# US 9,993,565 B2 · Method for treating IFNalpha related conditions

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- Number: US 9,993,565 B2
- Document ID: US9993565B2
- Status: Granted
- Kind: B2
- Application number: 14/110,312
- Filed: 2012-04-04
- Published: 2014-01-23
- Granted: 2018-06-12
- Earliest claimed: 2011-04-07
- Assignees: Neovacs
- Applicants: Geraldine Grouard-Vogel; Olivier Dhellin; Bernard Fanget; Pierre Vandepapeliere; Camille Roucairol
- Inventors: Geraldine Grouard-Vogel; Olivier Dhellin; Bernard Fanget; Pierre Vandepapeliere; Camille Roucairol
- Web page: https://patentgrep.com/patent/US9993565B2

## CPC

- A61K 47/64: Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent (peptidic linkers A61K47/65)
- A61K 38/212: {IFN-alpha}
- A61K 39/0008: {Antigens related to auto-immune diseases; Preparations to induce self-tolerance}
- A61K 47/643: {Albumins, e.g. HSA, BSA, ovalbumin or a Keyhole Limpet Hemocyanin [KHL]}
- A61K 47/646: {the entire peptide or protein drug conjugate elicits an immune response, e.g. conjugate vaccines}
- A61P 3/10: for hyperglycaemia, e.g. antidiabetics
- A61P 5/14: of the thyroid hormones, e.g. T3, T4
- A61P 9/00: Drugs for disorders of the cardiovascular system
- A61P 17/00: Drugs for dermatological disorders
- A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like
- A61P 19/02: for joint disorders, e.g. arthritis, arthrosis
- A61P 21/00: Drugs for disorders of the muscular or neuromuscular system
- A61P 27/02: Ophthalmic agents
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 31/18: for HIV
- A61P 37/00: Drugs for immunological or allergic disorders
- A61P 37/06: Immunosuppressants, e.g. drugs for graft rejection
- A61K 2039/6081: {Albumin; Keyhole limpet haemocyanin [KLH]}
- C12N 2760/20031: Uses of virus other than therapeutic or vaccine, e.g. disinfectant
- 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
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

An immunogenic product including IFNα coupled to a carrier protein molecule is capable to induce in vivo anti-IFNα antibodies and is useful in treating IFNα related conditions.

## Claims

### Claim 1

A method for treating systemic lupus erythematosus (SLE), Sjögren syndrome, type I diabetes, dermatomyositis and/or polymyositis in a subject in need thereof, by raising antibody levels against IFNα, the method comprising administering to the subject a therapeutically effective amount of an immunogenic product comprising IFNα coupled to keyhole limpet hemocyanin (KLH),
wherein said therapeutically effective amount is in the range of from 60 mcg to 240 mcg of immunogenic product per administration, and wherein the weight ratio of IFNα/KLH is in the range of 0.06 to 0.6, and
wherein said treating means at least one selected from the group consisting of alleviating symptoms, suppressing, diminishing or inhibiting any direct or indirect pathological consequences of the IFNα related condition, lowering the rate of progression of the IFNα related condition, ameliorating or palliating the state of the IFNα related condition, causing remission, maintaining remission state and improving prognosis.

### Claim 2 (depends on 1)

The method according to claim 1, wherein the immunogenic product is administrated to the subject at least twice in a month.

### Claim 3 (depends on 1)

The method according to claim 1, wherein the immunogenic product is administrated to the subject at least twice in a month, and then thereafter administrated to the subject at least once every three months.

### Claim 4 (depends on 2)

The method according to claim 2, wherein the immunogenic product is further administrated to the subject when, in a serum sample obtained from the subject, the amount of anti-IFNα antibodies is undetectable when quantified by ELISA or by bioassay to detect neutralizing anti-IFNα antibodies.

### Claim 5 (depends on 1)

The method according to claim 1, wherein the immunogenic product shows less than 5% of antiviral activity in the conditions of TEST B, wherein said TEST B is based on the protective effect of IFN on the cytopathic effect of vesicular stomatitis virus on Madin-Darby Bovine Kidney cells.

### Claim 6 (depends on 1)

The method according to claim 1, wherein the immunogenic product is capable of neutralizing the antiviral activity of IFNα in the conditions of TEST C, wherein said TEST C consists in evaluating the neutralizing capacity of the serum obtained from mice immunized with the immunogenic product by evaluating the cell viability in presence of the vesicular stomatitis virus replicating in Madin-Darby Bovine Kidney cells.

### Claim 7 (depends on 1)

The method according to claim 1, wherein the immunogenic product comprises at least one subtype of IFNα.

### Claim 8 (depends on 1)

The method according to claim 1, wherein the immunogenic product comprises the subtype IFNα 2b or 2a of IFNα.

### Claim 9 (depends on 1)

The method according to claim 1, wherein the immunogenic product is a vaccine, preferably in the form of an emulsion.

### Claim 10 (depends on 1)

The method according to claim 1, wherein said IFNα related condition is systemic lupus erythematosus (SLE).

### Claim 11 (depends on 1)

The method according to claim 1, wherein said IFNα related condition is Sjögren syndrome.

### Claim 12 (depends on 1)

The method according to claim 1, wherein said IFNα related condition is dermatomyositis and polymyositis.

### Claim 13 (depends on 1)

The method according to claim 1, wherein said IFNα related condition is type I diabetes.