Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving nucleic acid
Reexamination Certificate
1998-07-09
2001-02-27
Arthur, Lisa (Department: 1655)
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
Involving nucleic acid
C435S091200, C435S320100, C435S325000, C536S023100, C536S024300, C536S024310, C536S024330
Reexamination Certificate
active
06194152
ABSTRACT:
FIELD OF THE INVENTION
The invention relates to novel coding sequences and peptides derived from prostate tumors and to methods for detecting the presence of such tumor cells.
BACKGROUND OF THE INVENTION
Prostate carcinoma is a form of cancer that afflicts approximately 250,000 men in the United States each year, making it one of the most frequent cancers in Americans. It is also the second leading cause of cancer-related deaths in males in this country. While five-year survival rates for prostate carcinoma have generally improved over the past several decades, treatment for the advanced, metastatic form of the disease has not improved significantly.
Early detection and treatment of prostate cancer therefore remains one of the most effective measures to prevent further spread of and mortality from the disease. While a number of protein antigens have been discovered that are characteristic of malignant tumors, prostate tumors have not been particularly rich sources of target antigens that might be used for detection and/or immunotherapy of the disease, such as by passive immunotherapy.
It would therefore be useful to provide one or more disease-specific molecules or antigens that can be used in the early detection of prostate cancer. The present invention provides novel nucleotide sequences and corresponding expressed antigens that are useful in both the diagnosis and treatment of prostate carcinoma.
SUMMARY OF THE INVENTION
According to one aspect, the present invention is concerned with isolated nucleic acid molecules, which can be any form of RNA or DNA molecule that is useful, particularly in the area of diagnostic detection methods. The nucleic acid molecules described herein were identified on the basis of their unique presence in prostate tumor tissue samples. The molecules therefore have utility in detecting the presence, in a tissue or bodily fluid sample, of prostate tumor cells.
In one embodiment, the polynucleotides of the invention contain a region having sequence identity to a sequence selected from the group consisting of SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 6, SEQ ID NO: 7, and SEQ ID NO: 8, and SEQ ID NO: 14, or is complementary to such encoding nucleic acid sequences.
In another embodiment, the polynucleotides of the invention will hybridize under high stringency conditions to a sequence selected from the group consisting of SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 6, SEQ ID NO: 7, and SEQ ID NO: 8, and SEQ ID NO: 14, or the complement thereof.
Generally, according to a preferred aspect, the polynucleotide will be less than about 10 kilobases in length. In still a further aspect, the invention includes the recited polynucleotides. The invention also includes fragments of the polynucleotides of the present invention. In still another related aspect, the invention encompasses RNA molecules that are formed by translation of the foregoing nucleic acid sequences.
The isolated nucleic acid sequence may comprise the cDNA inserts of two pCR2.1 plasmid vectors (Invitrogen). The two clones which together make up the full-length SP 1-4 (SEQ ID NO: 14) sequence are designated pCR2.1/SP 1-4 (5′ RACE, SEQ ID NO: 27) and pCR2.1/SP 1-4 (3′ RACE, SEQ ID NO: 28). The approximate lengths of the plasmid inserts are 1.6 Kb and 4.0 Kb, respectively. The vectors deposited on Aug. 13, 1998 as ATCC 98827, 98828 and 98829 include the nucleotide sequences encoding SEQ ID NO: 15.
In another embodiment, the invention provides a vector comprising DNA encoding a prostate tumor antigen. A host cell comprising such a vector is also provided. By way of example, the host cells may be CHO cells,
E. coli,
insect cells or yeast. A process for producing prostate tumor antigens is further provided and comprises culturing host cells under conditions suitable for expression of a prostate tumor antigen and recovering the prostate tumor antigen from the cell culture.
Also useful and forming a part of the present invention are isolated nucleic acid molecules comprising DNA encoding prostate tumor antigens. In one aspect, the isolated nucleic acid comprises DNA encoding a prostate tumor antigen having an amino acid sequence selected from the group consisting of SEQ ID NOs: 9-11 and 15, or is complementary to such encoding nucleic acid sequences, and remains stably bound to it under at least moderate, and optionally, under high stringency conditions. Such peptides have utility in diagnostic assays, as well as in antigen compositions, such as peptide vaccines for use in eliciting humoral or cellular immune responses.
The invention further provides chimeric molecules comprising a prostate tumor antigen or extracellular domain thereof fused to a heterologous polypeptide or amino acid sequence. An example of such a chimeric molecule comprises a prostate tumor antigen fused to heterologous polypeptide which enhances the immunogenic properties of the antigen.
The invention also includes fragments of a prostate tumor antigen.
A further aspect of the invention is one or more antibodies which specifically bind to a prostate tumor antigen or an extracellular domain thereof. Optionally, the antibody is a monoclonal antibody. In still another aspect, the invention includes an antibody specific for a prostate tumor antigen. The antibody has diagnostic and therapeutic applications, particularly in treating prostate-related malignant disorders. Treatment methods include, but are not limited to, those which employ antisense or coding sequence polynucleotides for modulating the expression of prostate tumor antigen, as are treatment methods which employ antibodies specific for a prostate tumor antigen.
Diagnostic methods for detecting a prostate tumor antigen in specific tissue samples, and for detecting levels of expression of a prostate tumor antigen in tissues, also form part of the invention.
Furthermore, the polynucleotides recited above have particular utility in various nucleic acid-based detection assays Exemplary assays include in situ hybridization assays and PCR-based assays.
The invention also provides methods for diagnosing a prostate tumor-related condition in an individual. The presence of a prostate tumor antigen in a tissue from a first individual is measured and compared to a tissue from a second, unaffected individual. When a prostate tumor antigen is detected in said first individual and not in said second individual, the first individual is at risk for a prostate tumor related condition.
These and other objects and features of the invention will become more fully apparent when the following detailed description of the invention is read in conjunction with the accompanying drawings.
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Laus Reiner
Shapero Michael H.
Tsavaler Larisa
Arthur Lisa
Dehlinger Peter J.
Dendreon Corporation
Judge Linda R.
Souaya Jehanne
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