# US 2021/0340629 A1 · Biomarkers for cancer therapy

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- Number: US 2021/0340629 A1
- Document ID: US20210340629A1
- Status: Published application
- Kind: A1
- Application number: 17/274,126
- Filed: 2019-09-06
- Published: 2021-11-04
- Earliest claimed: 2018-09-06
- Assignees: The Council of the Queensland Institute of Medical Research
- Applicants: The Council of the Queensland Institute of Medical Research
- Inventors: Jason Lee; Fares Al-Ejeh
- Web page: https://patentgrep.com/patent/US20210340629A1

## CPC

- C12Q 1/6886: for cancer (immunoassay for cancer G01N33/575)
- C07K 16/2818: {against CD28 or CD152}
- G01N 33/5751: of the skin, e.g. melanoma
- A61K 2039/505: {comprising antibodies}
- C12Q 2600/106: Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism
- C12Q 2600/158: Expression markers
- G01N 2333/91017: with definite EC number (2.1.1.-)
- G01N 2800/52: Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
- 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
- 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

This invention relates generally to biomarkers that are useful for determining whether a subject with cancer is likely to respond to cancer therapy. The invention therefore relates to methods, kits and compositions for determining whether a subject is likely to respond to cancer therapy, and to methods of treatment based on a determination that a subject with cancer is likely to respond to cancer therapy. The invention also relates to methods for sensitizing a subject with cancer to cancer therapy.

## Claims

### Claim 1

A method for determining an indicator used in assessing a likelihood of a subject with cancer responding to cancer therapy, the method comprising, consisting or consisting essentially of:
(1) determining a biomarker value for at least one cancer therapy biomarker in a sample from the subject, wherein the, or one of the, cancer therapy biomarker(s) is an expression product of MAP1LC3B; and
(2) determining the indicator using the biomarker value(s), wherein the indicator is at least partially indicative of the likelihood of responsiveness to cancer therapy;
wherein the cancer therapy comprises therapy with an immune checkpoint inhibitor.

### Claim at position 2

-43. (canceled)

### Claim 44

A composition for determining an indicator used in assessing a likelihood of a subject with cancer responding to cancer therapy, the composition or solid support comprising, consisting, or consisting essentially of a MAP1LC3B transcript or cDNA thereof and at least one oligonucleotide primer or probe that hybridizes to the MAP1LC3B transcript or cDNA thereof, and an EHMT2 or EHMT1 transcript or cDNA thereof and at least one oligonucleotide primer or probe that hybridizes to the EHMT2 or EHMT1 transcript or cDNA thereof, wherein the cancer therapy comprises therapy with an immune checkpoint inhibitor.

### Claim 45

A solid support for determining an indicator used in assessing a likelihood of a subject with cancer responding to cancer therapy, the solid support comprising, consisting, or consisting essentially of at least one first oligonucleotide primer or probe immobilized to the solid support, wherein the at least one first oligonucleotide primer or probe hybridizes to a MAP1LC3B transcript or cDNA; and at least one second oligonucleotide primer or probe immobilized to the solid support, wherein the at least one second oligonucleotide primer or probe hybridizes to a EHMT2 or EHMT1 transcript or cDNA thereof, wherein the cancer therapy comprises therapy with an immune checkpoint inhibitor.

### Claim at position 5

-52. (canceled)