DK2686347T3 - Antistoffer mod CD70 - Google Patents

Antistoffer mod CD70 Download PDF

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DK2686347T3
DK2686347T3 DK12710486.7T DK12710486T DK2686347T3 DK 2686347 T3 DK2686347 T3 DK 2686347T3 DK 12710486 T DK12710486 T DK 12710486T DK 2686347 T3 DK2686347 T3 DK 2686347T3
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seq
antibody
human
amino acid
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Karen Silence
Peter Ulrichts
Torsten Dreier
Michael John Scott Saunders
Harald Wajant
Sofie Maria Elvire Gabriels
Mahan Moshir
Haard Johannes Joseph Wilhelmus De
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Argenx Bvba
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    • 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
    • C07K16/2875—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the NGF/TNF superfamily, e.g. CD70, CD95L, CD153, CD154
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/12—Drugs for disorders of the urinary system of the kidneys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/06—Antipsoriatics
    • 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
    • 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
    • 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
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/02—Antineoplastic agents specific for leukemia
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • 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
    • C07K16/2878—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95
    • 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
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/22—Immunoglobulins specific features characterized by taxonomic origin from camelids, e.g. camel, llama or dromedary
    • C—CHEMISTRY; METALLURGY
    • 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
    • C07K2317/40—Immunoglobulins specific features characterized by post-translational modification
    • C07K2317/41—Glycosylation, sialylation, or fucosylation
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/55—Fab or Fab'
    • 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
    • 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
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • 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
    • C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • C07K2317/732—Antibody-dependent cellular cytotoxicity [ADCC]
    • 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
    • C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • C07K2317/734—Complement-dependent cytotoxicity [CDC]
    • 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
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/77—Internalization into the cell
    • 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
    • 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
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance

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  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Rheumatology (AREA)
  • Cardiology (AREA)
  • Pain & Pain Management (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Neurology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
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  • Urology & Nephrology (AREA)
  • Hematology (AREA)
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  • Dermatology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
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Claims (13)

