# US 11,028,441 B2 · IL-10 as a predictive biomarker of responsiveness to house dust mite allergen immunotherapy

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- Number: US 11,028,441 B2
- Document ID: US11028441B2
- Status: Granted
- Kind: B2
- Application number: 16/069,332
- Filed: 2017-01-13
- Published: 2019-01-24
- Granted: 2021-06-08
- Earliest claimed: 2016-01-13
- Assignees: Stallergenes
- Applicants: Stallergenes
- Inventors: Laurent Mascarell; Véronique Bodo; Philippe Moingeon; Vincent Lombardi; Claire Gueguen
- Web page: https://patentgrep.com/patent/US11028441B2

## CPC

- C12Q 1/6883: for diseases caused by alterations of genetic material
- A61K 39/35: Allergens
- G01N 33/6863: {Cytokines, i.e. immune system proteins modifying a biological response such as cell growth proliferation or differentiation, e.g. TNF, CNF, GM-CSF, lymphotoxin, MIF or their receptors}
- G01N 33/6869: {Interleukin}
- A61K 2039/54: {characterised by the route of administration}
- C12Q 2600/106: Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism
- C12Q 2600/158: Expression markers
- G01N 2333/54: Interleukins [IL]
- G01N 2333/5428: IL-10
- G01N 2800/24: Immunology or allergic disorders
- 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
- 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)
- 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 concerns the use of IL-10 as a biological marker for predicting the responsiveness of a house dust mite allergic patient to house dust mite allergen immunotherapy.

## Claims

### Claim 1

A method for immunotherapy of house dust mite allergy in a patient comprising:
(i) selecting a patient for immunotherapy by implementing a method comprising:
a) measuring abundance of IL-10 mRNA in a biological sample from said patient,
b) comparing said abundance of IL-10 mRNA with a control,
c) identifying said patient as likely to be a responder to immunotherapy when
(c1) the abundance of IL-10 mRNA in the patient sample is equal to or greater than the level of expression in a control derived from a responder subject, or group of responder subjects, known to respond to said immunotherapy; or
(c2) the abundance of IL-10 mRNA in the patient sample is greater than the level of expression in a control derived from a non-responder subject, or group of non-responder subjects; or
(c3) the abundance of IL-10 mRNA in the patient sample is greater than the level of expression in a control derived from a randomly selected group of subjects; and
wherein said biological sample is taken before the commencement of immunotherapy, and wherein said immunotherapy comprises administration of a house dust mite allergen to said patient in order to treat house dust mite allergy, and
(ii) administering said house dust mite allergen to said patient identified as likely to be a responder to said immunotherapy.

### Claim 2 (depends on 1)

The method according to claim 1, wherein a responder demonstrates at least 10% improvement in clinical symptoms of house dust mite allergy and a non-responder demonstrates less than 10% improvement in clinical symptoms of house dust mite allergy.

### Claim 3 (depends on 1)

The method according to claim 1, wherein said IL-10 mRNA consists of the sequence SEQ ID NO: 1.

### Claim 4 (depends on 1)

The method according to claim 1, wherein the immunotherapy comprises administration of said house dust mite allergen to a mucosal surface, or administration of allergen via a subcutaneous, transdermal, intralymphatic or epicutaneous route.