B7-H1 AND METHODS OF DIAGNOSIS, PROGNOSIS, AND TREATMENT OF CANCER

• US 20110200620A1
• Filed: 01/24/2011
• Published: 08/18/2011
• Est. Priority Date: 10/06/2004
• Status: Active Grant

• Current Assignee: Eugene D. Kwon, Lieping Chen, Scott E. Strome
• Original Assignee: Eugene D. Kwon, Lieping Chen, Scott E. Strome
• Inventors: STROME, Scott E., KWON, Eugene D., CHEN, Lieping
• Granted Patent: US 8,747,833 B2
• Time in Patent Office: Days
• US Class Current: 424/174.1
• CPC Class Codes: A61K 2039/505 comprising antibodies
• CPC Class Codes: A61K 38/2013 IL-2
• CPC Class Codes: A61K 38/2026 IL-4
• CPC Class Codes: A61K 38/2066 IL-10
• CPC Class Codes: A61K 38/208 IL-12
• CPC Class Codes: A61K 38/2086 IL-13 to IL-16
• CPC Class Codes: A61K 38/212 IFN-alpha
• CPC Class Codes: A61K 38/215 IFN-beta
• CPC Class Codes: A61K 38/217 IFN-gamma
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 35/02 specific for leukemia
• CPC Class Codes: C07K 16/2803 against the immunoglobulin superfamily
• CPC Class Codes: C07K 16/2827 against B7 molecules, e.g. CD80, CD86
• CPC Class Codes: C07K 16/30 from tumour cells
• CPC Class Codes: C07K 2317/24 containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
• CPC Class Codes: C07K 2317/76 Antagonist effect on antigen, e.g. neutralization or inhibition of binding
• CPC Class Codes: C12N 15/113 Non-coding nucleic acids modulating the expression of genes, e.g. antisense oligonucleotides; Antisense DNA or RNA; Triplex- forming oligonucleotides; Catalytic nucleic acids, e.g. ribozymes; Nucleic acids used in co-suppression or gene silencing when used in plants C12N15/8218
• CPC Class Codes: C12N 15/1138 against receptors or cell surface proteins
• CPC Class Codes: C12N 2310/11 Antisense
• CPC Class Codes: C12N 2310/14 interfering N.A.
• CPC Class Codes: C12N 2320/30 : Special therapeutic applications
• CPC Class Codes: C12Q 1/6886 : for cancer immunoassay for cancer G01N33/574
• CPC Class Codes: C12Q 2600/106 : Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism
• CPC Class Codes: C12Q 2600/118 : Prognosis of disease development
• CPC Class Codes: C12Q 2600/158 : Expression markers
• CPC Class Codes: G01N 33/5088 : of vertebrates
• CPC Class Codes: G01N 33/5091 : for testing the pathological state of an organism
• CPC Class Codes: G01N 33/56972 : White blood cells
• CPC Class Codes: G01N 33/57407 : Specifically defined cancers
• CPC Class Codes: G01N 33/57438 : of liver, pancreas or kidney
• CPC Class Codes: G01N 33/57484 : involving compounds serving as markers for tumor, cancer, neoplasia, e.g. cellular determinants, receptors, heat shock/stress proteins, A-protein, oligosaccharides, metabolites

Abstract

The invention features methods of diagnosis by assessing B7-H1 expression in a tissue from a subject that has, or is suspected of having, cancer, methods of treatment with agents that interfere with B7-H1-receptor interaction, methods of selecting candidate subjects likely to benefit from cancer immunotherapy, and methods of inhibiting expression of B7-H1.

Claims

1. A method of diagnosis, the method comprising:

(a) providing a tissue sample from a subject suspected of having, or likely to develop, cancer of the tissue, wherein the sample comprises test cells, the test cells being cells of the tissue or leukocytes infiltrating the tissue; and

(b) assessing whether the test cells express B7-H1, wherein expression by some or all of the test cells is an indication that the subject has cancer.

2. The method of claim 1, wherein the tissue is renal tissue.

3. The method of claim 1, wherein the subject is a human.

4. A method of identifying a candidate for immunotherapy, the method comprising:

(a) providing a tissue sample from a subject with cancer of the tissue, wherein the tissue sample comprises test cells, the test cells being cancer cells or tumor-infiltrating leukocytes; and

(b) assessing the level of test cells in the tissue sample that express B7-H1, wherein, if B7-H1 expression is not detected in the test cells or if less than an immuno-inhibitory threshold level of the test cells express B7-H1, the subject is more likely to benefit from immunotherapy.

5. A method of determining the prognosis of a subject with cancer, the method comprising:

(a) providing a tissue sample from a subject with cancer of the tissue, wherein the tissue sample comprises test cells, the test cells being cancer cells or tumor-infiltrating leukocytes; and

(b) assessing the level of test cells in the tissue sample that express B7-H1, wherein, if a prognostic level, or more than a prognostic level, of the test cells express B7-H1, the subject is more likely to die of the cancer than if less than a prognostic level of the test cells express B7-H1.

6. The method of claim 5, wherein the assessing comprises detecting B7-H1 polypeptide.

7. The method of claim 6, wherein the detecting comprises contacting the tissue sample with an antibody that binds to the B7-H1 polypeptide.

8. The method of claim 6, wherein the detecting comprises fluorescence flow cytometry (FFC).

9. The method of claim 6, wherein the detecting comprises immunohistology.

10. The method of claim 5 wherein the assessing comprises detecting B7-H1 mRNA.

11. The method of claim 10, wherein the detecting comprises contacting the sample with a nucleic acid probe that hybridizes to the B7-H1 mRNA.

12. The method of claim 10, wherein the detecting comprises a reverse transcriptase-polymerase chain reaction.

13. The method of claim 10, wherein the detecting comprises in situ hybridization.

14. The method of claim 5, wherein the tissue is selected from the group consisting of lung, epithelial, connective, vascular, muscle, nervous, skeletal, lymphatic, prostate, cervical, breast, spleen, gastric, intestinal, oral, esophageal, dermal, liver, bladder, thyroid, thymic, adrenal, brain, gallbladder, pancreatic, uterine, ovarian, and testicular tissue.

15. The method of claim 5, wherein the tissue is renal tissue.

16. The method of claim 5, wherein the cancer of the tissue is renal cell carcinoma.

17. The method of claim 5, wherein the subject is a mammal.

18. The method of claim 5, wherein the mammal is a human.

19. A method of treating a subject afflicted with a tumor comprising:

(a) identifying a subject, wherein at least some tumor-infiltrating leukocytes in the subject express B7-H1; and

(b) administering to the subject an agent that interferes with an interaction between B7-H1

and a receptor for B7-H1.

20. The method of claim 19, wherein the agent comprises an antibody or an antigen-binding fragment thereof.

21. (canceled)