Abstract: Methods for identifying subjects having a cancer or pre-malignant condition that will benefit from anti-CD40 therapeutic agents that modulate CD40L-mediated CD40 signaling are provided. The methods comprise the use of biomarkers of cellular apoptosis, cell proliferation and survival, and CD40 signaling pathways to monitor ex vivo response to one or more anti-CD40 therapeutic agents of interest that modulate CD40 signaling on CD40-expressing neoplastic cells. The ex vivo prognostic assays can be used alone or in conjunction with other prognostic assays to identify candidate subjects who will benefit from treatment with anti-CD40 therapeutic agents. Methods of the invention also comprise the use of these biomarkers to monitor in vivo efficacy of treatment with an anti-CD40 therapeutic agent.

Abstract: Provided herein in certain embodiments are polypeptide complexes capable of binding to an antigen. Pharmaceutical compositions, method of using the polypeptide complexes are also provided.

Abstract: A composition for evaluating a biological condition is disclosed. The composition has (a) a sample composition comprising at least one of: i.) a bodily specimen comprising a target moiety; ii.) a positive control moiety; and iii.) a negative control moiety; (b) an antibody composition comprising at least one of: i.) at least one target antibody; ii.) at least one positive control identifying antibody; and iii.) at least one negative control identifying antibody; and (c) at least one reference composition comprising at least one of: i.) a target signal reference composition; and ii.) a reference identifier composition.

Abstract: The present invention is directed to providing a carrier which can transport a compound to a gut-associated lymphoid tissue efficiently without being degraded or digested. For that purpose, the carrier contains a coccoid cell of a gastric mucosa-damaging spiral bacterium. Preferably, the carrier is orally administered. By making this carrier carry an antigen and orally administering it, a local or a systemic immunological reaction to the antigen can be induced.

Abstract: The present invention relates to methods of identifying candidate compounds for the treatment of leukemia and diagnostic methods based on histone methylation and HoxA5 promoter activity.

Abstract: The present invention provides a blood analyzer and a blood analyzing method capable of obtaining information regarding B lymphocytes and T lymphocytes without using a fluorescence-labeled antibody. The blood analyzer of the present invention includes a blood specimen supplying portion, a sample preparation portion that prepares a measurement sample without using a fluorescence-labeled antibody by mixing a blood specimen supplied from the blood specimen supplying portion, a hemolyzing agent, and a fluorescent dye that stains nucleic acid, a light source, a first detector that detects fluorescence, a second detector that detects scattered light, and information processing portion that classifies lymphocytes based on the intensity of fluorescence and scattered light, and based on the fluorescence intensity of the classified lymphocytes, obtains information regarding B-lymphocytes and T-lymphocytes.

Abstract: The invention provides a multiparametric method of assessing the reaction of a patient's immune system to a test subject. The invention compares a patient sample reacted with a test sample and a third party sample and combines the assessments of the multiple parameters to correlate the test reaction with a clinical event.

Abstract: The present invention relates to novel uses of the MLN 51 gene or protein. The MLN 51 gene and protein is closely related to the development of rheumatoid arthritis and serve as biomarker and therapeutic target for rheumatoid arthritis, particularly chronic synovitis.

Abstract: Methods and systems for selectively capturing analytes, such as cells, e.g., circulating tumor cells (CTCs), from fluid samples are disclosed. The methods include contacting the sample with an analyte binding moiety that selectively binds to the analytes; optionally separating first components of the sample including a majority of the analytes bound to the binding moieties from second components of the sample using size-based separation, e.g.

Abstract: The invention concerns a device and a method for concentrating pathogenic germs potentiaily present in blood products or derivatives and for detecting said germs comprising the following steps: (a) subjecting a sample of said blood product to a blood cell aggregating treatment, (b) eliminating the aggregates formed at step (a) by passing the treated sample over a first filter allowing through the contaminating germs but not the cell aggregates, (c) selectively lyzing the residual cells of the filtrate obtained at step (b), (d) recuperating the contaminating germs by passing the lysate of step (c) over a second filter to detect the contaminating germs possibly trapped.

Abstract: This invention provides methods of using phagocytic cells alone or in combination with non-phagocytic cells in the diagnosis, prognosis, or monitoring of prenatal or pregnancy-related diseases or conditions. The invention also provides methods of using phagocytic cells alone or in combination with non-phagocytic cells to identify markers of prenatal or pregnancy-related diseases or conditions.

