Anti-p40 antibodies systems and methods

• US 9,708,395 B2
• Filed: 08/04/2016
• Issued: 07/18/2017
• Est. Priority Date: 02/28/2013
• Status: Active Grant

• Current Assignee: Biocare Medical LLC
• Original Assignee: Biocare Medical LLC
• Inventors: Tacha, David, Qi, Weimin
• Primary Examiner(s): Haq, Shafiqul
• Assistant Examiner(s): BELEI, CARMENCITA
• Application Number:
  US15/228,341
• Publication Number:
  US 20160333085A1
• Time in Patent Office: 348 Days
• CPC Class Codes: C07K 16/18 against material from animals or humans
• CPC Class Codes: C07K 16/28 against receptors, cell surface antigens or cell surface determinants
• CPC Class Codes: C07K 16/32 against translation products of oncogenes
• 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 2317/34 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 2317/565 Complementarity determining region [CDR]
• CPC Class Codes: G01N 33/5017 for testing neoplastic activity
• CPC Class Codes: G01N 33/574 for cancer
• CPC Class Codes: G01N 33/57423 of lung
• 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
• CPC Class Codes: G01N 33/57488 involving compounds identifable in body fluids
• CPC Class Codes: G01N 33/577 involving monoclonal antibodies binding reaction mechanisms characterised by the use of monoclonal antibodies; monoclonal antibodies per se are classified with their corresponding antigens; G01N33/53 - G01N33/576 take precedence

Abstract

The present invention is related to the anti-p40 antibodies, kits, cocktails, and use of anti-p40 antibodies for detection of cancer.

Claims

1. An isolated antibody or isolated antigen binding fragment thereof that binds specifically to p40 comprising heavy chain variable region complementarity determining region (CDR) consisting of amino acid sequences set forth in SEQ ID NOs:

6, 7, and 8; and

light chain variable region CDR consisting of amino acid sequences set forth in SEQ ID NOs;

9, 10, and 11, wherein p40 comprises SEQ ID NO;

3.

2. The isolated antibody or isolated antigen binding fragment thereof of claim 1 that specifically binds to at least one p40 polypeptide consisting of an amino acid sequence selected from the group consisting of SEQ ID NO:

3 and SEQ ID NO;

4.

3. The isolated antibody or isolated antigen binding fragment thereof of claim 1 wherein said isolated antibody or said isolated antigen binding fragment thereof comprises a light chain variable region comprising the amino acid sequence encoded by a nucleic acid sequence consisting of SEQ ID NO:

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

1.

4. A composition comprising the isolated antibody or isolated antigen binding fragment thereof of claim 1 and at least one additional isolated antibody or isolated antigen binding fragment thereof wherein said at least one additional isolated antibody or isolated antigen binding fragment thereof specifically binds to an antigen selected from a group consisting of DSG-3, CK4, CK5, Napsin A, HMWCK, p504s, CK5/14, CK7/18, CK8/18, Uroplakin II, Uroplakin III, and GATA-3.

5. The composition according to claim 4 wherein said isolated antibody or isolated antigen binding fragment thereof and said at least one additional isolated antibody or isolated antigen binding fragment thereof each bind specifically to proteins selected from a group consisting of:

p40 and DSG-3 and CK5 and Napsin A;

p40 and DSG-3 and CK5;

p40 and Napsin A;

p40 and HMWCK and p504s;

p40 and p504s and CK5/14;

p40 and CK5/14 and CK7/18;

p40 and CK5/14 and CK8/18;

p40 and Uroplakin II and Uroplakin III; and

p40 and Uroplakin II and Uroplakin III and GATA-3.

6. The composition according to claim 4 wherein said isolated antibody or isolated antigen binding fragment thereof and said at least one additional isolated antibody or isolated antigen binding fragment thereof each bind specifically to proteins selected from a group consisting of:

p40 and DSG-3 and Napsin A;

p40 and DSG-3; and

p40 and CK5.

7. The composition according to claim 4 wherein said isolated antibody or isolated antigen binding fragment thereof and said at least one additional isolated antibody or isolated antigen binding fragment thereof are derived from at least two different species.

8. The composition according to claim 7 wherein said at least two different species is selected from a group consisting of mouse, rabbit, goat, horse, chicken and human.

9. The isolated antibody or isolated antigen binding fragment thereof according to claim 1 wherein said isolated antibody or isolated antigen binding fragment thereof is selected from a group consisting of a monoclonal antibody, a humanized monoclonal antibody, a chimeric antibody and an antigen binding fragment thereof.

10. The isolated antibody or isolated antigen binding fragment thereof according to claim 9 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 and a chicken monoclonal antibody.

11. The isolated antibody or isolated antigen binding fragment thereof of claim 1, wherein the isolated antibody or isolated antigen binding fragment thereof is conjugated with a label.

12. The isolated antibody or isolated antigen binding fragment thereof of claim 11 wherein said label is selected from a group consisting of radioactive element, magnetic particles, radioisotope, fluorescent dye, enzyme, toxin, signal, stain, detection enzymes, horseradish peroxidase (HRP), alkaline phosphatase (AP), beta-galactosidase, chromogens, Fast Red, 3,3′

-diaminobenzidine, 3-amino-9-ethylcarbazole, 5-bromo-4-chloro-3-indolyl phosphate, 3,3′

,5,5′

-tetramethylbenzidine and 5-bromo-4-chloro-3-indolyl-β

-D-glucuronide.

13. A method for detecting p40 in a biological sample comprising the steps of:

(a) providing the isolated antibody or isolated antigen binding fragment thereof of claim 1; and

(b) detecting binding of said isolated antibody or said isolated antigen binding fragment thereof with the p40 antigen with an immunoassay comprising;

(i) contacting the biological sample with said isolated antibody or isolated antigen binding fragment thereof to form a complex; and

(ii) detecting the presence or absence the complex,

wherein the immunoassay is selected from the group consisting of immunohistochemistry (IHC), IHC of FFPE, IHC of frozen-tissue sections, immunocytochemistry and ELISA.

14. A method according to claim 13 wherein said biological sample is selected from a group consisting of normal tissue, lung tissue, neoplastic tissue, bladder 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, prostate tissue, lung tissue and breast tissue.