# US 2010/0166783 A1 · Method

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- Number: US 2010/0166783 A1
- Document ID: US20100166783A1
- Status: Published application
- Kind: A1
- Application number: 12/558,943
- Filed: 2009-09-14
- Published: 2010-07-01
- Earliest claimed: 2008-09-15
- Assignees: Glaxosmithkline Biologicals SA
- Inventors: Pierre Raphael Dupont; Swann Romain Jean-Thomas Gaulis; Thibault Marc Helleputte
- Web page: https://patentgrep.com/patent/US20100166783A1

## CPC

- G01N 33/6842: {Proteomic analysis of subsets of protein mixtures with reduced complexity, e.g. membrane proteins, phosphoproteins, organelle proteins}
- C12Q 1/6886: for cancer (immunoassay for cancer G01N33/575)
- C12Q 2600/106: Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism
- C12Q 2600/158: Expression markers
- G01N 2800/52: Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
- 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)
- 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

## Abstract

Gene expression profiles, microarrays comprising nucleic acid sequences representing gene expression profiles, and new diagnostic kits and methods are provided. The gene expression profiles, microarrays, and new diagnostic kits and methods find use in the treatment of specific populations of cancer patients suffering from MAGE expressing tumours, the populations characterised by their gene expression profile.

## Claims

### Claim 1

A method of classifying a patient as a responder or non-responder comprising the steps of:
(a) determining the expression levels of one or more genes in a patient-derived sample, wherein the gene(s) are selected from Table 1;
(b) classifying the patient to either a responder or non-responder group based on the expression levels of (a).

### Claim 2

A method of characterising a patient as a responder or non-responder to therapy comprising the steps:
(a) analysing a patient derived sample for differential expression of the gene products of one or more genes of Table 1, and
(b) characterising the patient from which the sample was derived as a responder or non-responder, based on the results of step (a),
wherein the characterisation step is optionally performed by reference or comparison to a standard.

### Claim 3 (depends on 2)

A method according to claim 2, in which the standard is a patient-derived sample from a patient having a known clinical outcome.

### Claim 4 (depends on 1)

A method according to claim 1, in which the one or more genes of Table 1 are at least 5, at least 10, at least 15, at least 20 and/or all the genes listed in Table 1 and/or any combination thereof.

### Claim 5 (depends on 2)

A method according to claim 2, in which the one or more genes of Table 1 are at least 5, at least 10, at least 15, at least 20 and/or all the genes listed in Table 1 and/or any combination thereof.

### Claim 6 (depends on 1)

A method according to claim 1, in which the one or more genes of Table 7 are 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32 or all of the genes of Table 1 and/or any combination thereof.

### Claim 7 (depends on 2)

A method according to claim 2, in which the one or more genes of Table 7 are 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32 or all of the genes of Table 1 and/or any combination thereof.

### Claim 8 (depends on 1)

A method according to claim 1, in which at least one gene product is upregulated.

### Claim 9 (depends on 2)

A method according to claim 2, in which at least one gene product is upregulated.

### Claim 10 (depends on 1)

A method according to claim 1, in which at least 80% of the gene products are upregulated.

### Claim 11 (depends on 2)

A method according to claim 2, in which at least 80% of the gene products are upregulated.

### Claim 12 (depends on 1)

A method according to claim 1, further comprising the step of determining whether the gene products are upregulated and/or downregulated as shown in Table 5.

### Claim 13 (depends on 2)

A method according to claim 2, further comprising the step of determining whether the gene products are upregulated and/or downregulated as shown in Table 5.

### Claim 14 (depends on 12)

A method according to claim 12, wherein a determination that the gene products are upregulated and/or downregulated as shown in Table 5 indicates a responder.

### Claim 15 (depends on 13)

A method according to claim 13, wherein a determination that the gene products are upregulated and/or downregulated as shown in Table 5 indicates a responder.

### Claim 16 (depends on 14)

A method as defined in claim 14, comprising the further step of identifying a patient as a responder, and selecting the patient for therapy.

### Claim 17 (depends on 15)

A method as defined in claim 15, comprising the further step of identifying a patient as a responder, and selecting the patient for therapy.

### Claim 18

A microarray comprising one or more polynucleotide probes complementary and hybridisable to a sequence of the gene product of at least one gene selected from the group of gene products listed in Table 1, in which the polynucleotide probes complementary and hybridisable to a sequence of the gene product of at least one gene selected from the group consisting of the gene products listed in Table 1 constitute at least 50% of the probes or probe sets on said microarray.

### Claim 19

A method of treating a patient characterised as a responder comprising the steps of:
(a) determining the expression levels of one or more gene products in a patient-derived sample, wherein the gene products are selected from the group of gene products s set forth Table 1;
(b) classifying the patient to either a responder or non-responder group based on the expression levels of (a); and
(c) if the patient is classified as a responder, administering a composition comprising a tumour associated antigen to the patient.

### Claim 20

A method of treating a patient characterised as a responder comprising the steps of:
(a) analysing a patient derived sample for differential expression of the gene products of one or more genes of Table 1;
(b) characterising the patient from which the sample was derived as a responder or non-responder, based on the results of step (a), wherein the characterisation step is optionally performed by reference or comparison to a standard; and
(c) if the patient is classified as a responder, administering a composition comprising a tumour associated antigen to the patient.
