Abstract: Human IgG1, IgG2, and IgG4 mutants having mutations in the hinge domain and exhibiting altered binding activity to Fc? receptors such as Fc?RIIB (CD32B). Also provided herein are methods for selectively activating immune responses in a subject using a therapeutic agent capable of targeting both an immune cell surface receptor and Fc?RIIB.

Abstract: Disclosed is a composition for extracting mycotoxins or aflatoxins from a food sample. The methods using the composition to detect and analyze the aflatoxins are also provided.

Abstract: Provided herein are methods and customized media compositions for culturing CIK NKT cells.

Abstract: The present disclosure relates to the finding that the ratio of circulating (i.e., peripheral blood) central memory T cells to circulating effector T cells in a cancer patient can predict whether a tumor has an inflammatory milieu or not. In addition, since having an inflammatory milieu (“hot tumor”) is a positive factor for responding to checkpoint inhibitors, e.g., PD-1 antagonists, this assay on peripheral blood can also be used to predict a response to a checkpoint inhibitor, e.g., an antibody or an antigen-binding portion thereof that specifically binds to a Programmed Death-1 (PD-1) receptor and inhibits PD-1 activity or an antibody or an antigen binding portion thereof that binds specifically to PD-1 ligand 1 (PD-L1) and inhibits PD-L1 activity.

Abstract: Provided herein, in one aspect, are antibodies that immunospecifically bind to PSGL-1, polynucleotides comprising nucleotide sequences encoding such antibodies, and expression vectors and host cells for producing such antibodies. Also provided herein are kits and pharmaceutical compositions comprising antibodies that specifically bind to PSGL-1, as well as methods of treating a disorder or disease caused by or associated with increased proliferation and/or numbers of activated T cells using the antibodies described herein.

Abstract: The disclosure relates to methods, treatment regimens, uses, kits and therapies for preventing graft rejection in solid organ transplantation, by employing anti-CD40 antibodies.

Abstract: A pharmaceutical composition containing an SOST antibody or an antigen-binding fragment thereof in an acetic acid-sodium acetate buffer solution is described. In addition, the pharmaceutical composition can also contain sugar, a nonionic surfactant or other excipients. After being stored for several months, the pharmaceutical composition exhibits good antibody stability.

Abstract: The present invention relates to methods of detecting, diagnosing and distinguishing between demyelinating diseases such as Multiple Sclerosis. The present invention also relates to methods of treating, and peptides for use in the treatment of, demyelinating diseases such as Multiple Sclerosis.

Abstract: The present disclosure relates to antibodies and binding fragments to a Tenascin, in particular the FBG domain of a Tenascin, which are potentially less immunogenic than the parent antibody. The disclosure also relates to compositions comprising the antibody or binding fragment and use of any one of the same for diagnosis, prognosis and/or treatment of disorders such as those associated with chronic inflammation. The disclosure further provides methods of making the antibodies.

Abstract: The present disclosure relates to an ?-fucosidase having ?-(1,2), ?-(1,3), ?-(1,4), and ?-(1,6) fucosidase activity. The present disclosure also relates to the compositions comprising the ?-fucosidase, and the methods of producing and using the ?-fucosidase in cleaving ?-(1,2), ?-(1,3), ?-(1,4), and/or ?-(1,6)-linked fucoses in the glycoconjugates.

Abstract: The invention provides methods of using expression levels of one or more immune cell gene signatures and/or combinations of immune cell gene signatures as selection criteria for selecting a patient having cancer for treatment with an immunotherapy. The invention further provides methods for selecting a patient having cancer who may benefit from a particular immunotherapy, such as an activating immunotherapy or a suppressing immunotherapy and administering to the patient the activating immunotherapy or suppressing immunotherapy to treat the cancer.

Abstract: Provided is an afucosylated monoclonal antibody. The monoclonal antibody is a human IgG antibody and has an afucosylated sugar chain structure at a heavy-chain sugar chain binding site. Also provided are application of the monoclonal antibody in the preparation of antineoplastic drugs, and a composition containing the monoclonal antibody. Compared with a fucosylated monoclonal antibody, the provided afucosylated monoclonal antibody has higher biological activity in vitro and in vivo and can be used for developing more effective therapeutic monoclonal antibody drugs.

Abstract: The present invention refers to a method of producing immunosuppressive bleed cells that can be used for the treatment of autoimmune diseases, in particular multiple sclerosis, organ graft rejection and graft-versus-host disease.

