SI2953977T1 - Imunokontrastno sredstvo za uporabo pri terapiji s konjugatom protitelo-zdravilo - Google Patents

Imunokontrastno sredstvo za uporabo pri terapiji s konjugatom protitelo-zdravilo Download PDF

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Publication number
SI2953977T1
SI2953977T1 SI201430556T SI201430556T SI2953977T1 SI 2953977 T1 SI2953977 T1 SI 2953977T1 SI 201430556 T SI201430556 T SI 201430556T SI 201430556 T SI201430556 T SI 201430556T SI 2953977 T1 SI2953977 T1 SI 2953977T1
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antibody
sequence
seq
immunoglobulin
binding protein
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SI201430556T
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English (en)
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Jochen Kruip
Susanta K. Sarkar
Mathias Gebauer
Christian Lange
Ingo Focken
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Sanofi
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    • 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
    • C07K16/3076Immunoglobulins [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 against structure-related tumour-associated moieties
    • C07K16/3092Immunoglobulins [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 against structure-related tumour-associated moieties against tumour-associated mucins
    • 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
    • C07K2317/35Valency
    • 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
    • C07K2317/60Immunoglobulins 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
    • C07K2317/60Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
    • C07K2317/64Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising a combination of variable region and constant region components
    • 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2319/00Fusion polypeptide
    • C07K2319/20Fusion polypeptide containing a tag with affinity for a non-protein ligand
    • C07K2319/21Fusion polypeptide containing a tag with affinity for a non-protein ligand containing a His-tag
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00Detection or diagnosis of diseases
    • G01N2800/52Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Cell Biology (AREA)
  • Peptides Or Proteins (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Optics & Photonics (AREA)
  • Physics & Mathematics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Claims (15)

  1. Imunokontrastno sredstvo za uporabo pri terapiji s konjugatom protitelo-zdravilo Patentni zahtevki
    1. Protitelesu podoben vezni protein, ki specifično veže MUC 1 -sialoglikotop povezan s tumorjem CA6, značilen po tem, da protitelesu podoben vezni protein vsebuje dva polipeptida, ki vsebujeta strukturi, ki jih predstavljata spodnji formuli (I) in (II): Vli-L,-VL2-Cl [I] Vh1-L2-Vh2-Chi [II] kjer: Vu predstavlja variabilno domeno lahke verige imunoglobulina, ki izhaja iz protitelesa DS6; V12 je variabilna domena lahke verige imunoglobulina, ki izhaja iz protitelesa DS6; Vhi je variabilna domena težke verige imunoglobulina, ki izhaja iz protitelesa DS6; Vh2 je variabilna domena težke verige imunoglobulina, ki izhaja iz protitelesa DS6; Cl je konstantna domena lahke verige imunoglobulina, kot je konstantna domena lahke verige imunoglobulina humane IGKC; Chi je konstantna domena težke verige imunoglobulina Cm, kot je konstantna domena težke verige imunoglobulina Chi; Li in L2 sta aminokislinska linkerja; in kjer polipeptidi s formulo I in polipeptidi s formulo II tvorijo bivalenten monospecifičen tandem imunoglobulin protitelesu podoben vezni protein; kjer polipeptid s formulo [I] vsebuje zaporedje, kije vsaj 80% enako z zaporedjem SEQ ID No: 1 in polipeptid s formulo II vsebuje zaporedje, kije vsaj 80% enako z zaporedjem SEQ ID No: 7.
  2. 2. Protitelesu podoben vezni protein po zahtevku 1, kjer sta Vli in Vl2 definirana z zaporedjem SEQ ID NO: 2; in sta VHi in Vh2 definirana z zaporedjem SEQ ID NO: 8.
  3. 3. Protitelesu podoben vezni protein po zahtevku 1 ali zahtevku 2, kjer Li predstavlja GGGGS ali GGGGSGGGGS (SEQ ID NO: 3).
  4. 4. Protitelesu podoben vezni protein po kateremkoli zahtevku od 1 do 3, kjer L2 predstavlja GGGGS ali GGGGSGGGGS (SEQ ID NO: 3).
  5. 5. Protitelesu podoben vezni protein po kateremkoli zahtevku od 1 do 4, kjer polipeptid s formulo [I] vsebuje zaporedje amino kislin SEQ ID NO: 1.
  6. 6. Protitelesu podoben vezni protein po kateremkoli zahtevku od 1 do 5, kjer the polipeptid s formulo [II] vsebuje zaporedje amino kislin SEQ ID NO: 7.
  7. 7. Protitelesu podoben vezni protein po kateremkoli zahtevku od 1 do 6, ki nadalje vsebuje vsaj radioaktivni označevalec, sredstvo za prikazovanje, terapevtsko sredstvo ali diagnostično sredstvo.
  8. 8. Protitelesu podoben vezni protein po zahtevku 7, kjer je radioaktivni označevalec, sredstvo za prikazovanje, terapevtsko sredstvo ali diagnostično sredstvo 110In,11'in, 177Lu, 18F, 52Fe, 62Cu, MCu, 67Cu, 67Ga, 68Ga, 86Y, 90Y, 89Zr, 94Tc, 94Tc, "mTc, 1201, 1231,124I, ‘25I, '3,1, 154-158Gd, 32P, "C, 13N, l50,186Re, l88Re,5‘Mn, 52mMn, 55Co,72As, 75Br, 76Br, 82mRb, ali 83Sr.
  9. 9. Protitelesu podoben vezni protein po zahtevku 7 ali 8, kjer radioaktivni označevalec, sredstvo za prikazovanje, terapevtsko sredstvo ali diagnostično sredstvo vsebuje eno ali več sredstev za prikazovalno platformo, izbrano iz skupine, ki vsebuje slikanje z magnetno resonanco (MRI); pozitronsko emisijsko tomografijo (PET); enofotonsko emisijsko tomografijo (SPECT); optično slikanje, računalniško tomografijo (CT); ultrazvok, rentgensko in fotoakustično slikanje.
  10. 10. Izolirana molekula nukleinske kisline, ki kodira polipeptide s formulo [I] in [II] protitelesu podobnega veznega proteina, kot je opisan v kateremkoli zahtevku od 1 do 6.
  11. 11. Izolirana molekula nukleinske kisline po zahtevku 10, kjer molekula nukleinske kisline vsebuje nukleotidno zaporedje SEQ ID NO: 5 ali SEQ ID NO: 10.
  12. 12. Ekspresijski vektor, ki vsebuje molekulo nukleinske kisline po zahtevku 10 ali 11.
  13. 13. Izolirana gostiteljska celica, ki vsebuje molekulo nukleinske kisline po zahtevku 10 ali 11, ali ekspresijski vektor po zahtevku 12.
  14. 14. Postopek izdelave protitelesu podobnega veznega proteina, ki specifično veže MUCl-sialoglikotop povezan s tumorjem CA6, ki obsega izražanje v celici ene ali več nukleinskih kislin, ki kodirajo polipeptide, ki imajo strukture, ki jih predstavljata spodnji formuli (I) in (II): VL.-L.-VL2-CL [I] Vh1-L2-Vh2-Chi [II] kjer: Vli predstavlja variabilno domeno lahke verige imunoglobulina, ki izhaja iz protitelesa DS6; Vl2 je variabilna domena lahke verige imunoglobulina, ki izhaja iz protitelesa DS6; VH1 je variabilna domena težke verige imunoglobulina, ki izhaja iz protitelesa DS6; Vh2 je variabilna domena težke verige imunoglobulina, ki izhaja iz protitelesa DS6; Cl je konstantna domena lahke verige imunoglobulina, kot je konstantna domena lahke verige imunoglobulina humane IGKC; Chi je konstantna domena težke verige imunoglobulina Cm, kot je konstantna domena težke verige imunoglobulina Chi; Li in L2 sta aminokislinska linkeija; in kjer polipeptidi s formulo I in polipeptidi s formulo II tvorijo bivalenten monospecifičen tandem imunoglobulin protitelesu podoben vezni protein; in kjer polipeptid s formulo [I] vsebuje zaporedje, kije vsaj 80% enako z zaporedjem SEQ ID No: 1 in polipeptid s formulo [II] vsebuje zaporedje, ki je vsaj 80% enako z zaporedjem SEQ ID No: 7
  15. 15. Postopek po zahtevku 14, kjer sta Vli in Vl2 definirana z zaporedjem SEQ ID NO: 2; in sta Vm in Vh2 definirana z zaporedjem SEQ ID NO: 8.
SI201430556T 2013-02-05 2014-02-05 Imunokontrastno sredstvo za uporabo pri terapiji s konjugatom protitelo-zdravilo SI2953977T1 (sl)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201361761190P 2013-02-05 2013-02-05
EP14305082 2014-01-21
EP14717073.2A EP2953977B1 (en) 2013-02-05 2014-02-05 Immuno imaging agent for use with antibody-drug conjugate therapy
PCT/IB2014/000279 WO2014122529A1 (en) 2013-02-05 2014-02-05 Immuno imaging agent for use with antibody-drug conjugate therapy

