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NZ763848B2 - Improved immunoglobulin variable domains - Google Patents
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NZ763848B2 - Improved immunoglobulin variable domains - Google Patents

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Publication number
NZ763848B2
NZ763848B2 NZ763848A NZ76384815A NZ763848B2 NZ 763848 B2 NZ763848 B2 NZ 763848B2 NZ 763848 A NZ763848 A NZ 763848A NZ 76384815 A NZ76384815 A NZ 76384815A NZ 763848 B2 NZ763848 B2 NZ 763848B2
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New Zealand
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amino acid
acid residue
heavy
kabat
chain isvd
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NZ763848A
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NZ763848A (en
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Carlo Boutton
Marie Ange Buyse
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Ablynx Nv
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Application filed by Ablynx Nv filed Critical Ablynx Nv
Publication of NZ763848A publication Critical patent/NZ763848A/en
Publication of NZ763848B2 publication Critical patent/NZ763848B2/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • 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
    • 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
    • C07K16/22—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
    • 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
    • C07K16/24—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • 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
    • C07K16/24—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/241—Tumor Necrosis Factors
    • 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
    • C07K16/24—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/244—Interleukins [IL]
    • 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
    • C07K16/28—Immunoglobulins [IG], 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 [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2863—Immunoglobulins [IG], 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
    • 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
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2866—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for cytokines, lymphokines, interferons
    • 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
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2875—Immunoglobulins [IG], 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 [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/30—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • 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
    • C07K16/32—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against translation products of oncogenes
    • 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
    • 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
    • C07K16/4283—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against immunoglobulins against an allotypic or isotypic determinant on Ig
    • C07K16/4291—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against immunoglobulins against an allotypic or isotypic determinant on Ig against IgE
    • 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
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • 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
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/35—Valency
    • 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®
    • 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
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/31—Fusion polypeptide fusions, other than Fc, for prolonged plasma life, e.g. albumin

Abstract

Heavy-chain immunoglobulin single variable domain (ISVD), in which the amino acid residue at position 112 is K or Q, wherein amino acid residue positions in the heavy-chain ISVD are indicated with the numbering according to Kabat.

Claims (28)