Abstract: This disclosure provides a method for treating a subject afflicted with a lung cancer, which method comprises administering to the subject therapeutically effective amounts of: (a) an antibody or an antigen-binding portion thereof that specifically binds to a Programmed Death-1 (PD-1) receptor and inhibits PD-1 activity; and (b) an antibody or an antigen-binding portion thereof that specifically binds to a Cytotoxic T-Lymphocyte Antigen-4 (CTLA-4) and inhibits CTLA-4 activity.

Abstract: The present invention relates to methods and pharmaceutical compositions for expressing a polynucleotide of interest in the peripheral nervous system of a subject. In particular, the present invention relates to a method for selectively expressing a polynucleotide of interest in the peripheral nervous system of a subject in need thereof comprising the step of transducing a peripheral nerve of the subject with an amount of an AVV9 vector containing the polynucleotide of interest.

Abstract: Compositions and methods for co-expressing a secretable vaccine protein (such as gp96-Ig) and T-cell co-stimulatory molecules from a single vector, among others, are provided herein. Materials and methods for using gp96-Ig vaccination and T-cell co-stimulation to treat a clinical condition (e.g., cancer) in a subject also are provided.

Abstract: A method for predicting and/or monitoring the efficacy of a c-Met inhibitor using a biomarker; a method for selecting a subject suitable for the application of a c-Met inhibitor using a biomarker; and a method for preventing and/or treating cancer comprising administering a c-Met inhibitor to the selected subject.

Abstract: A biomarker for predicting and/or monitoring the efficacy of a c-Met inhibitor; a composition for predicting and/or monitoring the efficacy of a c-Met inhibitor, comprising a material detecting the biomarker; a composition for selecting a subject suitable for the application of a c-Met inhibitor, comprising a material detecting the biomarker; a method for predicting and/or monitoring the efficacy of a c-Met inhibitor using the biomarker; a method for selecting a subject suitable for the application of a c-Met inhibitor using the biomarker; and a method for preventing and/or treating cancer comprising administering a c-Met inhibitor to the selected subject.

Abstract: Isolated non-naturally occurring populations of spermatozoa (15) having high purity and technologies to differentiate spermatozoa (28) based on characteristics such as mass, volume, orientation, or emitted light including methods of analysis and apparatus such as beam shaping optics (30) and detectors (32).

Abstract: There are provided an anti-c-Met/anti-Her2 bispecific antibody, and a method for preventing and/or treating cancer using the same.

Abstract: An anti c-Met antibody, a composition comprising the antibody, and a method for preventing or treating cancer by administering the composition is provided.

Abstract: The present invention relates to Fc variants with optimized Fc receptor binding properties, methods for their generation, Fc polypeptides comprising Fc variants with optimized Fc receptor binding properties, and methods for using Fc variants with optimized Fc receptor binding properties.

Abstract: The invention provides methods for the treatment of radiation exposure featuring agents that interfere with the expression, production, release, accumulation, or activity of a TNF?, IL6, EGF, IL1-alpha, IL1-beta, G-CSF, MCP-1, MIP-1, SCF, or RANTES receptor; or a TNF-?, IL6, EGF, IL1-alpha, IL1-beta, G-CSF, MCP-1, MIP-1, SCF, or RANTES peptide or fragment thereof.

Abstract: The invention relates to an isolated antibody, or fragment thereof, having high affinity for human A? protofibrils. The invention further relates to compositions that include the antibody, or a fragment thereof, and a pharmaceutically acceptable buffer. The invention further relates to a method of preventing or treating Alzheimer's disease, which includes the step of administering to a patient having or suspected of having Alzheimer's disease such an antibody, or fragment thereof or a composition that includes the antibody or a fragment thereof.

Abstract: The present invention relates to binding molecules that specifically bind to the human Fc gamma receptor expressed on the surface of natural killer (NK) cells and macrophages (i.e. Fc?RIIIA), and in particular binding molecules that specifically bind the A form Fc?RIII but do not bind to the B form of Fc?RIII, as well as to the use of such binding molecules in the diagnosis and treatment of disease. The invention further extends to polynucleotides encoding such binding molecules, host cells comprising such polynucleotides and methods of producing binding molecules of the invention using such host cells.

Abstract: The present invention relates to molecules, particularly polypeptides, more particularly immunoglobulins (e.g., antibodies), comprising a variant Fc region, wherein said variant Fc region comprises at least one amino acid modification relative to a wild-type Fc region, which variant Fc region binds Fc?RIIIA and/or Fc?RIIA with a greater affinity, relative to a comparable molecule comprising the wild-type Fc region. The molecules of the invention are particularly useful in preventing, treating, or ameliorating one or more symptoms associated with a disease, disorder, or infection. The molecules of the invention are particularly useful for the treatment or prevention of a disease or disorder where an enhanced efficacy of effector cell function (e.g., ADCC) mediated by Fc?R is desired, e.g., cancer, infectious disease, and in enhancing the therapeutic efficacy of therapeutic antibodies the effect of which is mediated by ADCC.

