DK2818483T3 - Medicinsk sammensætning til behandling og/eller forebyggelse af cancer - Google Patents

Medicinsk sammensætning til behandling og/eller forebyggelse af cancer Download PDF

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DK2818483T3
DK2818483T3 DK13752353.6T DK13752353T DK2818483T3 DK 2818483 T3 DK2818483 T3 DK 2818483T3 DK 13752353 T DK13752353 T DK 13752353T DK 2818483 T3 DK2818483 T3 DK 2818483T3
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antibody
ser
seq
caprin
gin
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DK13752353.6T
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Fumiyoshi Okano
Takanori Saito
Takayoshi Ido
Yoshitaka Minamida
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Toray Industries
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    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6801—Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
    • A61K47/6803—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
    • A61K47/6811—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a protein or peptide, e.g. transferrin or bleomycin
    • A61K47/6817—Toxins
    • A61K47/6819—Plant toxins
    • A61K47/6825—Ribosomal inhibitory proteins, i.e. RIP-I or RIP-II, e.g. Pap, gelonin or dianthin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6835—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site
    • A61K47/6849—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site the antibody targeting a receptor, a cell surface antigen or a cell surface determinant
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6835—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site
    • A61K47/6851—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site the antibody targeting a determinant of a tumour cell
    • 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
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • C07K16/28—Immunoglobulins [IG], 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 [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/30—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • 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
    • C07K2317/24—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
    • 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
    • C07K2317/70—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]

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
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  • Proteomics, Peptides & Aminoacids (AREA)
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  • Toxicology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Botany (AREA)
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  • Microbiology (AREA)
  • Hematology (AREA)
  • Oncology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
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  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
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Claims (16)

