HRP20220080T1 - Poboljšane imunoglobulinske varijabilne domene koje vežu serumski albumin - Google Patents

Poboljšane imunoglobulinske varijabilne domene koje vežu serumski albumin Download PDF

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HRP20220080T1
HRP20220080T1 HRP20220080TT HRP20220080T HRP20220080T1 HR P20220080 T1 HRP20220080 T1 HR P20220080T1 HR P20220080T T HRP20220080T T HR P20220080TT HR P20220080 T HRP20220080 T HR P20220080T HR P20220080 T1 HRP20220080 T1 HR P20220080T1
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seq
immunoglobulin variable
variable domain
amino acid
single immunoglobulin
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HRP20220080TT
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Marie-Ange Buyse
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Ablynx N.V.
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    • 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
    • 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
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—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
    • 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
    • A61K47/62—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 a protein, peptide or polyamino acid
    • A61K47/64—Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/42—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against immunoglobulins
    • C07K16/4208—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against immunoglobulins against an idiotypic determinant on Ig
    • C07K16/4241—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against immunoglobulins against an idiotypic determinant on Ig against anti-human or anti-animal Ig
    • 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
    • C07K2317/34—Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
    • 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
    • C07K2317/565—Complementarity determining region [CDR]
    • 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
    • C07K2317/567—Framework region [FR]
    • 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®

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biochemistry (AREA)
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  • Genetics & Genomics (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
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  • Pharmacology & Pharmacy (AREA)
  • Endocrinology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Claims (21)

