Anti-p40 antibodies systems and methods

• US 9,428,576 B2
• Filed: 08/28/2015
• Issued: 08/30/2016
• 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:
  US14/839,744
• Publication Number:
  US 20160009795A1
• Time in Patent Office: 368 Days
• US Class Current: 1/1
• 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 produced by the hybridoma deposited with the American Type Culture Collection (ATCC) under ATCC Patent Deposit Designation No. PTA-120163 or isolated antigen binding fragment of the isolated antibody, wherein the antibody or antigen binding fragment thereof specifically binds p40 comprising SEQ ID NO:

4.

2. 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 the at least one additional isolated antibody or isolated antigen binding fragment thereof specifically binds to an antigen selected from the group consisting of DSG-3, CK4, CK5, Napsin A, HMWCK, p504S, CK5/14, CK7/18, CK8/18, Uroplakin II, Uroplakin III and GATA-3.

3. The isolated antibody or isolated antigen binding fragment thereof of claim 1, wherein the isolated antibodies or isolated antigen binding fragments 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. The composition according to claim 2 wherein the isolated antigen binding fragment and the at least one additional isolated antibody or isolated antigen binding fragment of the isolated antigen binding fragment are derived from at least two different species.

5. The composition according to claim 4 wherein said at least two different species is selected from a group consisting of mouse, rabbit, goat, horse, chicken and human.

6. The composition according to claim 2 wherein the isolated antibody or isolated antigen binding fragment thereof and the at least one additional isolated antibodies or

isolated antigen binding fragments 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.

7. The composition according to claim 2 wherein the isolated antibody or the isolated antigen binding fragment thereof and said at least one additional isolated antibodies or isolated antigen binding fragments 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.

8. A kit comprising:

the isolated antibody or isolated antigen binding fragment thereof of claim 1; and

an antibody detection reagent of said isolated antibody or isolated antigen binding fragment thereof of claim 1 when bound to the p40 antigen.

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

10. The antibody according to claim 9 wherein said label is selected from a group consisting of a 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, 5-bromo-4-chloro-3-indolyl-β

-D-glucuronide, and any combination thereof.

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

(a) providing the kit of claim 8; and

(a) 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 the isolated antibody or isolated antigen binding fragment thereof produced by the hybridoma deposited with the American Type Culture Collection (ATCC) under ATCC Patent Deposit Designation No. PTA-120163, wherein the antibody or antigen fragment thereof specifically binds p40 comprising SEQ ID NO;

4 to form a complex; and

(ii) detecting the complex with the antibody detecting element provided in the kit, wherein the immunoassay is selected from the group consisting of immunohistochemistry (IHC), IHC of FFPE, IHC of frozen-tissue sections, immunocytochemistry, and ELISA.

12. The method for detecting p40 in a biological sample according to claim 11 wherein said biological sample comprises lung tissue, bladder tissue, breast tissue, and prostate tissue.

13. The method for detecting p40 in a biological sample according to claim 11 wherein said biological sample is selected from a group consisting of a normal 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.