Immunopotentiative composition

• US 8,728,474 B2
• Filed: 12/02/2010
• Issued: 05/20/2014
• Est. Priority Date: 07/03/2002
• Status: Active Grant

• Current Assignee: Dana-Farber Cancer Institute, ONO Pharmaceutical Company Limited, Tasuku Honjo
• Original Assignee: ONO Pharmaceutical Company Limited, Tasuku Honjo
• Inventors: Honjo, Tasuku, Minato, Nagahiro, Iwai, Yoshiko, Shibayama, Shiro
• Primary Examiner(s): OUSPENSKI, ILIA I
• Application Number:
  US12/959,307
• Publication Number:
  US 20110081341A1
• Time in Patent Office: 1,265 Days
• US Class Current: 424/144.1
• CPC Class Codes: A61K 2039/505 comprising antibodies
• CPC Class Codes: A61K 2039/507 Comprising a combination of two or more separate antibodies
• CPC Class Codes: A61K 31/7088 Compounds having three or more nucleosides or nucleotides
• CPC Class Codes: A61K 38/1774 Immunoglobulin superfamily (e.g. CD2, CD4, CD8, ICAM molecules, B7 molecules, Fc-receptors, MHC-molecules)
• CPC Class Codes: A61K 38/212 IFN-alpha
• CPC Class Codes: A61K 39/3955 against proteinaceous materials, e.g. enzymes, hormones, lymphokines
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 47/02 Inorganic compounds
• CPC Class Codes: A61K 47/26 Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
• 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 1/16 for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 31/00 Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• CPC Class Codes: A61P 31/04 Antibacterial agents
• CPC Class Codes: A61P 31/10 Antimycotics
• CPC Class Codes: A61P 31/12 Antivirals
• CPC Class Codes: A61P 31/14 for RNA viruses
• CPC Class Codes: A61P 31/16 for influenza or rhinoviruses
• CPC Class Codes: A61P 31/18 for HIV
• CPC Class Codes: A61P 31/20 for DNA viruses
• CPC Class Codes: A61P 31/22 : for herpes viruses
• CPC Class Codes: A61P 33/06 : Antimalarials
• CPC Class Codes: A61P 35/00 : Antineoplastic agents
• CPC Class Codes: A61P 35/02 : specific for leukemia
• CPC Class Codes: A61P 35/04 : specific for metastasis
• CPC Class Codes: A61P 37/04 : Immunostimulants
• CPC Class Codes: A61P 37/06 : Immunosuppressants, e.g. drugs for graft rejection
• CPC Class Codes: A61P 43/00 : Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: C07K 14/70521 : CD28, CD152
• CPC Class Codes: C07K 16/18 : against material from animals or humans
• CPC Class Codes: C07K 16/2803 : against the immunoglobulin superfamily
• CPC Class Codes: C07K 16/2818 : against CD28 or CD152
• CPC Class Codes: C07K 16/2827 : against B7 molecules, e.g. CD80, CD86
• CPC Class Codes: C07K 2317/21 : from primates, e.g. man
• CPC Class Codes: C07K 2317/24 : containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
• CPC Class Codes: C07K 2317/54 : F(ab')2
• CPC Class Codes: C07K 2317/73 : Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
• CPC Class Codes: C07K 2317/76 : Antagonist effect on antigen, e.g. neutralization or inhibition of binding
• 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: C12Q 1/025 : for testing or evaluating the effect of chemical or biological compounds, e.g. drugs, cosmetics antimicrobial activity C12Q1/18
• CPC Class Codes: G01N 2500/00 : Screening for compounds of potential therapeutic value
• CPC Class Codes: G01N 33/5011 : for testing antineoplastic activity
• CPC Class Codes: G01N 33/574 : for cancer
• CPC Class Codes: Y02A 50/30 : Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

Compositions for cancer or infection treatment via immunopotentiation caused by inhibition of immunosuppressive signal induced by PD-1, PD-L1, or PD-L2 and therapies using them, immunopotentiative substrates included as the active ingredient, screening methods of the substrates for cancer or infection treatment, cell lines used for the screening methods, evaluation methods that select the substrates for cancer treatment, and carcinoma cell transplanted mammals used for the evaluation methods. The compositions of the present invention that inhibits the function of PD-1, PD-L1, or PD-L2 are useful for treatment of cancer or infection.

