# US 12,410,221 B2 · Tumor antigens for determining cancer therapy

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- Number: US 12,410,221 B2
- Document ID: US12410221B2
- Status: Granted
- Kind: B2
- Application number: 18/176,283
- Filed: 2023-02-28
- Published: 2023-11-09
- Granted: 2025-09-09
- Earliest claimed: 2013-07-30
- Assignees: BioNTech SE; TRON—Translationale Onkologie an der Universitätsmedizin der Johannes Gutenberg-Universität Mainz
- Applicants: BioNTech SE; TRON—Translationale Onkologie an der Universitätsmedizin der Johannes Gutenberg—Universität Mainz
- Inventors: Ugur Sahin; Claudia Paret; Kirsten Vormbrock; Christian Bender; Petra Simon; Christoph Hartmann; Stefanie Hubich; Thomas Bukur; Thorsten Litzenberger
- Web page: https://patentgrep.com/patent/US12410221B2

## CPC

- C07K 14/4748: {Tumour specific antigens; Tumour rejection antigen precursors [TRAP], e.g. MAGE}
- A61K 39/0011: {Cancer antigens}
- A61K 39/001189: {PRAME}
- A61P 15/00: Drugs for genital or sexual disorders (for disorders of sex hormones A61P5/24); Contraceptives
- A61P 35/00: Antineoplastic agents
- C12Q 1/6886: for cancer (immunoassay for cancer G01N33/575)
- G01N 33/57515: of the breast
- G01N 33/5758: {involving compounds serving as markers for tumours, cancers or neoplasias, e.g. cellular determinants, receptors, heat shock/stress proteins, A-protein, oligosaccharides or metabolites}
- A61K 2039/507: {Comprising a combination of two or more separate antibodies}
- A61K 2039/53: {DNA (RNA) vaccination}
- A61K 2039/70: {Multivalent vaccine}
- C12Q 2600/106: Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism
- C12Q 2600/158: Expression markers
- C12Q 2600/16: Primer sets for multiplex assays
- G01N 2333/47: Assays involving proteins of known structure or function as defined in the subgroups
- 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)

## Abstract

The present invention relates to the treatment of cancer, in particular breast cancer, particularly triple-negative breast cancer. More particularly, the invention concerns methods for cancer treatment involving a specific set of tumor antigens.

## Claims

### Claim 1

A method for treating triple negative breast cancer in a patient having triple negative breast cancer, the method comprising:
(a) determining an expression pattern of a set of tumor antigens in a sample from the patient having triple negative breast cancer, wherein the set of tumor antigens comprises at least one selected from chromosome X open reading frame 61 (CXorf61), Preferentially expressed Antigen in Melanoma (PRAME), and cancer antigen 1 (CAGE1);
(b) diagnosing the patient having triple negative breast cancer as needing a cancer therapy regimen when at least one tumor antigen selected from CXorf61, PRAME, and CAGE1 is expressed; and
(c) treating the patient having triple negative breast cancer with an immunotherapeutic that targets the at least one tumor antigen expressed in the patient.

### Claim 2 (depends on 1)

The method of claim 1 wherein the expression pattern is determined in a sample obtained from a triple negative breast cancer patient.

### Claim 3 (depends on 2)

The method of claim 2 wherein the sample comprises cancer cells.

### Claim 4 (depends on 1)

The method of claim 1 wherein determining the expression pattern comprises a quantitative and/or qualitative determination of the expression of the tumor antigens.

### Claim 5 (depends on 1)

The method of claim 1 wherein determining the expression pattern comprises determining the expression of RNA and/or protein of the tumor antigens.

### Claim 6 (depends on 1)

The method of claim 1 wherein the immunotherapeutic provides one or more T cell epitopes of each of the tumor antigens of the set of tumor antigens which are expressed in cancer cells of the patient.

### Claim 7 (depends on 6)

The method of claim 6 wherein the immunotherapeutic is an RNA vaccine.

### Claim 8

A method for preventing or treating triple negative breast cancer in a patient comprising administering to said patient an immunotherapeutic targeting each tumor antigen of a set of tumor antigens, wherein the set of tumor antigens comprises at least one selected from CXorf61, PRAME, and CAGE1.

### Claim 9 (depends on 8)

The method of claim 8 which comprises inducing an immune response in the patient against each tumor antigen of the set of tumor antigens.

### Claim 10 (depends on 9)

The method of claim 9 wherein the immune response comprises a cellular response.

### Claim 11 (depends on 10)

The method of claim 10 wherein the immunotherapeutic is a vaccine and the cellular response is induced by administering the vaccine providing one or more T cell epitopes of each tumor antigen of the set of tumor antigens to the patient.

### Claim 12 (depends on 11)

The method of claim 11 wherein the one or more T cell epitopes are comprised in the vaccine in one or more peptides or polypeptides wherein said one or more peptides or polypeptides following administration are processed to produce the one or more T cell epitopes.

### Claim 13 (depends on 11)

The method of claim 11 wherein the vaccine is an RNA vaccine.