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HRP20202024T1 - Cd3-vežuća domena - Google Patents

Cd3-vežuća domena Download PDF

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Publication number
HRP20202024T1
HRP20202024T1 HRP20202024TT HRP20202024T HRP20202024T1 HR P20202024 T1 HRP20202024 T1 HR P20202024T1 HR P20202024T T HRP20202024T T HR P20202024TT HR P20202024 T HRP20202024 T HR P20202024T HR P20202024 T1 HRP20202024 T1 HR P20202024T1
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Croatia
Prior art keywords
binding protein
antigen
antigen binding
domain
seq
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HRP20202024TT
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English (en)
Inventor
Eugene Zhukovsky
Melvyn Little
Stefan Knackmuss
Uwe Reusch
Kristina Ellwanger
Ivica FUCEK
Michael WEICHEL
Markus ESER
Fionnuala McAleese-Eser
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Affimed Gmbh
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Publication date
Priority claimed from PCT/EP2014/002177 external-priority patent/WO2015018527A1/en
Application filed by Affimed Gmbh filed Critical Affimed Gmbh
Publication of HRP20202024T1 publication Critical patent/HRP20202024T1/hr

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803Immunoglobulins [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
    • C07K16/2809Immunoglobulins [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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2863Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for growth factors, growth regulators
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2878Immunoglobulins [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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/30Immunoglobulins [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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/30Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/31Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/30Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/33Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/567Framework region [FR]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/60Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
    • C07K2317/62Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising only variable region components
    • C07K2317/626Diabody or triabody
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/73Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/92Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94Stability, e.g. half-life, pH, temperature or enzyme-resistance

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
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  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
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Claims (15)

1. Antigenski vežući protein, naznačen time što sadrži najmanje jedno CD3-vežuće mjesto, gdje CD3-vežuće mjesto sadrži: (a) domenu varijabilnog teškog lanca (VH) kao što je opisano u SEQ ID NO:8 i domenu varijabilnog lakog lanca (VL) kao što je opisano u SEQ ID NO:3; ili (b) domenu varijabilnog teškog lanca (VH) kao što je opisano u SEQ ID NO:9 i domenu varijabilnog lakog lanca (VL) kao što je opisano u SEQ ID NO:4; ili (c) domenu varijabilnog teškog lanca (VH) čiji je slijed najmanje 95% istovjetan u usporedbi s VH kao što je opisano u SEQ ID NO:8, gdje je aminokiselinski ostatak na položaju 111 Y ili H, i domenu varijabilnog lakog lanca (VL) čiji je slijed najmanje 95% istovjetan u usporedbi s VL kao što je opisano u SEQ ID NO:3, gdje je aminokiselinski ostatak na položaju 49 G ili A; ili (d) domenu varijabilnog teškog lanca (VH) koja sadrži 1 do 5 konzerviranih aminokiselinskih zamjena u usporedbi s VH kao što je opisano u SEQ ID NO:8, gdje je aminokiselinski ostatak na položaju 111 Y ili H, i domenu varijabilnog lakog lanca (VL) koja sadrži 1 do 5 konzerviranih aminokiselinskih zamjena u usporedbi s VL kao što je opisano u SEQ ID NO:3, gdje je aminokiselinski ostatak na položaju 49 G ili A; i antigenski vežući protein iz (a), (b), (c) ili (d) nije bispecifični vežući protein koji se specifično veže na ljudski CD33 i ljudski CD3, gdje CD3-vežuće mjesto sadrži domena varijabilnog lakog lanca protiv CD3 koju se bira iz skupine koju čine SEQ ID NO:1-3 i domena varijabilnog teškog lanca protiv CD3 koju se bira iz skupine koju čine SEQ ID NO:6-8.
2. Antigenski vežući protein u skladu s patentnim zahtjevom 1, naznačen time što antigenski vežući protein nije bispecifično tandemno dijatijelo kojom se veže na CD33 i CD3.
3. Antigenski vežući protein u skladu s patentnim zahtjevom 1 ili 2, naznačen time što protein sadrži najmanje jednu dodatnu funkcionalnu domenu.
4. Antigenski vežući protein u skladu s patentnim zahtjevom 3, naznačen time što je najmanje jedna dodatna funkcionalna domena dodatno antigenski vežuće mjesto.
5. Antigenski vežući protein u skladu s patentnim zahtjevom 4, naznačen time što je dodatno antigenski vežuće mjesto specifično za tumorsku stanicu.
6. Antigenski vežući protein u skladu s patentnim zahtjevom 5, naznačen time što dodatno antigenski vežuće mjesto nije specifično za CD33.
7. Antigenski vežući protein u skladu s bilo kojim od patentnih zahtjeva 1 do 6, naznačen time što je antigenski vežući protein polivalentan.
8. Antigenski vežući protein u skladu s patentnim zahtjevom 7, naznačen time što je antigenski vežući protein multispecifično.
9. Antigenski vežući protein u skladu s patentnim zahtjevom 8, naznačen time što je antigenski vežući protein polimerni.
10. Antigenski vežući protein u skladu s patentnim zahtjevom 9, naznačen time što je antigenski vežući protein dimerni, te sadrži prvi polipeptid i drugi polipeptid, gdje svaki polipeptid ima najmanje četiri domene varijabilnog lanca spojene jedna za drugom, gdje antigenski vežući protein sadrži najmanje jedno CD3-vežuće mjesto u skladu s patentnim zahtjevom 1 i najmanje jedno dodatno antigenski vežuće mjesto specifično za drugi antigen.
11. Antigenski vežući protein u skladu s patentnim zahtjevom 10, naznačen time što svaki polipeptid ima najmanje četiri varijabilne domene, međusobno fuzionirane peptidnim spojnicama L1, L2 i L3 sljedećim redoslijedom: (i) VL (CD3)-L1-VH(2. antigen)-L2-VL(2. antigen)-L3-VH(CD3); (ii) VH (CD3)-L1-VL(2. antigen)-L2-VH(2. antigen)-L3-VL(CD3); (iii) VL(2. antigen)-L1-VH(CD3)-L2-VL(CD3)-L3-VH(2. antigen); ili (iv) VH(2. antigen)-L1-VL(CD3)-L2-VH(CD3)-L3-VL(2. antigen).
12. Antigenski vežući protein u skladu s patentnim zahtjevom 10, naznačen time što se spojnice L1, L2 i L3 sastoje od otprilike 12 ili manje aminokiselinskih ostataka.
13. Polinukleotid, naznačen time što kodira antigenski vežući protein u skladu s bilo kojim od patentnih zahtjeva 1 do 12.
14. Farmaceutski pripravak, naznačen time što sadrži (i) antigenski vežući protein u skladu s bilo kojim od patentnih zahtjeva 1 do 12, polinukleotid u skladu s patentnim zahtjevom 13 ili vektor koji sadrži polinukleotid u skladu s patentnim zahtjevom 13 i (ii) farmaceutski prihvatljivi nosač.
15. Antigenski vežući protein u skladu s bilo kojim od patentnih zahtjeva 1 do 12, naznačen time što je namijenjen upotrebi kao medikament.
HRP20202024TT 2014-08-07 2020-12-17 Cd3-vežuća domena HRP20202024T1 (hr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
PCT/EP2014/002177 WO2015018527A1 (en) 2013-08-07 2014-08-07 ANTIBODY BINDING SITES SPECIFIC FOR EGFRvIII
EP15154772.6A EP2982693A1 (en) 2014-08-07 2015-02-11 CD3 binding domain
EP15756850.2A EP3177646B1 (en) 2014-08-07 2015-08-05 Cd3 binding domain
PCT/EP2015/068070 WO2016020444A1 (en) 2014-08-07 2015-08-05 Cd3 binding domain

