# US 2014/0154238 A1 · Compositions And Methods For Treating, Diagnosing And Monitoring Disease > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2014/0154238 A1 - Document ID: US20140154238A1 - Status: Published application - Kind: A1 - Application number: 14/007,932 - Filed: 2012-03-28 - Published: 2014-06-05 - Earliest claimed: 2011-03-28 - Assignees: Hox Therapeutics Limited - Inventors: Richard Morgan - Web page: https://patentgrep.com/patent/US20140154238A1 ## CPC - A61P 35/00: Antineoplastic agents - C12N 15/113: Non-coding nucleic acids modulating the expression of genes, e.g. antisense oligonucleotides; {Antisense DNA or RNA; Triplex- forming oligonucleotides; Catalytic nucleic acids, e.g. ribozymes; Nucleic acids used in co-suppression or gene silencing (when used in plants C12N15/8218)} - A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00 - C07K 14/47: from mammals - C07K 14/705: Receptors; Cell surface antigens; Cell surface determinants {(tumour specific antigens C07K14/4748)} - C07K 16/18: against material from animals or humans - C12N 15/1135: {against oncogenes or tumor suppressor genes} - C12N 15/1138: {against receptors or cell surface proteins} - G01N 33/57515: of the breast - G01N 33/5752: of the lungs - G01N 33/57555: of the prostate - G01N 33/5759: {involving compounds localised on the membrane of tumour or cancer cells} - C12N 2310/14: interfering nucleic acids [NA] - G01N 2800/52: Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS - C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00) - 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 Compositions and methods which inhibit the expression of the TMEM92 gene or which inhibits the function of die TMEM92 protein can be used for treating, diagnosing and monitoring disease, for example cancer. ## Claims ### Claim 1 A method for treating a disease, preferably cancer, the method comprising administering to a patient a therapeutically effective amount of a composition which inhibits the expression of the TMEM92 gene or which inhibits the function of the TMEM92 protein. ### Claim 2 (depends on 1) A method according to claim 1, wherein the composition comprises a nucleic acid sequence which is (i) complementary to the nucleic acid sequence of SEQ ID NO:1 or a fragment or variant thereof; and/or (ii) hybridizable to the nucleic acid sequence of SEQ ID NO:1 or a fragment or variant thereof. ### Claim 3 (depends on 1) A method according to claim 1, wherein the composition comprises a nucleic acid molecule comprising a nucleic acid sequence which is (i) complementary to the nucleic acid sequence of SEQ ID NO:1 or a fragment or variant thereof; and/or (ii) hybridizable to the nucleic acid sequence of SEQ ID NO:1 or a fragment or variant thereof. ### Claim 4 (depends on 3) A method according to claim 3, wherein the nucleic acid molecule comprises double stranded RNA, optionally, wherein the nucleic acid molecule comprises small interfering RNA (siRNA). ### Claim 5 (depends on 1) A method according to claim 1, wherein the composition comprises an antibody which is capable of binding to the TMEM92 protein. ### Claim 6 (depends on 5) A method according to claim 5, wherein the antibody is conjugated to a detectable marker and/or a growth inhibitory agent, optionally, wherein the antibody is conjugated to a cytotoxic agent, antibiotic, lytic enzyme or radioactive isotope. ### Claim 7 (depends on 1) A method according to claim 1, wherein the composition comprises an antagonist of TMEM92 protein function. ### Claim 8 (depends on 1) A method according to claim 1, wherein the disease is cancer and cancer is selected from prostate cancer, non-small cell lung cancer and breast cancer. ### Claim 9 A biomarker, the biomarker comprising: i) a nucleic acid sequence comprising SEQ ID NO:1, or a fragment or variant thereof, or a nucleic acid molecule which comprises said nucleic acid sequence; or ii) an amino acid sequence comprising SEQ ID NO:2, or a fragment or variant thereof, or an amino acid molecule which comprises said amino acid sequence. ### Claim 10 (depends on 9) A biomarker according to claim 9, wherein the biomarker is a cancer biomarker, optionally selected from a prostate cancer biomarker, a non-small cell lung cancer biomarker and breast cancer biomarker. ### Claim 11 (depends on 9) A method for diagnosing disease in a patient or for identifying a patient at risk of developing disease, the method comprising: a) determining an amount of the biomarker of claim 9 in a sample obtained from a patient; b) comparing the amount of the determined biomarker in the sample from the patient to the amount of the biomarker in a normal control; wherein a difference in the amount of the biomarker in the sample from the patient compared to the amount of the biomarker in the normal control is associated with the presence of disease, or is associated with a risk of developing disease, optionally wherein the disease is cancer, for example selected from prostate cancer, non-small cell lung cancer and breast cancer. ### Claim 12 (depends on 9) A method for diagnosing disease in a