Abstract: The present disclosure relates to anti-CD200 antibodies (e.g., variant anti-CD200 antibodies having decreased or no effector function) and to biomarkers for use in a variety of diagnostic and therapeutic methods, e.g., determining whether a human has been administered one or more of the antibodies at a dose sufficient to induce a desired immunomodulatory effect in the human and/or selecting an appropriate dosing schedule for a patient.

Abstract: The invention relates to oligomers of a dimer, trimer, quatromer or pentamer of recombinant fusion proteins. Said oligomers are characterized in that the recombinant fusion proteins have at least one component A and at least one component B, whereby component A contains a protein or a protein segment with a biological function, in particular with a ligand function for antibodies, for soluble or membrane signal molecules, for receptors or an antibody, or an antibody segment, and component B contains a protein or a protein segment which dimerizes or oligomerizes the dimer, trimer, quatromer or pentamer of the recombinant fusion protein, without the action of third-party molecules. The invention also relates to the use of dimers or oligomers of this type for producing a medicament, to the fusion proteins which cluster in dimers or oligomers and to their DNA sequence and expression vectors or host cells comprising this DNA sequence.

Abstract: The present invention provides CD4+ T-cell epitopes in bone morphogenetic proteins (BMPs). In particular embodiments, the present invention provides CD4+ T-cell epitopes of BMP-7 and BMP-14. In some preferred embodiments, the present invention provides CD4+ T-cell epitopes of BMP-7 and BMP-14 that are suitable for modification to reduce the immunogenicity of the BMP-7 and BMP-14 proteins.

Abstract: A method and apparatus for analyzing a sputum cytology preparation. The sputum sample is fixed on a microscope slide and analyzed by a microscope combined with an image acquisition system and a computer having an image recognition system. The image recognition system detects mobile cells that are implicated in the body's inflammatory response and counts how many of such cells are on the slide. The computer generates an absolute number of such cells and percentage values for such cells out the total number of mobile cells classified. The computer then utilizes the absolute numbers, the ratios of mobile cells with respect to each other—or a combination of both to generate a score. The score represents a probabilistic determination of inflammation.

Abstract: The present invention is directed to methods for identifying which patients diagnosed with cancer will most benefit from treatment with an anti-cancer therapy comprising an ADCC-enhanced antibody.

Abstract: The invention relates to the discovery that HNA-3a and HNA-3b are antigens within a polypeptide sequence that is highly similar to the CTL2 amino acid sequence.

Abstract: Provided are isolated complexes comprising a major histocompatibility complex (MHC) class II and a type I diabetes-associated autoantigenic peptide, the isolated complex having a structural conformation which enables isolation of a high affinity entity which comprises an antigen binding domain capable of specifically binding to a native conformation of a complex composed of the MHC class II and the type I diabetes-associated autoantigenic peptide; and isolated high affinity entities comprising an antigen binding domain capable of specifically binding the complex, wherein the isolated high affinity entity does not bind to the MHC class II in an absence of the diabetes-associated autoantigenic peptide, wherein the isolated high affinity entity does not bind to the diabetes-associated autoantigenic peptide in an absence of the MHC class II; and methods and kits using same for diagnostic and therapeutic purposes.

Abstract: The present invention relates to D-amino acid peptides and their use in methods for the diagnosis and/or treatment of immune disorders such as systemic lupus erythematosus.

Abstract: Provided is a method for determining immunosuppression in an individual. The method entails testing blood cells for nuclear NFkB and/or nuclear NFAT. The blood cells can be from a sample of blood from an individual. The cells can be contacted with an activating agent to obtain activated cells, and the amount of nuclear NFkB and/or NFAT can be compared to a control. An amount of nuclear NFkB and/or NFAT that is higher than the control is considered to be indicative of insufficient immunosuppression in the individual. An amount of nuclear NFkB and/or NFAT that is lower than the control is considered to be indicative of excessive immunosuppression in the individual. An amount of nuclear NFkB and/or NFAT that is the same as the control is considered to be indicative of an appropriate amount of immunosuppression in the individual.

