Methods of using pegylated interleukin-10 for treating cancer

• US 9,943,568 B2
• Filed: 04/15/2014
• Issued: 04/17/2018
• Est. Priority Date: 04/18/2013
• Status: Active Grant

• Current Assignee: Armo BioSciences Inc.
• Original Assignee: Armo BioSciences Inc.
• Inventors: Oft, Martin
• Primary Examiner(s): STOICA, ELLY GERALD
• Application Number:
  US14/779,929
• Publication Number:
  US 20160058838A1
• Time in Patent Office: 1,463 Days
• Field of Search: None
• CPC Class Codes: A61K 38/2066 IL-10
• CPC Class Codes: A61K 47/02 Inorganic compounds
• CPC Class Codes: A61K 47/60 the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61P 1/04 for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
• CPC Class Codes: A61P 1/16 for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
• CPC Class Codes: A61P 17/06 Antipsoriatics
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/28 for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
• 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 3/06 Antihyperlipidemics
• CPC Class Codes: A61P 31/04 Antibacterial agents
• CPC Class Codes: A61P 31/12 Antivirals
• CPC Class Codes: A61P 31/14 for RNA viruses
• CPC Class Codes: A61P 31/18 for HIV
• CPC Class Codes: A61P 31/20 for DNA viruses
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 35/02 specific for leukemia
• CPC Class Codes: A61P 37/06 Immunosuppressants, e.g. drugs for graft rejection
• CPC Class Codes: A61P 7/02 Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
• 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 14/5428 : IL-10
• 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
• CPC Class Codes: C07K 2319/31 : fusions, other than Fc, for prolonged plasma life, e.g. albumin

Abstract

Methods of treating subjects having a disease or disorder responsive to IL-10, including methods of administration and dosing regimens associated therewith, are provided.

Claims

1. A method of treating cancer in a human subject, comprising administering to the human subject a therapeutically effective amount of a PEG-IL-10 agent sufficient to maintain an IL-10 serum trough concentration of the PEG-IL-10 agent in the human subject at or above 1 ng/ml over a period of time of at least one week;

wherein said administering treats cancer in the human subject.

2. The method of claim 1, wherein the PEG-IL-10 agent comprises mature human IL-10.

3. The method of claim 1, wherein the PEG-IL-10 agent comprises a variant of mature human IL-10, and wherein the variant exhibits activity comparable to the activity of mature human IL-10.

4. The method of claim 1, wherein the PEG-IL-10 agent comprises at least one PEG molecule covalently attached to at least one amino acid residue of at least one subunit of mature human IL-10.

5. The method of claim 1, wherein the PEG-IL-10 agent comprises a mixture of mono-pegylated and di-pegylated IL-10.

6. The method of claim 1, wherein the PEG component of the PEG-IL-10 agent has a molecular mass from about 5 kDa to about 20 kDa.

7. The method of claim 1, wherein the PEG component of the PEG-IL-10 agent has a molecular mass greater than about 20 kDa.

8. The method of claim 4, wherein at least one PEG molecule is covalently attached to at least one IL-10 subunit via a linker.

9. The method of claim 1, wherein the PEG-IL-10 agent is administered to the subject at least once daily.

10. The method of claim 1, further comprising administering at least one additional prophylactic or therapeutic agent.

11. The method of claim 1, wherein the IL-10 serum trough concentration is at least 1.25 ng/mL.

12. The method of claim 1, wherein the IL-10 serum trough concentration is at least 1.75 ng/mL.

13. The method of claim 1, wherein the PEG-IL-10 agent is administered to maintain an IL-10 serum trough concentration at or above 1 ng/ml is maintained over a period of time of at least two weeks.

14. The method of claim 1, wherein the PEG-IL-10 agent is administered to maintain an IL-10 serum trough concentration at or above 1 ng/ml is maintained over a period of time of at least one month.

15. The method of claim 1, wherein said administering is subcutaneous.

16. The method of claim 15, wherein said administering is once daily.