DK1481992T3 - Humaniserede antistoffer, som sekvestrerer amyloid-beta-peptid - Google Patents

Humaniserede antistoffer, som sekvestrerer amyloid-beta-peptid Download PDF

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DK1481992T3
DK1481992T3 DK04011466.2T DK04011466T DK1481992T3 DK 1481992 T3 DK1481992 T3 DK 1481992T3 DK 04011466 T DK04011466 T DK 04011466T DK 1481992 T3 DK1481992 T3 DK 1481992T3
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David M Holtzman
Ronald Demattos
Kelly R Bales
Steven M Paul
Naoya Tsurushita
Maximiliano Vasquez
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Washington Univ St Louis
Lilly Co Eli
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    • 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
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • 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
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    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/34—Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
    • C—CHEMISTRY; METALLURGY
    • 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
    • C07K2317/565—Complementarity determining region [CDR]
    • C—CHEMISTRY; METALLURGY
    • 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
    • C07K2317/567—Framework region [FR]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • 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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Claims (16)

1. Farmaceutisk sammensætning omfattende et humaniseret monoklonalt antistof, som specifikt binder en epitop indeholdt inden for positionerne 13-28 af Αβ til anvendelse ved forebyggelse eller behandling af præklinisk eller klinisk Alzheimers sygdom, hvor antistoffet omfatter: a) en let kæde omfattende tre komplementaritetsbestemmende regioner (CDRs) med let kæde med de følgende aminosyresekvenser: CDR1 med let kæde: 15 10 15 Arg Ser Ser Gin Ser Leu Ile Tyr Ser Asp Gly Asn Ala Tyr Leu His (SEQ ID NO:l); eller 15 10 13 Arg Ser Ser Gin Ser leu Val Tyr Ser Asp Gly Asn Ala Tyr Leu His (SEQ ID NO: 15); CDR2 med let kæde: 1 5 Lys Val Ser Asn Arg Phe Ser (SEQ ID NO:2); og CDR3 med let kæde: 1 5 Ser Gin Ser Thr His Val Pro Trp Thr (SEQ ID NO:3) og en letkæde-frameworksekvens fra en let kæde af human immunoglobulin; og: b) en tung kæde omfattende tre komplementaritetsbestemmende regioner (CDRs) med tung kæde med de følgende aminosyresekvenser: en CDR1 med tung kæde: 1 5 Arg Tyr Ser Met Ser (SEQ ID NO:4) CDR2 med tung kæde: 15 10 15 Gin Ile Asn Ser Val Gly Asn Ser Thr Tyr Tyr Pro Asp Thr Val Lys Gly (SEQ ID NO:5); eller 15 10 15 Gin Ile Asn Ser Val Gly Asn Ser Thr Tyr Tyr Pro Asp Ser Val Lys Gly (SEQ ID NO: 16); og CDR3 med tung kæde: i Gly Asp Tyr (SEQ ID NO:6) og en tungkæde-frameworksekvens fra en tung kæde af en human immunoglobulin.
2. Farmaceutisk sammensætning omfattende et humaniseret monoklonalt antistof, som specifikt binder en epitop indeholdt inden for positionerne 13-28 af Αβ til anvendelse ved forebyggelse, behandling eller omvending af kognitivt forfald hos et individ diagnosticeret med præklinisk eller klinisk Alzhei-mers sygdom, hvor antistoffet omfatter: a) en let kæde omfattende tre komplementaritetsbestemmende regioner (CDRs) med let kæde med de følgende aminosyresekvenser: CDR1 med let kæde: 15 10 15 Arg Ser Ser Gin Ser Leu Ile Tyr Ser Asp Gly Asn Ala Tyr Leu His (SEQ ID NO:l); eller 15 10 15 Arg Ser Ser Gin Ser Leu Val Tyr Ser Asp Gly Asn Ala Tyr Leu His (SEQ ID NO:15); CDR2 med let kæde: 1 5 Lys Val Ser Asn Arg Phe Ser (SEQ ID N0:2); og CDR3 med let kæde: 1 5 Ser Gin Ser Thr His Val Pro Trp Thr (SEQ ID NO:3) og en letkæde-frameworksekvens fra en let kæde af human immunoglobulin; og: b) en tung kæde omfattende tre komplementaritetsbestemmede regioner (CDRs) med tung kæde med de følgende aminosyresekvenser: a CDR1 med tung kæde: 1 5 Arg Tyr Ser Met Ser (SEQ ID NO:4) CDR2 med tung kæde: 15 10 15 Gin Ile Asn Ser Val Gly Asn Ser Thr Tyr Tyr Pro Asp Thr Val Lys Gly (SEQ ID NO:5); eller 15 10 15 Gin Ile Asn Ser Val Gly Asn Ser Thr Tyr Tyr Pro Asp Ser Val Lys Gly (SEQ ID NO: 16); og CDR3 med tung kæde: i Gly Asp Tyr (SEQ ID NO:6) og en tungkæde-frameworksekvens fra en tung kæde af human immunoglobulin.