Abstract: The present invention is directed to a method of generating antigen specific T cells. Furthermore, the invention is directed to antigen specific T cells, isolated transgenic TCR's, pharmaceutical compositions containing same and their use in adoptive cell therapy. This invention in particular pertains to the use of cells co-expressing allogeneic MHC molecules and antigens to induce peptide-specific T cells from non-selected allogeneic T cell repertoires.

Abstract: It is disclosed herein that antibodies specific for preproproteins or preproteins, which are synthesized by certain types of cells or tissues, can be used in immunohistochemistry assays to discriminate between the intracellular component of the protein (including the preproprotein, preprotein and/or proprotein forms of the protein) from the secreted component of the same protein. Accordingly, provided herein is an immunohistochemical method for specific detection of the intracellular form of a protein in a biological sample using an antibody specific for the preproprotein or preprotein form of the protein. In particular examples, the protein is albumin or an immunoglobulin light chain. Also disclosed herein are preproprotein-specific ore preprotein-specific antibodies that can be used to detect specific cell types, tissue lesions or other pathological foci and metastases by IHC. In particular, antibodies that specifically bind human preproalbumin, but do not bind the secreted form of albumin are disclosed.

Abstract: Methods and devices for reducing interference from leukocytes in an analyte immunoassay are provided. In one embodiment, a method is provided comprising the steps of amending a biological sample with magnetic sacrificial beads opsonized to leukocytes, binding leukocytes in the sample to the magnetic sacrificial beads, and magnetically retaining the beads out of contact from an immunosensor.

Abstract: The present invention provides for the identification of autoreactive T cell populations from individuals having autoimmune diseases, such as multiple sclerosis and EAE. Peptoids recognized by autoreactive T cells can be used to identify various types of autoimmune disease, and can also be used to target therapies against such populations.

Abstract: The present invention relates to disulphide bond stabilized recombinant MHC class II molecules. In particular, the present invention provides a recombinant MHC class II molecule, which comprises: (i) all or part of the extracellular portion of an MHC class II ? chain; (ii) all or part of the extracellular portion of an MHC class II ? chain; wherein (i) and (ii) provide a functional peptide binding domain and wherein (i) and (ii) are linked by a disulphide bond between cysteine residues located in the ?2 domain of said ? chain and the ?2 domain of said ? chain, wherein said cysteine residues are not present in native MHC class II ?2 and ?2 domains. Methods of producing these molecules in prokaryotic systems and various uses of these molecules form further aspects.

Abstract: There is provided a method for determining whether a subject has a bacterial infection comprising: identifying an abnormal expression of one or more of CD49e, CD 14, CD11c, CD49f, and CD29 on leucocytes in a sample obtained from the subject; wherein an abnormal expression of CD49e, CD 14, CD11c, CD49f or CD29 is indicative of the subject having a bacterial infection.

Abstract: Nucleic acids encoding mammalian, e.g., primate, receptors, purified receptor 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: The invention provides methods for identifying immunobinders, such as scFv antibodies, capable of specifically binding to cell surface antigens, and compositions identified according to said methods.

Abstract: The present invention is drawn to methods for measuring numbers, levels, and/or ratios of cells, such as lymphocytes, infiltrated into a solid tissue, such as a tumor or a tissue affected by an autoimmune disease, and to methods for making patient prognoses based on such measurements. In one aspect, methods of the invention comprise sorting lymphocytes from an accessible tissue, such as peripheral blood, into functional subsets, such as cytotoxic T cells and regulatory T cells, and generating clonotype profiles of each subset. An inaccessible disease-affected tissue is sampled and one or more clonotype profiles are generated. From the latter clonotype profiles, levels lymphocytes in each of the functional subsets are determined in the disease-affected tissue by their clonotypes, which are identified from lymphocytes sorted into subsets from the accessible tissue.

Abstract: The present invention is directed to proteins expressed by Mycobacterium tuberculosis and not by BCG and their use as diagnostic reagents.

Abstract: The present invention provides antibodies which bind to an epitope in the extracellular domain of human CC chemokine receptor 4 (CCR4) and which are capable of inhibiting the binding of macrophage-derived chemokine (MDC) and/or thymus and activation regulated chemokine (TARC) to CCR4. Also provided are inter alia immunoconjugates and compositions comprising such antibodies and methods and uses involving such antibodies, particularly in the medical and diagnostic fields.

