Systems and methods for anti-PAX8 antibodies

• US 9,417,243 B2
• Filed: 10/06/2014
• Issued: 08/16/2016
• Est. Priority Date: 05/10/2011
• Status: Active Grant

• Current Assignee: Biocare Medical, Inc., Biocare Medical LLC
• Original Assignee: Biocare Medical LLC
• Inventors: Qi, Weimin, Tacha, David
• Primary Examiner(s): Huff, Sheela J
• Application Number:
  US14/507,667
• Publication Number:
  US 20150056635A1
• Time in Patent Office: 680 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: C07K 16/18 against material from animals or humans
• CPC Class Codes: C07K 16/32 against translation products of oncogenes
• CPC Class Codes: C07K 2317/20 characterized by taxonomic origin
• CPC Class Codes: C07K 2317/23 from birds
• CPC Class Codes: C07K 2317/24 containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
• CPC Class Codes: C07K 2317/33 Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
• CPC Class Codes: C07K 2317/34 Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
• CPC Class Codes: C07K 2317/56 variable (Fv) region, i.e. VH and/or VL
• CPC Class Codes: C07K 2317/565 Complementarity determining region [CDR]
• CPC Class Codes: G01N 33/574 for cancer
• CPC Class Codes: G01N 33/57407 Specifically defined cancers
• CPC Class Codes: G01N 33/57434 of prostate
• CPC Class Codes: G01N 33/57438 of liver, pancreas or kidney
• CPC Class Codes: G01N 33/57446 of stomach or intestine
• CPC Class Codes: G01N 33/5748 involving oncogenic proteins

Abstract

The present invention is related to the anti-PAX8 antibodies, kits, cocktails, and use of anti-PAX8 antibodies for detection of cancer.

Claims

1. An antibody or fragment thereof that specifically binds to the amino acid sequence consisting of SEQ ID NO:

3.

2. An antibody or fragment thereof according to claim 1 wherein said antibody or fragment thereof comprises a polypeptide of the amino acid sequence encoded by the nucleic acid sequence of SEQ ID NO:

1 and SEQ ID NO;

2.

3. An antibody or fragment thereof according to claim 1 wherein said antibody or said fragment thereof comprises a light chain variable region comprising the amino acid sequence encoded by the nucleic acid sequence of SEQ ID NO:

2 and a heavy chain variable region comprising the amino acid sequence encoded by the nucleic acid sequence of SEQ ID NO;

1.

4. An antibody or fragment thereof according to claim 1 wherein said antibody or said fragment thereof binds specifically to at least PAX8.

5. An antibody or fragment thereof according to claim 4 wherein said antibody or said fragment thereof which binds specifically to at least PAX8 comprises an antibody or fragment thereof which binds specifically to at least PAX8 and does not bind to B-cells.

6. An antibody or fragment thereof according to claim 4 wherein said antibody or said fragment thereof which binds specifically to at least PAX8 comprises an antibody or fragment thereof which binds specifically to at least PAX8 and does not specifically bind to cells selected from a group consisting of neuroendocrine cells, pancreatic cells, and any combination thereof.

7. A composition according to claim 1 comprising said antibody or fragment thereof that specifically binds to at least one polypeptide with an amino acid sequence comprising residues of SEQ ID NO:

3 and at least one other antibody or fragment thereof.

8. A composition according to claim 7 wherein said at least two antibodies or fragments thereof are obtained from at least two different species.

9. A composition according to claim 8 wherein said at least two different species is selected from a group consisting of mouse, rabbit, goat, horse, chicken, human, and any combination thereof.

10. A composition according to claim 7 wherein said at least two antibodies or fragments thereof are used in a double-stain procedure.

11. A composition according to claim 7 wherein said at least two antibodies or fragments thereof are used in a staining procedure capable of providing different visualization results.

12. A composition according to claim 11 wherein said visualization results comprise color results.

13. A composition according to claim 7 wherein said at least one other antibody or fragment thereof binds specifically to an antigen selected from a group consisting of GATA-3, p63, PSA, ER, Mammaglobin, GCDFP-15, NKX3.1, Napsin A, TTF-1, CK20, CDX2, ERG, and any combination thereof.

14. A composition according to claim 7 wherein at least two antibodies or fragments thereof each bind specifically to proteins selected from a group consisting of:

PAX8 and GATA-3;

PAX8 and p63;

PAX8 and PSA;

PAX8 and PSA and GATA-3;

PAX8 and ER and Mammoglobin and GCDFP-15;

PAX8 and ER;

PAX8 and Mammoglobin;

PAX8 and GCDFP-15;

PAX8 and NKX3.1;

PAX8 and Napsin A and TTF-1;

PAX8 and Napsin A;

PAX8 and TTF-1;

PAX8 and CD20 and CDX2;

PAX8 and CD20;

PAX8 and CDX2;

PAX8 and ERG and GATA-3; and

PAX8 and ERG.

15. An antibody according to claim 1 wherein said antibody comprises a monoclonal antibody.

16. An antibody according to claim 15 wherein said monoclonal antibody is selected from a group consisting of a mouse monoclonal antibody, a rabbit monoclonal antibody, a goat monoclonal antibody, a horse monoclonal antibody, a chicken monoclonal antibody, a humanized monoclonal antibody, a chimeric antibody, and any combination thereof.

17. An antibody according to claim 1 wherein said antibody comprises an isolated antibody.

18. An antibody according to claim 1 wherein said fragment thereof comprises an antigen binding fragment thereof.

19. An antibody according to claim 1 and further comprising a label attached to said antibody or fragment thereof.

20. An antibody according to claim 19 wherein said label is selected from a group consisting of a radioactive element, magnetic particles, radioisotope, fluorescent dye, enzyme, toxin, signal, stain, and any combination thereof.

21. A method for detecting PAX8 in a biological sample comprising the steps of:

contacting a biological sample with said antibody or fragment thereof according to claim 1; and

detecting binding of said antibody with an antigen in said biological sample using said antibody detection element.

22. A method according to claim 21 wherein said biological sample is selected from a group consisting of a normal tissue, neoplastic tissue, kidney tissue, ovarian tissue, thyroid tissue, endometrial tissue, renal tissue, tonsil tissue, pancreas tissue, colon tissue, lymph node tissue, neoplastic pancreatic tissue, stomach tissue, bladder tissue, prostate tissue, lung tissue and breast tissue.

23. A method according to claim 21 wherein said detecting comprises a method selected from a group consisting of immunohistochemistry (IHC), IHC of FFPE, ICH of frozen-tissue sections, and ELISA.