DK2446904T3 - Anti-CD22-antistoffer, deres immunkonjugater og anvendelser deraf - Google Patents

Anti-CD22-antistoffer, deres immunkonjugater og anvendelser deraf Download PDF

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DK2446904T3
DK2446904T3 DK11187568.8T DK11187568T DK2446904T3 DK 2446904 T3 DK2446904 T3 DK 2446904T3 DK 11187568 T DK11187568 T DK 11187568T DK 2446904 T3 DK2446904 T3 DK 2446904T3
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antibody
seq
amino acid
cell
antibodies
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DK11187568.8T
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Allen J Ebens Jr
Alane M Gray
Wei-Ching Liang
Yan Wu
Shang-Fan Yu
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Genentech Inc
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    • C07—ORGANIC CHEMISTRY
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    • 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
    • C07K16/2803—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 immunoglobulin superfamily
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
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    • 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
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    • 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
    • A61K47/68031—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being an auristatin
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • 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
    • A61K47/68033—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a maytansine
    • A—HUMAN NECESSITIES
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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
    • A61K47/6849—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
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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
    • A61K47/6855—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 the tumour determinant being from breast cancer 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
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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • 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
    • C07K16/2896—Immunoglobulins [IGs], 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
    • 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
    • C07K16/30—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
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    • 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 (18)

