# US 2014/0194596 A1 · Dual Specificity Antibody Fusions

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- Number: US 2014/0194596 A1
- Document ID: US20140194596A1
- Status: Published application
- Kind: A1
- Application number: 14/101,083
- Filed: 2013-12-09
- Published: 2014-07-10
- Earliest claimed: 2007-09-26
- Assignees: UCB Pharma S.A.
- Applicants: UCB Pharma S.A.
- Inventors: David Paul Humphreys; Emma Dave; Laura Griffin; Sam Philip Heywood
- Web page: https://patentgrep.com/patent/US20140194596A1

## CPC

- C07K 16/468: {Immunoglobulins having two or more different antigen binding sites, e.g. multifunctional antibodies}
- A61P 1/04: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
- A61P 1/16: for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
- A61P 3/10: for hyperglycaemia, e.g. antidiabetics
- A61P 9/00: Drugs for disorders of the cardiovascular system
- A61P 9/10: for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
- A61P 9/12: Antihypertensives
- A61P 11/00: Drugs for disorders of the respiratory system
- A61P 11/02: Nasal agents, e.g. decongestants
- A61P 11/06: Antiasthmatics
- A61P 13/12: of the kidneys
- A61P 17/00: Drugs for dermatological disorders
- A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like
- A61P 17/06: Antipsoriatics
- A61P 19/02: for joint disorders, e.g. arthritis, arthrosis
- A61P 25/00: Drugs for disorders of the nervous system
- A61P 27/02: Ophthalmic agents
- A61P 27/12: for cataracts
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 35/00: Antineoplastic agents
- A61P 37/02: Immunomodulators
- A61P 37/06: Immunosuppressants, e.g. drugs for graft rejection
- A61P 37/08: Antiallergic agents (antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14)
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C07K 16/00: Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K 16/18: against material from animals or humans
- C07K 16/245: {IL-1}
- C07K 2317/24: containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
- C07K 2317/31: multispecific
- C07K 2317/522: CH1 domain
- C07K 2317/54: F(ab')2
- C07K 2317/55: Fab or Fab'
- C07K 2317/569: Single domain, e.g. dAb, sdAb, VHH, VNAR or nanobody®
- C07K 2317/64: comprising a combination of variable region and constant region components
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

The present invention provides dual specificity antibody fusion proteins comprising an antibody Fab or Fab′ fragment with specificity for an antigen of interest, said fragment being fused to at least one single domain antibody which has specificity for a second antigen of interest.

## Claims

### Claim 1

A dual specificity antibody fusion protein comprising an antibody Fab fragment or an antibody Fab′ fragment with specificity for an antigen of interest, said fragment being fused to two single domain antibodies that have specificity for serum albumin, wherein one single domain antibody is fused to the C-terminus of the light chain of the Fab fragment or the Fab′ fragment and the other single domain antibody is fused to the C-terminus of the heavy chain of the Fab fragment or the Fab′ fragment, and wherein one single domain antibody is a VH domain comprising the sequence given in SEQ ID NO: 62 for CDR-H1, the sequence given in SEQ ID NO: 63 for CDR-H2 and the sequence given in SEQ ID NO: 64 for CDR-H3, and the other single domain antibody is a VL domain comprising the sequence given in SEQ ID NO: 65 for CDR-L1, the sequence given in SEQ ID NO: 66 for CDR-L2 and the sequence given in SEQ ID NO: 67 for CDR-L3, wherein the VH domain is fused to the C-terminus of the heavy chain of the Fab fragment or the Fab′ fragment and the VL domain is fused to the C-terminus of the light chain of the Fab fragment or the Fab′ fragment.

### Claim 2 (depends on 1)

The fusion protein according to claim 1 wherein each single domain antibody is humanised.

### Claim 3 (depends on 1)

The fusion protein according to claim 1 wherein the Fab or Fab′ is humanised.

### Claim 4 (depends on 1)

The fusion protein according to claim 1, wherein each single domain antibody fused to the antibody Fab or Fab′ fragment is fused via a linker of the amino acid sequence wherein the linker sequence is selected from the group consisting of SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3 and SEQ ID NO: 45.

### Claim 5 (depends on 1)

The fusion protein according to claim 1, in which the VH domain is linked to the C-terminus of the heavy chain of the Fab or Fab′ fragment via a linker having the sequence given in SEQ ID NO: 2 or SEQ ID NO: 45 and the VL domain is linked to the C-terminus of the light chain of the Fab or Fab′ fragment via a linker having the sequence given in SEQ ID NO: 1 or SEQ ID NO: 45.

### Claim 6 (depends on 1)

The fusion protein according to claim 1, wherein the serum albumin is human serum albumin.

### Claim 7 (depends on 1)

A pharmaceutical composition comprising a dual specificity antibody fusion protein of claim 1.
