DK3126383T3 - Modificeret j-kæde - Google Patents

Modificeret j-kæde Download PDF

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DK3126383T3
DK3126383T3 DK15718304.7T DK15718304T DK3126383T3 DK 3126383 T3 DK3126383 T3 DK 3126383T3 DK 15718304 T DK15718304 T DK 15718304T DK 3126383 T3 DK3126383 T3 DK 3126383T3
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igm
igg
iga
chain
antibody
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DK15718304.7T
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Bruce Keyt
Leonard George Presta
Fen Zhang
Ramesh Baliga
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Igm Biosciences Inc
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    • 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
    • C07K16/2803—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
    • C07K16/2809—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 against the T-cell receptor (TcR)-CD3 complex
    • 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
    • A61K39/39558—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against tumor tissues, cells, antigens
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • 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
    • 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
    • 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
    • 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
    • C07K16/2803—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
    • C07K16/283—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 against Fc-receptors, e.g. CD16, CD32, CD64
    • 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
    • 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
    • C07K16/2887—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against CD20
    • 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
    • C07K16/46—Hybrid immunoglobulins
    • C07K16/468—Immunoglobulins having two or more different antigen binding sites, e.g. multifunctional antibodies
    • 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
    • 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
    • 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
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/31—Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • 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
    • C07K2317/569—Single domain, e.g. dAb, sdAb, VHH, VNAR or nanobody®
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/60—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
    • C07K2317/62—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising only variable region components
    • C07K2317/622—Single chain antibody (scFv)
    • 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

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Claims (18)

