ORGANIC CHEMISTRY
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    • C07K2317/00—Immunoglobulins specific features
    • 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
    • C07K2317/565—Complementarity determining region [CDR]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
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    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value

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  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
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Claims (19)

1. Antitelo ili njegov antigen-vezujući fragment, koji se specifično vezuje za humani interleukin-6 receptor (hIL-6R) sa KD od otprilike 500 pM i manjom i, 300 pM i manjom, mereno površinskom plazmon rezonancom.
2.    Antitelo ili njegov antigen-vezujući fragment, kao u patentnom zahtevu 1, koje vezuje hIL-6R sa afinitetom od najmanje 2-puta većim u odnosu na njegovo vezivanje za majmunski IL-6R.
3.    Antitelo ili antigen vezujući fragment, kao u patentnom zahtevu 1 ili 2, koji sadrže domen komplementarnog determinišućeg regiona 3 (CDR3)teškog lanca i CDR3 domen lakog lanca, gde: teški lanac CDR3 domena obuhvata amino kiselinsku sekvencu formule: X1-X2-X3-X4-X1-X2-X1-X8-X9-X10-X11-X12-X13-X14-X15-X16-X11-X18-X19 (SEQ ID NO: 247) u kojoj je: X1=Ala, X2=Lys, X3=Gly, X4=Arg, X1=Asp, X2=Ser ili Ala, X7=Phe, X8=Asp, X9=Ile, X10=Pro ili ga nema, X11=Phe ili ga nema, X12=Val ili ga nema, X13=Tyr ili ga nema, Xl4=Tyr ili ga nema, X15=Tyr ili ga nema, Xl6=Gly ili ga nema, X17 =Met ili ga nema, X18=Asp ili ga nema i, X19=Val ili ga nema; i laki lanac CDR3 domena obuhvata amino kiselinsku sekvencu formule: X1-X2-X3-X4-X1-X2-X7-X8-X9(SEQ ID NO: 250) u kojoj je: X1=Gln, X2=Gln ili His, X3=Ala, X4=Asn ili Tyr, X1=Ser, X2=Phe, X7=Pro, X2=Pro i, X9=Thr.
4. Antitelo ili antigen vezujući fragment, kao u patentnom zahtevu 3, koji dalje sadrže teški    lanac    CDR1    domena,     koji    obuhvata    amino    kiselinsku sekvencu formule:    X1-X2-X3-X4-X5-X6-X7-X8 (SEQ ID NO: 245) u kojoj je: X1=Gly ili Arg, X2=Phe, X3=Thr, X4=Phe, X1=Asp, X2=Asp, X7=Tyr i, X8=Ala; teški    lanac    CDR2    domena,     koji    obuhvata    amino    kiselinsku sekvencu formule:    X1-X2-X3-X4-X1-X2-X7-X8 (SEQ ID NO: 246) u kojoj je: X1=Ile ili Val, X2=Ser, X3=Trp, X4=Asn, X1=Ser, X2=Gly, X7=Ser i, X8=Ile; laki    lanac    CDR1    domena,     koji    obuhvata    amino    kiselinsku sekvencu formule:    X1-X2-X3-X4-X5-X6-X7-X8 (SEQ ID NO: 248) u kojoj je: X1=Gln, X2=Gly, X3=Ile, X4=Ser, X1=Ser i, X6=Trp; i laki    lanac    CDR2    domena,     koji    obuhvata    amino    kiselinsku sekvencu formule: X3-X2-X3 (SEQ ID NO: 249) u kojoj je: X1=Gly ili Ala, X2=Ala i, X3=Ser.
5. Antitelo ili antigen vezujući fragment, kao u patentnom zahtevu 1 ili 2, koji sadrže: teški    lanac    CDR3    domena    koji    je    odabran    iz grupe,     koja se sastoji    od SEQ    ID NO:     25,     153,     9,     185,     41,     57, 73,     89,     105,     121,     137, 169, 201 i 217; i laki lanac CDR3 domena koji je odabran iz grupe, koja se sastoji    od SEQ    ID NO:     33,     161,     17,     193,     49,     65, 81,     97,     113,     129,     145, 177, 209 i 225.
6. Antitelo ili antigen vezujući fragment, kao u patentnom zahtevu 5, koji dalje sadrže: teški lanac    CDR1    domena    koji    je    odabran    iz    grupe,     koja    se sastoji    od    SEQ    ID    NO:     21,     149,     5,     181,     37,     53,     69,     85,     101,     117,     133, 165, 197 i 213; teški lanac    CDR2    domena    koji    je    odabran    iz    grupe,     koja    se sastoji    od    SEQ    ID    NO:     23,     151,     7,     183,     39,     55,     71,     87,     103,     119,     135, 167, 199 i 215; laki lanac    CDR1    domena    koji    je    odabran    iz    grupe,     koja    se sastoji    od    SEQ    ID    NO:     29,     157,     13,     189,     45,     61,     77,     93,     109,     125,     141, 173, 205 i    221;     i laki lanac    CDR2    domena    koji    je    odabran    iz    grupe,     koja    se sastoji    od    SEQ    ID    NO:     31,     159,     15,     191,     47,     63,     79,     95,     111,     127,     143, 175, 207 i 223.
