Abstract: Disclosed are methods for detecting, diagnosing or monitoring a renal cancer in a subject. The methods include detecting quantity of one or more polypeptides or fragments thereof comprised by body fluid such as urine, wherein the one or more polypeptides or fragments thereof, can be present at elevated levels in a subject with, a kidney cancer, as compared to a subject without a kidney cancer. Non-limiting examples of such polypeptides include aquaporin-1, adipose differentiation-related protein, and paired box protein-2. Antibody probes can be used to detect or quantify the polypeptides. In some embodiments, mass spectroscopy can be used to detect or quantify the polypeptides, or to identify a polypeptide in a body fluid sample from a subject with a kidney cancer.

Abstract: The present invention relates to antibody molecules, in particular antibody molecules that bind Transforming Growth Factor beta (TGF?), and uses thereof. More particularly, the invention relates to antibody molecules that bind and preferably neutralize TGF?1, TGF?2 and TGF?3, so-called “pan-specific” antibody molecules, and uses of such antibody molecules. Preferred embodiments within the present invention are antibody molecules, whether whole antibody (e.g. IgG, such as IgG1 or IgG4) or antibody fragments (e.g. scFv, Fab, dAb).

Abstract: To provide a more convenient and more accurate method of assaying ProGRP by improving the stability of ProGRP which is known to be unstable in a biological sample. By using a blood sample in a condition in which a blood coagulation factor is not activated is used as a sample, the degradation of ProGRP is suppressed, whereby it is possible to store a sample for a long period of time and to improve the accuracy of an assay.

Abstract: Novel modulators, including antibodies and derivatives thereof, and methods of using such modulators to treat hyperproliferative disorders are provided.

Abstract: Isolated peptides, compositions and methods of use for treating tumors infiltrated with macrophages, such as glioblastomas.

Abstract: Cellular and genetic signatures and methods of using same for subcategorizing stage III melanoma tumors are described herein. The signatures and methods are particularly useful with regard to establishing more distinct criteria on which basis to differentiate stage IIIB and IIIC melanoma patients. Assessment of the cellular and genetic signatures of a melanoma sample using methods described herein yields information on which basis differential survival duration and sensitivity to various cancer therapies can be predicted for a Stage IIIB or Stage IIIC melanoma patients. As described herein, gene expression profiling, determination of mitotic index (MI), and quantification of tumor infiltrating leukocytes (TILs) and CD3+ cells in metastatic lesions may be utilized to predict or assess drug response, drug sensitivity, and clinical outcome in metastatic melanoma patients.

Abstract: Disclosed is an animal model that can be used, among other things, to generate biomarkers for the prognosis and/or diagnosis of acute kidney injury, more specifically sepsis-induced acute kidney injury. Disclosed are three such biomarkers. The disclosure specifically relates to human chitinase 3-like protein 1 for use as a biomarker.

Abstract: The number of midbody derivatives in a cell may be modulated by modulating autophagy induced by NBR1. Exemplary methods include modulating the amount or activity of NBR1 in the cell, potentiating or inhibiting binding between NBR1 and Cep55 in the cell, or modulating the amount of Cep55 in the cell. These methods can be used in the treatment of cancers or in methods of reprogramming cells.

Abstract: The present invention relates to anti-ErbB2 antibody variants or antigen-binding fragments thereof, nucleic acid molecules encoding them, and their uses. The antibody variants of the present invention are capable of binding to ErbB2 with high affinity. Therefore, the antibody variants are ability to effectively prevent or treat various cancers with a low amount.

Abstract: Methods and kits for diagnosing cancer or a pre-malignant lesion by determining the presence and/or level of circulating CD24 of a subject are provided. Also provided are methods and kits for determining if a subject is predisposed to gastrointestinal cancer by the determining the presence or absence, in a homozygous or heterozygous form of cancer associated genotype(s) in the CD24 and/or APC nucleic acid sequences. Also provided are methods and kits for monitoring efficacy of cancer therapy by determining the presence and/or level of circulating CD24 of a subject.

