# US 10,369,197 B2 · Use of CD24 for lowering low-density lipoprotein cholesterol levels

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- Number: US 10,369,197 B2
- Document ID: US10369197B2
- Status: Granted
- Kind: B2
- Application number: 15/572,330
- Filed: 2016-05-06
- Published: 2018-04-26
- Granted: 2019-08-06
- Earliest claimed: 2015-05-07
- Assignees: Oncoimmune, Inc.
- Applicants: Oncolmmune, Inc.
- Inventors: Yang Liu; Pan Zheng
- Web page: https://patentgrep.com/patent/US10369197B2

## CPC

- A61K 38/177: {Receptors; Cell surface antigens; Cell surface determinants}
- A61P 9/10: for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
- C07K 14/70596: {Molecules with a "CD"-designation not provided for elsewhere}
- G01N 33/502: {for testing non-proliferative effects}
- G01N 33/92: involving lipids, e.g. cholesterol {, lipoproteins, or their receptors (steroid hormones G01N33/743)}
- C07K 2319/30: Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
- G01N 2333/70596: Molecules with a "CD"-designation not provided for elsewhere in G01N2333/705
- G01N 2800/323: Arteriosclerosis, Stenosis
- 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

The present invention relates to the use of a CD24 protein for lowering low-density lipoprotein cholesterol levels, treating and preventing atherosclerosis, and for reducing risk of cardiovascular disease.

## Claims

### Claim 1

A method of reducing low-density lipoprotein (LDL) cholesterol (LDL-C) levels in a human subject in need thereof, comprising administering a CD24 protein to the subject, wherein the CD24 protein comprises: (a) a mature human CD24 polypeptide comprising the sequence set forth in SEQ ID NO: 1 or 2; and, (b) a Fc region of a human IgG protein; and, wherein the Fc region is fused at the C-terminus of the CD24 protein.

### Claim 2 (depends on 1)

The method of claim 1, wherein the subject has an elevated LDL-C.

### Claim 3 (depends on 2)

The method of claim 2, wherein the subject has a LDL-C greater than or equal to 75 mg/dL.

### Claim 4 (depends on 2)

The method of claim 2, wherein the subject has a LDL-C of greater than or equal to 70 mg/dL or 190 mg/dL.

### Claim 5 (depends on 1)

The method of claim 1, wherein the subject has been previously treated with another LDL-C-lowering drug.

### Claim 6 (depends on 5)

The method of claim 5, wherein the other LDL-C-lowering drug is a statin.

### Claim 7 (depends on 5)

The method of claim 5, wherein the other LDL-C-lowering drug is an antagonist of PCSK9.

### Claim 8 (depends on 1)

The method of claim 1, wherein the CD24 protein is soluble.

### Claim 9 (depends on 1)

The method of claim 1, wherein the CD24 protein is glycosylated.

### Claim 10 (depends on 1)

The method of claim 1, wherein the Fc region comprises a hinge region and CH2 and CH3 domains of the human IgG protein.

### Claim 11 (depends on 10)

The method of claim 10, wherein the human IgG protein is selected from the group consisting of IgG1, IgG2, IgG3, and IgG4.

### Claim 12 (depends on 11)

The method of claim 11, wherein the CD24 protein comprises the sequence set forth in SEQ ID NO: 6, ii, or 12.

### Claim 13 (depends on 1)

The method of claim 1, wherein the CD24 protein is produced using a eukaryotic protein expression system.

### Claim 14 (depends on 13)

The method of claim 13, wherein the expression system comprises a vector contained in a Chinese Hamster Ovary cell line or a replication-defective retroviral vector.

### Claim 15 (depends on 14)

The method of claim 14, wherein the replication-defective retroviral vector is stably integrated into the genome of a eukaryotic cell.

### Claim 16

A method of treating atherosclerosis in a human subject in need thereof, comprising administering a CD24 protein to the subject, wherein the amino acid sequence of the CD24 protein consists of SEQ ID NO: 6, 11, or 12.

### Claim 17

A method of lowering the risk of atherosclerotic cardiovascular disease in a human subject in need thereof, comprising administering a CD24 protein to the subject, wherein the amino acid sequence of the CD24 protein consists of SEQ ID NO: 6, 11, or 12.

### Claim 18 (depends on 12)

The method of claim 12, wherein the amino acid sequence of the CD24 protein consists of the sequence set forth in SEQ ID NO: 6, ii or 12.

### Claim 19 (depends on 16)

The method of claim 16, wherein the CD24 protein is soluble.

### Claim 20 (depends on 17)

The method of claim 17, wherein the CD24 protein is soluble.

### Claim 21

A method of reducing LDL-C levels in a human subject in need thereof, comprising administering to the subject a CD24 protein consisting of the sequence set forth in SEQ ID NO: 6.