Abstract: Methods, uses, agents and compositions useful for the diagnosis, prevention and/or treatment of inflammatory conditions, such as neuroinflammatory conditions such as multiple sclerosis, and for the identification and selection of inflammatory cytokine-secreting T cell or a precursor thereof, based on the expression and/or modulation of melanoma cell adhesion molecule (MCAM) are disclosed.

Abstract: The invention relates to a humanized form of an antibody capable of preventing tissue factor (coagulation factor F3) signaling but which does not interfere with Factor VII binding or FX binding to tissue factor and does not prolong coagulation time. The antibody of the invention is useful in treating conditions, such as tumor progression, in which the associated cells express tissue factor and tissue factor signaling occurs.

Abstract: The present invention provides methods of treating a mammal having chronic obstructive pulmonary disease (COPD), independent of both smoking status and asthma status, with a therapeutically effective amount of an anti-IgE moiety. In accordance with the invention, COPD patients with an elevated serum IgE level may benefit from the treatment methods disclosed. In certain instances, the methods of the disclosure have been found to be useful for the treatment of COPD patients regardless of their skin test results and/or in vitro reactivity to a perennial aeroallergen. Anti-IgE moieties, in accordance with the invention, include but are not limited to any IgG antibody that selectively binds to a given mammal immunoglobulin E (e.g., human immunoglobulin E) such as humanized anti-IgE, humanized murine monoclonal antibody, and/or Omalizumab.

Abstract: The present invention is in the fields of cell biology, immunology and oncology. The invention provides humanized antibodies that recognize ?v?6 integrins, which antibodies comprise a variable region of nonhuman origin and at least a portion of an immunoglobulin of human origin. The invention also provides methods for preparation of such antibodies, pharmaceutical compositions comprising them, and methods of treating, diagnosing and/or preventing various diseases and disorders by administering the humanized anti-?v?6 antibodies of the invention. The invention also relates to the identification of differential expression of the integrin ?v?6 on the surfaces of tumor cells and tissues, the use of this differential expression in determining the metastatic potential of tumor cells, and methods of diagnosis and treatment/prevention of tumor metastasis and for elimination of residual metastatic tumor cells using ligands, particularly antibodies, that bind to integrin ?v?6.

Abstract: The present invention concerns chimeric or humanized antibodies or antigen-binding fragments thereof that comprise specific CDR sequences, disclosed herein. Preferably, the antibodies or fragments comprise specific heavy and light chain variable region sequences disclosed herein. More preferably, the antibodies or fragments also comprise specific constant region sequences, such as those associated with the nG1m1,2 or Km3 allotypes. The antibodies or fragments may bind to a human histone protein, such as H2B, H3 or H4. The antibodies or fragments are of use to treat a variety of diseases that may be associated with histones, such as autoimmune disease (e.g.

Abstract: An aqueous composition having increased protein stability is obtained by: a. determining a pH at which the protein has stability at the desired temperature; b. adding to the composition at least one displacement buffer wherein the displacement buffer has a pKa that is at least 1 unit greater or less than the pH of step (a); and c. adjusting the pH of the composition to the pH of step (a); wherein the aqueous composition does not comprise a conventional buffer at a concentration greater than about 2 mM and wherein the conventional buffer has a pKa that is within 1 unit of the pH of step (a).

Abstract: An antagonist of the interaction between the Gp96 receptor and E. coli AIEC strains, for the prevention or treatment of inflammatory bowel disease. The antagonist is for specifically blocking or reducing the interaction between Gp96 receptor and the outer membrane vesicles (OMVs), typically the outer protein membrane OmpA of E. coli AIEC strains. The inventions provides for pharmaceutical compositions containing such an antagonist, which may be an antibody against gp96 or OmpA, or a gp96 or OmpA polypeptide. It may be combined to an antagonist of the interaction between the CEACAM6 receptor and E. coli AIEC strains, such as an anti-CEACAM6 antibody, a CEACAM6 polypeptide, or a mannoside or particle having a mannose unit. The invention also relates to a method for the diagnosis of inflammatory bowel disease, or of the determination of a predisposition of a person to develop inflammatory bowel disease.