Abstract: The present invention concerns compositions and methods of use of bispecific antibodies comprising at least one binding site for Trop-2 (EGP-1) and at least one binding site for CD3. The bispecific antibodies are of use for inducing an immune response against a Trop-2 expressing tumor, such as carcinoma of the esophagus, pancreas, lung, stomach, colon, rectum, urinary bladder, breast, ovary, uterus, kidney or prostate. The methods may comprising administering the bispecific antibody alone, or with one or more therapeutic agents such as antibody-drug conjugates, interferons (preferably interferon-?), and/or checkpoint inhibitor antibodies. The bispecific antibody is capable of targeting effector T cells, NK cells, monocytes or neutrophils to induce leukocyte-mediated cytotoxicity of Trop-2+ cancer cells. The cytotoxic immune response is enhanced by co-administration of interferon, checkpoint inhibitor antibody and/or ADC.

Abstract: The invention provides methods of monitoring differential gene expression of biomarkers to determine patient sensitivity to Human Double Minute inhibitors (MDM2i), methods of determining the sensitivity of a cell to an MDM2i by measuring biomarkers and methods of screening for candidate MDM2i.

Abstract: A device and array coupled to capture molecules are provided. Specifically, the device and array can be used for detecting the presence and concentration of biomarkers in a sample from a subject. The device and array can also allow the use of a method for scoring a sample for, e.g., the purpose of diagnosing a disease. The method can also be advantageous to applications where there is a need to accurately determine the disease stage of a subject for the purpose of making therapeutic decisions.

Abstract: The present invention relates to a combination of an allosteric mTOR inhibitor and a catalytic mTOR inhibitor for use in the prevention or treatment of neurodegenerative diseases, for example Huntington's Disease, and products and pharmaceutical compositions comprising such a combination for use in the prevention or treatment of such neurodegenerative diseases.

Abstract: The present invention relates to a method for determining the anti-tumor efficacy of monoclonal antibodies in pre-clinical rodent testings and the use of said method for the reduction of side testings.

Abstract: This invention relates generally to the THAP1 gene and mutations in this gene, as well as the THAP1 protein and mutations in this protein, that are associated with dystonia. The invention relates to the identification, isolation, cloning and characterization of the DNA sequence corresponding to the wild type and mutant THAP1 genes, as well as isolation and characterization of their transcripts and gene products. The invention further relates to methods and kits useful for detecting mutations in THAP1 that are associated with dystonia, as well as to methods and kits useful for diagnosing dystonia. The present invention also relates to therapies for treating dystonia, including gene therapeutics and protein/antibody based therapeutics.

Abstract: The present invention provides antibodies useful as therapeutics for treating and/or preventing diseases associated with cells expressing CLDN6, including tumor-related diseases such as ovarian cancer, lung cancer, gastric cancer, breast cancer, hepatic cancer, pancreatic cancer, skin cancer, malignant melanoma, head and neck cancer, sarcoma, bile duct cancer, cancer of the urinary bladder, kidney cancer, colon cancer, placental choriocarcinoma, cervical cancer, testicular cancer, and uterine cancer.

Abstract: Methods of screening human female subject for a risk of ovarian cancer are described. High levels of calcium in serum are shown to be significantly positively associated with the risk of ovarian cancer and can advantageously be used to triage women into risk categories for more intensive testing. Also included are preoperative methods of determining if an adnexal mass is likely to be malignant or benign.

Abstract: The present invention relates to compositions and methods for treating, characterizing and diagnosing ovarian cancer. In particular, the present invention provides methods for treating and/or preventing ovarian cancer in a subject by administering to the subject an effective amount of Mullerian Inhibiting substance and/or an effective amount of an agent that inhibits BCRP1. The present invention further provides methods to identify and/or enrich for populations of ovarian cancer stem cells and populations of somatic ovarian stem cells, in particular, enrichment for populations of coelomic somatic ovarian stem cells, subcoelomic/stromal somatic ovarian stem cells and periphilar medullary somatic ovarian stem cells. The present invention also provides somatic ovarian stem cell markers and ovarian cancer stem cell markers, as well as methods to identify agents which selectively inhibit the proliferation of ovarian cancer stem cells as compared to somatic ovarian stem cells.