1. IgM-, IgA-, IgG/IgM- eller IgG/IgA-antistof, der omfatter en modificeret J-kæde, hvor den modificerede J-kæde omfatter en fremmed bindingsdel, der er indført i en nativ J-kædesekvens, og hvor IgG/IgM- eller IgG/IgA-antistoffet er et hybridantistof, der indeholder et IgM-eller IgA-halestykke i den tunge IgG-kæde og har evnen til at inkorporere og danne polymerer med den modificerede J-kæde.
2. IgM-, IgA-, IgG/IgM- eller IgG/IgA-antistof ifølge krav 1, hvor den native J-kædesekvens er den native humane J-kædesekvens ifølge SEQ ID NO: 1 eller et funktionelt fragment deraf.
3. IgM-, IgA-, IgG/IgM- eller IgG/IgA-antistof ifølge krav 1 eller krav 2, hvor den fremmede bindingsdel er et polypeptid, der er indført i den native humane J-kædesekvens ifølge SEQ ID NO: 1 ved hjælp af direkte eller indirekte fusion, og hvor den fremmede bindingsdel eventuelt er indført ved hjælp af indirekte fusion via en peptidlinker i eller omkring en C-og/eller N-terminal af den fremmede bindingsdel, eventuelt inden for ca. 10 rester af C- og/eller N-terminalen, og hvor peptidlinkeren er ca. 10 til ca. 20 aminosyrer lang.
4. IgM-, IgA-, IgG/IgM- eller IgG/IgA-antistof ifølge et hvilket som helst af kravene 1 til 3, hvor den fremmede bindingsdel er indført i den native humane J-kædesekvens mellem cysteinresterne 92 og 101 i SEQ ID NO: 1 ved hjælp af indirekte fusion via en peptidlinker.
5. IgM-, IgA-, IgG/IgM- eller IgG/IgA-antistof ifølge et hvilket som helst af kravene 1 til 3, hvor den fremmede bindingsdel er indført i den native humane J-kædesekvens ifølge SEQ ID NO: 1 i eller tæt på et glycosyleringssted ved hjælp af indirekte fusion via en peptidlinker.
6. IgM-, IgA-, IgG/IgM- eller IgG/IgA-antistof ifølge krav 1, hvor den fremmede bindingsdel er indført i den native humane J-kædesekvens ifølge SEQ ID NO: 1 ved hjælp af kemisk eller kemo-enzymatisk derivatisering, eventuelt ved hjælp af en spaltbar eller ikke-spaltbar kemisk linker, hvor den spaltbare linker eventuelt er en kemisk labil linker eller en enzymlabil linker, og hvor den spaltbare eller ikke-spaltbare linker eventuelt er valgt fra gruppen, der består af N-succinimidyl-3-(2-pyridyldithio)-propionat (SPDP), succinimidyl-4-(N-maleimidomethyl)-cyclohexan-l-carboxylat (SMCC), N-succinimidyl-4-(2-pyridylthio)-pentanoat (SPP), iminothiolan (IT), bifunktionelle derivater af imidoestere, aktive estere, aldehyder, bis-azidoforbindelser, bis-diazoniumderivater, diisocyanater og bis-aktive fluorforbindelser.
7. IgM-, IgA-, IgG/IgM- eller IgG/IgA-antistof ifølge krav 6, hvor den modificerede J-kæde er modificeret ved insertion af et enzymgenkendelsessted og ved posttranslationel binding af en fremmed bindingsdel i enzymgenkendelsesstedet via en peptid- eller ikke-peptidlinker.
8. IgM-, IgA-, IgG/IgM- eller IgG/IgA-antistof ifølge et hvilket som helst af kravene 1 til 7, hvor den fremmede bindingsdel er valgt fra gruppen, der består af antistoffer, antigenbindende fragmenter af antistoffer, antistof- lægemiddel-konjugater, antistoflignende molekyler, antigenbindende fragmenter af antistoflignende molekyler, opløselige og membranbundne proteiner, ligander, receptorer, viruslignende partikler, proteintoksiner, enzymer og alternative skeletstrukturer, hvor den alternative skeletstruktur eventuelt er valgt fra gruppen, der består af: darpiner, fibronectin-domæner, adnectiner og knottiner, og hvor den fremmede bindingsdel eventuelt er et antigenbindende fragment valgt fra gruppen, der består af: F(ab')2, F(ab)2, Fab', Fab, Fv, scFv og enkeltdomæneantistof.
9. IgM-, IgA-, IgG/IgM- eller IgG/IgA-antistof ifølge et hvilket som helst af kravene 1 til 8, hvor den fremmede bindingsdel binder til en effektorcelle, hvor effektorcellen er valgt fra gruppen, der består af: T-celler, naturlige dræber (NK)-celler, makrofager og neutrofiler.
10. IgM-, IgA-, IgG/IgM- eller IgG/IgA-antistof ifølge krav 9, hvor eff ektorcellen er en T-celle, og hvor den fremmede bindingsdel binder til et CD3s-polypeptid på T-cellen.
11. IgM-, IgA-, IgG/IgM- eller IgG/IgA-antistof ifølge krav 9, hvor eff ektorcellen er en NK-celle, og hvor den fremmede bindingsdel binder til et mål valgt fra gruppen, der består af CD16, CD64 og NKG2D på NK-cellen.
12. IgM-, IgA-, IgG/IgM- eller IgG/IgA-antistof ifølge et hvilket som helst af kravene 1 til 11, der omfatter en flerhed af fremmede bindingsdele.
13. IgM-, IgA-, IgG/IgM- eller IgG/IgA-antistof ifølge et hvilket som helst af kravene 1 til 12, hvor recipientantistoffet for den modificerede J-kæde er monospecifikt, bispecifikt eller multispecifikt.
14. IgM-, IgA-, IgG/IgM- eller IgG/IgA-antistof ifølge et hvilket som helst af kravene 1 til 13, der binder til en hæmatologisk cancercelle eller en fast tumorcelle, hvor antistoffet binder til en eller flere af CDIM, CD19, CD20, CD22, CD33, CD70, CD56, CD138.
15. IgM-, IgA-, IgG/IgM- eller IgG/IgA-antistof ifølge krav 14, hvor antistoffet binder til CD20, og den fremmede bindingsdel på den modificerede J-kæde binder til CD3s.
16. IgM-, IgA-, IgG/IgM- eller IgG/IgA-antistof ifølge et hvilket som helst af kravene 1 til 13, der binder til et viralt antigen, hvor det virale antigen er et HBV-PreSl-antigen eller et HIV-gpl20-antigen.
17. Sammensætning, der omfatter IgM-, IgA-, IgG/IgM- eller IgG/IgA-antistoffet ifølge et hvilket som helst af kravene 1 til 16, som eventuelt er en farmaceutisk sammensætning, der yderligere omfatter et farmaceutisk acceptabelt bæremateriale.
18. IgM-, IgA-, IgG/IgM- eller IgG/IgA-antistof ifølge et hvilket som helst af kravene 1 til 16 eller sammensætning ifølge krav 17 til anvendelse til behandling af en cancer eller virussygdom.
DK15718304.7T 2014-04-03 2015-04-02 Modificeret j-kæde DK3126383T3 (da)

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US201461974738P 2014-04-03 2014-04-03
PCT/US2015/024149 WO2015153912A1 (en) 2014-04-03 2015-04-02 Modified j-chain

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US (5) US10400038B2 (da)
EP (3) EP3126383B8 (da)
JP (2) JP6744822B2 (da)
KR (3) KR20220044377A (da)
CN (2) CN106459213B (da)
AU (3) AU2015240595B2 (da)
BR (1) BR112016022841B1 (da)
CA (1) CA2944647A1 (da)
DK (2) DK3560954T3 (da)
ES (2) ES2887299T3 (da)
HU (2) HUE042829T2 (da)
IL (3) IL292311A (da)
MX (2) MX366588B (da)
NZ (1) NZ725568A (da)
PL (2) PL3126383T3 (da)
PT (2) PT3560954T (da)
RU (2) RU2021134101A (da)
SG (2) SG10201909716RA (da)
SI (2) SI3560954T1 (da)
WO (1) WO2015153912A1 (da)
ZA (1) ZA201606906B (da)

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