1. Jednostruka imunoglobulinska varijabilna domena koja se veže na serumski albumin koja sadrži: (a) CDR1 prema Abm koja je odabrana od sljedećih sekvenci: GFTFSTGEMA (SEQ ID NO: 8) i GFTFDTSSML (SEQ ID NO:13) i koja je poželjno GFTFDTSSML (SEQ ID NO:13); i (b) CDR2 prema Abm koja je odabrana od sljedećih sekvenci: SISSSGATTY (SEQ ID NO:9) i VIHQSGTPTY (SEQ ID NO:14) i koja je poželjno VIHQSGTPTY (SEQ ID NO:14); i (c) CDR3 prema Abm koja je odabrana od sljedećih sekvenci: PRHPQGGVTFDY (SEQ ID NO:7), FPSTHGKFDY (SEQ ID NO: 12) i FPSSRMKFDY (SEQ ID NO: 15) i koja je poželjno FPSTHGKFDY (SEQ ID NO: 12) ili FPSSRMKFDY (SEQ ID NO: 15) i koja je najpoželjnije FPSSRMKFDY (SEQ ID NO: 15); pri čemu navedena jednostruka imunoglobulinska varijabilna domena ima ne više od 7, kao što je ne više od 5, poželjno ne više od 3, kao što je samo 3, 2 ili 1 aminokiselinskih razlika u okvirima u usporedbi sa sekvencom aminokiseline iz SEQ ID NO: 1, ne uzimajući u obzir mutacije na položaju(ima) 11, 89, 110 ili 112 prema Kabatu koje mogu biti prisutne i ne uzimajući u obzir bilo koje C-terminalno proširenje koje može biti prisutno; u kojoj: - aminokiselinski ostatak na položaju 11 je poželjno odabran od L ili V; i - aminokiselinski ostatak na položaju 89 je poželjno prikladno odabran od T, V ili L; i - aminokiselinski ostatak na položaju 110 je poželjno prikladno odabran od T, K ili Q; i - aminokiselinski ostatak na položaju 112 je poželjno prikladno odabran od S, K ili Q; tako da (i) položaj 89 je T; ili (ii) položaj 89 je L i položaj 11 je V; ili (iii) položaj 89 je L i položaj 110 je K ili Q; ili (iv) položaj 89 je L i položaj 112 je K ili Q; ili (v) položaj 89 je L i položaj 11 je V i položaj 110 je K ili Q; ili (vi) položaj 89 je L i položaj 11 je V i položaj 112 je K ili Q; ili (vii) položaj 11 je V i položaj 110 je K ili Q; ili (viii) položaj 11 je V i položaj 112 je K ili Q; i pri čemu navedena jednostruka imunoglobulinska varijabilna domena ima smanjeno vezanje s već postojećim protutijelima prisutnim u serumu pacijenata sa SLE u usporedbi sa SEQ ID NO: 1.
2. Jednostruka imunoglobulinska varijabilna domena prema patentnom zahtjevu 1, naznačena time što ima C-terminalno proširenje (X)n, u kojem n je 1 do 10, poželjno 1 do 5, kao što je 1, 2, 3, 4 ili 5 (i poželjno 1 ili 2, kao što je 1); a svaki X je (poželjno prirodno prisutan) aminokiselinski ostatak koji se neovisno bira, te je poželjno neovisno odabran iz skupine koju čine alanin (A), glicin (G), valin (V), leucin (L) ili izoleucin (I).
3. Jednostruka imunoglobulinska varijabilna domena prema bilo kojem od patentnih zahtjeva 1 ili 2, naznačena time što ima D i/ili E1D mutaciju na položaju 1.
4. Jednostruka imunoglobulinska varijabilna domena prema bilo kojem od patentnih zahtjeva 1 do 3, naznačena time što ima: - CDR1 prema Abm koja je GFTFDTSSML (SEQ ID NO: 13); i - CDR2 prema Abm koja je VIHQSGTPTY (SEQ ID NO:14); i - CDR3 prema Abm koja je odabrana od sljedećih sekvenci: FPSTHGKFDY (SEQ ID NO: 12) ili FPSSRMKFDY (SEQ ID NO: 15) i koja je poželjno FPSSRMKFDY (SEQ ID NO: 15).
5. Jednostruka imunoglobulinska varijabilna domena prema patentnom zahtjevu 4, naznačena time što ima: - CDR1 prema Abm koja je GFTFDTSSML (SEQ ID NO: 13); i - CDR2 prema Abm koja je VIHQSGTPTY (SEQ ID NO:14); i - CDR3 prema Abm koja je FPSSRMKFDY (SEQ ID NO: 15).
6. Jednostruka imunoglobulinska varijabilna domena prema bilo kojem od patentnih zahtjeva 1 do 5, naznačena time što ima: - ne više od 5 aminokiselinskih razlika u okvirima u usporedbi sa sekvencom aminokiseline iz SEQ ID NO: 1, ne uzimajući u obzir bilo koje mutacije na položaju(ima) 11, 89, 110 ili 112 koje mogu biti prisutne i ne uzimajući u obzir bilo koje C-terminalno proširenje koje može biti prisutno.
7. Jednostruka imunoglobulinska varijabilna domena prema bilo kojem od patentnih zahtjeva 1 do 6, koja sadrži sljedeće aminokiselinske ostatke: - 11V u kombinaciji s 89L; ili - 11V u kombinaciji s 110K ili 110Q; - 11V u kombinaciji s 112K ili 112Q; - 11V u kombinaciji s 89L i 110K ili 110Q; ili - 11V u kombinaciji s 89L i 112K ili 112Q.
8. Jednostruka imunoglobulinska varijabilna domena prema bilo kojem od patentnih zahtjeva 1 do 7, koja sadrži sljedeće aminokiselinske ostatke: - 89L u kombinaciji s 11V; ili - 89L u kombinaciji s 110K ili 110Q; ili - 89L u kombinaciji s 112K ili 112Q; ili - 89L u kombinaciji s 11V i 110K ili 110Q; ili - 89L u kombinaciji s 11V i 112K ili 112Q.