3. Farmaceutisk sammensætning til anvendelse ifølge krav 1 eller krav 2, hvor antistoffet omfatter en CDR1 med let kæde: 15 10 15 Arg Ser ser Gin ser heu ile Tyr ser Asp Gly Asn Ala Tyr Leu His (SEQ ID NO:l); og en CDR2 med tung kæde: 15 10 15 Gin Ile Asn Ser Val Gly Asn Ser Thr Tyr Tyr Pro Asp Thr Val Lys Gly (SEQ ID NO:5).
4. Farmaceutisk sammensætning til anvendelse ifølge et hvilket som helst foregående krav hvor antistoffet omfatter en humaniseret variabel region med let kæde omfattende den følgende sekvens: Asp Xaa Val Met Thr Gin Xaa Pro Leu Ser Leu Pro Val Xaa Xaa Gly 15 10 15 Gin Pro Ala Ser Ile Ser Cys Arg Ser Ser Gin Ser Leu Xaa Tyr Ser 20 25 30 Asp Gly A.sn Ala Tyr Leu His Trp Phe Leu Gin Lys Pro Gly Gin Ser 35 40 45 Pro Xaa Leu Leu Ile Tyr Lys Val Ser Asn Arg Phe Ser Gly Val Pro 50 55 60 Asp Arg Phe Ser Gly Ser Gly Ser Gly Thr Asp Phe Thr Leu Lys Ile 65 70 75 80 Ser Arg Val Glu Ala Glu Asp Xaa Gly Val Tyr Tyr Cys Ser Gin Ser 85 90 95 Thr His Val Pro Trp Thr Phe Gly Xaa Gly Thr Xaa Xaa Glu Ile Lys 100 1C 5 110 Arg (SEQ ID NO:7) hvor: Xaa ved position 2 er Val eller Ile; Xaa ved position 7 er Ser eller Thr; Xaa ved position 14 er Thr eller Ser; Xaa ved position 15 er Leu eller Pro; Xaa ved position 30 er Ile eller Val; Xaa ved position 50 er Arg, Gin, eller Lys; Xaa ved position 88 er Val eller Leu; Xaa ved position 105 er Gin eller Gly; Xaa ved position 108 er Lys eller Arg; og Xaa ved position 109 er Val eller Leu; og en variabel region med tung kæde omfattende den følgende sekvens: Xaa Va 1 bin Leu Va 1 Glu Xaa Gly bly Gly Leu Va 1 Gin Pro Gly Gly 15 10 15 Ser Leu Arg Leu Ser Cys Ala Ala Ser Gly Phe Thr Phe Ser Arg Tyr 2C 25 30 Ser Met Ser Trp Val Arg Gin Ala Pro Gly Lys Gly Leu Xaa Leu Val 35 10 45 Ala Gin Ile Asn Ser Val Gly Asn Ser Thr Tyr Tyr Pro Asp Xaa Val 50 55 60 Lys Gly Arg Phe Thr Ile Ser Arg Asp Asn Xaa Xaa Asn Thr Leu Tyr 65 70 75 80 Leu Gin Met Asn Ser Leu Arg Ala Xaa Asp Thr Ala Val Tyr Tyr Cys 85 90 95 Ala Ser Gly Asp Tyr Trp Gly Gin Gly Thr Xaa Val Thr Val Ser Ser 100 105 110 (SEQ ID NO:8); hvor: Xaa ved position 1 er Glu eller Gin; Xaa ved position 7 er Ser eller Leu; Xaa ved position 46 er Glu, Val, Asp, eller Ser; Xaa ved position 63 er Thr eller Ser; Xaa ved position 75 er Ala, Ser, Val, eller Thr; Xaa ved position 76 er Lys eller Arg; Xaa ved position 89 er Glu eller Asp; og Xaa ved position 107 er Leu eller Thr.
5. Farmaceutisk sammensætning til anvendelse ifølge krav 4, hvor antistoffet har en variabel region med let kæde med sekvensen angivet af SEQ ID NO:9 and en variabel region med tung kæde angivet af SEQ ID NO:10.
6. Farmaceutisk sammensætning til anvendelse ifølge et hvilket som helst foregående krav, hvor antistoffet omfatter en let kæde med sekvensen angivet af SEQ ID NO:11 og en tung kæde med sekvensen angivet af SEQ ID NO:12.
