# US 9,040,668 B2 · Anti-serum albumin binding variants

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- Number: US 9,040,668 B2
- Document ID: US9040668B2
- Status: Granted
- Kind: B2
- Application number: 13/698,794
- Filed: 2011-05-20
- Published: 2013-05-23
- Granted: 2015-05-26
- Earliest claimed: 2010-05-20
- Assignees: Glaxo Group Limited
- Applicants: Elena De Angelis; Carolyn Enever; Haiqun Liu; Oliver Schon; Malgorzata Pupecka-Swider
- Inventors: Elena De Angelis; Carolyn Enever; Haiqun Liu; Oliver Schon; Malgorzata Pupecka-Swider
- Web page: https://patentgrep.com/patent/US9040668B2

## CPC

- C07K 16/18: against material from animals or humans
- A61K 47/6843: {the antibody targeting a material from animals or humans}
- A61P 3/10: for hyperglycaemia, e.g. antidiabetics
- C07K 16/2878: {against the NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95}
- C07K 16/468: {Immunoglobulins having two or more different antigen binding sites, e.g. multifunctional antibodies}
- A61K 2039/505: {comprising antibodies}
- C07K 14/765: Serum albumin, e.g. HSA
- C07K 2317/21: from primates, e.g. man
- C07K 2317/31: multispecific
- C07K 2317/565: Complementarity determining region [CDR]
- C07K 2317/567: Framework region [FR]
- C07K 2317/569: Single domain, e.g. dAb, sdAb, VHH, VNAR or nanobody®
- C07K 2317/92: Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
- C07K 2317/94: Stability, e.g. half-life, pH, temperature or enzyme-resistance
- C07K 2319/00: Fusion polypeptide
- C07K 2319/31: fusions, other than Fc, for prolonged plasma life, e.g. albumin
- C07K 2319/33: fusions for targeting to specific cell types, e.g. tissue specific targeting, targeting of a bacterial subspecies
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

The invention relates to improved variants of the anti-serum albumin immunoglobulin single variable domain DOM7h-11, as well as ligands and drug conjugates comprising such variants, compositions, nucleic acids, vectors and hosts.

## Claims

### Claim 1

An anti-serum albumin (SA) immunoglobulin single variable domain comprising an amino acid sequence selected from the group consisting of: SEQ ID NO: 412 (DOM7h-11-56), SEQ ID NO: 413 (DOM7h-11-57), SEQ ID NO: 414 (DOM7h-11-65), SEQ ID NO: 415 (DOM7h-11-67), SEQ ID NO: 416 (DOM7h-11-68), SEQ ID NO: 417 (DOM7h-11-69), SEQ ID NO:418 (DOM7h-11-79), SEQ ID NO:419 (DOM7h-11-80), SEQ ID NO:420 (DOM7h-11-90), SEQ ID NO:421 (DOM7h-11-86), SEQ ID NO:422 (DOM7h-11-87), and SEQ ID NO:423 (DOM7h-11-88).

### Claim 2 (depends on 1)

A multispecific ligand comprising the anti-SA immunoglobulin single variable domain of claim 1, and a binding moiety that specifically binds a target antigen other than SA.

### Claim 3 (depends on 1)

The anti-SA immunoglobulin single variable domain of claim 1, wherein the variable domain is conjugated to a new chemical entity (NCE) drug.

### Claim 4 (depends on 1)

A fusion protein comprising a polypeptide or peptide drug fused to the anti-SA immunoglobulin single variable domain according to claim 1, wherein the fusion protein comprises a linker selected from the group consisting of: SEQ ID NO: 437 (TVAAPS) and TVA between the single variable domain and the drug.

### Claim 5 (depends on 1)

A composition comprising the anti-SA immunoglobulin single variable domain of claim 1, and a pharmaceutically acceptable diluent, carrier, excipient or vehicle.

### Claim 6 (depends on 4)

A composition comprising the fusion protein of claim 4, and a pharmaceutically acceptable diluent, carrier, excipient or vehicle.

### Claim 7 (depends on 2)

A composition comprising the multispecific ligand of claim 2, and a pharmaceutically acceptable diluent, carrier, excipient or vehicle.

### Claim 8

An anti-SA immunoglobulin single variable domain comprising SEQ ID NO:421 (DOM7h-11-86).

### Claim 9

An anti-SA immunoglobulin single variable domain comprising SEQ ID NO:420 (DOM7h-11-90).