Abstract: The present invention relates to the use of TFF3 in the diagnosis and detection of Barrett's esophagus using non-invasive, non-endoscopic methods.

Abstract: The invention is directed to a releasable conjugate comprising a biotinylated ligand having a biotin moiety, a ligand moiety (Ligand1) and a biotin-binding molecule (bbm) bound to the biotin moiety of the biotinylated ligand. The ligand moiety of the biotinylated ligand may be separated by a spacer group consisting of polyethylene glycol. Furthermore, the invention relates to a method for cleaving the releasable conjugate by providing biotin or streptavidin and an auxiliary release agent in a sufficient concentration to displace the biotin-binding molecule (bbm) from the biotin moiety of the biotinylated ligand and a method for separation of target cells from a cell sample utilizing the conjugate.

Abstract: Microplates or microstrips having wells with extended length to receive immunosorbent elements protruding from a rod at the same modular distance of wells arranged in standard microstrips or microplates and methods of use are provided. A solid phase is constituted by the extended wells, each of which immobilize a different type of cell or molecule in the sample; the other solid phase is constituted by immunosorbent elements protruding from a rod, each of which has been previously coated with one of the same markers to be detected in the sample. Ligands for markers to be detected are added in a liquid phase to the wells; allowing the ligands competitively bind to the immunosorbent elements, inversely proportional to the quantity of the markers of each type of cell or molecule immobilized on the proper extended well. These ligands are simultaneously quantifiable by an immunoenzymatic assay using chromogenic substrate and a spectrophotometer.

Abstract: Provided herein are methods of modulating IL-33 activity, e.g., for the purpose of treating immune diseases and conditions, as well as methods of screening for compounds capable antagonizing IL-33 signaling.

Abstract: Isolated peptides composed of the amino acid sequence of SEQ ID NO: 33 or fragments thereof that bind to HLA antigens and have cytotoxic T lymphocyte (CTL) inducibility and thus are suitable for use in the context of cancer immunotherapy, more particularly cancer vaccines are described herein. The present invention further provides peptides that include one, two, or several amino acid insertions, substitutions or additions to the aforementioned peptides or fragments, but yet retain the requisite cytotoxic T cell inducibility. Further provided are nucleic acids encoding any of these aforementioned peptides as well as pharmaceutical agents, substances and compositions including any of the aforementioned peptides or nucleic acids. The peptides, nucleic acids, pharmaceutical agents, substances and compositions of this invention find particular utility in the treatment of cancers and tumors.

Abstract: The invention described herein relates to novel genes and their encoded proteins, termed Mutants Associated with Resistance to STI-571 (e.g., T315I Bcr-Abl), and to diagnostic and therapeutic methods and compositions useful in the management of various cancers that express MARS. The invention further provides methods for identifying molecules that bind to and/or modulate the functional activity of MARS.

Abstract: The present disclosure relates to an immune signature of tumor infiltrating leukocytes. In particular, the disclosure provides methods and kits for determining the immune signature of tumor infiltrating leukocytes for use in assessing risk of cancer recurrence and long term survival, and for developing a treatment regimen for a cancer patient.

Abstract: The present invention relates to selectively controlling the function of a helper T cell. In the present invention, a mouse lacking a gene involved in ganglioside biosynthesis (ganglioside GM3 synthetase gene) (SAT-I KO) was produced and analyzed. As a result, the present invention provides, for example, a method for screening a substance which induces selective suppression of the function of a helper T cell in an immune response, including control of production of a sphingoglycolipid in the helper T cell, and moderation or suppression of an excessive immune response caused by the suppression of the function, that is, a substance having an immunosuppression activity, an anti-asthmatic action and/or an anti-allergic action.

Abstract: Nucleic acids encoding mammalian cytokine receptor, e.g., for cytokine IL-B50, purified proteins and fragments thereof. Antibodies, both polyclonal and monoclonal, are also provided. Methods of using the compositions for both diagnostic and therapeutic utilities are described.

Abstract: Isolated human monoclonal antibodies which bind to and inhibit human CD20, and related antibody-based compositions and molecules, are disclosed. The human antibodies can be produced by a transfectoma or in a non-human transgenic animal, e.g., a transgenic mouse, capable of producing multiple isotypes of human monoclonal antibodies by undergoing V-D-J recombination and isotype switching. Also disclosed are pharmaceutical compositions comprising the human antibodies, non-human transgenic animals and hybridomas which produce the human antibodies, and therapeutic and diagnostic methods for using the human antibodies.