7. Anvendelse af en farmaceutisk sammensætning omfattende et humaniseret monoklonalt antistof, som specifikt binder en epitop indeholdt inden for positionerne 13-28 af Αβ til fremstilling af et medikament til forebyggelse eller behandling af præklinisk eller klinisk Alzheimers sygdom, hvor antistoffet omfatter: a) en let kæde omfattende tre komplementaritetsbestemmende regioner (CDRs) med let kæde med de følgende aminosyresekvenser: CDR1 med let kæde: 15 10 15 Arg Ser Ser Gin Ser Len Ile Tyr Ser Asp Gly Asn Ala Tyr Leu His (SEQ ID NO:l); eller 15 10 15 Arg Ser Ser Gin Ser Leu Val Lyr Ser Asp Gly Asn Ala Tyr Leu His (SEQ ID NO:15); CDR2 med let kæde: 1 5 Lys Val Ser Asn Arg Phe Ser (SEQ ID NO:2); og CDR3 med let kæde: 1 5 Ser Gin Ser Thr His Val Pro Trp Thr (SEQ ID NOl3) og en letkæde-frameworksekvens fra en let kæde af human immunoglobulin; og: b) en tung kæde omfattende tre komplementaritetsbestemmende regioner (CDRs) med tung kæde med de følgende aminosyresekvenser: en CDR1 med tung kæde: 1 5 Arg Tyr Ser Met Ser (SEQ ID NO:4) CDR2 med tung kæde: 15 10 15 Gin Ile Asn Ser Val Gly Asn Ser Thr Tyr Tyr Pro Asp Thr Val Lys Gly (SEQ ID NO:5); eller 15 10 15 Gin Ile Asn Ser Val Gly Asn Ser Thr Tyr Tyr Pro Asp Ser Val Lys Gly (SEQ ID NO: 16); og CDR3 med tung kæde: 1 Gly Asp Tyr (SEQlDNO:6) og en tungkæde-frameworksekvens fra en tung kæde af human immunoglobulin.
8. Anvendelse af en farmaceutisk sammensætning omfattende et humaniseret monoklonalt antistof, som specifikt binder en epitop indeholdt inden for positionerne 13-28 af Αβ til fremstilling af et medikament til forebyggelse, behandling eller omvending af kognitivt forfald hos et individ diagnosticeret med præklinisk eller klinisk Alzheimers sygdom, hvor antistoffet omfatter: a) en let kæde omfattende tre komplementaritetsbestemmende regioner (CDRs) med let kæde med de følgende aminosyresekvenser: CDR1 med let kæde: 15 10 15 Arg Ser Ser Gin Ser Leu Ile Tyr Ser Asp Gly Asn Ala Tyr Leu His (SEQ ID NO:l); eller 15 10 15 Arg Ser Ser Gin Ser Leu Val Tyr Ser Asp Gly Asn Ala Tyr Leu His (SEQ ID NO: 15); CDR2 med let kæde: 1 5 Lys Val Ser Asn Arg Phe Ser (SEQ ID NO:2); og CDR3 med let kæde: 1 5 Ser Gin Ser Thr His Val Pro Trp Thr (SEQ ID NO:3) og en letkæde-frameworksekvens fra en let kæde af human immunoglobulin; og: b) en tung kæde omfattende tre komplementaritetsbestemmende regioner (CDRs) med tung kæde med de følgende aminosyresekvenser: en CDR1 med tung kæde: 1 5 Arg Tyr Ser Met Ser (SEQ ID NO:4) CDR2 med tung kæde: 15 10 15 Gin Ile Asn Ser Val Gly Asn Ser Thr Tyr Tyr Pro Asp Thr Val Lys Gly (SEQ ID NO:5); eller 15 10 15 Gin Ile Asn Ser Val Gly Asn Ser Thr Tyr Tyr Pro Asp Ser Val Lys Gly (SEQ ID NO: 16); og CDR3 med tung kæde: i Gly Asp Tyr (SEQ ID NO:6) og en tungkæde-frameworksekvens fra en tung kæde af human immunoglobulin.
9. Anvendelse af en farmaceutisk sammensætning ifølge krav 7 eller krav 8, hvor antistoffet omfatter en CDR1 med let kæde: 15 10 15 Arg Ser Ser Gin Ser Leu Ile Tyr Ser A.sp Gly Asn Ala Tyr Leu His (SEQ ID NO:l); og en CDR2 med tung kæde: 15 10 15 Gin Ile Asn Ser Val Gly Asn Ser Thr Tyr Tyr Pro Asp Thr Val Lys Gly (SEQ ID NO:5).
