# US 10,118,949 B2 · Compositions, methods and uses

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- Number: US 10,118,949 B2
- Document ID: US10118949B2
- Status: Granted
- Kind: B2
- Application number: 14/551,931
- Filed: 2014-11-24
- Published: 2015-06-11
- Granted: 2018-11-06
- Earliest claimed: 2007-07-31
- Assignees: Affibody AB
- Applicants: Affibody AB
- Inventors: Lars Abrahmsén; Andreas Jonsson; Jakob Dogan; Per-Åke Nygren
- Web page: https://patentgrep.com/patent/US10118949B2

## CPC

- C07K 14/00: Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K 14/31: from Staphylococcus (G)
- C07K 14/315: from Streptococcus (G), e.g. Enterococci
- C07K 14/535: Granulocyte CSF; Granulocyte-macrophage CSF
- C07K 14/605: Glucagons
- C07K 14/61: Growth hormone [GH], i.e. somatotropin
- C07K 14/755: Factors VIII {, e.g. factor VIII C (AHF), factor VIII Ag (VWF)}
- C07K 16/18: against material from animals or humans
- A61K 38/00: Medicinal preparations containing peptides (peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00)
- C07K 2319/00: Fusion polypeptide
- C07K 2319/70: containing domain for protein-protein interaction
- 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 a class of engineered polypeptides having a binding affinity for albumin. It also relates to new methods and uses that exploit binding by these and other compounds to albumin in different contexts, some of which have significance for the treatment of disease in mammals including humans.

## Claims

### Claim 1

An engineered albumin binding polypeptide comprising SEQ ID NO:266, SEQ ID NO: 272, SEQ ID NO: 282, SEQ ID NO: 284, SEQ ID NO: 306, SEQ ID NO: 496, or SEQ ID NO: 500; or the amino acid sequence having 93% or greater identity to the full-length sequence of SEQ ID NO:266, SEQ ID NO: 272, SEQ ID NO: 282, SEQ ID NO: 284, SEQ ID NO: 306, SEQ ID NO: 496, or SEQ ID NO: 500: wherein the albumin binding polypeptide binds to human serum albumin such that the KD value of the interaction is at most 1×10−9 M.

### Claim 2 (depends on 1)

The albumin binding polypeptide according to claim 1, wherein the amino acid sequence comprises SEQ ID NO: 496 or the amino acid sequence having 93% or greater identity to the full-length sequence of SEQ ID NO: 496.

### Claim 3 (depends on 1)

The albumin binding polypeptide according to claim 1, which binds to human serum albumin such that the KD value of the interaction is at most 1×10−10 M.

### Claim 4 (depends on 3)

The albumin binding polypeptide according to claim 3, which binds to human serum albumin such that the KD value of the interaction is at most 1×10−11 M.

### Claim 5 (depends on 4)

The albumin binding polypeptide according to claim 4, which binds to human serum albumin such that the KD value of the interaction is at most 1×10−12 M.

### Claim 6 (depends on 1)

The albumin binding polypeptide according to claim 1, further comprising one or more additional amino acid(s) positioned on one or both sides of the albumin binding motif.

### Claim 7 (depends on 6)

The albumin binding polypeptide according to claim 6, in which said additional amino acid(s) enhance binding of albumin by the polypeptide.

### Claim 8 (depends on 6)

The albumin binding polypeptide according to claim 6, in which said additional amino acid(s) improves a characteristic selected from production, purification, stabilization in vivo or in vitro, coupling and detection of the polypeptide, and any combination thereof.

### Claim 9 (depends on 1)

A multimer of albumin binding polypeptides, comprising at least two albumin binding polypeptides according to claim 1 as monomer units.

### Claim 10 (depends on 9)

The multimer according to claim 9, in which the amino acid sequences of the monomer units are the same.

### Claim 11 (depends on 9)

The multimer according to claim 9, in which the amino acid sequences of the monomer units are different.

### Claim 12 (depends on 1)

A fusion protein comprising
i) a first moiety consisting of an albumin binding polypeptide according to claim 1; and
ii) a second moiety consisting of a polypeptide having a desired biological activity.

### Claim 13 (depends on 12)

The fusion protein according to claim 12, in which said desired biological activity is a therapeutic activity.

### Claim 14 (depends on 12)

The fusion protein according to claim 12, in which said desired biological activity is a binding activity.

### Claim 15 (depends on 12)

The fusion protein according to claim 12, in which said desired biological activity is an enzymatic activity.

### Claim 16 (depends on 12)

The fusion protein according to claim 12, in which said second moiety is selected from the group consisting of GLP-1; HGH; G-CSF; IL-1 receptor agonist; TNF-α; and blood clotting factors VII, VIII, IX, X.

### Claim 17 (depends on 12)

The fusion protein according to claim 12, in which said second moiety is a binding moiety capable of selective interaction with a target molecule, which binding moiety is selected from the group consisting of antibodies and fragments and domains thereof retaining antibody binding activity; microbodies, maxybodies, avimers and other small disulfide-bonded proteins; and binding proteins derived from a scaffold selected from the group consisting of staphylococcal protein A and domains thereof, lipocalins, ankyrin repeat domains, cellulose binding domains, Y crystallines, green fluorescent protein, human cytotoxic T lymphocyte-associated antigen 4, protease inhibitors, PDZ domains, peptide aptamers, staphylococcal nuclease, tendamistats, fibronectin type III domain, zinc fingers, conotoxins, and Kunitz domains.

### Claim 18 (depends on 17)

The fusion protein according to claim 17, in which said target molecule is selected from the group consisting of Aβ peptide; disease-associated amyloid peptides; toxins, bacterial toxins, snake venoms; blood clotting factors, von Willebrand factor; interleukins, IL-13; myostatin; pro-inflammatory factors, TNF-α, TNF-α receptor, IL-8; complement factor C3a, complement factor C5a; hypersensitivity mediators, histamine, IgE; tumor-related antigens, CD19, CD20, CD22, CD30, CD33, CD40, CD52, CD70, cMet, HER1, HER2, HER3, HER4, CA9, CEA, IL-2 receptor, MUC1, PSMA, and TAG-72.

### Claim 19 (depends on 12)

The fusion protein according to claim 12, further comprising a label.

### Claim 20 (depends on 19)

The fusion protein according to claim 19, in which said label is selected from the group consisting of fluorescent dyes and metals, chromophoric dyes, chemiluminescent compounds and bioluminescent proteins, enzymes, radionuclides and particles.