# US 2014/0193333 A1 · Therapeutic and diagnostic target

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- Number: US 2014/0193333 A1
- Document ID: US20140193333A1
- Status: Published application
- Kind: A1
- Application number: 14/127,788
- Filed: 2012-06-28
- Published: 2014-07-10
- Earliest claimed: 2011-06-28
- Assignees: Oxford Biotherapeutics Ltd
- Inventors: Christian Rohlff; Alasdair Stamps
- Web page: https://patentgrep.com/patent/US20140193333A1

## CPC

- C07K 16/18: against material from animals or humans
- A61K 39/0011: {Cancer antigens}
- A61P 1/04: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
- A61P 3/10: for hyperglycaemia, e.g. antidiabetics
- A61P 9/10: for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
- A61P 11/06: Antiasthmatics
- A61P 17/00: Drugs for dermatological disorders
- A61P 17/06: Antipsoriatics
- A61P 19/02: for joint disorders, e.g. arthritis, arthrosis
- A61P 19/06: Antigout agents, e.g. antihyperuricemic or uricosuric agents
- A61P 25/00: Drugs for disorders of the nervous system
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 35/00: Antineoplastic agents
- A61P 35/02: specific for leukemia
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C07K 14/435: from animals; from humans
- C07K 16/005: {constructed by phage libraries}
- C07K 16/2896: {against molecules with a "CD"-designation, not provided for elsewhere}
- C07K 16/30: from tumour cells
- C12Q 1/6886: for cancer (immunoassay for cancer G01N33/575)
- G01N 33/566: using specific carrier or receptor proteins as ligand binding reagents {where possible specific carrier or receptor proteins are classified with their target compounds}
- G01N 33/57505: of the blood, e.g. leukaemia
- C07K 2317/55: Fab or Fab'
- C07K 2317/732: Antibody-dependent cellular cytotoxicity [ADCC]
- C07K 2317/77: Internalization into the cell
- C12Q 2600/158: Expression markers
- G01N 2500/04: Screening involving studying the effect of compounds C directly on molecule A (e.g. C are potential ligands for a receptor A, or potential substrates for an enzyme A)
- H01M 10/058: Construction or manufacture
- H01M 50/15: for prismatic or rectangular cells (H01M50/153 takes precedence)
- Y02E 60/10: Energy storage using batteries
- 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
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- 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)
- H01M: PROCESSES OR MEANS, e.g. BATTERIES, FOR THE DIRECT CONVERSION OF CHEMICAL ENERGY INTO ELECTRICAL ENERGY
- Y02E: REDUCTION OF GREENHOUSE GAS [GHG] EMISSIONS, RELATED TO ENERGY GENERATION, TRANSMISSION OR DISTRIBUTION

## Abstract

The present invention provides methods and compositions for treatment, screening, diagnosis and prognosis of acute myeloid leukemia (AML), B-cell chronic lymphocytic leukemia, breast cancer, colorectal cancer, kidney cancer, head and neck cancer, lung cancer, ovarian cancer or pancreatic cancer, for monitoring the effectiveness of acute myeloid leukemia (AML), B-cell chronic lymphocytic leukemia, breast cancer, colorectal cancer, kidney cancer, head and neck cancer, lung cancer, ovarian cancer or pancreatic cancer treatment, and for drug development. The present invention also provides methods and compositions for depletion of immune cells to treat inflammatory diseases.

## Claims

### Claim 1

(canceled)

### Claim 2

A method for the treatment or prophylaxis of disease wherein BST1 is expressed in said disease, which comprises administering to a subject in need thereof a therapeutically effective amount of an affinity reagent which binds to BST1.

### Claim 3 (depends on 2)

The method according to claim 2, wherein said disease is cancer including acute myeloid leukemia (AML), B-cell chronic lymphocytic leukemia, breast cancer, colorectal cancer, kidney cancer, head and neck cancer, lung cancer, ovarian cancer or pancreatic cancer.

### Claim 4 (depends on 2)

The method according to claim 2, wherein said disease is an inflammatory disease including asthma, gout, crohns, lupus, multiple sclerosis, rheumatoid arthritis, psoriasis, diabetes or atherosclerosis.

### Claim 5 (depends on 2)

The method according to claim 2, wherein the affinity reagent binds specifically to BST1.

### Claim 6 (depends on 2)

The method according to claim 2, wherein the affinity reagent is an antibody or a functional fragment thereof or an antibody mimetic.

### Claim 7 (depends on 6)

The method according to claim 6, wherein the affinity reagent is a monoclonal antibody.

### Claim 8 (depends on 6)

The method according to claim 6, wherein the affinity reagent is a chimeric antibody, a human antibody, a humanized antibody, a single chain antibody, a defucosylated antibody or a bispecific antibody.