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HRP20202024T1 true HRP20202024T1 (hr) 2021-02-19

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US (1) US10066015B2 (hr)
EP (2) EP2982693A1 (hr)
JP (1) JP6669722B2 (hr)
CN (1) CN107001468B (hr)
AU (1) AU2015299039B2 (hr)
BR (1) BR112017002422B1 (hr)
CA (1) CA2957462C (hr)
DK (1) DK3177646T3 (hr)
HR (1) HRP20202024T1 (hr)
HU (1) HUE051919T2 (hr)
LT (1) LT3177646T (hr)
RU (1) RU2742691C2 (hr)
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WO (1) WO2016020444A1 (hr)

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EP3177646B1 (en) 2020-10-07
CN107001468A (zh) 2017-08-01
RU2017105120A3 (hr) 2019-02-20
DK3177646T3 (da) 2020-12-07
AU2015299039A1 (en) 2017-03-02
BR112017002422A2 (pt) 2017-11-28
JP2017529067A (ja) 2017-10-05
AU2015299039B2 (en) 2021-01-21
HUE051919T2 (hu) 2021-04-28
RU2742691C2 (ru) 2021-02-09
EP3177646A1 (en) 2017-06-14
CA2957462A1 (en) 2016-02-11
CA2957462C (en) 2023-10-17
JP6669722B2 (ja) 2020-03-18
RU2017105120A (ru) 2018-09-10
SI3177646T1 (sl) 2021-04-30
US10066015B2 (en) 2018-09-04
LT3177646T (lt) 2021-01-11
BR112017002422B1 (pt) 2024-02-20
EP2982693A1 (en) 2016-02-10
CN107001468B (zh) 2021-04-09
WO2016020444A1 (en) 2016-02-11
US20160039934A1 (en) 2016-02-11

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