# US 6,800,469 B1 · Methods for diagnosis and therapy of autoimmune disease, such as insulin dependent diabetes mellitus, involving retroviral superantigens

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- Number: US 6,800,469 B1
- Document ID: US6800469B1
- Status: Granted
- Kind: B1
- Application number: 09/490,700
- Filed: 2000-01-24
- Granted: 2004-10-05
- Earliest claimed: 1997-07-22
- Assignees: NovImmune S.A.
- Inventors: Bernard Conrad; Bernard Mach
- Web page: https://patentgrep.com/patent/US6800469B1

## CPC

- G01N 33/5091: {for testing the pathological state of an organism}
- A01K 67/0275: Genetically modified vertebrates, e.g. transgenic
- A61P 3/10: for hyperglycaemia, e.g. antidiabetics
- A61P 37/00: Drugs for immunological or allergic disorders
- C07K 14/005: from viruses
- C12Q 1/48: involving transferase
- C12Q 1/702: {for retroviruses}
- G01N 33/5008: {for testing or evaluating the effect of chemical or biological compounds, e.g. drugs, cosmetics}
- G01N 33/502: {for testing non-proliferative effects}
- G01N 33/5047: {Cells of the immune system}
- G01N 33/505: {involving T-cells}
- G01N 33/5052: {involving B-cells}
- G01N 33/564: for pre-existing immune complex or autoimmune disease {, i.e. systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, rheumatoid factors or complement components C1-C9}
- G01N 33/56977: {HLA or MHC typing}
- G01N 33/56983: {Viruses}
- G01N 33/68: involving proteins, peptides or amino acids {(involving lipoproteins G01N33/92)}
- A01K 2217/05: Animals comprising random inserted nucleic acids (transgenic)
- A01K 2217/20: Animal model comprising regulated expression system
- A01K 2227/105: Murine
- A01K 2267/0325: Animal model for autoimmune diseases
- A61K 38/00: Medicinal preparations containing peptides (peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00)
- C12N 2740/10022: New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
- C12N 2740/13021: Viruses as such, e.g. new isolates, mutants or their genomic sequences
- C12N 2740/13022: New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
- C12Q 1/686: Polymerase chain reaction [PCR]
- C12Q 2600/158: Expression markers
- G01N 2333/15: Retroviridae, e.g. bovine leukaemia virus, feline leukaemia virus, feline leukaemia virus, human T-cell leukaemia-lymphoma virus
- G01N 2500/00: Screening for compounds of potential therapeutic value
- G01N 2800/042: Disorders of carbohydrate metabolism, e.g. diabetes, glucose metabolism
- G01N 2800/24: Immunology or allergic disorders
- 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)
- A01K: ANIMAL HUSBANDRY; AVICULTURE; APICULTURE; PISCICULTURE; FISHING; REARING OR BREEDING ANIMALS, NOT OTHERWISE PROVIDED FOR; NEW BREEDS OF ANIMALS
- 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)
- 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)
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

The invention relates to a process for the diagnosis of a human autoimmune disease, including presymptomatic diagnosis, said human autoimmune disease being associated with human retrovirus (HERV) having Superantigen (SAg) activity, comprising specifically detecting in a biological sample of human origin at least one of the following: (I) the mRNA of an expressed human endogenous retrovirus having Superantigen (SAg) activity, or fragments of such expressed retroviral mRNA, said retrovirus being associated with a given autoimmune disease, or (II) protein or peptide expressed by said retrovirus, or (III) antibodies specific to the protein expressed by said endogenous, or (IV) SAg activity specifically associated with said endogenous retrovirus, detection of any of the species (I) to (IV) indicating presence of autoimmune disease or imminent onset of autoimmune disease.

## Claims

### Claim 1

An isolated polypeptide comprising the amino acid sequence of SEQ ID NO:36.

### Claim 2

An isolated polypeptide comprising the amino acid sequence of SEQ ID NO:40.

### Claim 3

An isolated polypeptide comprising the amino acid sequence of SEQ ID NO:41.

### Claim 4 (depends on 1, 2)

A composition comprising the polypeptide as in any one of claims 1, 2, and 3 and a pharmaceutically-acceptable carrier.