The present invention provides compositions and methods for detecting the expression and/or activation levels of components of signal transduction pathways in tumor cells such as triple-negative metastatic breast tumor cells. Information on the expression and/or activation levels of components of signal transduction pathways derived from use of the present invention can be used for cancer diagnosis, prognosis, and in the design of cancer treatments.

The invention describes the use of high CD31 and/or tumor VEGFA as selection criteria for determining patient benefit or responsiveness to a VEGF antagonist, such as bevacizumab. The present invention also describes the use of high CD31 and/or tumor VEGFA as a selection criterion for treating cancer patients, such as ovarian cancer patients, who are undergoing a chemotherapy and/or anti-cancer therapy regimen, with a VEGF antagonist, such as bevacizumab.

The invention provides methods and compositions to detect expression of one or more biomarkers, including FGFR3, TP53, and/or EGFR, for treating, diagnosing, and providing a prognosis for cancer, e.g., bladder cancer. The invention also provides kits and articles of manufacture for use in the methods.

Provided are anti-epidermal growth factor receptor (EGFR) antibodies, aglycosylated CDR-H2 anti-EGFR antibodies, and antigen binding fragments thereof. Also provided are isolated nucleic acid molecules that encode the anti-EGFR antibodies or antigen binding fragments thereof, related expression vectors, and host cells. Provided are methods of making anti-epidermal growth factor receptor (EGFR) antibodies, aglycosylated CDR-H2 anti-EGFR antibodies, and antigen binding fragments thereof. Also provided are related pharmaceutical compositions and methods of their use to treat subjects.

The problem addressed by the present invention is to provide a marker for detecting hepatocellular carcinoma, wherein the hepatocellular carcinoma marker comprises a glycoprotein that first becomes present in the liver with the occurrence of cancer, without depending on changes in the state of the liver. The present invention provides a hepatocellular carcinoma marker comprising an NPA lectin-binding glycoprotein having an NPA lectin-binding glycan epitope that has at least one of the following properties (1) to (5): (1) the glycan epitope does not include core fucose (fucose α1.fwdarw.6 glycan); (2) the glycan epitope comprises a complex-type glycan having three (four or fewer) mannoses; (3) the glycan epitope does not include a high-mannose-type glycan having five or more mannoses; (4) the glycan epitope comprises a complex-type glycan that does not depend on the property of binding to LCA lectin; and (5) the glycan epitope comprises a complex-type glycan that does not depend on the property of binding to ConA lectin. By detecting the hepatocellular carcinoma marker of the present invention in a test sample, it is possible to determine the presence of hepatocellular carcinoma or the level of progression or malignancy of carcinoma.

The present invention provides a reporter for a protein fragment complementation assay characterized in that the reporter is a fused protein comprising a first fragment, a second fragment and a protein kinase sequence section, wherein the first fragment and the second fragment are derived from different sections of the same split protein, and wherein the protein kinase sequence section intervenes between the first fragment and the second fragment and wherein the kinase sequence section comprises a kinase domain sequence and one or more regulatory sequence(s). Further the invention provides polynucleotides and cells encoding for the reporter as well as methods of conducting a protein fragment complementation assay with the reporter according to the invention.

The present invention provides methods for selecting a suitable anticancer drug therapy, and for identifying and predicting response, for the treatment of colorectal cancer. The present invention also provides methods for monitoring the status of colorectal cancer and monitoring how a patient with colorectal cancer is responding to anticancer drug therapy. The present invention further provides methods for the rational selection of therapy with one or more anticancer drugs tailored to target signal transduction pathway components with dysregulated expression and/or activation levels in patients with somatic mutations in an oncogene.

Biomarkers for the detection and identification of a precursor of conventional dendritic cell (cDC) (pre-DC) and its cell subsets (pre-cDC1 or pre-cDC2), are defined, which include CD169, CD327, AXL, CD271, CD324 and combinations thereof for detecting pre-DCs. Methods for detecting a disease or condition, prognosis of an existing disease or condition comprising determining the number of pre-DC cells in sample from a subject as compared to control, as well as methods of treating a patient comprising administration of antibodies against CD169, CD327, AXL, CD271, CD324 and combinations thereof are also disclosed. In addition, an immunogenic composition comprising one or more binding molecules specific for one or more biomarkers or antigen of a target disease and/or one or more cells selected from the group consisting of early pre-DC, pre-cDC1 and pre-cDC2 are also disclosed for eliciting an immune response against an infectious disease or cancer.

The present invention relates to the fields of medicine and molecular diagnostics. In particular, it relates to a novel method for the treatment, prevention and/or delay of cancer and to a diagnostic method involving detection of a novel auto-active and intracellular mutant of MET.

The invention provides methods of measuring and/or quantifying the presence and/or amount of Her-3 and/or Her-3 in a complex and the presence and/or amount of p95 in a sample. The invention also provides antibodies specific for Her-3.