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NZ743471B2 - Improved immunoglobulin variable domains - Google Patents
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NZ743471B2 - Improved immunoglobulin variable domains - Google Patents

Improved immunoglobulin variable domains Download PDF

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Publication number
NZ743471B2
NZ743471B2 NZ743471A NZ74347115A NZ743471B2 NZ 743471 B2 NZ743471 B2 NZ 743471B2 NZ 743471 A NZ743471 A NZ 743471A NZ 74347115 A NZ74347115 A NZ 74347115A NZ 743471 B2 NZ743471 B2 NZ 743471B2
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NZ
New Zealand
Prior art keywords
amino acid
heavy
single variable
variable domain
immunoglobulin single
Prior art date
Application number
NZ743471A
Other versions
NZ743471A (en
Inventor
Carlo Boutton
Marie Ange Buyse
Original Assignee
Ablynx Nv
Filing date
Publication date
Application filed by Ablynx Nv filed Critical Ablynx Nv
Publication of NZ743471A publication Critical patent/NZ743471A/en
Publication of NZ743471B2 publication Critical patent/NZ743471B2/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
    • C07K16/24—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
    • C07K2317/30—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
    • 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

Disclosed are heavy chain immunoglobulin single variable domains (ISVD) that are directed against TNF comprising CDRs according to SEQ ID NOs 317-319 or SEQ ID NOs 335-337, and in which (i) position 112 is K or Q; or (ii) position 110 is K or Q and position 11 is V; or (iii) position 89 is T and position 11 is V; or (iv) position 89 is L and position 110 is K or Q; or (v) position 11 is V and position 89 is L; or any suitable combination of (i) to (v), wherein the amino acid residues are indicated with the numbering according to Kabat. Also disclosed are heavy chain ISVDs in which the amino acid residue at position 89 is T and (i) the amino acid residue at position 11 is V or (ii) the ISVD contains a C-terminal extension (X)n in which n is 1 to 10 and each X is an amino acid residue that is independently chosen, wherein the amino acid residues are indicated with the numbering according to Kabat.

Claims (19)

1. A heavy-chain immunoglobulin single variable domain that is directed against TNF, in which (i) CDR1 is SEQ ID NO: 317; (ii) CDR2 is SEQ ID NO: 318; and (iii) CDR3 is SEQ ID NO: 319, or in which (i) CDR1 is SEQ ID NO: 335; (ii) CDR2 is SEQ ID NO: 336; and (iii) CDR3 is SEQ ID NO: 337; and in which (i) position 112 is K or Q; or (ii) position 110 is K or Q and position 11 is V; or (iii) position 89 is T and position 11 is V; or (iv) position 89 is L and position 110 is K or Q; or (v) position 11 is V and position 89 is L; or any suitable combination of (i) to (v), wherein the amino acid positions are indicated with the numbering according to Kabat.
2. The heavy-chain immunoglobulin single variable domain according to claim 1, in which: ­ the amino acid residue at position 11 is chosen from L, V or K; and ­ the amino acid residue at position 14 is chosen from A or P; and ­ the amino acid residue at position 41 is chosen from A or P; and ­ the amino acid residue at position 89 is chosen from T, V or L; and ­ the amino acid residue at position 108 is chosen from Q or L; and ­ the amino acid residue at position 110 is chosen from T, K or Q; and ­ the amino acid residue at position 112 is chosen from S, K or Q; such that either (i) position 112 is K or Q; or (ii) position 110 is K or Q and position 11 is V; or (iii) position 89 is T and position 11 is V; or (iv) position 89 is L and position 110 is K or Q; or (v) position 11 is V and position 89 is L; or any suitable combination of (i) to (v) , wherein the amino acid positions are indicated with the numbering according to Kabat.
3. The heavy-chain immunoglobulin single variable domain according to any one of claim 1 or 2 in which the amino acid residue at position 112 is K or Q, wherein the amino acid positions are indicated with the numbering according to Kabat.
4. The heavy-chain immunoglobulin single variable domain according to any one of claim 1 or 2 in which the amino acid residue at position 110 is K or Q and the amino acid 219 residue at position 11 is V, wherein the amino acid positions are indicated with the numbering according to Kabat.
5. The heavy-chain immunoglobulin single variable domain according to any one of claim 1 or 2 in which the amino acid residue at position 89 is T and position 11 is V, wherein the amino acid positions are indicated with the numbering according to Kabat.
6. The heavy-chain immunoglobulin single variable domain according to any one of claim 1 or 2 in which the amino acid residue at position 89 is L and the amino acid residue at position 110 is K or Q, wherein the amino acid positions are indicated with the numbering according to Kabat.
7. The heavy-chain immunoglobulin single variable domain according to any one of claim 1 or 2 in which the amino acid residue at position 11 is V and the amino acid residue at position 89 is L, wherein the amino acid positions are indicated with the numbering according to Kabat.
8. The heavy-chain immunoglobulin single variable domain according to any one of the preceding claims that further contains (i) an P14A substitution or an A14P substitution and/or (ii) a Q108L substitution, wherein the amino acid positions are indicated with the numbering according to Kabat.
9. The heavy-chain immunoglobulin single variable domain according to any one of the preceding claims, in which said heavy-chain immunoglobulin single variable domain contains a C-terminal extension (X)n , in which (i) n is 1 to 10; and (ii) each X is an amino acid residue that is independently chosen.
10. The heavy-chain immunoglobulin single variable domain according to claim 9, wherein n is 1 to 5.
11. The heavy-chain immunoglobulin single variable domain according to claim 9, wherein n is 1 or 2. 220
12. The heavy-chain immunoglobulin single variable domain according to claim 9, wherein n is 1.
13. The heavy-chain immunoglobulin single variable domain according to any one of claims 9 to 12 wherein each X is a naturally occurring amino acid residue that is independently chosen.
14. The heavy-chain immunoglobulin single variable domain according to any one of claims 9 to 12 wherein each X is independently chosen from the group consisting of alanine (A), glycine (G), valine (V), leucine (L) or isoleucine (I).
15. The heavy-chain immunoglobulin single variable domain according to any one of the preceding claims, which is a VHH domain, a humanized VHH domain or a camelized VH domain.
16. The heavy-chain immunoglobulin single variable domain according to claim 1 or 2, having an amino acid sequence that is chosen from the amino acid sequences of SEQ ID NO’s: 320, 324 to 330, 332 to 333.
17. The heavy-chain immunoglobulin single variable domain according to claim 1 or 2, having an amino acid sequence that is chosen from the amino acid sequences of SEQ ID NO’s: 338, 342 to 348, 350 to 351.
18. Protein, polypeptide or other compound or construct that comprises at least one heavy-chain immunoglobulin single variable domain according to any one of claims 1 to 17.
19. Protein, polypeptide or other compound or construct according to claim 18, that has a half-life (expressed as t
NZ743471A 2015-05-13 Improved immunoglobulin variable domains NZ743471B2 (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
NZ743471A NZ743471A (en) 2024-07-26
NZ743471B2 true NZ743471B2 (en) 2024-10-30

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