1. Et antistof eller et antigen-bindende fragment deraf, som binder til humant CD70, hvor nævnte antistof eller antigen-bindende fragment omfatter mindst et tungkæde-variabelt domæne (VH) omfattende en variabel tung-kæde CDR3, en variabel tung-kæde CDR2 og en variabel tung-kæde CDR1, og mindst et letkæde-variabelt domæne (VL) omfattende en variabel let-kæde CDR3, en CDR2 med variabel let-kæde og en variabel let-kæde CDR1 hvor den variable tung-kæde CDR3 omfatter eller består af SEQ ID NO: 50 (DAGYSNHVPIFDS); den variable tung-kæde CDR2 omfatter eller består af SEQ ID NO: 27 (DINNEGGTTYYADSVKG); den variable tung-kæde CDR1 omfatter eller består af SEQ ID NO: 11 (VYYMN); den variable let-kæde CDR3 omfatter eller består af SEQ ID NO: 160 (ALFISNPSVE); den variable let-kæde CDR2 omfatter eller består af SEQ ID NO: 119 (NTNTRHS); og den variable let-kæde CDR1 omfatter eller består af SEQ ID NO: 250 (GLKSGSVTSDNFPT).
2. Isoleret antistof eller antigen-bindende fragment ifølge krav 1, der omfatter et tungkæde-variabelt domæne (VH) omfattende eller bestående af aminosyresekvensen vist som SEQ ID NO: 223 eller en aminosyresekvens som er mindst 90%, 95%, 97 %, 98% eller 99% identisk med denne og et letkæde-variabelt domæne (VL) omfattende eller bestående af aminosyresekvensen vist som SEQ ID NO: 241 eller en aminosyresekvens som er mindst 90%, 95%, 97% , 98% eller 99% identisk med denne.
3. Isoleret antistof eller antigen-bindende fragment ifølge krav 2, der omfatter et tungkæde-variabelt domæne (VH) omfattende eller bestående af aminosyresekvensen vist som SEQ ID NO: 223, og et letkæde-variabelt domæne med (VL) omfattende eller bestående af aminosyresekvens vist som SEQ ID NO:241
4. Antistof ifølge ethvert af de foregående krav, som er et Llama-humant kimært antistof, hvori VH og VL domænerne er afledt fra Llama, og et eller flere af de konstante domæner er afledt fra et humant immunoglobulin, og som valgfrit omfatter hængselregionen, CH2-domænet og CH3-domænet af et humant IgG, fortrinsvis et humant lgG1.
5. Antistof eller antigen-bindende fragment ifølge ethvert af de foregående krav, som udviser en eller flere effektorfunktioner valgt blandt antistofafhængig celleformidlet cytotoksicitet (ADCC), hvori antistoffet eller antigenbindingsfragmentet valgfrit udviser forøget ADCC-funktion ved sammenligning med et ækvivalent antistof omfattende et nativt humant Fc-domæne, komplementafhængig cytotoksicitet (CDC) og antistofafhængig cellemedieret fagocytose (ADCP) mod celler, der udtrykker humant CD70 på celleoverfladen, såsom CD70-udtrykkende cancerceller.
6. Antistof ifølge ethvert af de foregående krav, som er et ikke-fucosyleret IgG, fortrinsvis et ikke-fucosyleret humant lgG1.
7. Isoleret polynukleotid, der koder for antistoffet eller det antigen-bindende fragment ifølge et hvilket som helst af de foregående krav.
8. Ekspressionsvektor omfattende polynukleotidet ifølge krav 7, der er operativt forbundet med regulatoriske sekvenser, som tillader ekspression af det antigenbindende polypeptid i en værtscelle eller et cellefrit ekspressionssystem.
9. Værtscelle eller cellefrit ekspressionssystem indeholdende ekspressionsvektoren ifølge krav 8.
10. En fremgangsmåde til fremstilling af et rekombinant antistof eller antigenbindende fragment deraf, der omfatter dyrkning af værtscellen eller det cellefrie ekspressionssystem ifølge krav 9 under betingelser, der tillader ekspression af antistoffet eller det antigen-bindende fragment og udvinding af det udtrykte antistof eller antigen-bindende fragment.
11. Farmaceutisk sammensætning omfattende et antistof eller antigen-bindende fragment ifølge et hvilket som helst af kravene 1 til 6 og mindst en farmaceutisk acceptabel bærer eller excipiens.
12. Antistof eller antigen-bindende fragment ifølge ethvert af kravene 1 til 6 til anvendelse i (a) inhibering af væksten af CD70-udtrykkende tumorceller i en human patient; eller (b) behandling eller forebyggelse af kræft hos en human patient, hvor nævnte cancer valgfrit er en cancer, som udviser lav kopieringstals ekspression af CD70.
13. Antistof eller antigen-bindende fragment ifølge ethvert af kravene 1 til 6 til anvendelse til behandling eller forebyggelse af kræft i en human patient, nævnte cancer er valgt fra gruppen bestående af: stortcellet B-celle lymfom, kronisk lymfatisk leukæmi, Burkitt lymfom, Hodgkin lymfom, Non-Hodgkins lymfom, mantelcellelymfom, pankreatisk karcinom, kutant T-celle-lymfom, mavekræft, lungekræft, melanom, glioblastom og æggestokkræft.
DK12710486.7T 2011-03-16 2012-03-16 Antistoffer mod CD70 DK2686347T3 (da)

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Application Number Priority Date Filing Date Title
US201161453390P 2011-03-16 2011-03-16
US201161503871P 2011-07-01 2011-07-01
PCT/EP2012/054733 WO2012123586A1 (en) 2011-03-16 2012-03-16 Antibodies to cd70

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US (6) US9765148B2 (da)
EP (1) EP2686347B1 (da)
JP (2) JP5982409B2 (da)
CN (1) CN103596979B (da)
AU (1) AU2012228194B2 (da)
BR (1) BR112013021562B1 (da)
CA (1) CA2828753C (da)
CY (1) CY1120471T1 (da)
DK (1) DK2686347T3 (da)
ES (1) ES2670874T3 (da)
HU (1) HUE039849T2 (da)
IL (1) IL228001B (da)
PL (1) PL2686347T3 (da)
PT (1) PT2686347T (da)
RU (1) RU2604196C2 (da)
SI (1) SI2686347T1 (da)
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