Abstract: Screening assays and methods of using same for screening to identify modulator agents or compounds that affect pcdh18 mediated inhibition of T cell effector function are described herein. Pharmaceutical and immunogenic compositions comprising agents or compounds that modulate pcdh18 mediated inhibition of T cell effector function are also encompassed. Methods for modulating pcdh18 mediated inhibition of T cell effector function using agents identified using assays described herein in pharmaceutical and immunogenic compositions are also envisioned. Adenocarcinoma is an exemplary tumor type that expresses pcdh18 and for which such pharmaceutical and immunogenic compositions would confer benefit to patients. Also encompassed are methods for reducing pcdh18 mediated inhibition of T cell effector function so as to achieve more effective T cell responses to pcdh18 expressing tumors.

Abstract: A reagent for classifying and counting leukocytes containing (1) a cyanine fluorescent dye; and (2) a glycoside compound; a reagent kit containing the reagent for classifying and counting leukocytes as well as its preparation process; and a process for classifying and counting blood cells using the reagent or kit are provided. Using the reagent, kit and/or process provided, leukocytes can be classified and counted in four groups with a high degree of differentiation and a better classification among each subpopulation of leukocytes, especially in that it successfully addresses the indistinct classification between lymphocytes and monocytes and between the eosinophils and neutrophils in a scattergram.

Abstract: The present invention relates to a soluble polypeptide comprised of repeat modules. More particularly, the present invention relates to a soluble fusion polypeptide of the N-terminal domain of internalin and LRR (Leucine rich repeat) family protein, a method for preparing the polypeptide, a vector comprising a nucleic acid sequence encoding the polypeptide, a host cell comprising the vector, a method for producing a solubility and folding-improved fusion polypeptide by expressing the vector in the host cell, and a method for improving the solubility and folding of the fusion polypeptide. Further, the present invention relates to a method for preparing the polypeptide bound with a specific target and analyzing the efficacy of the soluble polypeptide.

Abstract: The present invention reagents and methods for setting up an instruments having a multiplicity of detector channels for analyzing a multiplicity of fluorescent dyes. The present invention is particularly applicable in the field of flow cytometry.

Abstract: The present invention provides antibodies directed against ICOS or a derivative thereof which neutralize ICOS engagement on Treg by inhibiting the fixation between ICOS and ICOS-L and abrogate proliferation of Treg induced by plasmacytoid dendritic cells. The present invention further provides antibodies directed against ICOS or a derivative thereof which induce IL-10 and IFN? production, induce CD4+ T cells proliferation, reduce Tconv proliferation, and increase the immunosuppressive function of Treg.

Abstract: Embodiments of the present disclosure feature a filtration system comprising a filtration module for particle filtration and methods of using the device for the isolation of particles (e.g., viable cells). Advantageously, embodiments of the device provide for the high throughput filtration of large volumes of sample while preserving cell viability and. providing high yields.

Abstract: The present invention provides a cytokine-based culture method for ex vivo expansion of NK cells from postembryonic hematopoietic stem cells into a fully closed, large-scale, cell culture bioprocess. We optimized enrichment of CD34+ cells followed by efficient expansion in gas-permeable cell culture bags. Thereafter, expanded CD34+ cells could be reproducibly amplified and differentiated into CD56+CD3? NK cell products with a mean expansion of more than 2,000 fold and a purity of >90%. Also provided are collections of cultured cells having specific properties.

Abstract: The present invention relates to a new binder molecule useful e.g. as an immune suppressor. In particular, it has been recognized that the UL11 protein of human the cytomegalovirus, binds to the CD45 molecule, potentially altering the immune system of an individual. In addition, the present invention relates to binder molecules, in particular, fusion molecules containing the CD45 binding domain of the UL11 protein in combination with a second molecule of interest for delivery of said molecule to cells expressing the CD45 molecule. Moreover, the present invention relates to pharmaceutical compositions comprising the UL11 protein of human cytomegalovirus, or derivatives or homologs thereof, or a nucleic acid sequence encoding the same.

