Novel gene deletions and translocations involving chromosome 2 resulting in fusion proteins combining part of Anaplastic Lymphoma Kinase (ALK) kinase with part of a secondary protein have been identified herein in human solid tumors, e.g. non-small cell lung carcinoma (NSCLC). Secondary proteins include Echinoderm Microtubule-Associated Protein-Like 4 (EML-4) and TRK-Fusion Gene (TFG). The EML4-ALK fusion protein, which retains ALK tyrosine kinase activity, was confirmed to drive the proliferation and survival of NSCLC characterized by this mutation. The invention therefore provides, in part, isolated polynucleotides and vectors encoding the disclosed mutant ALK kinase polypeptides, probes for detecting it, isolated mutant polypeptides, recombinant polypeptides, and reagents for detecting the fusion and truncated polypeptides. The disclosed identification of this new fusion protein enables methods for screening for compounds that inhibit the proteins, and methods for inhibiting the progression of a cancer characterized by the mutant polynucleotides or polypeptides.

This invention relates to humanized antibodies that selectively bind the 31.1 epitope on the A33 protein differentially expressed in cancers including, lung cancer, ovarian cancer, pancreas cancer, breast cancer, and colon cancer, and diagnostic and therapeutic usages.

The invention discloses oncogenic fusion proteins. The invention provides methods for treating gene-fusion based cancers.

The present invention relates to detecting serum anti-FadA antibodies in test samples from a patient. Additionally, aspects of the present invention provide the basis for detection of serum anti-FadA antibody levels from test samples and correlation with various conditions of clinical relevance.

A method for therapy control of HPV16 positive carcinoma, an antibody for use in the corresponding diagnostic method as well as a test for performing the method. In particular, a serologic method for monitoring the development of the amount of antibodies in samples, which were taken from a patient before and after the treatment of a HPV16 positive carcinoma over a predetermined period of time. In addition, an immunologic test in the form of a kit, with which the method can be performed.

A reliable assay to specifically detect CD155 in tissue sections has widespread use because CD155 is expressed widely among tumor types. Additionally, detected expression of CD 155 in glioblastoma cells is at levels commensurate with susceptibility to PVSRIPO (a poliovirus construct) infection and killing. An anti-CD155 antibody can achieve mono-specific detection of CD155 in immunoblots of tumor homogenates and immunohistochemistry of tumor formalin fixed, paraffin embedded sections. The assay can be used to determine appropriate use of PVSRIPO in oncolytic immunotherapy against cancers.

A problem to be addressed by the present invention is to provide: a method for detecting bone metastasis of cancer (excluding castration resistant prostate cancer) in a simple and highly accurate manner; and a reagent that can be used in the method. Bone metastasis of cancer (excluding castration resistant prostate cancer) is detected by measuring an intact growth and differentiation factor 15 (GDF15) propeptide level, a GDF15 propeptide fragment level, and the total of an intact GDF15 propeptide level and a GDF15 propeptide fragment level in a sample. The above described method for detecting bone metastasis of cancer includes a method for detecting bone metastasis of prostate cancer other than castration resistant prostate cancer, renal cancer, lung cancer, breast cancer, thyroid cancer, pancreatic cancer, bladder cancer, colon cancer, melanoma, myeloma, or lymphoma. Further, the reagent for detecting bone metastasis of cancer (excluding castration resistant prostate cancer) includes an antibody that specifically recognizes GDF15 propeptide.

A Prussian blue/zinc oxide-carbon nanotube composite is provided, the nanotube composite being selective and sensitive for detection of hydrogen peroxide, which is important for screening for early cancer detection, monitoring cardiovascular disease, detecting onset of food spoilage, and enzymatic reactions that produce hydrogen peroxide as a byproduct. Also provided are methods using said zinc oxide-carbon nanotube composite in which standard addition is used in combination with chronoamperometry detection to quantify the level of hydrogen peroxide in a biological sample.

The present invention relates to a method for producing a medicament for the treatment or prevention of a tumor in a subject or a diagnostic agent for the detection of a tumor in a subject comprising (A) determining the expression of at least one nucleic acid molecule and/or at least one protein or peptide in a sample obtained from said subject, wherein the at least one nucleic acid molecule is selected from nucleic acid molecules (a) encoding a polypeptide comprising or consisting of the amino acid sequence of any one of SEQ ID NOs 1 to 5, (b) comprising or consisting of the nucleotide sequence of any one of SEQ ID NOs 6 to 10, (c) encoding a polypeptide which is at least 85% identical, preferably at least 90% identical, and most preferred at least 95% identical to the amino acid sequence of (a), (d) consisting of a nucleotide sequence which is at least 95% identical, preferably at least 96% identical, and most preferred at least 98% identical to the nucleotide sequence of (b), (e) consisting of a nucleotide sequence which is degenerate with respect to the nucleic acid molecule of (d), (f) consisting of a fragment of the nucleic acid molecule of any one of (a) to (e), said fragment comprising at least 150 nucleotides, preferably at least 300 nucleotides, more preferably at least 450 nucleotides, and most preferably at least 600 nucleotides, and (g) corresponding to the nucleic acid molecule of any one of (a) to (f), wherein T is replaced by U, and wherein the at least one protein or peptide is selected from proteins or peptides being encoded by the nucleic acid molecule of any one of (a) to (g); and (B) producing a medicament capable of inhibiting the expression of the at least nucleic acid molecule and/or the at least one protein or peptide in the subject, if the at least one nucleic acid molecule and/or at least one protein or peptide is expressed in (A), and/or (B′) producing a diagnostic agent capable of detecting in vivo the sites of expression of the at least nucleic acid molecule and/or the at least one protein or peptide in the subject, if the at least one nucleic acid molecule and/or at least one protein or peptide is expressed in (A).

The present invention includes methods of detecting follicular regulatory T cells (T.sub.FR) comprising: obtaining a biological sample from a subject and detecting whether T.sub.FR are increased in the tumor sample by contacting the biological sample with antibodies that detect CD3.sup.+CD4.sup.+ FOXP3.sup.+BCL6.sup.+ T cells CD3.sup.+CD4.sup.+CXCR5.sup.+GITR.sup.+ T cells, or both, when compared to a healthy subject, and detecting the increase of T.sub.FR in the tumor sample. The present invention also includes combination therapy that depletes follicular regulatory T cells (T.sub.FR) with minimal effect on regulatory T cells (T.sub.REGS) to prevent or reduce immune related adverse effects (irAEs).