1. Immunkonjugat, som omfatter et antistof eller et antigenbindende fragment deraf kovalent bundet til et cytotoksisk middel, hvor antistoffet eller det antigenbindende fragment deraf er et monoklonalt antistof eller antigenbindende fragment deraf, som binder til CD22 og omfatter et variabelt tungkædedo-mæne med aminosyresekvensen med SEQ ID NO:16, og et variabelt letkæ-dedomæne, som har aminosyresekvensen med SEQ ID NO:18, og hvor antistoffet eller det antigenbindende fragment deraf yderligere omfatter en cystein ved position 205 af letkæden ifølge Kabat-nummereringskonventionen eller position 118 af tungkæden ifølge EU-nummereringskonventionen.
2. Immunkonjugat ifølge krav 1, hvor antistoffet: (i) omfatter en tungkæde med mindst 90% sekvensidentitet med aminosyresekvensen med SEQ ID NO:88; (ii) omfatter en letkæde med mindst 90% sekvensidentitet med aminosyresekvensen med SEQ ID NO:87; (iii) omfatter en tungkæde med fuld længde omfattende aminosyresekvensen med SEQ ID NO:88, og en letkæde med fuld længde omfattende aminosyresekvensen med SEQ ID NO:87; eller (iv) er et antistof med fuld længde, hvor tungkæderne har aminosyresekvensen med SEQ ID NO:88, og letkæderne har aminosyresekvensen med SEQ ID NO:87.
3. Immunkonjugat ifølge krav 1 eller 2, hvor antistoffet omfatter: (i) en tungkædesekvens, der er udvalgt blandt SEQ ID NOS:88 eller 92; (ii) en letkædesekvens, der er udvalgt blandt SEQ ID NOS:87 eller 91; (ii) en letkædesekvens med SEQ ID NO:87 og en tungkædesekvens med SEQ ID NO:92; eller (iv) en letkædesekvens med SEQ ID NO:91 og en tungkædesekvens med SEQ ID NO:88.
4. Immunkonjugat ifølge et af kravene 1 til 3, hvor CD22 er pattedyrs-CD22.
5. Immunkonjugat ifølge krav 4, hvor CD22 er menneskelig CD22.
6. Immunkonjugat ifølge et af kravene 1 til 3, hvor antistoffet binder til en epitop i en region af CD22 fra aminosyre 22-240 af SEQ ID NO:27.
7. Immunkonjugat ifølge et af kravene 1 til 6, hvor det antigenbindende antistoffragment er udvalgt blandt et Fab-, Fab'-SH-, Fv-, scFv- eller (Fab')2-fragment.
8. Immunkonjugat ifølge et af kravene 1 til 7, hvor det cytotoksiske middel eventuelt er valgt blandt et toksin, et kemoterapeutisk middel, en lægemiddelenhed, et antibiotikum, en radioaktiv isotop og et nukleolytisk enzym.
9. Immunkonjugat ifølge et af kravene 1 til 8, hvor immunkonjugatet har formlen Ab-(L-D)p, hvor: (a) Ab er antistoffet ifølge et af kravene 1 til 7; (b) L er en linker, som omfatter et eller flere linkerkomponenter; (c) D er en lægemiddelenhed,
10. Immunkonjugat ifølge et af kravene 1 til 9, hvor antistoffet er kovalent bundet til en auristatin- eller en maytansinoid-lægemiddelenhed, hvorved der dannes et antistof-lægemiddel-konjugat.
11. Immunkonjugat ifølge krav 10, omfattende et antistof (Ab), og en auristatin- eller maytansinoid-lægemiddelenhed (D), hvor det cysteingensplejsede antistof er bundet til D via en eller flere frie cysteinaminosyrer ved hjælp af en linkerenhed (L); hvor forbindelsen har formlen I: Ab-(L-D)p I hvor p er 1,2, 3 eller 4.
12. Immunkonjugat ifølge krav 11, hvor: (i) per 2; (ii) L er SMCC, SPP, BMPEO, MC-val-cit-PAB eller MC; eller (iii) D er: (a) MMAE med strukturen:
hvor den bølgede linje indikerer bindingsstedet til linkeren L; (b) MMAE med strukturen:
hvor den bølgede linje indikerer bindingsstedet til linkeren L; (c) DM1 med strukturen:
hvor den bølgede linje indikerer bindingsstedet til linkeren L.
13. Immunkonjugat ifølge krav 11, hvor L har formlen: -Aa-Ww-Yy- hvor: A er en Stretcher-enhed, der er kovalent bundet til en cysteinthiol af det cysteingenspejsede antistof (Ab); a er 0 eller 1; hvert W uafhængigt er en aminosyreenhed; w er et heltal fra 0 til 12; Y er en Spacer-enhed, der er kovalent bundet til lægemiddelenheden; og y er 0,1 eller 2.
14. Immunkonjugat ifølge krav 13: (i) med følgende form:
hvor PAB er para-aminobenzylcarbamoyl, og R17 er et divalent radikal udvalgt blandt (CH2)r, C3-C8 carbocyclyl, 0-(CH2)r, arylen, (CH2)r-arylen, -arylen-(CH2)r-, (CH2)r-(C3-C8 carbocyclyl), (C3-C8 carbocyclyl)-(CH2)r, C3-C8 heterocyclyl, (CH2)r-(C3-C8 heterocyclyl), -(C3-C8 heterocyclyl)-(CH2)r-, -(CH2)rC(0)NRb(CH2)r-, -(CH2CH20)r-, -(CH2CH20)r-CH2-, (CH2)rC(0)NRb(CH2CH20)r-, -(CH2)rC(0)NRb(CH2CH20)r-CH2-, (CH2CH20)rC(0)NRb(CH2CH20)r-, -(CH2CH20)rC(0)NRb(CH2CH20)r- CH2-, og -(CH2CH20)rC(0)NRb(CH2)r- ; og Rb er H, C1-C6 alkyl, phenyl, eller benzyl; og r er uafhængigt et heltal mellem 1 og 10; (ii) hvor Ww er valin-citrullin; (iii) hvor R17 er (CH2)5 eller (CH2)2; (iv) med følgende formel:
eller: (v) med følgende formel:
15. Immunkonjugat ifølge krav 11, hvor: (i) L er MC-vc-PAB; og D er MMAE eller MMAF; eller (ii) Ab omfatter en letkædesekvens med SEQ ID NO:87 og en tungkædese-kvens med SEQ ID NO:92 som defineret i krav 3(ii), eller en letkædesekvens med SEQ ID NO:91 og en tungkædesekvens med SEQ ID NO:88 som defineret i krav 3 (iv); og L er MC-vc-PAB; og D er MMAE.
16. Farmaceutisk sammensætning omfattende immunkonjugatet ifølge et hvilket som helst af kravene 1 til 15 og en farmaceutisk acceptabel bærer.
17. Farmaceutisk sammensætning ifølge krav 16 til anvendelse ved en fremgangsmåde til behandling af en B-celleproliferativ lidelse.
18. Farmaceutisk sammensætning ifølge krav 16 til anvendelse ifølge krav 17, hvor den B-celleproliferative lidelse er udvalgt blandt lymfom, ikke-Hodgkins lymfom (NHL), aggressivt NHL, recidivt aggressivt NHL, recidivt indolent NHL, refraktært NHL, refraktært indolent NHL, kronisk lymfocytleukæmi (CLL), lille lymfocytlymfom, leukæmi, hårcelleleukæmi (HCL), akut lymfocytleukæmi (ALL) og mantlecellelymfom.
DK11187568.8T 2006-05-30 2007-05-29 Anti-CD22-antistoffer, deres immunkonjugater og anvendelser deraf DK2446904T3 (da)

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