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EP (1) EP2953977B1 (sl)
JP (1) JP6605331B2 (sl)
KR (1) KR20150113197A (sl)
CN (1) CN105229034B (sl)
AU (1) AU2014213687B2 (sl)
CA (1) CA2900154A1 (sl)
DK (1) DK2953977T3 (sl)
ES (1) ES2657053T3 (sl)
HU (1) HUE037909T2 (sl)
LT (1) LT2953977T (sl)
MX (1) MX2015010145A (sl)
PL (1) PL2953977T3 (sl)
PT (1) PT2953977T (sl)
RU (1) RU2015137858A (sl)
SG (2) SG11201506054XA (sl)
SI (1) SI2953977T1 (sl)
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EP1294904A1 (en) * 2000-06-30 2003-03-26 Vlaams Interuniversitair Instituut voor Biotechnologie vzw. Heterodimeric fusion proteins
JP2007503202A (ja) 2003-07-21 2007-02-22 イミュノジェン・インコーポレーテッド Ca6抗原特異的な細胞毒性コンジュゲートおよびその使用方法
JP2009504193A (ja) * 2005-08-22 2009-02-05 イミュノジェン・インコーポレーテッド Ca6抗原特異的細胞傷害性コンジュゲート、および該コンジュゲートを用いる方法
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AU2014213687B2 (en) 2018-12-06
WO2014122529A1 (en) 2014-08-14
DK2953977T3 (en) 2018-01-22
LT2953977T (lt) 2018-02-12
CN105229034A (zh) 2016-01-06
PT2953977T (pt) 2018-01-29
RU2015137858A (ru) 2017-03-13
PL2953977T3 (pl) 2018-04-30
CA2900154A1 (en) 2014-08-14
HUE037909T2 (hu) 2018-09-28
KR20150113197A (ko) 2015-10-07
JP6605331B2 (ja) 2019-11-13
JP2016509606A (ja) 2016-03-31
EP2953977B1 (en) 2017-10-25
SG10201707391QA (en) 2017-10-30
ES2657053T3 (es) 2018-03-01
SG11201506054XA (en) 2015-08-28
MX2015010145A (es) 2016-05-31
AU2014213687A1 (en) 2015-08-20
CN105229034B (zh) 2019-12-10
EP2953977A1 (en) 2015-12-16

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