Interferon-beta-1a-immunoglobulin fusion proteins and uses

• US 7,527,946 B2
• Filed: 06/15/2004
• Issued: 05/05/2009
• Est. Priority Date: 10/16/1998
• Status: Expired due to Fees

• Current Assignee: Biogen Idec MA Inc. (Biogen, Inc.)
• Original Assignee: Biogen Idec MA Inc. (Biogen, Inc.)
• Inventors: Brickelmaier, Margot, Hochman, Paula, Whitty, Adrian, Runkel, Laura
• Primary Examiner(s): Saoud; Christine J
• Assistant Examiner(s): Seharaseyon; Jegatheesan
• Application Number:
  US10/868,673
• Publication Number:
  US 20050214253A1
• Time in Patent Office: 1,785 Days
• Field of Search: None
• US Class Current: 435/69.51
• CPC Class Codes: 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
• CPC Class Codes: A61P 11/02 Nasal agents, e.g. decongestants
• CPC Class Codes: A61P 15/00 Drugs for genital or sexual disorders for disorders of sex hormones A61P5/24; Contraceptives
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61P 21/00 Drugs for disorders of the muscular or neuromuscular system
• CPC Class Codes: A61P 25/02 for peripheral neuropathies
• CPC Class Codes: A61P 27/02 Ophthalmic agents
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 31/12 Antivirals
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 35/02 specific for leukemia
• CPC Class Codes: A61P 37/00 Drugs for immunological or allergic disorders
• CPC Class Codes: A61P 37/02 Immunomodulators
• CPC Class Codes: A61P 37/06 Immunosuppressants, e.g. drugs for graft rejection
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system
• CPC Class Codes: A61P 9/10 for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
• CPC Class Codes: C07K 14/565 IFN-beta
• CPC Class Codes: C07K 2319/00 Fusion polypeptide
• CPC Class Codes: C07K 2319/30 Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto

Abstract

A fusion polypeptide is described having the amino acid sequence X-Y-Z, or portion thereof, comprising the amino acid sequence of a glycosylated interferon-beta (X); Y is an optional linker moiety; and Z is a polypeptide comprising at least a portion of a polypeptide other than glycosylated interferon-beta. It is preferred that X is human interferon-beta-1a. Mutants of interferon-beta-1a are also described.

Claims

1. An isolated DNA encoding a fusion polypeptide comprising:

(a) an amino acid sequence, the amino acid sequence being located in the amino terminal region of said fusion polypeptide, selected from the group consisting of SEQ ID NOs;

45-59; and

(b) a hinge, CH2 and CH3 domains of an immunoglobulin, said domains being located in the carboxy terminal region of the fusion polypeptide.

2. The isolated DNA of claim 1, wherein the immunoglobulin is of the IgG class.

3. A recombinant DNA comprising the isolated DNA of claim 1 or 2 and an expression control sequence, wherein the expression control sequence is operatively linked to the isolated DNA.

4. An isolated host cell comprising the recombinant DNA of claim 3.

5. A method of producing a recombinant polypeptide comprising:

(a) providing a population of host cells according to claim 4;

(b) growing said population of cells under conditions whereby the polypeptide encoded by said recombinant DNA is expressed; and

(c) isolating the expressed polypeptide.

6. A pharmaceutical composition comprising a therapeutically effective amount of the a fusion polypeptide comprising:

(a) an amino acid sequence selected from the group consisting of SEQ ID NOs;

45-59; and

(b) a hinge, CH2 and CH3 domains of an immunoglobulin.

7. The pharmaceutical composition of claim 6, wherein the polypeptide is glycosylated at an amino acid in the amino acid sequence.

8. The pharmaceutical composition of claim 6, wherein the immunoglobulin is of the IgG class.

9. The pharmaceutical composition of claim 6, wherein the polypeptide is covalently linked to a polyalkylglycol polymer.

10. The pharmaceutical composition of claim 9, wherein the polyalkylglycol polymer is coupled to the N-terminus of the polypeptide.