# US 11,028,168 B2 · Use of a CD6 binding partner and method based thereon

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- Number: US 11,028,168 B2
- Document ID: US11028168B2
- Status: Granted
- Kind: B2
- Application number: 16/215,496
- Filed: 2018-12-10
- Published: 2019-11-14
- Granted: 2021-06-08
- Earliest claimed: 2013-07-23
- Assignees: Biocon Limited
- Applicants: Biocon Limited
- Inventors: Pradip Nair; Ramakrishnan Melarkode; Bala S. Manian; Abhijit Barve; Usha Bughani; Jose Enrique Montero Casimiro
- Web page: https://patentgrep.com/patent/US11028168B2

## CPC

- A61P 1/04: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
- C07K 16/28: against receptors, cell surface antigens or cell surface determinants
- A61P 3/10: for hyperglycaemia, e.g. antidiabetics
- A61P 17/06: Antipsoriatics
- A61P 19/02: for joint disorders, e.g. arthritis, arthrosis
- 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
- C07K 16/2896: {against molecules with a "CD"-designation, not provided for elsewhere}
- G01N 33/564: for pre-existing immune complex or autoimmune disease {, i.e. systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, rheumatoid factors or complement components C1-C9}
- A61K 2039/505: {comprising antibodies}
- C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- G01N 2333/7155: for interleukins [IL]
- 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)
- 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)

## Abstract

The present disclosure relates to methods for treatment and prevention of disease conditions mediated by T-helper 17 (Th17) and/or T-helper 1 (Th1) T lymphocytes (T cells). In particular, the present disclosure relates to use of anti-CD6 antibody for treatment of disease conditions mediated by auto-reactive Th17 and Th1 T lymphocytes. The methods of the present disclosure further have utility in methods for modulating an immune response by suppressing production of the cytokine IL-23R, thereby decreasing inflammation mediated by Th17 cells.

## Claims

### Claim 1

A method of treatment for an autoimmune disease in a subject, wherein the autoimmune disease is an Inflammatory Bowel Disease, the method comprising administering to the subject a binding partner that specifically binds to CD6, wherein the binding partner is a humanized antibody Itolizumab or a functional fragment thereof that specifically binds to D1 of CD6; and wherein the subject has an increased number of T helper 17 (Th17) cells when compared to a healthy subject.

### Claim 2 (depends on 1)

The method of claim 1, wherein the subject also has an increased number of T helper 1 (Th1) cells when compared to a healthy subject.

### Claim 3 (depends on 1)

The method of claim 1, wherein the Inflammatory Bowel Disease is Crohn's disease or ulcerative colitis.

### Claim 4 (depends on 1)

The method of claim 1, wherein the humanized antibody is Itolizumab.

### Claim 5 (depends on 1)

The method of claim 1, wherein the functional fragment is a Fab-fragment or a single-chain variable fragment (scFv).

### Claim 6 (depends on 1)

The method of claim 1, wherein the method includes monitoring IL-23R expression on blood cells and/or dendritic cells of the subject.

### Claim 7 (depends on 1)

The method of claim 1, wherein the method comprises a reduction of one or more of TNF-alpha, IFN-gamma, IL-17, and IL-17A in a body fluid of the patient.

### Claim 8 (depends on 1)

The method of claim 1, wherein the method comprises a reduction of expression of IL-23R on one or more of monocytes, T helper cells, and natural killer cells in a body fluid of the patient.