Abstract: The present invention relates to novel CD3 epsilon peptides, antibodies against the novel CD3 epsilon peptides. The invention also relates to methods of identifying an immunodeficiency (such as severe combined immunodeficiency (SCID) or a T cell immunodeficiency) in a patient, which may involve antibodies against CD3 epsilon peptides.

Abstract: The present invention relates to methods for isolating human forkhead box P3 (Foxp3+) CD4+ regulatory T cells (herein referred to a Foxp3+ Treg cells) from a sample containing (i) peripheral blood mononuclear cells (PBMCs), (ii) a lymphocyte containing fluid, or (iii) a lymphocyte containing tissue, a kit for isolating human Foxp3+ Treg cells, and the use of anti-CD49d antibody for the isolation of human Foxp3+ Treg cells.

Abstract: A method for determining the mass and concentration of certain particles or cells from a mixed population of cells, such as a patient's blood sample. The cells to be determined are each marked with a monoclonal antibody, to which colloidal iron is coupled. The blood sample is filled into a test tube with a capillary section and a magnet is used to gather the marked cells and move them to the capillary section. A test tube rack is constructed to hold the test tube with the capillary section and a measurement scale is provided for determining the mass and concentration of the marked cells.

Abstract: Numerous diseases have been linked to the production of regulator cells. The present invention relates to the observation that the immune system is cycling in these diseases. Based on these observations, the present invention provides methods for treating diseases such as cancer and a HIV infection. The present invention also relates to methods of determining when a therapy to treat a disease characterized by the production of regulator cells should be administered to a patient.

Abstract: The invention provides methods and compositions for treating various autoimmune diseases (such as systemic lupus erythematousu) with an interferon inhibitor (such as an anti-intereron-alpha monoclonal antibody). More specifically, the invention provides a method of diagnosing, monitoring and adjusting the treatment of such a patient by way of an interferon signature metric (interferon response gene measurement value), a certain anti-dsDNA antibody titre or being ENA? (levels of extractable nuclear antigens lower than a healthy level). Furthermore, the invention provides articles of manufacture associated with such a diagnosis.

Abstract: The invention relates to biomarkers associated with preterm delivery. More specifically, the invention provides methods of measuring biomarkers including but not limited to cytokines, cytokine receptors, cytokine receptor antagonists, chemokines, chemokine receptors, and/or chemokine receptor antagonists found in women that are at risk for preterm delivery. The diagnostic methods may be performed on whole blood.

Abstract: The present invention relates to novel, specific-binding therapeutic and/or diagnostic proteins directed against Cytotoxic T-Lymphocyte Antigen 4 (CTLA-4) also known as CD152, which proteins preferably are muteins of a lipocalin protein, more preferably of lipocalin 2 (Lcn2 or NGAL). The invention also relates to nucleic acid molecules encoding such proteins and to methods for generation and use of such proteins and nucleic acid molecules. Accordingly, the invention also is directed to pharmaceutical and/or diagnostic compositions comprising such lipocalin proteins, including uses of these proteins.

Abstract: The invention provides for the synthesis of more effective generators of a T-cell immune response by providing peptide derivatives that are MHC class I-restricted antigens. The peptide derivatives of the present invention are prepared or derived from a parent peptide of 8 to 11 amino acid residues in length, wherein the peptide derivative contains a non-natural amino acid substituted in place of a naturally-occurring amino acid residue at one or more primary anchor positions in the parent peptide or at position 6, position 7, or the C-terminus. The exemplary polypeptides are derived from the survivin, hTERT, CYP1B1 and MART-1 antigens.

Abstract: Disclosed are an anti-human TIM-3 antibody having high ADCC activity or antibody fragment thereof by screening a monoclonal antibody or antibody fragment thereof which binds to the amino acid sequence of the extracellular region of TIM-3 or its three-dimensional structure and exhibits ADCC activity; a hybridoma which produces the antibody; a DNA encoding the antibody; a vector comprising the DNA; a transformant which is obtainable by introducing the vector; a method for producing the antibody or the antibody fragment thereof which comprises using the hybridoma or the transformant; and a therapeutic agent and a diagnostic agent comprising the antibody or the antibody fragment thereof as an active ingredient.