Abstract: To provide a cell culture method capable of sustaining in-vivo functions for a long time by suppressing dedifferentiation. A cell culture method in accordance with the present invention is to culture cells in a multi-layered state in a minute partitioned space and to obtain a tissue structure having a function resembling an in-vivo function. When the cells are mammary gland epithelial cells, a hollow acinus-like structure can be formed. The minute partitioned space is particularly preferably a micro container in a cell culture container having a plurality of such micro containers on the surface.

Abstract: We characterized a total of 175 HLA-DR-associated phosphopeptides using sequential affinity isolation, biochemical enrichment, mass spectrometric sequencing and comparative analysis. Many were derived from source proteins which may have roles in cancer development, growth and metastasis. Most were expressed exclusively by either melanomas or transformed B cells, suggesting the potential to define cell type-specific phosphatome “fingerprints”. We generated HLA-DR?1*0101-restricted CD4+ T cells specific for a phospho-MART-1 peptide identified in two melanoma cell lines. These T cells showed specificity for phosphopeptide-pulsed antigen presenting cells as well as for intact melanoma cells. MHC II-restricted phosphopeptides recognizable by human CD4+ T cells are potential targets for cancer immunotherapy.

Abstract: Herein is reported a fusion polypeptide according to formula (I): NH2—S2—X1—S1—COOH, wherein X1 comprises either a random amino acid sequence or an amino acid sequence derived from a first polypeptide, S2 and S1 are non-overlapping amino acid sequences derived from a second polypeptide, and denotes a peptide bond, wherein the second polypeptide is a polypeptide with peptidyl-prolyl cis/trans-isomerase activity (PPIase activity) or is derived from the FKBP-fold domain family, wherein X1 is inserted in place of the insert-in-flap-domain of the second polypeptide.

Abstract: Described here is an automated robotic device that isolates circulating tumor cells (CTCs) or other biological structures with extremely high purity. The device uses powerful magnetic rods covered in removable plastic sleeves. These rods sweep through blood samples, capturing, e.g., cancer cells labeled with antibodies linked to magnetically responsive particles such as superparamagnetic beads. Upon completion of the capturing protocol, the magnetic rods undergo several rounds of washing, thereby removing all contaminating blood cells. The captured target cells are released into a final capture solution by removing the magnetic rods from the sleeves. Additionally, cells captured by this device show no reduced viability when cultured after capture. Cells are captured in a state suitable for genetic analysis. Also disclosed are methods for single cell analysis. Being robotic allows the device to be operated with high throughput.

Abstract: The present invention provides uses of cytokeratins as markers for diagnosing epithelium derived cancers. The present invention provides cancer-related epitopes of cytokeratins and monoclonal antibodies which specifically recognize the epitopes. The present invention also provides methods for the early screen, diagnosis or prognosis of epithelium derived cancers in subjects, methods for the evaluation of therapeutic effect of related medicaments or therapies, and kits for accomplishing the methods.

Abstract: Novel peptide inhibitors of GSK-3, compositions containing same and uses thereof are disclosed. The novel peptide inhibitors are substrate-competitive inhibitors and have an amino acid sequence designed so as to bind to a defined binding site subunit in GSK-3. Also disclosed are GSK-3 substrate competitive inhibitors which bind to the defined binding site subunit in the enzyme. Also disclosed are mutants of GSK-3 and uses thereof for identifying a putative GSK-3 substrate competitive inhibitor.

Abstract: There are provided peptides derived from antibodies with reactivity against a GPI linkage epitope and functionally-equivalent ligands. These peptides can be used in the therapy and diagnosis of a variety of diseases, all of which are considered to be caused by the inappropriate presence in the body of autoantibodies which are reactive with GPI linkage epitopes. There is also described a mechanism of action of these autoantibodies which compromises the organism, so causing disease, and a method of prevention of disease and detection of the autoantibody.

