# US 11,897,944 B2 · Immunoglobulin single variable domain (ISVD) capable of binding to serum albumin

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- Number: US 11,897,944 B2
- Document ID: US11897944B2
- Status: Granted
- Kind: B2
- Application number: 16/477,927
- Filed: 2018-01-17
- Published: 2019-12-05
- Granted: 2024-02-13
- Earliest claimed: 2017-01-17
- Assignees: Ablynx N.V.
- Applicants: Ablynx N.V.
- Inventors: Stephanie Staelens; Soren Steffensen; Erika Morizzo; An Cerdobbel
- Web page: https://patentgrep.com/patent/US11897944B2

## CPC

- C07K 16/18: against material from animals or humans
- A61K 2039/505: {comprising antibodies}
- C07K 2317/22: from camelids, e.g. camel, llama or dromedary
- C07K 2317/24: containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
- C07K 2317/30: characterized by aspects of specificity or valency
- C07K 2317/33: Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
- C07K 2317/50: characterized by immunoglobulin fragments
- C07K 2317/56: variable (Fv) region, i.e. VH and/or VL
- C07K 2317/569: Single domain, e.g. dAb, sdAb, VHH, VNAR or nanobody®
- C07K 2317/62: comprising only variable region components
- C07K 2317/622: Single chain antibody (scFv)
- C07K 2317/624: Disulfide-stabilized antibody (dsFv)
- C07K 2317/626: Diabody or triabody
- C07K 2317/92: Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)

## Abstract

The present invention relates to amino acid sequences that can bind to serum albumin. In particular, the present invention relates to immunoglobulin single variable domains, and in particular heavy-chain immunoglobulin single variable domains, that can bind to serum albumin. The invention also relates to proteins, polypeptides and other constructs, compounds, molecules or chemical entities that comprise at least one of the immunoglobulin single variable domains binding to serum albumin that are described herein.

## Claims

### Claim 1

An immunoglobulin single variable domain (ISVD) capable of binding to serum albumin that comprises:
a complementarity-determining region 1 (CDR1) having the amino acid sequence GSNISSYVMG (SEQ ID NO: 11) or GSTISSYVMG (SEQ ID NO: 12); and
a complementarity-determining region 2 (CDR2) having the amino acid sequence AISRSGGYTY (SEQ ID NO: 13); and
a complementarity-determining region 3 (CDR3) having the amino acid sequence GRYSAWYSQSYEYDY (SEQ ID NO: 14).

### Claim 2 (depends on 1)

The ISVD according to claim 1, wherein the CDR1 has the amino acid sequence GSNISSYVMG (SEQ ID NO:11).

### Claim 3 (depends on 1)

The ISVD according to claim 1, wherein the CDR1 has the amino acid sequence GSTISSYVMG (SEQ ID NO: 12).

### Claim 4 (depends on 1)

The ISVD according to claim 1, that is a heavy-chain immunoglobulin single variable domain.

### Claim 5 (depends on 1)

The ISVD according to claim 1, that is a VHH, a humanized VHH or a camelized VH.

### Claim 6 (depends on 1)

The ISVD according to claim 1, that has a degree of sequence identity with the sequence of SEQ ID NO: 18 of at least 85%,
wherein the CDRs are not taken into account for determining the degree of sequence identity.

### Claim 7 (depends on 6)

The ISVD according to claim 6, that has no more than 7 amino acid differences with the sequence of SEQ ID NO: 18,
wherein the CDRs are not taken into account for determining the amino acid differences.

### Claim 8 (depends on 1)

The ISVD according to claim 1, that has a degree of sequence identity with the sequence of SEQ ID NO: 19 of at least 85%,
wherein the CDRs are not taken into account for determining the degree of sequence identity.

### Claim 9 (depends on 8)

The ISVD according to claim 8, that has no more than 7 amino acid differences with the sequence of SEQ ID NO: 19, wherein the CDRs are not taken into account for determining the amino acid differences.

### Claim 10 (depends on 1)

The ISVD according to claim 1, wherein the ISVD is capable of cross-blocking the binding of the amino acid sequence of SEQ ID NO: 18 and/or SEQ ID NO: 19 to human serum albumin.

### Claim 11 (depends on 1)

The ISVD according to claim 1, further comprising:
a leucine (L), a lysine (K), or a valine (V) at Kabat position 11;
an alanine (A) or a proline (P) at Kabat position 14;
an alanine (A), a leucine (L), a proline (P), a serine (S), or a threonine (T) at Kabat position 41;
a glutamic acid (E) or a glycine (G) at Kabat position 42;
an alanine (A) or a threonine at Kabat position 87;
an alanine (A), a leucine (L), or a threonine at Kabat position 89;
a leucine (L) at Kabat position 108;
a lysine (K) or a glutamine (Q) at Kabat position 110;
a lysine (K) or a glutamine (Q) at Kabat position 112; or
a combination thereof.

### Claim 12 (depends on 1)

The ISVD according to claim 1, that is a VHH and that contains a proline (P) at Kabat position 14 and/or glutamine (Q) at Kabat position 108.

### Claim 13

An immunoglobulin single variable (ISVD) domain capable of binding to serum albumin and that is chosen from one of the amino acid sequences of SEQ ID NOs: 18 to 59.

### Claim 14 (depends on 1)

A polypeptide that comprises the ISVD capable of binding to serum albumin according to claim 1.

### Claim 15 (depends on 14)

The polypeptide according to claim 14:
wherein the polypeptide comprises an ISVD having: a leucine (L), a lysine (K), or a valine (V) at Kabat position 11; an alanine (A) or a proline (P) at Kabat position 14; an alanine (A), a leucine (L), a proline (P), a serine (S), or a threonine (T) at Kabat position 41; a glutamic 11475485.1 acid (E) or a glycine (G) at Kabat position 42; an alanine (A) or a threonine at Kabat position 87; an alanine (A), a leucine (L), or a threonine at Kabat position 89; a leucine (L) at Kabat position 108; a lysine (K) or a glutamine (Q) at Kabat position 110; a lysine (K) or a glutamine (Q) at Kabat position 112; or a combination thereof.

### Claim 16 (depends on 14)

A pharmaceutical composition comprising the polypeptide according to claim 14.