9. Jednostruka imunoglobulinska varijabilna domena prema bilo kojem od patentnih zahtjeva 1 do 7, koja sadrži sljedeće aminokiselinske ostatke: - 110K ili 110Q u kombinaciji s 11V; ili - 110K ili 110Q u kombinaciji s 89L; ili - 110K ili 110Q u kombinaciji s 11V i 89L.
10. Jednostruka imunoglobulinska varijabilna domena prema bilo kojem od patentnih zahtjeva 1 do 7, koja sadrži sljedeće aminokiselinske ostatke: - 112K ili 112Q u kombinaciji s 11V; ili - 112K ili 112Q u kombinaciji s 89L; ili - 112K ili 112Q u kombinaciji s 11V i 89L.
11. Jednostruka imunoglobulinska varijabilna domena prema bilo kojem od patentnih zahtjeva 1 do 7, koja sadrži sljedeći aminokiselinski ostatak: - 89T.
12. Jednostruka imunoglobulinska varijabilna domena prema patentnom zahtjevu 1, naznačena time što ima sekvencu aminokiseline koja je odabrana od sekvenci aminokiselina prema SEQ ID NO: 16 do 99.
13. Jednostruka imunoglobulinska varijabilna domena prema patentnom zahtjevu 12, naznačena time što ima sekvencu aminokiseline koja je odabrana od sekvenci aminokiselina prema SEQ ID NO: 44 do 99.
14. Jednostruka imunoglobulinska varijabilna domena prema patentnom zahtjevu 13, naznačena time što ima sekvencu aminokiseline koja je jedna od slijedećih sekvenci: SEQ ID NO:72, SEQ ID NO:73, SEQ ID NO:74, SEQ ID NO:75, SEQ ID NO:76, SEQ ID NO:77, SEQ ID NO:79, SEQ ID NO:80, SEQ ID NO:81, SEQ ID NO:82, SEQ ID NO:83, SEQ ID NO:84, SEQ ID NO:85, SEQ ID NO:86, SEQ ID NO:87, SEQ ID NO:88, SEQ ID NO:89, SEQ ID NO:90, SEQ ID NO:91, SEQ ID NO:93, SEQ ID NO:94, SEQ ID NO:95, SEQ ID NO:96, SEQ ID NO:97, SEQ ID NO:98 ili SEQ ID NO:99.
15. Jednostruka imunoglobulinska varijabilna domena prema patentnom zahtjevu 13, naznačena time što ima sekvencu aminokiseline koja je jedna od slijedećih sekvenci: SEQ ID NO: 50, SEQ ID NO: 64, SEQ ID NO: 78 ili SEQ ID NO: 92, i poželjno SEQ ID NO: 78 ili SEQ ID NO: 92.
16. Protein, polipeptid, konstrukt, molekula ili kemijski entitet koji sadrži jednu ili više jednostrukih imunoglobulinskih varijabilnih domena prema bilo kojem od patentnih zahtjeva 1 do 15.
17. Nukleinska kiselina naznačena time što kodira jednostruku imunoglobulinsku varijabilnu domenu prema bilo kojem od patentnih zahtjeva 1-15 i/ili protein ili polipeptid prema patentnom zahtjevu 16.
18. Ne-ljudski domaćin ili stanica domaćin koja sadrži nukleinsku kiselinu prema patentnom zahtjevu 17, i/ili koja eksprimira jednostruku imunoglobulinsku varijabilnu domenu prema bilo kojem od patentnih zahtjeva 1-15, ili polipeptid prema patentnom zahtjevu 16.
19. Postupci za pripravu imunoglobulinske varijabilne domene prema bilo kojem od patentnih zahtjeva 1-15 i/ili polipeptida prema patentnom zahtjevu 16, naznačeni time što obuhvaćaju kultiviranje ili održavanje stanice domaćina prema patentnom zahtjevu 18 pod uvjetima u kojima navedena stanica domaćin proizvodi ili eksprimira imunoglobulinsku varijabilnu domenu ili polipeptid, te po izboru izoliranje tako dobivene imunoglobulinske varijabilne domene ili polipeptida.
20. Pripravak ili proizvod koji sadrži jednostruku imunoglobulinsku varijabilnu domenu prema bilo kojem od patentnih zahtjeva 1-15 i/ili protein, polipeptid, konstrukt, molekulu ili kemijski entitet prema patentnom zahtjevu 16.
21. Jednostruka imunoglobulinska varijabilna domena prema bilo kojem od patentnih zahtjeva 1-15 ili protein, polipeptid, konstrukt, molekula ili kemijski entitet prema patentnom zahtjevu 16 za upotrebu u terapiji.
HRP20220080TT 2015-11-13 2016-10-28 Poboljšane imunoglobulinske varijabilne domene koje vežu serumski albumin HRP20220080T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201562254813P 2015-11-13 2015-11-13
EP16790934.0A EP3374392B1 (en) 2015-11-13 2016-10-28 Improved serum albumin-binding immunoglobulin variable domains
PCT/EP2016/076088 WO2017080850A1 (en) 2015-11-13 2016-10-28 Improved serum albumin-binding immunoglobulin variable domains

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US (2) US11142569B2 (hr)
EP (2) EP3974449A1 (hr)
JP (2) JP7195142B2 (hr)
CN (2) CN108290943A (hr)
AU (1) AU2016351710B2 (hr)
DK (1) DK3374392T3 (hr)
ES (1) ES2905912T3 (hr)
HR (1) HRP20220080T1 (hr)
HU (1) HUE057241T2 (hr)
LT (1) LT3374392T (hr)
PL (1) PL3374392T3 (hr)
PT (1) PT3374392T (hr)
RS (1) RS62857B1 (hr)
SI (1) SI3374392T1 (hr)
WO (1) WO2017080850A1 (hr)

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