Claims

1. A method for treatment of a tumor in a patient, comprising administering to the patient a pharmaceutically effective amount of an anti-PD-1 monoclonal antibody.

2. The method of claim 1, wherein the anti-PD-1 monoclonal antibody binds to human PD-1 and is a chimeric, humanized, or human antibody.

3. The method of claim 2, wherein the tumor is one or more selected from the group consisting of a carcinoma, squamous carcinoma, adenocarcinoma, sarcoma, leukemia, neuroma, melanoma, and lymphoma.

4. The method of claim 3, wherein the squamous carcinoma is in the lung, cervical canal, eyelid, tunica conjunctiva, vagina, oral cavity, skin, urinary bladder, tongue, larynx, or gullet.

5. The method of claim 3, wherein the adenocarcinoma is in the prostate, small intestine, endometrium, cervical canal, large intestine, lung, pancreas, gullet, intestinum rectum, uterus, stomach, mammary gland, or ovary.

6. The method of any one of claims 1 to 5, wherein the pharmaceutically effective amount of the anti-PD-1 monoclonal antibody is administered to the patient in combination with a pharmaceutically effective amount of one or more chemotherapy drugs.

7. The method of claim 6, wherein the one or more chemotherapy drugs are selected from the group consisting of an alkylating agent, a nitrosourea agent, an antimetabolite, an antitumor antibiotic, an alkaloid derived from a plant, a topoisomerase inhibitor, a hormone therapy medicine, a hormone antagonist, an aromatase inhibitor, a P-glycoprotein inhibitor and a platinum complex derivative.

12. The method of claim 2 or 9, wherein tumor proliferation is suppressed.

13. The method of claim 2 or 9, wherein tumor metastasis is suppressed.

14. The method of claim 2 or 9, wherein the anti-human PD-1 monoclonal antibody is administered to the patient in combination with interferon-alpha.

15. The method of claim 2 or 9, wherein the anti-human PD-1 monoclonal antibody is administered to the patient in combination with an anti-CTLA-4 antibody.

16. The method of claim 2 or 9, wherein the anti-human PD-1 monoclonal antibody is administered to the patient in combination with a tumor antigen.

17. The method of claim 16, wherein the tumor antigen is selected from the group consisting of HLA-A1 or HLA-A2 restrictive peptide of malignant melanoma MAGE-1 or MAGE-3, MART-1, gp100, HER2/neu peptide of a mammary or ovarian carcinoma, MUC-1 peptide of an adenocarcinoma, and NY-ESO-1 of a metastatic carcinoma.

8. A method for treatment of a melanoma in a patient, comprising administering to the patient a pharmaceutically effective amount of an anti-PD-1 monoclonal antibody.

9. The method of claim 8, wherein the anti-PD-1 monoclonal antibody binds to human PD-1 and is a chimeric, humanized, or human antibody.

10. The method of claim 9, wherein the pharmaceutically effective amount of the anti-human PD-1 monoclonal antibody is administered to the patient in combination with a pharmaceutically effective amount of one or more chemotherapy drugs.

11. The method of claim 10, wherein the one or more chemotherapy drugs are selected from the group consisting of an alkylating agent, a nitrosourea agent, an antimetabolite, an antitumor antibiotic, an alkaloid derived from a plant, a topoisomerase inhibitor, a hormone therapy medicine, a hormone antagonist, an aromatase inhibitor, a P-glycoprotein inhibitor and a platinum complex derivative.