7. Antitelo ili antigen vezujući fragment, kao u patentnom zahtevu 5 ili 6, gde CDR teškog lanca i CDR lakog lanca sadrže: SEQ ID    NO:     21, 23, 25 i SEQ ID    NO: 29,     31,     33; SEQ ID    NO:     149, 151,     153    i SEQ    ID NO:     157,     159,     161; SEQ ID    NO:     5, 7, 9 i    SEQ    ID NO:     13, 15, 17;     i SEQ ID    NO:     181, 183,     185    i SEQ    ID NO:     189,     191,     odnosno 193.
8. Antitelo ili antigen vezujući fragment, kao u patentnom zahtevu 1 ili 2, koje sadrži varijabilni region teškog lanca (HCVR), odabran iz grupe, koja se sastoji od SEQ ID NO: 19,     147, 3, 179, 227, 231, 35, 51,     67, 83,     99, 115, 131, 239, 241, 163, 235, 195 i 211; i promenljivi region lakog lanca (LCVR), odabran iz grupe, koja se sastoji od SEQ ID NO: 27,     155,     11,     187,     229,     233,     43,     59,     75,     91, 107, 123, 139, 171, 237, 203 i 219.
9. Antitelo ili antigen vezujući fragment, kao u patentnom zahtevu 8, koje sadrži HCVR/LCVR parove, odabrane iz grupe, koja se sastoji od SEQ ID NO: 19/27; 147/155; 3/11; 179/187; 227/229; 231/233; 35/43; 51/59; 67/75; 83/91; 99/107; 115/123; 131/139; 239/155; 241/155; 163/171; 235/237; 195/203 i 211/219.
10.    Izolovani molekul nukleinske kiseline koji kodira antitelo ili antigen vezujući fragment, kao u bilo kom od prethodnih patentnih zahteva.
11.    Vektor, koji obuhvata nukleotidnu sekvencu, kao u patentnom zahtevu 10.
12.    Sistem domaćin-vektor za proizvodnju antitela ili antigen vezujućeg fragmenta antitela koje specifično vezuje humani IL-6 receptor, koji obuhvata vektor, kao u patentnom zahtevu 11 u pogodnoj ćeliji domaćina.
13.    Sistem domaćin-vektor, kao u patentnom zahtevu 12, u kome je ćelija domaćina prokariotska ili eukariotska ćelija odabrana od E. coli ili CHO ćelije.
14.    Postupak proizvodnje anti-IL-6R antitela ili njegovog antigen-vezujućeg fragmenta, koji obuhvata uzgajanje ćelija sistema domaćin-vektor, kao u patentnom zahtevu 12 ili 13, u uslovima koji omogućavaju proizvodnju antitela ili njegovog fragmenta i vađenje tako proizvedenog antitela ili njegovog fragmenta.
15.    Upotreba antitela ili antigen-vezujućeg fragmenta antitela, kao u bilo kom od patentnih zahteva 1 do 9, u proizvodnji leka za upotrebu za umanjivanje ili inhibiranje bolesti ili poremećaja kod ljudi, posredovanih IL-6.
16.    Antitelo ili antigen-vezujući fragment antitela, kao u bilo kom od patentnih zahteva 1 do 9, za upotrebu u umanjivanju ili inhibiciji bolesti ili poremećaja kod ljudi, koji su posredovani IL-6.
17.    Farmaceutska smeša koja sadrži antitelo ili antigen-vezujući fragment antitela, kao u bilo kom od patentnih zahteva 1 do 9 i, farmaceutski prihvatljiv nosač ili podlogu.
18.    Postupak umanjivanja ili inhibisanja bolesti ili poremećaja kod ljudi, koji su posredovani IL-6, postupak obuhvata primenjivanje pacijentu čoveku, efektivne količine antitela ili antigen-vezujućeg fragmenta antitela, kao u bilo kom od patentnih zahteva 1 do 9.
19.    Postupak, kao u patentnom zahtevu 18, u kome je bolest ili poremećaj posredovan IL-6 artritis, kao hronični reumatoidni artritis;
MEP-2008-853A 2006-06-02 2007-06-01 Antitijela visokog afiniteta prema humanom il-6 receptoru ME00519B (me)

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Application Number Priority Date Filing Date Title
US81066406P 2006-06-02 2006-06-02
US84323206P 2006-09-08 2006-09-08
PCT/US2007/013062 WO2007143168A2 (en) 2006-06-02 2007-06-01 High affinity antibodies to human il-6 receptor

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