# US 12,178,865 B2 · CDKN2A companion diagnostic for bladder cancer interferon therapy > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,178,865 B2 - Document ID: US12178865B2 - Status: Granted - Kind: B2 - Application number: 17/965,739 - Filed: 2022-10-13 - Published: 2023-10-05 - Granted: 2024-12-31 - Earliest claimed: 2017-12-12 - Assignees: Trizell Ltd. - Applicants: Trizell Limited - Inventors: Colin P. Dinney - Web page: https://patentgrep.com/patent/US12178865B2 ## CPC - A61K 39/04: Mycobacterium, e.g. Mycobacterium tuberculosis - A61P 35/04: specific for metastasis - A61K 38/21: Interferons {[IFN]} - A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca - C07K 14/56: IFN-alpha - C12N 7/00: Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof (preparing medicinal viral antigen or antibody compositions, e.g. virus vaccines, A61K39/00) - C12N 15/86: Viral vectors - C12Q 1/6886: for cancer (immunoassay for cancer G01N33/575) - G01N 33/57557: {of other specific parts of the body, e.g. brain} - A61K 48/00: Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy - C12N 2750/14143: viral genome or elements thereof as genetic vector - C12Q 2600/106: Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism - C12Q 2600/158: Expression markers - G01N 2800/00: Detection or diagnosis of diseases - G01N 2800/7028: Cancer - 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) - C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00) - 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) ## Abstract A method of treating bladder cancer comprising diagnosing bladder cancer in a human, measuring the human's level of CDKN2A expression, and then instilling into the human an agent which induces interferon expression. ## Claims ### Claim 1 A method of treating Bacillus Calmette-Guérin unresponsive non-muscle invasive bladder cancer in a human, comprising: a. diagnosing Bacillus Calmette-Guérin unresponsive non-muscle invasive bladder cancer in a human, b. measuring a level of CDKN2A expression in a sample obtained from the human, c. selecting a human based on the level of CDKN2A expression measured in step b), and d. instilling into the lumen of the bladder of said human selected from step c) with a non-replicating vector comprising nadofaragene firadenovec. ### Claim 2 (depends on 1) The method of claim 1, where the bladder cancer is high-grade. ### Claim 3 (depends on 1) The method of claim 1, where said measuring the human's level of CDKN2A expression entails taking a bladder tissue sample and measuring the level of CDKN2A expression in that tissue sample. ### Claim 4 (depends on 1) The method of claim 1, wherein said measuring the human's level of CDKN2A expression entails taking a urine sample and measuring the level of CDKN2A expression in it. ### Claim 5 (depends on 4) The method of claim 4, wherein said measuring the level of CDKN2A expression comprises analyzing the exosomes in said urine sample. ### Claim 6 (depends on 4) The method of claim 4, wherein said measuring the level of CDKN2A expression comprises analyzing fee DNA in said urine sample. ### Claim 7 (depends on 1) The method of claim 1, further comprising the step of administering to said human a checkpoint inhibitor after said step of measuring the level of CDKN2A expression. ### Claim 8 (depends on 1) The method of claim 1, wherein said step of measuring the human's level of CDKN2A expression comprises using fluorescent in situ hybridization using a probe able to hybridize with a portion of CDKN2A. ### Claim 9 (depends on 8) The method of claim 8, wherein said probe comprises a portion which hybridizes with at least one exon contained in CDKN2A. ### Claim 10 (depends on 8) The method of claim 8, wherein said probe is about 40 bp in length. ### Claim 11 (depends on 9) The method of claim 9, wherein said probe is about 40 bp in length. ### Claim 12 A method of treating Bacillus Calmette-Guérin unresponsive non-muscle invasive bladder cancer in a human, comprising: a. diagnosing Bacillus Calmette-Guérin unresponsive non-muscle invasive bladder cancer in a human, b. measuring a level of CDKN2A expression in an urine sample obtained from the human, wherein measuring the level of CDKN2A expression comprises analyzing exosomes or free DNA in the urine sample, c. selecting a human based on the level of CDKN2A expression measured in step b), and d. instilling into the lumen of the bladder of said human selecting in step c) with a non-replicating vector comprising nadofaragene firadenovec. ### Claim 13 (depends on 12) The method of claim 12, wherein said step of measuring the human's level of CDKN2A expression comprises using fluorescent in situ hybridization using a probe able to hybridize with a portion of CDKN2A. ### Claim 14 (depends on 12) The method of claim 12, wherein said probe comprises a portion which hybridizes with at least one exon contained in CDKN2A. ### Claim 15 (depends on 13) The method of claim 13, wherein said probe is about 40 bp in length. ### Claim 16 (depends on 14) The method of claim 14 wherein said probe is about 40 bp in length.