36P6D5: secreted tumor antigen

• US 7,507,541 B2
• Filed: 05/24/2007
• Issued: 03/24/2009
• Est. Priority Date: 10/28/1999
• Status: Expired due to Fees

• Current Assignee: Agensys, Inc. (Astellas Pharma Incorporated)
• Original Assignee: Agensys, Inc. (Astellas Pharma Incorporated)
• Inventors: Raitano, Arthur B., Faris, Mary, Afar, Daniel E. H., Jakobovits, Aya, Hubert, Rene S., Mitchell, Steve Chappell
• Primary Examiner(s): Aeder; Sean E
• Application Number:
  US11/805,969
• Publication Number:
  US 20080019971A1
• Time in Patent Office: 670 Days
• Field of Search: 435/7.1
• US Class Current: 435/7.1
• CPC Class Codes: A61K 2039/505 comprising antibodies
• CPC Class Codes: A61K 2039/53 DNA (RNA) vaccination
• CPC Class Codes: A61K 38/00 Medicinal preparations containing peptides peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00
• CPC Class Codes: A61K 39/00 Medicinal preparations containing antigens or antibodies materials for immunoassay G01N33/53
• CPC Class Codes: A61K 39/0011 Cancer antigens
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 35/04 specific for metastasis
• CPC Class Codes: C07K 14/47 from mammals
• CPC Class Codes: C07K 16/18 against material from animals or humans
• CPC Class Codes: C07K 16/3069 Reproductive system, e.g. ovaria, uterus, testes, prostate
• 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 2600/136 Screening for pharmacological compounds
• CPC Class Codes: C12Q 2600/154 Methylation markers
• CPC Class Codes: G01N 33/574 for cancer
• CPC Class Codes: G01N 33/57419 of colon
• CPC Class Codes: G01N 33/57434 of prostate
• 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: 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

Described is a gene and its encoded secreted tumor antigen, termed 36P6D5, and to diagnostic and therapeutic methods and compositions useful in the management of various cancers which express 36P6D5, particularly including cancers of the bladder, kidney, prostate, breast, colon, ovary and pancreas.

Claims

1. A method of detecting the presence of breast, colon, kidney or pancreatic cancer expressing 36P6D5 protein that comprises determining the level of 36P6D5 protein expressed by cells in a breast, colon, kidney or pancreatic test tissue sample from an individual, wherein the 36P6D5 protein comprises SEQ ID NO:

2, and comparing the level so determined to the level of 36P6D5 expressed in a corresponding normal breast, colon, kidney or pancreatic tissue sample, the presence of elevated 36P6D5 protein in the test sample relative to the normal sample providing an indication of the presence of such cancer in the individual.

2. The method of claim 1, wherein determining the level of 36P6D5 protein expressed by the cells comprises contacting the cells with an antibody that specifically binds 36P6D5 protein comprising the amino acid sequence of SEQ ID NO:

2.

3. The method of claim 2, wherein the antibody comprises a polyclonal antibody.

4. The method of claim 2, wherein the antibody comprises a monoclonal antibody.

12. The method of claim 1, wherein breast tissue is examined.

13. The method of claim 1, wherein colon tissue is examined.

14. The method of claim 1, wherein kidney tissue is examined.

15. The method of claim 1, wherein pancreatic tissue is examined.

5. A method of monitoring 36P6D5 gene products comprising determining the status of 36P6D5 gene products expressed by cells in a test breast, colon, kidney or pancreatic tissue sample from an individual, wherein the 36P6D5 gene product is a protein comprising SEQ ID NO:

2, and comparing the status so determined to the status of 36P6D5 gene products in a corresponding normal breast, colon, kidney or pancreatic sample, the presence of elevated status of 36P6D5 gene products in the test sample relative to the normal sample providing an indication of dysregulated breast, colon, kidney or pancreatic cell growth within the individual.

16. The method of claim 5, wherein the status of the 36P6D5 gene products is determined in a test breast tissue sample.

17. The method of claim 5, wherein the status of the 36P6D5 gene products is determined in a test colon tissue sample.

18. The method of claim 5, wherein the status of the 36P6D5 gene products is determined in a test kidney tissue sample.

19. The method of claim 5, wherein the status of the 36P6D5 gene products is determined in a test pancreatic tissue sample.

6. A method of examining a biological breast, colon, kidney or pancreatic sample for evidence of dysregulated cellular growth comprising comparing the status of 36P6D5 in the biological breast, colon, kidney or pancreatic sample to the status of 36P6D5 in a corresponding normal breast, colon, kidney or pancreatic sample, wherein the status of 36P6D5 in the biological sample is evaluated by examining levels of 36P6D5 protein expression, wherein the 36P6D5 protein comprises SEQ ID NO:

2, and wherein elevations in the status of 36P6D5 in the biological sample are associated with dysregulated breast, colon, kidney or pancreatic cellular growth.

20. The method of claim 6, wherein a breast sample is examined.

21. The method of claim 6, wherein a colon sample is examined.

22. The method of claim 6, wherein a kidney sample is examined.

23. The method of claim 6, wherein a pancreatic sample is examined.

7. A method of diagnosing the presence of breast, colon, kidney or pancreatic cancer in an individual comprising:

(a) determining the level of 36P6D5 protein expressed in a test breast, colon, kidney or pancreatic sample obtained from the individual, wherein the 36P6D5 protein comprises SEQ ID NO;

2; and

(b) comparing the level so determined to the level of 36P6D5 protein expressed in a comparable known normal breast, colon, kidney or pancreatic tissue sample,

the presence of elevated 36P6D5 protein in the test sample relative to the normal tissue sample providing an indication of the presence of cancer.

8. The method of claim 7, wherein the sample is a colon sample.

9. The method of claim 7, wherein determining the level of 36P6D5 protein expressed in the test sample comprises contacting the sample with an antibody that specifically binds 36P6D5 protein comprising the amino acid sequence of SEQ ID NO:

2.

10. The method of claim 9, wherein the antibody comprises a polyclonal antibody.

11. The method of claim 9, wherein the antibody comprises a monoclonal antibody.

24. The method of claim 7, wherein the sample is a breast sample.

25. The method of claim 7, wherein the sample is a kidney sample.

26. The method of claim 7, wherein the sample is a pancreatic sample.