patient or for identifying a patient at risk of developing disease, the method comprising: determining an amount of the biomarker of claim 9 in a sample obtained from a patient, wherein the presence of the biomarker is associated with the presence of disease or is associated with a risk of developing disease, optionally wherein the disease is cancer, for example selected from prostate cancer, non-small cell lung cancer and breast cancer. ### Claim 13 (depends on 9) A method for monitoring the progression of disease in a patient, the method comprising: a) determining an amount of the biomarker of claim 9 in a sample obtained from a patient; b) comparing the amount of the determined biomarker in the sample from the patient to the amount of the biomarker in a normal control; and c) repeating steps (a) and (b) at two or more time intervals, wherein an increase in the amount of the biomarker from the patient over time is associated with an increase in the progression of disease and a decrease in the amount of the biomarker from the patient over time is associated with a decrease in the progression of disease, optionally wherein the disease is cancer, for example selected from prostate cancer, non-small cell lung cancer and breast cancer. ### Claim 14 (depends on 9) A method for monitoring the efficacy of a treatment for disease, comprising detecting and/or quantifying the presence of the biomarker of claim 9 in a biological sample obtained from a patient, optionally wherein the disease is cancer, for example selected from prostate cancer, non-small cell lung cancer and breast cancer. ### Claim 15 (depends on 9) A method for treating a patient with a disease, preferably cancer, the method comprising administering to a patient a therapeutically effective amount of a biomarker of claim 9, optionally, wherein the cancer is selected from prostate cancer, non-small cell lung cancer and breast cancer. ### Claim 16 (depends on 9) A method for imaging disease, for example cancer, in a patient, the method comprising administering to a patient an antibody or fragment thereof that binds to a biomarker of claim 9, optionally wherein the cancer is selected from prostate cancer, non-small cell lung cancer and breast cancer. ### Claim 17 (depends on 16) A method according to claim 16, wherein the antibody is conjugated to a detectable marker. ### Claim 18 (depends on 9) A composition comprising; (A) a biomarker of claim 9; (B) a nucleic acid sequence which is (i) complementary to the nucleic acid sequence of SEQ ID NO:1 or a fragment or variant thereof; and/or (ii) hybridizable to the nucleic acid sequence of SEQ ID NO:1 or a fragment or variant thereof; (C) a nucleic acid molecule comprising a nucleic acid sequence which is (i) complementary to the nucleic acid sequence of SEQ ID NO:1 or a fragment or variant thereof; and/or (ii) hybridizable to the nucleic acid sequence of SEQ ID NO:1 or a fragment or variant thereof; (D) a host cell which contains the nucleic acid molecule; (E) a vector, for example a DNA plasmid, comprising a nucleic acid sequence which is (i) complementary to the nucleic acid sequence of SEQ ID NO:1 or a fragment or variant thereof; and/or (ii) hybridizable to the nucleic acid sequence of SEQ ID NO:1 or a fragment or variant thereof; (F) an antibody or fragment thereof which is capable of binding to the TMEM92 protein; (G) an antibody or fragment thereof which is capable of binding to a biomarker of claim 9; and/or (H) an antagonist of TMEM92 protein function, for example a small molecule antagonist. ### Claim 19 (depends on 18) A composition according to claim 18, wherein the composition is a pharmaceutical composition. ### Claim 20 (depends on 18) A composition according to claim 18 for use in therapy or diagnosis of disease, optionally in relation to cancer. ### Claim 21 (depends on 18) Use of a composition according to claim 18 in therapy or diagnosis of disease, optionally in relation to cancer. ### Claim 22 (depends on 18) A vaccine comprising a composition of claim 18. ### Claim 23 (depends on 1) A kit for use in a method according to claim 1, wherein the kit comprises a ligand capable of binding or specifically recognising a biomarker comprising, i) a nucleic acid sequence comprising SEQ ID NO:1, or a fragment or variant thereof, or a nucleic acid molecule which comprises said nucleic acid sequence; or ii) an amino acid sequence comprising SEQ ID NO:2, or a fragment or variant thereof, or an amino acid molecule which comprises said amino acid sequence, detectable in a body fluid and reporter means. ### Claim 24 (depends on 11) A kit for use in a method according to claim 11, wherein the kit comprises a ligand capable of binding or specifically recognising a biomarker comprising, i) a nucleic acid sequence comprising SEQ ID NO:1, or a fragment or variant thereof, or a nucleic acid molecule which comprises said nucleic acid sequence; or ii) an amino acid sequence comprising SEQ ID NO:2, or a fragment or variant thereof, or an amino acid molecule which comprises said amino acid sequence, detectable in a body fluid and reporter means.