1. Antistof eller fragment deraf, som har immunologisk reaktivitet med et delvist CAPRIN-1-polypeptid bestående af aminosyresekvensen, der er vist i SEQ ID NO: 5.
2. Antistof eller fragment deraf ifølge krav 1, hvor antistoffet eller fragmentet deraf har cytotoksisk aktivitet mod en cancercelle, der udviser et CAPRIN-1 -protein.
3. Antistof eller fragment deraf ifølge krav 1 eller 2, hvor antistoffet er et mo-noklonalt antistof eller et polyklonalt antistof.
4. Antistof eller fragment deraf ifølge et af kravene 1 til 3, hvor antistoffet er et humant antistof, et humaniseret antistof, et kimærisk antistof, et enkeltkædet antistof eller et multispecifikt antistof.
5. Antistof eller fragment deraf ifølge et af kravene 1 til 4, hvor antistoffet eller fragmentet deraf omfatter: (i) en variabel region med tung kæde omfattende komplementaritetsbestemmende regioner bestående af aminosyresekvensen, der er vist i SEQ ID NO: 8, 9 og 10 (hhv. CDR1, CDR2 og CDR3) og en variabel region med let kæde omfattende komplementaritetsbestemmende regioner bestående af aminosyresekvensen, der er vist i SEQ ID NO: 11, 12 og 13 (hhv. CDR1, CDR2 og CDR3) og har immunologisk reaktivitet med CAPRIN-1-proteinet; eller (ii) en variabel region med tung kæde omfattende komplementaritetsbestemmende regioner bestående af aminosyresekvensen, der er vist i SEQ ID NO: 8, 9 og 14 (hhv. CDR1, CDR2 og CDR3) og en variabel region med let kæde omfattende komplementaritetsbestemmende regioner bestående af aminosyresekvensen, der er vist i SEQ ID NO: 11, 12 og 13 (hhv. CDR1, CDR2 og CDR3) og har immunologisk reaktivitet med CAPRIN-1-proteinet; eller (iii) en variabel region med tung kæde omfattende komplementaritetsbestemmende regioner med aminosyresekvenserne, der er vist i SEQ ID NO: 26, 27 og 28 (hhv. CDR1, CDR2 og CDR3) og en variabel region med let kæde omfattende komplementaritetsbestemmende regioner med aminosyre- sekvenserne, der er vist i SEQ ID NO: 30, 31 og 32 (hhv. CDR1, CDR2 og CDR3) og har immunologisk reaktivitet med CAPRIN-1-proteinet; eller (iv) en variabel region med tung kæde omfattende komplementaritetsbestemmende regioner med aminosyresekvenserne, der er vist i SEQ ID NO: 36, 37 og 38 (hhv. CDR1, CDR2 og CDR3) og en variabel region med let kæde omfattende komplementaritetsbestemmende regioner med aminosyresekvenserne, der er vist i SEQ ID NO: 40, 41 og 42 (hhv. CDR1, CDR2 og CDR3) og har immunologisk reaktivitet med CAPRIN-1-proteinet; eller (v) en variabel region med tung kæde omfattende komplementaritetsbestemmende regioner med aminosyresekvenserne, der er vist i SEQ ID NO: 46, 47 og 48 (hhv. CDR1, CDR2 og CDR3) og en variabel region med let kæde omfattende komplementaritetsbestemmende regioner med aminosyresekvenserne, der er vist i SEQ ID NO: 40, 41 og 42 (hhv. CDR1, CDR2 og CDR3) og har immunologisk reaktivitet med CAPRIN-1-proteinet.
6. Antistof eller fragment deraf ifølge krav 5 del (i), hvor antistoffet eller fragmentet deraf omfatter: (i) en variabel region med tung kæde bestående af aminosyresekvensen, der er vist i SEQ ID NO: 52 og en variabel region med let kæde bestående af aminosyresekvensen, der er vist i SEQ ID NO: 54 og har immunologisk reaktivitet med CAPRIN-1-proteinet; eller (ii) en variabel region med tung kæde bestående af aminosyresekvensen, der er vist i SEQ ID NO: 21 og en variabel region med let kæde bestående af aminosyresekvensen, der er vist i SEQ ID NO: 23 og har immunologisk reaktivitet med CAPRIN-1-proteinet; eller (iii) en variabel region med tung kæde bestående af aminosyresekvensen, der er vist i SEQ ID NO: 25 og en variabel region med let kæde bestående af aminosyresekvensen, der er vist i SEQ ID NO: 23 og har immunologisk reaktivitet med CAPRIN-1-proteinet.
7. Antistof eller fragment deraf ifølge krav 5 del (ii), hvor antistoffet eller fragmentet deraf omfatter en variabel region med tung kæde bestående af aminosyresekvensen, der er vist i SEQ ID NO: 16 og en variabel region med let kæde bestående af aminosyresekvensen, der er vist i SEQ ID NO: 18 og har immunologisk reaktivitet med CAPRIN-1-proteinet.
8. Antistof eller fragment deraf ifølge krav 5 del (iii), hvor antistoffet eller fragmentet deraf omfatter en variabel region med tung kæde bestående af aminosyresekvensen, der er vist i SEQ ID NO: 29 og en variabel region med let kæde bestående af aminosyresekvensen, der er vist i SEQ ID NO: 33 og har immunologisk reaktivitet med CAPRIN-1-proteinet.
9. Antistof eller fragment deraf ifølge krav 5 del (iv), hvor antistoffet eller fragmentet deraf omfatter en variabel region med tung kæde bestående af aminosyresekvensen, der er vist i SEQ ID NO: 39 og en variabel region med let kæde bestående af aminosyresekvensen, der er vist i SEQ ID NO: 43 og har immunologisk reaktivitet med CAPRIN-1-proteinet.
10. Antistof eller fragment deraf ifølge krav 5 del (v), hvor antistoffet eller fragmentet deraf omfatter en variabel region med tung kæde bestående af aminosyresekvensen, der er vist i SEQ ID NO: 49 og en variabel region med let kæde bestående af aminosyresekvensen, der er vist i SEQ ID NO: 43 og har immunologisk reaktivitet med CAPRIN-1-proteinet.
11. Antistof eller fragment deraf ifølge et af kravene 1 til 10, hvor antistoffet eller fragmentet deraf er konjugeret med et antitumormiddel.
12. Farmaceutisk sammensætning omfattende et antistof eller et fragment deraf ifølge et af kravene 1 til 11 som en aktiv bestanddel.
13. Kombinationslægemiddel omfattende en farmaceutisk sammensætning ifølge krav 12 og en farmaceutisk sammensætning, der omfatter et antitumormiddel.
14. Antistof eller fragment deraf ifølge et af kravene 1 til 11 eller farmaceutisk sammensætning ifølge krav 12 eller kombinationslægemiddel ifølge krav 13 til anvendelse i en fremgangsmåde til behandling og/eller forebyggelse af cancer.
15. Antistof, fragment, farmaceutisk sammensætning eller kombinationslægemiddel til anvendelse i en fremgangsmåde til behandling og/eller forebyggelse af cancer ifølge krav 14, hvor cancertypen er brystcancer, nyrecancer, pankreascancer, tyktarmscancer, lungecancer, hjernetumor, mavecancer, livmoderhalscancer, æggestokcancer, prostatacancer, urinblærecancer, spi-serørscancer, leukæmi, lymfom, fibrosarkom, mastocytom eller melanom.
16. DNA, der koder for et antistof eller fragmentet deraf ifølge et af kravene 1 til 10.
DK13752353.6T 2012-02-21 2013-02-21 Medicinsk sammensætning til behandling og/eller forebyggelse af cancer DK2818483T3 (da)

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JP2012035238 2012-02-21
PCT/JP2013/054403 WO2013125654A1 (ja) 2012-02-21 2013-02-21 癌の治療及び／又は予防用医薬組成物

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US (1) US9573993B2 (da)
EP (1) EP2818483B1 (da)
JP (1) JP6187256B2 (da)
KR (1) KR102005786B1 (da)
CN (1) CN104114582B (da)
AU (1) AU2013223161B2 (da)
BR (1) BR112014021102A2 (da)
CA (1) CA2864869C (da)
DK (1) DK2818483T3 (da)
ES (1) ES2643241T3 (da)
HU (1) HUE034736T2 (da)
IN (1) IN2014KN01715A (da)
MX (1) MX357505B (da)
PL (1) PL2818483T3 (da)
PT (1) PT2818483T (da)
RU (1) RU2631804C2 (da)
WO (1) WO2013125654A1 (da)

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