# US 9,040,048 B2 · Antibody molecules having specificity for human OX40

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- Number: US 9,040,048 B2
- Document ID: US9040048B2
- Status: Granted
- Kind: B2
- Application number: 13/672,077
- Filed: 2012-11-08
- Published: 2013-09-19
- Granted: 2015-05-26
- Earliest claimed: 2011-11-11
- Assignees: Ucb Biopharma Sprl
- Applicants: Ucb Pharma S.A.
- Inventors: Ralph Adams; Pallavi Bhatta; Sam Philip Heywood; David Paul Humphreys
- Web page: https://patentgrep.com/patent/US9040048B2

## CPC

- C07K 16/18: against material from animals or humans
- A61K 39/3955: {against proteinaceous materials, e.g. enzymes, hormones, lymphokines}
- A61P 1/04: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
- A61P 3/10: for hyperglycaemia, e.g. antidiabetics
- A61P 11/00: Drugs for disorders of the respiratory system
- A61P 11/06: Antiasthmatics
- A61P 13/12: of the kidneys
- A61P 19/02: for joint disorders, e.g. arthritis, arthrosis
- A61P 21/04: for myasthenia gravis
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 37/00: Drugs for immunological or allergic disorders
- 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)
- C07K 16/2866: {against receptors for cytokines, lymphokines, interferons}
- C07K 16/2878: {against the NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95}
- A61K 2039/505: {comprising antibodies}
- C07K 2317/31: multispecific
- C07K 2317/55: Fab or Fab'
- C07K 2317/622: Single chain antibody (scFv)
- C07K 2317/624: Disulfide-stabilized antibody (dsFv)
- C07K 2317/64: comprising a combination of variable region and constant region components
- C07K 2317/73: Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
- C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- 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: 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 antibody molecules having specificity for antigenic determinants of human OX40, therapeutic uses of the antibody molecules and methods for producing said antibody molecules.

## Claims

### Claim 1

A bispecific antibody fusion protein which binds human OX40 and human serum albumin comprising:
a heavy chain comprising, in sequence from the N-terminal, a first heavy chain variable domain (VH1), a CH1 domain and a second heavy chain variable domain (VH2),
a light chain comprising, in sequence from the N-terminal, a first light chain variable domain (VL1), a CL domain and a second light chain variable domain (VL2),
wherein said heavy and light chains are aligned such that VH1 and VL1 form a first antigen binding site and VH2 and VL2 form a second antigen binding site,
wherein the antigen bound by the first antigen binding site is human OX40 and the antigen bound by the second antigen binding site is human serum albumin,
wherein the first variable domain of the heavy chain (VH1)comprises the sequence given in SEQ ID NO:1 for CDR-H1, the sequence given in SEQ ID NO:2 for CDR-H2 and the sequence given in SEQ ID NO:3 for CDR-H3 and the first variable domain of the light chain (VL1comprises the sequence given in SEQ ID NO:4 for CDR-L1, the sequence given in SEQ ID NO:5 for CDR-L2 and the sequence given in SEQ ID NO:6 for CDR-L3,
wherein the second heavy chain variable domain (VH2)has the sequence given in SEQ ID NO:11 and the second light chain variable domain (VL2)has the sequence given in SEQ ID NO:12 and
the second heavy chain variable domain (VH2)and second light chain variable domain (VL2) are linked by a disulphide bond.

### Claim 2 (depends on 1)

The bispecific antibody fusion protein according to claim 1 which antagonises the binding of OX40 to OX40L.

### Claim 3 (depends on 1, 2)

A bispecific antibody fusion protein according to claim 1 or claim 2 in which there is a peptide linker between the CH1 domain and the second heavy chain variable domain (VH2).

### Claim 4 (depends on 1, 2)

The bispecific antibody fusion protein according to claim 1 or 2 in which there is a peptide linker between the CL domain and the second light chain variable domain (VL1).

### Claim 5 (depends on 1, 2)

The antibody fusion protein according to claim 1 or 2 wherein the first heavy chain variable domain (VH1)comprises the sequence given in SEQ ID NO:8.

### Claim 6 (depends on 1, 2)

The antibody fusion protein according to claim 1 or 2 wherein the first light chain variable domain (VL1comprises the sequence given in SEQ ID NO:7.

### Claim 7 (depends on 1, 2)

The antibody fusion protein according to claim 1 or 2, wherein the heavy chain comprises the sequence given in SEQ ID NO:15.

### Claim 8 (depends on 1, 2)

The antibody fusion protein according to claim 1 or 2, wherein the light chain comprises the sequence given in SEQ ID NO:16.

### Claim 9 (depends on 1, 2)

A pharmaceutical composition comprising a bispecific antibody fusion protein according to claim 1 or 2, in combination with one or more of a pharmaceutically acceptable excipient, diluent or carrier.

### Claim 10 (depends on 9)

The pharmaceutical composition according to claim 9, additionally comprising other active ingredients.

### Claim 11

A bispecific antibody fusion protein which binds human OX40 and human serum albumin, having a heavy chain comprising the sequence given in SEQ ID NO:15 and a light chain comprising the sequence given in SEQ ID NO:16.