Abstract: It is disclosed herein that SPANX-B is uniquely expressed in a number of human tumors and that SPANX-B is an immunogenic antigen that is recognized by human T cells inducing helper CD4+ and cytolytic CD8+ T cell responses. Specific SPANX-B polypeptides and polynucleotides are disclosed that can be used to generate an immune response. In several embodiments, these polypeptides can be used for the treatment of a variety of cancers, including melanoma, colon carcinoma, ovarian cancer, breast cancer, myeloma, lung carcinoma and renal cancer.

Abstract: Cell-based immunotherapy (e.g., immunization or vaccination) may be improved by frequent administration to a human subject of allogeneic cancer cells secreting a modified heat shock protein (e.g., gp96), depletion of B cells in the subject, or both. Antigen (e.g., epitope derived from neoantigen or tumor antigen of allogeneic or syngeneic cancer cells) may induce a specific immune response in the subject. For example, the epitope bound in an immunogenic complex with the secreted heat shock protein may be obtained from allogeneic cancer cells coexpressing both secreted gp96 and antigen, or from syngeneic cancer cells of the subject expressing only antigen.

Abstract: Disclosed is a method for distinguishing a mesenchymal stem cell comprising, using at least one gene selected from the genes having the nucleotide sequences indicated by the accession numbers shown in Table 1 as a distinguish marker, detecting the difference in expression of the distinguish marker between a mesenchymal stem cell and a connective tissue cell to distinguish the mesenchymal stem cell from the connective tissue cell. This method enables to distinguish an undifferentiated mesenchymal stem cell from other connective tissue cell such as fibroblasts, osteoblasts, chondrocytes and adipose cells with good accuracy. A mesenchymal stem cell given by this method or a composition comprising the mesenchymal stem sell can be used as a therapeutic for use in the regenerative medicine.

Abstract: The present invention relates to a cytokeratin 8/18 complex-specific autoantibody or a fragment comprising an antigen-binding site (paratope) thereof, the use thereof in the diagnosis of breast cancer, a polypeptide having an amino acid sequence of an epitope specifically binding to the autoantibody, a composition for diagnosing breast cancer comprising an agent capable of measuring an expression level of the autoantibody or the fragment comprising an antigen-binding site thereof, a hybridoma cell line producing the autoantibody, and a kit for diagnosing breast cancer comprising the composition of the present invention. Further, the present invention relates to a method for diagnosing breast cancer, comprising the step of detecting the cytokeratin 8/18 complex-specific autoantibody or the fragment comprising the antigen-binding site thereof using the composition of the present invention, and a method for screening a therapeutic agent for breast cancer using the autoantibody.

Abstract: This application provides to a method for identifying one or more prostate tissue samples in a database that are closest to a test prostate sample, which can be used to aid pathologists when examining prostate tissues to attain reliable and consistent diagnoses of prostate cancer. Also provided are databases and computer algorithms that can be used with such methods.

Abstract: The present invention relates to a system and a method for the immunological detection of several substances or a substance having several features in one step, the detection reaction being based on an immunological sandwich type method and being in particular characterized in that it can easily be carry out and is designed as a “one-pot method”, which means that all detection steps are carried out in one reaction batch without any wash steps and with only one addition of reagents.

Abstract: A biosensor for use in detecting the presence of diseases, the biosensor comprising a detector for detecting a presence of at least one marker indicative of a specific disease. A method of determining efficacy of a pharmaceutical for treating a disease or staging disease by administering a pharmaceutical to a sample containing markers for a disease, detecting the amount of at least one marker of the disease in the sample, and analyzing the amount of the marker in the sample, whereby the amount of marker correlates to pharmaceutical efficacy or disease stage. Markers for gynecological disease. An immuno-imaging agent comprising labeled antibodies, whereby the labeled antibodies are isolated and reactive to proteins overexpressed in vivo. Informatics software for analyzing the arrays, the software including analyzing means for analyzing the arrays.

