# US 2020/0399367 A1 · Anti-cd47 antibodies and uses thereof

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- Number: US 2020/0399367 A1
- Document ID: US20200399367A1
- Status: Published application
- Kind: A1
- Application number: 16/999,578
- Filed: 2020-08-21
- Published: 2020-12-24
- Earliest claimed: 2019-06-19
- Assignees: Lepu Biopharma Co., Ltd.
- Applicants: Lepu Biopharma Co., Ltd.
- Inventors: Wenci Gong; Zhaokun Meng; Yiwei Tou
- Web page: https://patentgrep.com/patent/US20200399367A1

## CPC

- A61K 39/39558: {against tumor tissues, cells, antigens}
- A61P 35/00: Antineoplastic agents
- A61P 37/00: Drugs for immunological or allergic disorders
- C07K 16/2803: {against the immunoglobulin superfamily}
- G01N 33/53: Immunoassay; Biospecific binding assay; Materials therefor
- G01N 33/6854: {Immunoglobulins}
- A61K 2039/505: {comprising antibodies}
- C07K 2317/24: containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
- C07K 2317/31: multispecific
- C07K 2317/33: Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
- C07K 2317/565: Complementarity determining region [CDR]
- 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
- G01N 2333/70596: Molecules with a "CD"-designation not provided for elsewhere in G01N2333/705
- 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
- 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)
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

Provided are anti-CD47 antibodies and fragments thereof. The antibodies and fragments thereof specifically bind to the CD47 protein. Methods of using the antibodies or fragments thereof for treating and diagnosing diseases such as cancer and atherosclerosis are also provided.

## Claims

### Claim 1

An antibody or fragment thereof, wherein the antibody or fragment thereof has specificity to a human CD47 (Cluster of Differentiation 47) protein and comprises:
(a) a VH CDR1 comprising the amino acid sequence of SEQ ID NO: 1;
(b) a VH CDR2 comprising the amino acid sequence of SEQ ID NO: 2 or SEQ ID NO: 7;
(c) a VH CDR3 comprising the amino acid sequence of SEQ ID NO: 3 or SEQ ID NO: 8;
(d) a VL CDR1 comprising the amino acid sequence of SEQ ID NO: 4 or SEQ ID NO: 9;
(e) a VL CDR2 comprising the amino acid sequence of SEQ ID NO: 5; and
(f) a VL CDR3 comprising the amino acid sequence of SEQ ID NO: 6 or SEQ ID NO: 10.

### Claim 2 (depends on 1)

The antibody or fragment thereof of claim 1, wherein the VH CDR1 comprises the amino acid sequence of SEQ ID NO: 1, the VH CDR2 comprises the amino acid sequence of SEQ ID NO: 2, the VH CDR3 comprises the amino acid sequence of SEQ ID NO: 3, the VL CDR1 comprises the amino acid sequence of SEQ ID NO: 4, the VL CDR2 comprises the amino acid sequence of SEQ ID NO: 5, and the VL CDR3 comprises the amino acid sequence of SEQ ID NO: 6.

### Claim 3 (depends on 2)

The antibody or fragment thereof of claim 2, comprising a heavy chain variable region comprising an amino acid sequence selected from the group consisting of SEQ ID NOs: 11 and 15-16 and a light chain variable region comprising an amino acid sequence selected from the group consisting of SEQ ID NOs: 12 and 17.

### Claim 4

(canceled)

### Claim 5 (depends on 3)

The antibody or fragment thereof of claim 3, wherein the heavy chain variable region comprises the amino acid sequence of SEQ ID NO:15 or 16, and the light chain variable region comprises the amino acid sequence of SEQ ID NO:17.

### Claim 6 (depends on 1)

The antibody or fragment thereof of claim 1, wherein the VH CDR1 comprises the amino acid sequence of SEQ ID NO: 1, the VH CDR2 comprises the amino acid sequence of SEQ ID NO: 7, the VH CDR3 comprises the amino acid sequence of SEQ ID NO: 8, the VL CDR1 comprises the amino acid sequence of SEQ ID NO: 9, the VL CDR2 comprises the amino acid sequence of SEQ ID NO: 5, and the VL CDR3 comprises the amino acid sequence of SEQ ID NO: 10.

