# US 2019/0375840 A1 · Binding agents

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- Number: US 2019/0375840 A1
- Document ID: US20190375840A1
- Status: Published application
- Kind: A1
- Application number: 16/543,884
- Filed: 2019-08-19
- Published: 2019-12-12
- Earliest claimed: 2017-08-18
- Assignees: Ultrahuman Four Limited
- Applicants: Ultrahuman Four Limited
- Inventors: William James Jonathan Finlay
- Web page: https://patentgrep.com/patent/US20190375840A1

## CPC

- C07K 16/28: against receptors, cell surface antigens or cell surface determinants
- C07K 16/2803: {against the immunoglobulin superfamily}
- A61K 39/001129: {Molecules with a "CD" designation not provided for elsewhere}
- A61P 35/00: Antineoplastic agents
- A61K 39/39558: {against tumor tissues, cells, antigens}
- C07K 2317/21: from primates, e.g. man
- C07K 2317/24: containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
- C07K 2317/33: Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
- C07K 2317/565: Complementarity determining region [CDR]
- 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: 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 and antigen-binding portions thereof which bind specifically to CD47 (Cluster of Differentiation 47, also known as integrin associated protein [IAP]). In aspects of the invention, the anti-CD47 antibody molecules and antigen-binding portions thereof specifically bind to human CD47 and cynomolgus monkey CD47. Medical uses of the anti-CD47 antibody molecules and antigen-binding portions of the invention are disclosed. The anti-CD47 antibody molecules and antigen-binding portions of the invention represent modified and optimised binding molecules compared with a VxP037 murine/humanized anti-CD47 antibody described in WO2014/093678A2.

## Claims

### Claim 1

An antibody molecule that specifically binds to human Integrin Associated Protein (CD47) and cynomolgus monkey CD47, or an antigen-binding portion thereof, wherein the antibody molecule or antigen-binding portion comprises:
(a) a heavy chain variable region comprising a heavy chain complementarity determining region (HCDR) 1 of SEQ ID NO: 49, a HCDR2 of SEQ ID NO: 50, and a HDCR3 of SEQ ID NO: 51; and a light chain variable region comprising a light chain complementarity determining region (LCDR) 1 of SEQ ID NO: 52, a LCDR2 of SEQ ID NO: 53, and a LDCR3 of SEQ ID NO: 54; or
(b) a heavy chain variable region comprising a HCDR1 of SEQ ID NO: 49, a HCDR2 of SEQ ID NO: 50, and a HDCR3 of SEQ ID NO: 51; and a light chain variable region comprising a LCDR1 of SEQ ID NO: 52, a LCDR2 of SEQ ID NO: 85, and a LDCR3 of SEQ ID NO: 54.

### Claim at position 2

-6. (canceled)

### Claim 7 (depends on 1)

The antibody molecule or antigen-binding portion of claim 1, wherein the antibody molecule or antigen-binding portion is human, humanized or chimeric.

### Claim 8 (depends on 1)

The antibody molecule or antigen-binding portion of claim 1, wherein the heavy chain variable region, the light chain variable region, or both the heavy chain variable region and the light chain variable region comprise a human variable domain framework scaffold into which the CDRs have been inserted.

### Claim 9 (depends on 1)

The antibody molecule or antigen-binding portion of claim 1, wherein the heavy chain variable region comprises an IGHV5-51 human germline scaffold into which the HCDR1, HCDR2 and HCDR3 sequences have been inserted.

### Claim 10 (depends on 1)

The antibody molecule or antigen-binding portion of claim 1, wherein the light chain variable region comprises an IGKV2-28 human germline scaffold into which the LCDR1, LCDR2 and LCDR3 sequences have been inserted.

### Claim 11 (depends on 1)

The antibody molecule or antigen-binding portion of claim 1, wherein the antibody molecule or antigen-binding portion comprises an immunologically inert constant region.

### Claim 12 (depends on 1)

The antibody molecule or antigen-binding portion of claim 1, wherein the antibody molecule or antigen-binding portion is a Fab fragment, a F(ab)2 fragment, an Fv fragment, a tetrameric antibody, a tetravalent antibody, a multispecific antibody or an scFv.

### Claim 13

(canceled)

### Claim 14 (depends on 1)

A nucleic acid molecule encoding the antibody molecule or antigen-binding portion of claim 1.

### Claim at position 11

-17. (canceled)

### Claim 18 (depends on 1)

A pharmaceutical composition comprising the antibody molecule or antigen-binding portion of claim 1.

### Claim 19

(canceled)

### Claim 20 (depends on 1)

A method for treating cancer in a subject, comprising administering to the subject an effective amount of the antibody molecule or antigen-binding portion of claim 1.

### Claim 21 (depends on 20)

The method of claim 20, wherein the cancer is pancreatic cancer, melanoma, breast cancer, lung cancer, bronchial cancer, colorectal cancer, prostate cancer, stomach cancer, ovarian cancer, urinary bladder cancer, brain or central nervous system cancer, peripheral nervous system cancer, esophageal cancer, cervical cancer, uterine or endometrial cancer, cancer of the oral cavity or pharynx, liver cancer, kidney cancer, testicular cancer, biliary tract cancer, small bowel or appendix cancer, salivary gland cancer, thyroid gland cancer, adrenal gland cancer, osteosarcoma, chondrosarcoma, or cancer of hematological tissues.

### Claim at position 16

-34. (canceled)

### Claim 35 (depends on 1)

The antibody molecule or antigen-binding portion of claim 1, wherein the antibody molecule or antigen-binding portion specifically binds to mouse CD47.

### Claim 36 (depends on 12)

The antibody molecule or antigen-binding portion of claim 12, wherein the multispecific antibody is a bivalent antibody.

### Claim 37 (depends on 14)

A pharmaceutical composition comprising the nucleic acid molecule of claim 14.

### Claim 38 (depends on 18)

The pharmaceutical composition of claim 18, further comprising a pharmaceutically acceptable excipient, carrier, buffer or stabilizer.

### Claim 39 (depends on 37)

The pharmaceutical composition of claim 37, further comprising a pharmaceutically acceptable excipient, carrier, buffer or stabilizer.

### Claim 40 (depends on 18)

A method for treating cancer in a subject, comprising administering to the subject an effective amount of the pharmaceutical composition of claim 18.

### Claim 41 (depends on 40)

The method of claim 40, wherein the cancer is pancreatic cancer, melanoma, breast cancer, lung cancer, bronchial cancer, colorectal cancer, prostate cancer, stomach cancer, ovarian cancer, urinary bladder cancer, brain or central nervous system cancer, peripheral nervous system cancer, esophageal cancer, cervical cancer, uterine or endometrial cancer, cancer of the oral cavity or pharynx, liver cancer, kidney cancer, testicular cancer, biliary tract cancer, small bowel or appendix cancer, salivary gland cancer, thyroid gland cancer, adrenal gland cancer, osteosarcoma, chondrosarcoma, or cancer of hematological tissues.