Abstract: Disclosed are methods and compositions of anti-B cell antibodies, preferably anti-CD22 antibodies, for diagnosis, prognosis and therapy of B-cell associated diseases, such as B-cell malignancies, autoimmune disease and immune dysfunction disease. In certain embodiments, trogocytosis induced by anti-B cell antibodies may determine antibody efficacy, disease responsiveness and prognosis of therapeutic intervention. In other embodiments, optimal dosages of therapeutic antibody may be selected by monitoring the degree of trogocytosis induced by anti-B cell antibodies.

Abstract: The present invention provides a reagent for analysis of immature leukocytes comprising: a surfactant which can damage cell membranes of erythrocytes and mature leukocytes, a solubilizing agent which can shrink the damaged blood cells and a dye for staining nucleic acid, wherein the reagent has an osmotic pressure of not lower than 10 mOsm/kg and lower than 150 mOsm/kg.

Abstract: This invention provides methods for to the use of the difference in phosphodiester (PDE)/phosphomonoester (PME) ratio in biological fluids, as an analytical criterion to image both the presence and degree of viral infection in-vivo.

Abstract: The present invention relates to a distinct B cell subset, B10 cells, that regulate T cell mediated inflammatory responses through the secretion of interleukin-10 (IL-10). The invention also relates to the use of B10 cells in the manipulation of immune and inflammatory responses, and in the treatment of disease. Therapeutic approaches involving adoptive transfer of B10 cells, or expansion of their endogenous levels for controlling autoimmune or inflammatory diseases and conditions are described. Ablation of B10 cells, or inhibition of their IL-10 production can be used to upregulate immunodeficient conditions, ameliorate infectious diseases and/or to treat tumors/cancer. Diagnostic applications are also encompassed.

Abstract: The present invention provides methods for identifying viral virulence factors and for identifying cellular polypeptides to which the viral polypeptides bind. The cellular polypeptide is useful as a therapeutic target or as a therapeutic agent for treating diseases and disorders, including immunological diseases or disorders.

Abstract: This invention is directed to methods and compositions for diagnosis, prognosis and for determining methods of treatment. The physiological status of a cell present in a sample (e.g. clinical sample) can be used in diagnosis or prognosis of a condition (e.g. Chronic Lymphocytic Leukemia), in patient selection for therapy, to monitor treatment and to modify or optimize therapeutic regimens.

Abstract: An in-vitro process for the quick determination of the infection status of a Mycobacterium tuberculosis infection from whole blood in terms of active or latent tuberculosis, comprising the steps of: stimulating an antigen-specific T cell that is present in a first sample of whole blood with purified protein derivative (PPD) in the presence of antibodies against CD28, or CD28 and CD49d; processing of PPD by antigen-presenting cells (APC) by incubating for 1.5 h to 2.5 h, especially for 2 h, at 35° C. to 39° C., especially at 37° C., optionally with adding CO2; then adding a secretion inhibitor; effecting an intensive mixing; and another incubation for a period of at least 2.5 h at a temperature of from 35° C. to 39° C.

Abstract: Multiplexed assays are disclosed for detection of duster differentiation 4 (CD4) glycoprotein expressed on the cell surface of I-helper cells, monocytes, macrophages, and dendritic cells; cluster differentiation 25 (CD25), a type transmembrane protein present on activated T-cells, activated B-cells, thymocytes, myeloid precursors, and oligodendrocytes; and Forkhead box P3 (FOXP3), an intracellular protein involved in immune system responses in cell cultures, tissues samples, humans, and biological samples. The multiplexed assays can be used to detect 1r-cells, activated I-cells, and other similar cell types (e.g. natural T regulatory cells, adaptive/induced T regulatory T cells). The multiplexed assays employ quantum dots of various shapes, types, compositions, coatings, sizes, ligands and other such characteristics.

Abstract: The present invention provides an agent for the prophylaxis or therapy of autoimmune diseases or allergic diseases, which contains an anti-Embigin antibody, particularly an anti-Embigin antibody showing cytotoxicity or a cytotoxicity inducing activity, an agent for the prophylaxis or therapy of diseases involving Th17 cell, and a cytotoxic agent to Th17 cell. In addition, an agent for detection of Th17 cell, which contains an anti-Embigin antibody, a convenient detection method of Th17 cell, which uses the agent, a method of efficiently delivering a drug and the like in a Th17 cell selective manner, which uses an anti-Embigin antibody, and a drug delivery system to Th17 cell are provided.