1. Heavy-chain immunoglobulin single variable domain (ISVD), in which the amino acid residue at position 112 is K or Q, wherein amino acid residue positions in the heavy-chain ISVD are indicated with the numbering according to Kabat.
2. The heavy-chain ISVD according to claim 1, that has a C-terminal sequence (positions 109 to 113 according to Kabat) that is VTVKS (SEQ ID NO:1) or VTVQS (SEQ ID NO:2), or a sequence that has one amino acid difference (i.e. at one of the positions 109, 110, 111 or 113) with either the sequence VTVKS and/or VTVQS and that still has either the amino acid residue K or Q at position 112.
3. The heavy-chain ISVD according to any of claims 1 or 2, that contains an amino acid residue at position 11 that is chosen from L, E, K, V and Y, wherein amino acid residue positions in the heavy-chain ISVD are indicated with the numbering according to Kabat.
4. The heavy-chain ISVD according to any of claims 1 to 3, in which the amino acid residue at position 11 is E and the amino acid residue at position 112 is K, wherein amino acid residue positions in the heavy-chain ISVD are indicated with the numbering according to Kabat.
5. The heavy-chain ISVD according to any of claims 1 to 3, in which the amino acid residue at position 11 is V and the amino acid residue at position 112 is K, wherein amino acid residue positions in the heavy-chain ISVD are indicated with the numbering according to Kabat.
6. The heavy-chain ISVD according to any of claims 1 to 5, that contains an amino acid residue at position 89 that is chosen from L, M, T and V, wherein amino acid residue positions in the heavy-chain ISVD are indicated with the numbering according to Kabat.
7. The heavy-chain ISVD according to claim 6, that contains an amino acid residue at position 89 that is chosen from L and T, wherein amino acid residue positions in the heavy-chain ISVD are indicated with the numbering according to Kabat.
8. The heavy-chain ISVD according to claim 7, that contains an amino acid residue at position 89 that is L, wherein amino acid residue positions in the heavy-chain ISVD are indicated with the numbering according to Kabat.
9. The heavy-chain ISVD according to claim 7, that contains an amino acid residue at position 89 that is T, wherein amino acid residue positions in the heavy-chain ISVD are indicated with the numbering according to Kabat.
10. The heavy-chain ISVD according to claim 8, in which the amino acid residue at position 89 is L and/or the amino acid residue at position 11 is V, wherein amino acid residue positions in the heavy-chain ISVD are indicated with the numbering according to Kabat.
11. Heavy-chain ISVD according to any of claims 1 to 10, in which the amino acid residue at position 110 is chosen from T, K and Q, wherein amino acid residue positions in the heavy-chain ISVD are indicated with the numbering according to Kabat.
12. The heavy-chain ISVD according to any of claims 1 to 11, in which the amino acid residue at position 108 is L, wherein amino acid residue positions in the heavy-chain ISVD are indicated with the numbering according to Kabat.
13. The heavy-chain ISVD according to claim 1, in which: ­ the amino acid residue at position 11 is one of K, L and V; and ­ the amino acid residue at position 14 is one of A and P; and ­ the amino acid residue at position 41 is one of A and P; and ­ the amino acid residue at position 89 is one of L, M, T and V; and ­ the amino acid residue at position 108 is one of Q and L; and ­ the amino acid residue at position 110 is one of T, K and Q; and ­ the amino acid residue at position 112 is one of K and Q.
14. The heavy-chain ISVD according to claim 13, in which: ­ the amino acid residue at position 11 is one of L and V; and ­ the amino acid residue at position 14 is one of A and P; and ­ the amino acid residue at position 41 is one of A and P; and ­ the amino acid residue at position 89 is one of L, T and V; and ­ the amino acid residue at position 108 is one of Q and L; and ­ the amino acid residue at position 110 is T; ­ the amino acid residue at position 112 is one of K and Q.
15. The heavy-chain ISVD according to claim 13, in which: ­ the amino acid residue at position 11 is V; and ­ the amino acid residue at position 14 is one of A and P; and ­ the amino acid residue at position 41 is one of A and P; and ­ the amino acid residue at position 89 is L; and ­ the amino acid residue at position 108 is one of Q and L; and ­ the amino acid residue at position 110 is T; ­ the amino acid residue at position 112 is one of K and Q.
16. The heavy-chain ISVD according to claim 13, in which: ­ the amino acid residue at position 11 is one of L and V; and ­ the amino acid residue at position 14 is one of A and P; and ­ the amino acid residue at position 41 is one of A and P; and ­ the amino acid residue at position 89 is T; and ­ the amino acid residue at position 108 is one of Q and L; and ­ the amino acid residue at position 110 is T; ­ the amino acid residue at position 112 is one of K and Q.