Abstract: A pharmaceutical composition for intraperitoneal delivery of an anti-neoplastic agent is provided for treating cancers associated with aberrant mucin expression, preferably ovarian cancer and pancreatic, prostate, metastatic breast, bladder and lung cancers. The composition comprises nanomicelles loaded with the anti-neoplastic agent, and antibodies such as anti-MUC16, anti-MUC1 or anti-MUC4 are conjugated to these nanomicelles. The antibody-bound nanomicelles are optionally embedded in a biodegradable pH- and thermo-responsive hydrogel capable of sol-gel transition at body temperature. The pharmaceutical composition is implantable in the peritoneum, where it transforms into a semi-solid gel at the body's core temperature. In response to pH, the hydrogel swells and releases the antibody-bound nanomicelles. The nanomicelles specifically target mucin antigens on cancer cells.

Abstract: The present invention pertains to anti-mucin antibodies having improved antigen binding and/or recognition properties as well as a method for improving the antigen binding and/or recognition of an anti-mucin antibody. In particular, the present invention is directed to anti-MUC1 antibodies which are useful in the treatment of cancer.

Abstract: The disclosure provides a method for immunotherapy of a subject afflicted with cancer, comprises administering to the subject a composition comprising a therapeutically effective amount of an antibody that inhibits signaling from the PD-1/PD-L1 signaling pathway. This disclosure also provides a method for immunotherapy of a subject afflicted with cancer comprising selecting a subject that is a suitable candidate for immunotherapy based on an assessment that the proportion of cells in a test tissue sample from the subject that express PD-L1 on the cell surface exceeds a predetermined threshold level, and administering a therapeutically effective amount of an anti-PD-1 antibody to the selected subject. The invention additionally provides rabbit mAbs that bind specifically to a cell surface-expressed PD-L1 antigen in a FFPE tissue sample, and an automated IHC method for assessing cell surface expression in FFPE tissues using the provided anti-PD-L1 Abs.

Abstract: The present invention provides an image registration device and method, an image segmentation device and method and a medical image apparatus. The image registration device includes: a rigid registration unit for performing a rigid registration of a first input image with a second input image, which is a reference, to obtain first deformation information; a first non-rigid registration unit for performing a first non-rigid registration of the first and second input images by taking the first deformation information as the initial deformation information to obtain second deformation information; and a second non-rigid registration unit for performing a second non-rigid registration of the first and second input images by taking the second deformation information as the initial deformation information to obtain third deformation information. By combining rigid registration with non-rigid registration, the present invention realizes a fast image registration.

Abstract: A method for preparing neoplastically transformed cells from human-derived cells, including the step of introducing human telomerase catalytic subunit (hTERT) gene, SV40 small T antigen (SV40ST) gene, and an antisense oligonucleotide derived from human 28S rRNA into the human-derived cells. The method for preparing neoplastically transformed cells from human-derived cells can be utilized when a variety of human normal cells are induced to be neoplastically transformed in order to elucidate cancer onset mechanisms, so that the method can be effectively utilized in search of target molecules for a new medicament.

Abstract: The present invention provides methods and compositions for screening, diagnosis and prognosis of colorectal cancer, kidney cancer, liver cancer, lung cancer, lymphoid leukaemia (particularly chronic lymphocytic leukaemia), ovarian cancer or pancreatic cancer, for monitoring the effectiveness of colorectal cancer, kidney cancer, liver cancer, lung cancer, lymphoid leukaemia (particularly chronic lymphocytic leukaemia), ovarian cancer or pancreatic cancer treatment, and for drug development.

Abstract: The invention provides multiparametric anti-SPARC antibody-based techniques for predicting the response to chemotherapy.

Abstract: The present disclosure provides antimicrobial peptides, and compositions comprising same. The present disclosure further provides methods of inhibiting microbial growth.

Abstract: Compositions and methods for use in methods and kits for the detection of an increased risk of pancreatic cancer are provided. Cyst fluid samples isolated from patients that are positive for at least three of the following markers, mucin 1, mucin 2, mucin 5AC, mucin 5B, mucin 6, CEA CAM 1, CEACAM 5, CEACAM 6, CEACAM 7, CEACAM 8, S100-A6, S100-A8, S100-A9 and S100-A11 indicate that such patients are at greater risk for development of pancreatic cancer when compared to cyst fluid samples isolated from patients lacking these markers.

