# US 11,999,772 B2 · Antibodies comprising a polypeptide inserted in framework 3 region

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- Number: US 11,999,772 B2
- Document ID: US11999772B2
- Status: Granted
- Kind: B2
- Application number: 17/259,090
- Filed: 2019-07-10
- Published: 2022-03-10
- Granted: 2024-06-04
- Earliest claimed: 2018-07-11
- Assignees: Ucb Biopharma Srl
- Applicants: Ucb Biopharma Srl
- Inventors: Ralph Adams; Terence Seward Baker; Xiaofeng Liu
- Web page: https://patentgrep.com/patent/US11999772B2

## CPC

- C07K 14/5443: {IL-15}
- C07K 16/00: Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K 14/505: Erythropoietin [EPO]
- C07K 14/535: Granulocyte CSF; Granulocyte-macrophage CSF
- C07K 14/5428: {IL-10}
- C07K 14/55: IL-2
- C07K 16/18: against material from animals or humans
- C07K 16/244: {Interleukins [IL]}
- C07K 16/248: {IL-6}
- C07K 16/2809: {against the T-cell receptor (TcR)-CD3 complex}
- C07K 16/2818: {against CD28 or CD152}
- C07K 2317/24: containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
- C07K 2317/31: multispecific
- C07K 2317/55: Fab or Fab'
- C07K 2317/56: variable (Fv) region, i.e. VH and/or VL
- C07K 2317/567: Framework region [FR]
- C07K 2317/569: Single domain, e.g. dAb, sdAb, VHH, VNAR or nanobody®
- C07K 2317/622: Single chain antibody (scFv)
- 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 2319/00: Fusion polypeptide
- 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)

## Abstract

The present invention provides antibodies comprising a variable (V) domain and an insert polypeptide, wherein the insert polypeptide is within the framework 3 region of the V domain.

## Claims

### Claim 1

An antibody comprising a variable (V) domain and an insert polypeptide, wherein (a) the insert polypeptide is within framework 3 region of the VH domain between amino acid residues 73 and 74, between amino acid residues 74 and 75, or between amino acid residues 75 and 76, or (b) wherein the insert polypeptide is within framework 3 region of the VL domain between amino acid residues 67 and 68, between amino acid residues 68 and 69, or between amino acid residues 69 and 70.

### Claim 2 (depends on 1)

The antibody according to claim 1, wherein the insert polypeptide is in the VH domain: (i) between amino acid residues 73 and 74; (ii) between amino acid residues 74 and 75; or (iii) between amino acid residues 75 and 76.

### Claim 3 (depends on 1)

The antibody according to claim 1, wherein one or more amino acid residues between 73 and 76 of the VH domain are replaced by the insert polypeptide.

### Claim 4 (depends on 1)

The antibody according to claim 1, wherein the insert polypeptide is in the VL domain: (i) between amino acid residues 67 and 68; (ii) between amino acid residues 68 and 69; or (iii) between amino acid residues 69 and 70.

### Claim 5 (depends on 1)

The antibody according to claim 1, wherein one or more amino acid residues between 67 and 70 of the VL domain are replaced by the insert polypeptide.

### Claim 6 (depends on 1)

The antibody according to claim 1, which is a full-length antibody.

### Claim 7 (depends on 1)

The antibody according to claim 1, which is a full-length IgG.

### Claim 8 (depends on 1)

The antibody according to claim 1, which is a Fab, Fab′, F(ab′)2, VHH, or scFv.

### Claim 9 (depends on 1)

The antibody according to claim 1, which is humanised.

### Claim 10 (depends on 1)

The antibody according to claim 1, wherein said V domain binds to human serum albumin.

### Claim 11 (depends on 10)

The antibody according to claim 10, which comprises a VL domain comprising CDR-L1 having the sequence set forth in SEQ ID NO: 3; CDR-L2 having the sequence set forth in SEQ ID NO: 4; and CDR-L3 having the sequence set forth in SEQ ID NO: 5.

### Claim 12 (depends on 11)

The antibody according to claim 11, which comprises a VL domain comprising the sequence set forth in SEQ ID NO: 2 or SEQ ID NO: 102.

### Claim 13 (depends on 12)

The antibody according to claim 12, which comprises a L chain comprising the sequence set forth in SEQ ID NO: 1.

### Claim 14 (depends on 10)

The antibody according to claim 10, which comprises a VH domain comprising CDR-H1 having the sequence set forth in SEQ ID NO: 8; CDR-H2 having the sequence set forth in SEQ ID NO: 9; and CDR-H3 having the sequence set forth in SEQ ID NO: 10.

### Claim 15 (depends on 14)

The antibody according to claim 14, which comprises a VH domain comprising the sequence set forth in SEQ ID NO: 7 or SEQ ID NO: 103.

### Claim 16 (depends on 15)

The antibody according to claim 15, which comprises a H chain comprising the sequence set forth in SEQ ID NO: 6.

### Claim 17 (depends on 1)

The antibody according to claim 1, wherein the insert polypeptide is a cytokine.

### Claim 18 (depends on 17)

The antibody according to claim 17, wherein the cytokine is selected from IL-10, IL-15, IL-2, G-CSF, GM-CSF and EPO.

### Claim 19 (depends on 1)

The antibody according to claim 1, wherein the insert polypeptide is a second antibody.

### Claim 20 (depends on 19)

The antibody according to claim 19, wherein the second antibody is an scFv or a domain antibody.

### Claim 21 (depends on 20)

The antibody according to claim 20, wherein the the domain antibody is a VHH comprising a sequence selected from SEQ ID NOs: 67, 69 and 89.

### Claim 22 (depends on 20)

The antibody according to claim 20, wherein the second antibody binds to the same antigen as the V domain.

### Claim 23 (depends on 22)

The antibody according to claim 22, wherein the second antibody binds to a different epitope compared to the V domain.

### Claim 24 (depends on 20)

The antibody according to claim 20, wherein the second antibody binds to a different antigen to the antibody comprising a V domain.

### Claim 25 (depends on 20)

The antibody according to claim 20, wherein the second antibody binds to IL-17 and the antibody comprising a V domain binds to human serum albumin (HSA).

### Claim 26 (depends on 20)

The antibody according to claim 20, wherein the second antibody binds to CD3 and the antibody comprising a V domain binds to CD28.

### Claim 27 (depends on 20)

The antibody according to claim 20, wherein the second antibody binds to CD28 and the antibody comprising a V domain binds to CD3.

### Claim 28 (depends on 1)

An isolated DNA molecule or a pair of DNA molecules encoding the antibody according to claim 1.

### Claim 29 (depends on 1)

A cloning or expression vector or a pair of cloning or expression vectors encoding the antibody according to claim 1.

### Claim 30 (depends on 29)

A host cell comprising a cloning or expression vector or a pair of cloning of expression vectors according to claim 29.

### Claim 31 (depends on 1, 30)

A process for the production of an antibody as defined in claim 1, comprising culturing the host cell of claim 30 and isolating the antibody.

### Claim 32 (depends on 1)

A pharmaceutical composition comprising an antibody as defined in claim 1 in combination with one or more of a pharmaceutically acceptable excipient, diluent or carrier.