Abstract: The invention is generally directed to reducing inflammation by means of cells that secrete factors that reduce leukocyte extravasation. Specifically, the invention is directed to methods using cells that secrete factors that downregulate the expression of cellular adhesion molecules in vascular endothelial cells. Downregulating expression of cellular adhesion molecules reduces leukocyte adhesion to the endothelial cells such that extravasation is reduced. The end result is a reduction of inflammation. The cells are non-embryonic non-germ cells that have pluripotent characteristics. These may include expression of pluripotential markers and broad differentiation potential.

Abstract: The present invention relates to compositions and methods of diagnosing and treating autoimmune and inflammatory disorders that are characterized by IL-23R loss-of-function mutations.

Abstract: The present invention is directed to methods of diagnosis and treatment of autoimmune diseases based on the identification of a novel population of B cells known as Autoimmune- or Age-related B cells (“ABCs”). These cells express the CDI Ic cell surface protein and exhibit a unique gene expression profile. The ABCs increase in numbers in subjects that are prone to developing autoimmune diseases or in healthy individuals, particularly females, as they age. Accordingly, the present invention includes methods and kits for diagnosis of autoimmune diseases based on the detection of the ABCs before overt symptoms of the disease become detectable. The present invention also includes methods of treatment of autoimmune diseases by targeting the ABCs, as well as methods for assessing the efficacy of treatments of autoimmune diseases.

Abstract: Disclosed are methods for determining the risk of tumor cells undergoing metastasis, for assessing the prognosis of a subject undergoing treatment for a localized tumor, and for determining a course of treatment for a localized tumor comprising detecting the presence of an endothelial cell, a macrophage, and an invasive tumor cell in direct apposition in a tumor sample from a subject.

Abstract: The present invention relates to enhancing, modulating or stimulating the immune response to MMP-2 expressing tumors, including melanoma, and to the modulation and application of immune modulators and MMP-2 peptides for melanoma or other MMP-2 expressing tumor vaccines. The invention provides methods and means to activate an effective response to MMP-2 expressing tumors and modulate the ability of MMP-2 to skew CD4+ T cell responses toward that of TH2 cells, which are less effective mediators of tumor cell clearance than TH1 cells. Methods and assays are provided for screening for compounds, agents, or peptides capable of enhancing or activating immune responses, particularly to melanoma.

Abstract: Methods, devices, systems, and apparatuses are provided for the image analysis of measurement of biological samples.

Abstract: The present invention relates to a method of producing an antibody that cross-reacts with multiple KIR2DL polypeptides and neutralizes the inhibitory activity of such polypeptides.

Abstract: The invention relates to the field of medical diagnostics. Provided are methods and kits for determining the health status of a subject, for early detection of tissue damage, for early diagnosis and monitoring of a disease, and/or for evaluation of treatment effectiveness in a subject using circulating tissue macrophages (CTM) as a mirror of disrupted tissue homeostasis and disease.

Abstract: The invention relates to identifying tumor-associated genetic products and encoding nucleic acids thereof. A therapy and diagnosis of diseases in which the tumor-associated genetic products are aberrantly expressed, proteins, polypeptides and peptides which are expressed in association with tumor and the encoding nucleic acids for said proteins, polypeptides and peptides are also disclosed.

Abstract: The invention is directed to methods of screening for HLA antibodies comprising detecting antibodies specific for native HLA antigens and denatured HLA antigens. The invention also provides for methods of removing antibodies specific for denatured HLA antigens or antibodies specific for native HLA antigens from a serum sample. In addition, the invention also provides for method of predicting whether a transplant recipient has an increased risk for rejecting the transplanted organ.

Abstract: The present invention relates to devices and methods for measuring the quantity of multiple analytes in a sample. The device is designed such that each of the analyte sensing elements is configured to measure the quantity of a predetermined analyte and where the machine executable instructions are configured to select the proper analyte sensing element corresponding to the analyte to be measured.

Abstract: Polypeptides which comprise a receptor-ligand pair involved in T-cell activation are disclosed. Nucleic acid molecules encoding the polypeptides, and vectors and host cells for expressing the polypeptides are also disclosed. The polypeptides, or agonists and antagonists thereof, are used to treat T-cell mediated disorders.

Abstract: Peptides, modified peptides and antibody or antibody fragment, which inhibit the activity of MIA (Melanoma Inhibitory Activity), for detecting, preventing and curing vitiligo are disclosed.