17. The heavy-chain ISVD according to any of claims 1 to 16, that has a framework 4 (FW4 sequence) that is either: a) one of the FW4 sequences of SEQ ID NOs: 3 to 5, 7 to 14, 16 to 20; b) a sequence that has no more than three amino acid differences with at least one of the FW4 sequences of SEQ ID NOs 3 to 5, 7 to 14, 16 to 20, in which (i) the amino acid residue at the position corresponding to position 112 of the Kabat numbering is either K or Q; and in which (ii) the amino acid residue at the position corresponding to position 103 of the Kabat numbering is W or R; (iii) the amino acid residue at the position corresponding to position 104 of the Kabat numbering is G; (iv) the amino acid residue at the position corresponding to position 106 of the Kabat numbering is G; (v) the amino acid residue at the position corresponding to position 107 of the Kabat numbering is T; (vi) the amino acid residue at the position corresponding to position 108 of the Kabat numbering is Q or L (and in humanized heavy-chain immunoglobulin single variable domains L); (vii) the amino acid residue at the position corresponding to position 109 of the Kabat numbering is V; (viii) the amino acid residue at the position corresponding to position 110 of the Kabat numbering is T; (ix) the amino acid residue at the position corresponding to position 111 of the Kabat numbering is V.
18. The heavy-chain ISVD according to claim 17 wherein the the framework 4 (FW4) is sequence (b) and that has no more than two amino acid differences with at least one of SEQ ID Nos 3 to 5, 7 to 14, 16 to 20.
19. The heavy-chain ISVD according to claim 17 or claim 18, that has a framework 4 (FW4 sequence) that is either: c) WGQGTQVTVKS (SEQ ID NO:3) or WGQGTQVTVQS (SEQ ID NO:12); or d) a sequence that has no more than three amino acid differences with SEQ ID NO:3 and/or SEQ ID NO: 12, in which (i) the amino acid residue at the position corresponding to position 112 of the Kabat numbering is either K or Q; and in which (ii) the amino acid residue at the position corresponding to position 103 of the Kabat numbering is W or R; (iii) the amino acid residue at the position corresponding to position 104 of the Kabat numbering is G; (iv) the amino acid residue at the position corresponding to position 106 of the Kabat numbering is G; (v) the amino acid residue at the position corresponding to position 107 of the Kabat numbering is T; (vi) the amino acid residue at the position corresponding to position 108 of the Kabat numbering is Q or L (and in humanized heavy-chain immunoglobulin single variable domains L); (vii) the amino acid residue at the position corresponding to position 109 of the Kabat numbering is V; (viii) the amino acid residue at the position corresponding to position 110 of the Kabat numbering is T; (ix) the amino acid residue at the position corresponding to position 111 of the Kabat numbering is V.
20. The heavy-chain ISVD according to claim 19 that has a framework 4 (FW4) that is sequence (b) and that has no more than two amino acid differences with SEQ ID NO:3 and/or SEQ ID NO:12.
21. The heavy-chain ISVD according to claim 19 that has a framework 4 (FW4) that is a sequence (b) and that has only one amino acid difference with SEQ ID NO:3 and/or SEQ ID NO:12.
22. The heavy-chain ISVD according to any of claims 1 to 21, wherein the amino acid residue at position 113 is selected from S, T, A, L, P, F, E, V, wherein amino acid residue positions in the heavy-chain ISVD are indicated with the numbering according to Kabat.
23. The heavy-chain ISVD according to any of claims 1 to 22, that is a VHH domain, a humanized VHH domain or a camelized VH domain.
24. The heavy-chain ISVD according to any of claims 1 to 23, which is directed against Kv1.3, IL-23, OX40L, IgE, CXCR4, HER3, TNF, c-Met, RANKL, CXCR7 or A-beta.
25. The heavy-chain ISVD according to any of claims 1 to 23, which can specifically bind to human serum albumin.
26. The heavy-chain ISVD according to claim 25, in which: - CDR1 is the amino acid sequence SFGMS (SEQ ID NO:41); - CDR2 is the amino acid sequence SISGSGSDTLYADSVKG (SEQ ID NO:42); and - CDR3 is the amino acid sequence GGSLSR (SEQ ID NO:43).
27. The heavy-chain ISVD according to any of claims 25 or 326, which has at least 80% sequence identity with at least one of Alb-1 (SEQ ID NO: 52 of , SEQ ID NO:767 in the present specification), Alb-8 (SEQ ID NO: 46) and/or Alb-23 (SEQ ID NO:61).
28. The heavy-chain ISVD according to claim 27 having at least 85% sequence identity with at least one of Alb-1, Alb-8 and/or Alb-23.
NZ763848A 2015-05-13 Improved immunoglobulin variable domains NZ763848B2 (en)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US201461994552P 2014-05-16 2014-05-16
US201462014015P 2014-06-18 2014-06-18
US201462040167P 2014-08-21 2014-08-21
US201462047560P 2014-09-08 2014-09-08
US201562133600P 2015-03-16 2015-03-16
NZ726448A NZ726448B2 (en) 2015-05-13 Improved immunoglobulin variable domains

Publications (2)

Publication Number Publication Date
NZ763848A NZ763848A (en) 2024-08-30
NZ763848B2 true NZ763848B2 (en) 2024-12-03

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