10. Anvendelse af en farmaceutisk sammensætning ifølge et af kravene 7 til 9, hvor antistoffet omfatter en humaniseret variabel region med let kæde omfattende den følgende sekvens: Asp Xaa Val Met Thr Gin Xaa Pro Leu Ser Leu Pro Val Xaa Xaa Gly 15 10 15 Gin Pro Ala Ser Ile Ser Cys Arg Ser Ser Gin Ser Leu Xaa Tyr Ser 20 25 30 Asp Gly Asm Ala Tyr Leu His Trp Phe Leu Gin Lys Pro Gly Gin Ser 35 40 45 Pro Xaa Leu Leu Ile Tyr Lys Val Ser Asn Arg Phe Ser Gly Val Pro 50 55 60 Asp Arg Phe Ser Gly Ser Gly Ser Gly Thr Asp Phe Thr Leu Lys lie 65 70 75 80 Ser Arg Val Glu Ala Glu Asp Xaa Gly Val Tyr Tyr Cys Ser Gin Ser 85 90 95 Thr His Val Pro Trp Thr Phe Gly Xaa Gly Thr Xaa Xaa Glu lie Lys 100 105 110 Arg (SEQ ID NO:7) hvor: Xaa ved position 2 er Val eller Ile; Xaa ved position 7 er Ser eller Thr; Xaa ved position 14 er Thr eller Ser; Xaa ved position 15 er Leu eller Pro; Xaa ved position 30 er Ile eller Val; Xaa ved position 50 er Arg, Gin, eller Lys; Xaa ved position 88 er Val eller Leu; Xaa ved position 105 er Gin eller Gly; Xaa ved position 108 er Lys eller Arg; og Xaa ved position 109 er Val eller Leu; og en variabel region med tung kæde omfattende den følgende sekvens: Xaa Val Gin Leu Val Glu Xaa Gly Gly Gly Leu Val Gin Pro Gly Gly 15 10 15 Ser Leu Arg Leu Ser Cys Ala Ala Ser Gly Phe Thr Phe Ser Arg Tyr 20 25 30 Ser Met Ser Trp Val Arg Gin Ala Pro Gly Lys Gly Leu Xaa Leu Val 35 40 45 Ala Gin Ile Asn Ser Val Gly Asn Ser Thr Tyr Tyr Pro Asp Xaa Val 50 55 60 Lys Gly Arg Phe Thr Ile Ser Arg Asp Asn Xaa. Xaa Asn Thr Leu Tyr 65 70 75 8D Leu Gin Met Asn Ser Leu Arg Ala Xaa Asp Thr Ala Val Tyr Tyr Cys 85 90 95 Ala Ser Gly Asp Tyr Trp Gly Gin Gly Thr Xaa Val Thr Val Ser Ser 100 105 110 (SEQ ID NO:8); hvor: Xaa ved position 1 er Glu eller Gin; Xaa ved position 7 er Ser eller Leu; Xaa ved position 46 er Glu, Val, Asp, eller Ser; Xaa ved position 63 er Thr eller Ser; Xaa ved position 75 er Ala, Ser, Val, eller Thr; Xaa ved position 76 er Lys eller Arg; Xaa ved position 89 er Glu eller Asp; og Xaa ved position 107 er Leu eller Thr.
11. Anvendelse af en farmaceutisk sammensætning ifølge krav 10, hvor antistoffet har en variabel region med let kæde med sekvensen angivet af SEQ ID NO:9 og en variabel region med tung kæde angivet af SEQ ID NO:10.
12. Anvendelse af en farmaceutisk sammensætning ifølge et af kravene 7 til 11, hvor antistoffet omfatter en let kæde med sekvensen angivet af SEQ ID NO:11 og en tung kæde med sekvensen angivet af SEQ ID NO:12.
13. Humaniseret antistof eller fragment deraf omfattende en variabel region med let kæde af sekvensen angivet af SEQ ID NO:9 og en variabel region med tung kæde afgivet af SEQ ID NO:10 til anvendelse inden for behandling.
14. Humaniseret antistof eller fragment deraf til anvendelse ifølge krav 13, hvor antistoffet eller fragmentet deraf omfatter en let kæde med sekvensen angivet af SEQ ID NO:11 og en tung kæde med sekvensen angivet af SEQ ID NO:12.
15. Humaniseret antistof eller fragment deraf ifølge krav 13 eller krav 14 til anvendelse ved forebyggelse eller behandling af præklinisk eller klinisk Alz- heimers sygdom.
16. Humaniseret antistof eller fragment deraf ifølge krav 13 eller krav 14 til anvendelse ved forebyggelse, behandling eller omvending af kognitivt forfald hos et individ diagnosticeret med præklinisk eller klinisk Alzheimers sygdom.
DK04011466.2T 2000-02-24 2001-02-26 Humaniserede antistoffer, som sekvestrerer amyloid-beta-peptid DK1481992T3 (da)

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US18460100P 2000-02-24 2000-02-24
US25449800P 2000-12-08 2000-12-08
US25446500P 2000-12-08 2000-12-08
EP01913081A EP1257584B2 (en) 2000-02-24 2001-02-26 Humanized antibodies that sequester amyloid beta peptide

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