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Compositions and methods for the therapy and diagnosis of breast cancer

Compositions and methods for the therapy and diagnosis of breast cancer description/claims

The Sequence Listing associated with this application is provided in text format in lieu of a paper copy, and is hereby incorporated by reference into the specification. The name of the text file containing the Sequence Listing is 210121—470C20_SEQUENCE_LISTING.txt. The text file is 501 KB, was created on Oct. 30, 2007, and is being submitted electronically via EFS-Web, concurrent with the filing of the specification.

The present invention relates generally to therapy and diagnosis of cancer, such as breast cancer. The invention is more specifically related to polypeptides, comprising at least a portion of a breast tumor protein, and to polynucleotides encoding such polypeptides. Such polypeptides and polynucleotides are useful in pharmaceutical compositions, e.g., vaccines, and other compositions for the diagnosis and treatment of breast cancer.

Breast cancer is a significant health problem for women in the United States and throughout the world. Although advances have been made in detection and treatment of the disease, breast cancer remains the second leading cause of cancer-related deaths in women, affecting more than 180,000 women in the United States each year. For women in North America, the life-time odds of getting breast cancer are one in eight.

2. Description of the Related Art

No vaccine or other universally successful method for the prevention or treatment of breast cancer is currently available. Management of the disease currently relies on a combination of early diagnosis (through routine breast screening procedures) and aggressive treatment, which may include one or more of a variety of treatments such as surgery, radiotherapy, chemotherapy and hormone therapy. The course of treatment for a particular breast cancer is often selected based on a variety of prognostic parameters, including an analysis of specific tumor markers. See, e.g., Porter-Jordan and Lippman, Breast Cancer 8:73-100 (1994). However, the use of established markers often leads to a result that is difficult to interpret, and the high mortality observed in breast cancer patients indicates that improvements are needed in the treatment, diagnosis and prevention of the disease.

Accordingly, there is a need in the art for improved methods for the treatment and diagnosis of breast cancer. The present invention fulfills these needs and further provides other related advantages.

In one aspect, the present invention provides polynucleotide compositions comprising a sequence selected from the group consisting of:

(a) sequences provided in SEQ ID NO:1-61, 63-175, 178, 180, 182-468, 474, 476, 477, 479, 482, 484, 486, 489-492, 504-506, 510-513, 520-533, 548-550, 564, 566-569, and 576;

(b) complements of the sequences provided in SEQ ID NO:1-61, 63-175, 178, 180, 182-468, 474, 476, 477, 479, 482, 484, 486, 489-492, 504-506, 510-513, 520-533, 548-550, 564, 566-569, and 576;

(c) sequences consisting of at least 20 contiguous residues of a sequence provided in SEQ ID NO:1-61, 63-175, 178, 180, 182-468, 474, 476, 477, 479, 482, 484, 486, 489-492, 504-506, 510-513, 520-533, 548-550, 564, 566-569, and 576;

(d) sequences that hybridize to a sequence provided in SEQ ID NO:1-61, 63-175, 178, 180, 182-468, 474, 476, 477, 479, 482, 484, 486, 489-492, 504-506, 510-513, 520-533, 548-550, 564, 566-569, and 576, under moderately stringent conditions;

(e) sequences having at least 75% identity to a sequence of SEQ ID NO:1-61, 63-175, 178, 180, 182-468, 474, 476, 477, 479, 482, 484, 486, 489-492, 504-506, 510-513, 520-533, 548-550, 564, 566-569, and 576;

(f) sequences having at least 90% identity to a sequence of SEQ ID NO:1-61, 63-175, 178, 180, 182-468, 474, 476, 477, 479, 482, 484, 486, 489-492, 504-506, 510-513, 520-533, 548-550, 564, 566-569, and 576; and

(g) degenerate variants of a sequence provided in SEQ ID NO:1-61, 63-175, 178, 180, 182-468, 474, 476, 477, 479, 482, 484, 486, 489-492, 504-506, 510-513, 520-533, 548-550, 564, 566-569, and 576.

In one preferred embodiment, the polynucleotide compositions of the invention are expressed in at least about 20%, more preferably in at least about 30%, and most preferably in at least about 50% of breast tumors samples tested, at a level that is at least about 2-fold, preferably at least about 5-fold, and most preferably at least about 10-fold higher than that for normal tissues.

The present invention, in another aspect, provides polypeptide compositions comprising an amino acid sequence that is encoded by a polynucleotide sequence described above.

The present invention further provides polypeptide compositions comprising an amino acid sequence selected from the group consisting of sequences recited in SEQ ID NO:62, 176, 179, 181, 469-473, 475, 478, 483, 485, 487, 488, 493-503, 507-509, 514-519, 534-547, 551-553, 565, 570-573, and 577-627.

In certain preferred embodiments, the polypeptides and/or polynucleotides of the present invention are immunogenic, i.e., they are capable of eliciting an immune response, particularly a humoral and/or cellular immune response, as further described herein.

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