Abstract: Embodiments relate generally to an automated multiplex immunoassay for qualitatively and/or quantitatively detecting a plurality of targets on a tissue sample. Kits and apparatuses for practicing such assays are also provided.

Abstract: The present invention is directed to methods of using biomarkers to assess treatment of gastrointestinal inflammatory disorders with beta7 antagonists. More particularly, the present invention relates to methods of using the level of gut-homing lymphocytes in peripheral blood, the level of drug occupancy on gut-homing lymphocytes, and/or the level of beta7 integrin receptors on gut-homing lymphocytes as indicators (or biomarkers) of the effect, efficacy, safety, prognosis, and/or dosing of therapeutic agents, such as beta7 integrin antagonists, for the treatment of gastrointestinal inflammatory disorders.

Abstract: The present invention relates to methods for increasing the therapeutic efficacy of immunoglobulin G class 3 (IgG3) antibodies, immunoglobulin G class 3 (IgG3) antibodies with an improved therapeutic efficacy and the use thereof as a medicament, in particularly a medicament for immunotherapy. Specifically, the present invention relates to methods for increasing the therapeutic efficacy of an immunoglobulin G class 3 (IgG3) antibody comprising providing a mutated immunoglobulin G class 3 (IgG3) antibody, wherein the mutation, as compared to the parent immunoglobulin G class 3 (IgG3) antibody, comprises a replacement of the amino acid arginine (R) at position 435 in the CH3 domain with the amino acid histidine (H), and antibodies obtained by the present methods and their use as a medicament.

Abstract: Nucleic acids encoding various monocyte-derived proteins and related compositions, including purified proteins and specific antibodies are described. Methods of using such composition are also provided.

Abstract: An in vitro method for the analysis of the genetic predisposition of an individual to develop adverse effects related to non-metallic materials implanted into the body. The method comprises determining if in a biological sample from an individual there is/are present the antigen/s HLA-B*08 and/or HLA-DRB1*03 of the major histocompatibility complex. The use of a kit for carrying out the determination and the use of the antigens as genetic markers is also disclosed.

Abstract: The invention relates to a method for quantitatively identifying relevant HLA-bound peptide antigens from primary tissue specimens on a large scale without labeling approaches. This method can not only be used for the development of peptide vaccines, but is also highly valuable for a molecularly defined immunomonitoring and the identification of new antigens for any immunotherapeutic strategy in which HLA-restricted antigenic determinants function as targets, such as a variety of subunit vaccines or adoptive T-cell transfer approaches in cancer, or infectious and autoimmune diseases.

Abstract: The invention provides methods for identifying immunobinders, such as scFv antibodies, capable of specifically binding to cell surface antigens, and compositions identified according to said methods.

Abstract: The invention provides kits and methods for detecting or monitoring the number of cells in sample. The cell comprises a cell surface associated protein (CSAP) comprising a cytoplasmic (cytosolic) and an extracellular (ecto) domain. The kit comprises: (i) a chromatographic device; and (ii) a CSAP-binding agent. The method comprises: (i) optionally contacting the sample with an agent capable of lysing or permeabilizing CSAP bearing cells; (ii) contacting the sample with a CSAP-binding agent that binds to the cytoplasmic domain of the CSAP; and (iii) directly or indirectly evaluating the level or presence of bound CSAP in the sample.

Abstract: In one aspect, the present invention provides methods for the classification, diagnosis, prognosis, theranosis, and/or prediction of an outcome of an autoimmune disease in a subject.

Abstract: The present invention provides an approach for the determination of the activation states of a plurality of proteins in single cells. This approach permits the rapid detection of heterogeneity in a complex cell population based on activation states, expression markers and other criteria, and the identification of cellular subsets that exhibit correlated changes in activation within the cell population. Moreover, this approach allows the correlation of cellular activities or properties. In addition, the use of modulators of cellular activation allows for characterization of pathways and cell populations. Several exemplary diseases that can be analyzed using the invention include AML, MDS, and MPN.