Abstract: Biomarkers of anthracycline cardiotoxicity are provided. In certain aspects, methods are provided for determining whether a subject will develop cardiotoxicity upon treatment with an anthracycline, such as doxorubicin, by measuring the level of Top2b expression in the subject. In further aspects, methods of a treating a subjects with anthracycline therapeutics and cardioprotective agents are provided.

Abstract: The present invention relates to a for determining the presence, absence or amount of biologically active or inactive HGF in a sample, comprising the steps: bringing the sample in contact with a gel comprising a HGF binding component of the extracellular matrix or cell membrane, adding toluidine blue to the gel, correlating the color of the gel and/or a liquid in contact with the gel with the presence, absence or amount of biologically active HGF in the sample. It also relates to a kit of parts comprising toluidine blue and a gel comprising at least one HGF-binding component of the extracellular matrix or cell membrane, such as a proteoaminoglycan or a glucosaminoglycan, and optionally buffers, vials and sampling instruments and to a gel comprising at least one HGF-binding component of the extracellular matrix or cell membrane, such as a proteoaminoglycan or a glucosaminoglycan, toluidine blue and HGF.

Abstract: Without limitation, this disclosure relates to compositions and methods for detecting and quantifying the expression of insulin receptor isoform A (IR-A) and/or insulin receptor isoform B (IR-B) in a tissue sample. The disclosure also relates to methods of diagnosis and classification based at least in part upon detecting and quantifying the expression of insulin receptor isoform A (IR-A) and/or insulin B (IR-B) in a tissue sample. Methods of treating a subject based upon such a classification are among additional aspects of the disclosure presented herein.

Abstract: The present invention is directed generally to compositions and methods for obtaining secretion of antibodies or antigen-binding antibody fragments from prokaryotes without the need for a signal peptide through making use of mutant host strains with altered secretory properties. In particular, the invention provides host cells and methods for obtaining secretion of antibodies or antigen-binding antibody fragments from bacteria without the need for a signal peptide and provides diverse libraries of antibody sequence resulting from such methods. The invention additionally provides diverse libraries.

Abstract: Disclosed herein are methods and compositions for determining the sensitivity or enhancing the sensitivity of cells to the effects of topoisomerase I inhibitors. Also disclosed are methods and compositions for inducing cell death, apoptosis and/or growth arrest which may be used for tumor suppression.

Abstract: The present invention provides a CTL inducer composition which comprises one or more peptides selected from the group consisting of the peptides of SEQ ID NOS: 1 to 27 in the Sequence Listing, and can be used for the treatment or prevention of cancer or a hepatitis C virus-related disease in two or more patient groups selected from the group consisting of an HLA-A2 positive patient group, an HLA-A24 positive patient group, an HLA-A26 positive patient group, and an HLA-A3 supertype positive patient group.

Abstract: Methods and compositions for diagnosing and treating diseases, particularly cancer, associated with differential expression of cancer-associated targets (CAT) in disease cells compared to healthy cells are provided. Also provided are antagonists and agonists of CAT, and methods for screening agents that modulate CAT level or activity in vivo or in vitro.

Abstract: Methods for diagnosis and treatment of a cancer treatable with a c-Abl inhibitor are provided. Methods for diagnosing a cancer treatable with a c-Abl inhibitor include providing a biological sample from subject, determining an amount in the sample of geminin, c-Abl, or both, and comparing the amount of geminin, c-Abl, or both, if present, to a control level to thereby diagnose a subject as having a cancer treatable with a c-Abl inhibitor if there is a measurable difference in the amount of geminin, c-Abl, or both in the sample as compared to the control level. Methods for treating a cancer include identifying a subject as having a cancer treatable with a c-Abl inhibitor by determining an amount of geminin, c-Abl, or both, and then administering an effective amount of a c-Abl inhibitor to the subject. Screening methods for identifying compounds useful for inhibiting c-Abl are also provided.