Abstract: The present invention relates to novel therapies for treating autoimmune and inflammatory diseases. More specifically, the present invention relates to a use of low dose interleukin-2 for the treatment of type I diabetes and other autoimmune and/or inflammatory diseases.

Abstract: The present invention relates to novel regulatory T cell proteins. One protein, designated PD-L3, resembles members of the PD-L1 family, and co-stimulates ?CD3 proliferation of T cells in vitro. A second, TNF-like, protein has also been identified as being upregulated upon ?CD3/?GITR stimulation. This protein has been designated Treg-sTNF.

Abstract: The present invention provides a method for determining whether an antibody or antigen-binding fragment thereof will cause ADCC when administered to a subject. Host cells that may be used in such a method are also provided.

Abstract: The invention provides, in certain embodiments, a method of detecting an indicator of renal injury or renal disease. The method entails assaying a urine sample for hematopoietic growth factor inducible neurokinin-1 (HGFIN), wherein the presence of HGFIN at an elevated level indicates the presence and/or degree of renal injury or renal disease, and/or the rate of loss of renal function. In other embodiments, the invention provides a method of detecting an indicator of systemic inflammation. This method entails assaying a biological sample for HGFIN, wherein the presence of HGFIN at an elevated level indicates the presence and/or degree of systemic inflammation. Also provided, are methods of determining progression of these conditions, as well as methods of determining subjects' response to treatment.

Abstract: Provided herein are methods of detecting and/or monitoring the presence or severity of an immune disorder in a subject, including detecting a frequency of a Th2a subset of CD4+ T cells in a biological sample of the subject. In some embodiments, the detecting includes: (a) detecting a frequency of CD4+ T cells in a biological sample of said subject; (b) detecting a frequency of a Th2a subset of the CD4+ T cells in the biological sample; and (c) comparing the frequency of the Th2a subset with the frequency of the CD4+ T cells.

Abstract: Inflammatory state in a subject is assayed by determining the level of expression of A3 adenosine receptor (A3AR) in white blood cells (WBC), e.g. circulating WBCs, from the subject. A high level of expression of A3AR is indicative of an inflammatory state in the subject. This assay can be used for determining whether a patient known to have an inflammatory state should be treated with an A3AR agonist to reduce the inflammatory state. The patient will be so treated only if the level of A3AR in the WBC of the subject is above a predefined threshold, which is about twice the level of A3AR in WBC of healthy subjects. The inflammatory state may particularly be rheumatoid arthritis or uveitis.

Abstract: Disclosed is a rapid, non-invasive and highly specific and sensitive diagnostic assay for the identification of individuals with autoimmune chronic urticaria, which makes use of CD203c, and in some embodiments, additional proteins, as a marker for the disease. Test kits for diagnosis of an individual suspected of having autoimmune chronic urticaria are also disclosed. Also disclosed are a method of identifying compounds useful for treating autoimmune chronic urticaria and a method of treating autoimmune chronic urticaria.

Abstract: Drug Linker compounds and Drug Linker Ligand conjugates are provided that have auristatins linked via the C-terminus. The conjugates show efficacy without the need for a self-immolative group to release the drug.

Abstract: Methods and compositions are provided for inducing the proliferation of regulatory T cells. These methods find a number of uses, including, for example, treating autoimmune and rheumatoid diseases. Also provided are reagents and kits that find use in these methods.

Abstract: The present invention provides a method of predicting the risk of a patient for developing adverse drug reactions, particularly SJS or TEN. It was discovered that an HLA-B allele, HLA-B* 1502, is associated with SJS/TEN that is induced by a variety of drugs. The correlation with HLA-B* 1502 is most significant for carbamazepine-induced SJS/TEN, wherein all the patients tested have the HLA-B* 1502 allele. In addition, another HLA-B allele, HLA-B*5801, is particularly associated with SJS/TEN induced by allopurinol. Milder cutaneous reactions, such as maculopapular rash, erythema multiforme (EM), urticaria, and fixed drug eruption, are particularly associated with a third allele, HLA-B *4601. For any of the alleles, genetic markers (e.g., HLA markers, microsatellite, or single nucleotide polymorphism markers) located between DRB1 and HLA-A region of the specific HLA-B haplotype can also be used for the test.