DK2850104T3 - Cd33-antistoffer og anvendelse heraf til cancerbehandling - Google Patents

Cd33-antistoffer og anvendelse heraf til cancerbehandling Download PDF

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DK2850104T3
DK2850104T3 DK13790467.8T DK13790467T DK2850104T3 DK 2850104 T3 DK2850104 T3 DK 2850104T3 DK 13790467 T DK13790467 T DK 13790467T DK 2850104 T3 DK2850104 T3 DK 2850104T3
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gly
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May Kung Sutherland
Maureen Ryan
Django Sussman
Patrick Burke
Scott Jeffrey
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Seattle Genetics Inc
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    • 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
    • C07K16/2803—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A61K31/551—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having two nitrogen atoms, e.g. dilazep
    • A—HUMAN NECESSITIES
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    • 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
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    • 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
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    • 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
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    • 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
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    • 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
    • C07K16/2896—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against molecules with a "CD"-designation, not provided for elsewhere
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    • C07—ORGANIC CHEMISTRY
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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
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
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    • 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
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    • 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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    • C07K2317/50—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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    • C07K2317/50—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
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    • 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
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    • C07—ORGANIC CHEMISTRY
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    • C07K2317/00—Immunoglobulins specific features
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    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S530/00—Chemistry: natural resins or derivatives; peptides or proteins; lignins or reaction products thereof
    • Y10S530/808—Materials and products related to genetic engineering or hybrid or fused cell technology, e.g. hybridoma, monoclonal products
    • Y10S530/809—Fused cells, e.g. hybridoma

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  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
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Claims (16)

1. Isoleret antistof, der specifikt binder til det humane CD33-protein, hvor antistoffet omfatter tre tungkæde-komplementaritetsbestemmende områder (CDR): tungkæde-CDRl, der består af SEQ ID NO: 19, tungkæde-CDR2, der består af SEQ ID NO: 20, og tungkæde-CDR3, der består af SEQ ID NO: 21; og tre letkæde-CDR: letkæde-CDRl, der består af SEQ ID NO: 22, letkæde-CDR2, der består af SEQ ID NO: 23, og letkæde-CDR3, der består af SEQ ID NO: 24.
2. Antistof ifølge krav 1, hvor antistoffet er valgt fra et murint antistof, et kimærisk antistof og et humaniseret antistof.
3. Antistof ifølge krav 2, hvor antistoffet er et humaniseret antistof.
4. Humaniseret antistof ifølge krav 3, hvor antistoffet omfatter et variabelt maturt tungkædeområde med en aminosyresekvens, der er mindst 90 % identisk med SEQ ID NO: 18, forudsat at position H48 er indtaget af I, position H66 er indtaget af K, position H67 er indtaget af A, position H69 er indtaget af L, position H71 er indtaget af A, og position H94 er indtaget af S, og et variabelt maturt letkædeområde, der er mindst 90 % identisk med SEQ ID NO: 8, forudsat at position L22 er indtaget af N, position L46 er indtaget af T, position L69 er indtaget af Q, og position L71 af Y, bestemt ved Kabat-nummereringssystemet.
5. Humaniseret antistof ifølge krav 3, der omfatter et variabelt maturt tungkædeområde med en aminosyresekvens, der er mindst 95 % identisk med SEQ ID NO: 18, og et variabelt maturt letkædeområde, der er mindst 95 % identisk med SEQ ID NO: 8.
6. Humaniseret antistof ifølge krav 3, hvor det variable mature tungkædeområde er kondenseret til en konstant tungkæderegion og det variable mature letkædeområde er kondenseret til en konstant letkæderegion, eventuelt hvor det konstante tungkædeområde er en mutant form af et naturligt konstant humant område, der har reduceret binding til en Fey-receptor i forhold til det konstante naturlige humane område.
7. Humaniseret antistof ifølge krav 2, hvor det konstante tungkædeområde er af IgGl-isotype, eventuelt hvor det konstante tungkædeområde har en aminosyresekvens, der omfatter SEQ ID NO: 27, og det konstante letkædeområde har en aminosyresekvens, der omfatter SEQ ID NO: 25, eller hvor det konstante tungkædeområde har en aminosyresekvens, der omfatter SEQ ID NO: 29 (S239C), og det konstante letkædeområde har en aminosyresekvens, der omfatter SEQ ID NO: 25.
8. Humaniseret antistof ifølge krav 3, hvor det variable mature tungkædeområde har en aminosyresekvens betegnet SEQ ID NO: 18 og det variable mature letkædeområde har en aminosyresekvens betegnet SEQ ID NO: 8.
9. Antistof ifølge et hvilket som helst af de foregående krav, hvor antistoffet er konjugeret til et cytotoksisk middel.
10. Antistof ifølge krav 9, hvor det cytotoksiske middel er konjugeret til antistoffet via en enzymfraspaltelig linker.
11. Antistof ifølge krav 9 eller 10, hvor det cytotoksiske middel er en DNA-minor-groove-binder.
12. Antistof ifølge et hvilket som helst af kravene 9-11, hvor det cytotoksiske middel har formlen
13. Antistof ifølge et hvilket som helst af de foregående krav til anvendelse i behandling af en patient, der har eller har risiko for at få en cancer.
14. Antistof til anvendelse ifølge krav 13, hvor canceren er akut myeloid leukæmi (AML), myelodysplastisk syndrom (MDS), akut promyelocytisk leukæmi (APL), kronisk myelogen leukæmi (CML), kronisk myelomonocytisk leukæmi (CMML), kroniske myeloproliferative forstyrrelser, akut præcursor B-celle lymfoblastisk leukæmi (preB-ALL), akut præcursor T-celle lymfoblastisk leukæmi (preT-ALL), multipelt myelom (MM), mastcellesygdom eller myeloidt sarkom.
15. Farmaceutisk sammensætning, der omfatter et humaniseret eller kimærisk antistof ifølge krav 1.
16. Farmaceutisk sammensætning, der omfatter antistoffet ifølge krav 12.
DK13790467.8T 2012-05-18 2013-05-15 Cd33-antistoffer og anvendelse heraf til cancerbehandling DK2850104T3 (da)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201261649110P 2012-05-18 2012-05-18
US13/804,227 US20130309223A1 (en) 2012-05-18 2013-03-14 CD33 Antibodies And Use Of Same To Treat Cancer
PCT/US2013/041209 WO2013173496A2 (en) 2012-05-18 2013-05-15 Cd33 antibodies and use of same to treat cancer

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US (4) US20130309223A1 (da)
EP (2) EP3421048A1 (da)
JP (1) JP6454269B2 (da)
KR (2) KR102100467B1 (da)
CN (1) CN104936617B (da)
AU (3) AU2013262788B2 (da)
CA (1) CA2873286C (da)
DK (1) DK2850104T3 (da)
EA (1) EA029987B1 (da)
ES (1) ES2686618T3 (da)
IL (1) IL235733B (da)
IN (1) IN2014DN10653A (da)
MX (1) MX350808B (da)
NZ (1) NZ702748A (da)
SG (1) SG11201407610WA (da)
TW (1) TWI593707B (da)
WO (1) WO2013173496A2 (da)
ZA (1) ZA201409224B (da)

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