### Claim 9 (depends on 6)

The method according to claim 6, wherein the functional antibody fragment is a UniBody, a domain antibody or a Nanobody.

### Claim 10 (depends on 6)

The method according to claim 6, wherein the antibody mimetic is an Affibody, a DARPin, an Anticalin, an Avimer, a Versabody or a Duocalin.

### Claim 11 (depends on 2)

The method according to claim 2, wherein the affinity reagent contains or is conjugated to a therapeutic moiety.

### Claim 12 (depends on 11)

The method according to claim 11, wherein the therapeutic moiety is a cytotoxic moiety or a radioactive isotope.

### Claim 13 (depends on 11)

The method according to claim 11, wherein the affinity reagent is an antibody drug conjugate.

### Claim 14 (depends on 2)

The method according to claim 2, wherein the affinity reagent elicits antibody-dependent cellular cytotoxicity (ADCC).

### Claim 15 (depends on 2)

The method according to claim 2, wherein the affinity reagent elicits complement dependent cytotoxicity (CDC).

### Claim 16 (depends on 2)

The method according to claim 2, wherein the affinity reagent elicits T-cell cytotoxicity.

### Claim 17 (depends on 2)

The method for the treatment or prophylaxis of disease according to claim 2, wherein the disease is cancer and wherein the affinity reagent induces apoptosis of cancer cells, kills or reduces the number of cancer stem cells and/or kills or reduces the number of circulating cancer cells.

### Claim 18 (depends on 2)

The method according to claim 2, wherein the affinity reagent modulates a physiological function of BST1, inhibits ligand binding to BST1 and/or inhibits a signal transduction pathway mediated by BST1.

### Claim 19

(canceled)

### Claim 20

(canceled)

### Claim 21

(canceled)

### Claim 22

(canceled)

### Claim 23

A method of detecting, diagnosing and/or screening for or monitoring the progression of disease wherein BST1 is expressed in said disease, or of monitoring the effect of a drug or therapy wherein BST1 is expressed in said disease, in a subject which comprises detecting the presence or level of BST1, or one or more fragments thereof, or the presence or level of nucleic acid encoding BST1 or which comprises detecting a change in the level thereof in said subject.

### Claim 24 (depends on 23)

The method according to claim 23 which comprises detecting the presence of BST1, or one or more fragments thereof, or the presence of nucleic acid encoding BST1, in which either (a) the presence of an elevated level of BST1 or said one or more fragments thereof or an elevated level of nucleic acid encoding BST1 in the subject as compared with the level in a healthy subject, or (b) the presence of a detectable level of BST1 or said one or more fragments thereof or a detectable level of nucleic acid encoding BST1 in the subject as compared with a corresponding undetectable level in a healthy subject is indicative of the presence of cancer wherein BST1 is expressed in said cancer, in said subject.

### Claim 25

A method of detecting, diagnosing and/or screening for or monitoring the progression of a disease wherein BST1 is expressed in said disease, or of monitoring the effect of a drug or therapy wherein BST1 is expressed in said disease, in a subject which comprises detecting the presence or level of antibodies capable of immunospecific binding to BST1, or one or more fragments thereof.

### Claim 26 (depends on 23)

The method according to claim 23, wherein the presence of BST1, or one or more fragments thereof, or the presence of nucleic acid encoding BST1 is detected by analysis of a biological sample obtained from the subject.

### Claim 27 (depends on 23)

The method according to claim 23, wherein the presence of BST1, or one or more fragments thereof, is detected using an affinity reagent which binds to BST1.

### Claim 28 (depends on 27)

The method according to claim 27 wherein the affinity reagent is selected from the group consisting of an antibody or a functional fragment thereof or an antibody mimetic.

### Claim 29 (depends on 27)

The method according to claim 27 wherein the affinity reagent contains or is conjugated to a detectable label.

### Claim 30 (depends on 23)

The method according to claim 23, wherein said disease is cancer including acute myeloid leukemia (AML), B-cell chronic lymphocytic leukemia, breast cancer, colorectal cancer, kidney cancer, head and neck cancer, lung cancer, ovarian cancer and pancreatic cancer.

### Claim 31 (depends on 23)

The method according to claim 23, wherein said disease is an inflammatory disease including asthma, gout, crohns, lupus, multiple sclerosis, rheumatoid arthritis, psoriasis, diabetes and atherosclerosis.

### Claim 32 (depends on 2)

The method according to claim 2, wherein the subject is a human.

### Claim 33

A method for identifying an agent for the treatment or prophylaxis of disease wherein BST1 is expressed in said disease, wherein the method comprises (a) contacting BST1, or one or more fragments thereof, with a candidate agent; and (b) determining whether the agent binds to BST1, or one or more fragments thereof.

### Claim 34

(canceled)

### Claim 35

(canceled)

### Claim 36

(canceled)

### Claim 37

(canceled)