### Claim 7 (depends on 6)

The antibody or fragment thereof of claim 6, comprising a heavy chain variable region comprising an amino acid sequence selected from the group consisting of SEQ ID NOs: 13 and 18-19, and a light chain variable region comprising an amino acid sequence selected from the group consisting of SEQ ID NOs: 14 and 20.

### Claim 8

(canceled)

### Claim 9

The antibody or fragment thereof of claim, wherein the heavy chain variable region comprises the amino acid sequence of SEQ ID NO:18 or 19, and the light chain variable region comprises the amino acid sequence of SEQ ID NO:20.

### Claim 10 (depends on 1)

The antibody or fragment thereof of claim 1, wherein the antibody or fragment thereof is a humanized antibody.

### Claim 11 (depends on 1)

A bispecific antibody comprising a fragment of claim 1 and a second antigen-binding fragment having a second specificity.

### Claim 12 (depends on 11)

The bispecific antibody of claim 11, wherein the second specificity is to a molecule on an immune cell.

### Claim 13 (depends on 12)

The bispecific antibody of claim 12, wherein the molecule is selected from the group consisting of PD-L1, PD-1, CTLA-4, LAG-3, CD28, CD122, 4-1BB, TIM3, OX-40, OX40L, CD40, CD40L, LIGHT, ICOS, ICOSL, GITR, GITRL, TIGIT, CD27, VISTA, B7H3, B7H4, HEVM, BTLA, KIR, and any combination thereof.

### Claim 14 (depends on 11)

The bispecific antibody of claim 11, wherein the fragment and the second antigen-binding fragment each is independently selected from a Fab fragment, a single-chain variable fragment (scFv), or a single-domain antibody.

### Claim 15 (depends on 1)

A composition comprising the antibody or fragment thereof of claim 1 and a pharmaceutically acceptable carrier.

### Claim 16 (depends on 1)

One or more polynucleotides encoding the antibody or fragment thereof of claim 1.

### Claim 17 (depends on 1)

An isolated cell comprising one or more polynucleotide encoding the antibody or fragment thereof of claim 1.

### Claim 18 (depends on 1)

A method of treating cancer in a patient in need thereof, comprising administering to the patient an effective amount of the antibody or fragment thereof of claim 1.

### Claim at position 19

19-20. (canceled)

### Claim 21 (depends on 18)

The method of claim 18, wherein the cancer is selected from the group consisting of bladder cancer, liver cancer, colon cancer, rectal cancer, endometrial cancer, leukemia, lymphoma, pancreatic cancer, small cell lung cancer, non-small cell lung cancer, breast cancer, urethral cancer, head and neck cancer, gastrointestinal cancer, stomach cancer, oesophageal cancer, ovarian cancer, renal cancer, melanoma, prostate cancer, thyroid cancer, and any combination thereof.

### Claim 22

(canceled)

### Claim 23 (depends on 1)

A method of treating an autoimmune or inflammatory disease in a patient in need thereof, comprising administering to the patient an effective amount of the antibody or fragment thereof of claim 1.

### Claim 24 (depends on 23)

The antibody or fragment thereof of claim 23, wherein the autoimmune or inflammatory disease is selected from the group consisting of a Parkinson's disease, arthritis, rheumatoid arthritis, multiple sclerosis, psoriasis, psoriatic arthritis, Crohn's disease, inflammatory bowel disease, ulcerative colitis, lupus, systemic lupus erythematous, juvenile rheumatoid arthritis, juvenile idiopathic arthritis, Grave's disease, Hashimoto's thyroiditis, Addison's disease, celiac disease, dermatomyositis, multiple sclerosis, myasthenia gravis, pernicious anemia, Sjogren syndrome, type I diabetes, vasculitis, uveitis, atherosclerosis and ankylosing spondylitis.

### Claim 25

(canceled)

### Claim 26 (depends on 1)

A method of detecting expression of CD47 in a sample, comprising contacting the sample with an antibody or fragment thereof of claim 1 under conditions for the antibody or fragment thereof to bind to the CD47, and detecting the binding which indicates expression of CD47 in the sample.