Abstract: This invention provides novel erbB2-binding internalizing antibodies. The antibodies, designated F5 and C1, specifically bind to c-erbB2 antigen and, upon binding, are readily internalized into the cell bearing the c-erbB2 marker. Chimeric molecules comprising the F5 and/or C1 antibodies attached to one or more effector molecules are also provided.

Abstract: Provided herein are methods and compositions for treating a subject suffering from a deficiency in ?-L-Iduronidase in the CNS. The methods include systemic administration of a bifunctional fusion antibody comprising an antibody to a human insulin receptor and an ?-L-Iduronidase. A therapeutically effective systemic dose is based on the specific CNS uptake characteristics of human insulin receptor antibody-?-L-Iduronidase fusion antibodies as described herein.

Abstract: The present invention is based, in part, on the discovery that galectin-1 (Gal1) plays a role in viral-associated PTLD, e.g., EBV-associated PTLD and hypoxia associated angiogenesis disorders. Accordingly, the invention relates to compositions, kits, and methods for diagnosing, prognosing, monitoring, treating and modulating viral-associated PTLD, e.g., EBV-associated PTLD and hypoxia associated angiogenesis disorders.

Abstract: Antibodies and fragments thereof have high affinity for human ?-synuclein protofibrils and low binding of ?-synuclein monomers, wherein the antibodies or fragments have specified Complementarity Determining Region (CDR) sequences. Compositions comprise such an antibody or fragment and methods of detecting ?-synuclein protofibrils use such an antibody or fragment. In further embodiments, methods of preventing, delaying onset of or treating a neurodegenerative disorder with ?-synuclein pathology comprise administering such an antibody or fragment, and such an antibody or fragment is used in the manufacture of a pharmaceutical composition for treatment of a neurodegenerative disorder with ?-synuclein pathology. Such an antibody or fragment is used in the diagnosis or monitoring of the development of a neurodegenerative disorder with ?-synuclein pathology, and in methods for reducing or inhibiting ?-synuclein aggregation by administration of such an antibody or fragment.

Abstract: The present invention relates to antibodies or fragments thereof that specifically bind the extracellular domain of Fc?RIIB, particularly human Fc?RIIB, and block the Fc binding site of human Fc?RIIB. The invention provides methods of treating cancer and/or regulating immune complex-mediated cell activation by administering the antibodies of the invention to enhance an immune response. The invention also provides methods of breaking tolerance to an antigen by administering an antigen-antibody complex and an antibody of the invention.

Abstract: The present invention provides peptides, and fragments thereof, and antibodies, or fragments thereof comprising the same, wherein the peptide comprises at least one amino acid substitution compared to wild type 5c8 antibody. The present invention also provides compositions and methods of treating CD154-related diseases or disorders in a subject.

Abstract: The present invention comprises a humanized monoclonal antibody that binds to the chemokine receptor CCR4. This antibody is derived from Mab 1567 and recognizes the same epitope. Binding of the invented antibody to CCR4 inhibits ligand-mediated activities and is used to treat symptoms of cancer. Moreover, the antibody is used in combination with vaccines to suppress the activity of regulatory T cells.

Abstract: The present invention provides antibodies that bind FGFR2IIIb, wherein the antibodies are afucosylated. The present invention provides compositions comprising antibodies that bind FGFR2IIIb, wherein at least 95% of the antibodies in the composition are afucosylated. In some embodiments, methods of treating cancer comprising administering afucosylated anti-FGFR2IIIb antibodies are provided.

Abstract: The invention provides hybrid constant regions and antibodies or fusion proteins incorporating the same. The hybrid constant regions include at least CH2 and CH3 regions of an IgG or IgA constant region and C?3 and C?4 regions of a C? constant region. The hybrids retain properties of both component constant regions. The hybrids retain the ability of a C? constant region to form multivalent complexes, e.g., pentameric or hexameric structures. IgG hybrids also retain IgG properties including pH-dependent FcRn binding, which is associated with a relatively long in vivo half-life, and specific binding to protein G, which facilitates purification. Depending on the isotype and subtype, the nature of the antigen and presence of additional IgG CH1 and hinge domains, IgG hybrids may also retain properties of specific binding to protein A, and effector functions ADCC, CDC and opsonization. IgA hybrids retain the property of IgA of binding to an Fc-alpha receptor CD89.

Abstract: The present invention relates to molecules, particularly polypeptides, more particularly immunoglobulins (e.g., antibodies), comprising a variant Fc region, wherein said variant Fc region comprises at least one amino acid modification relative to a wild-type Fc region, which variant Fc region binds Fc?RIIIA and/or Fc?RIIA with a greater affinity, relative to a comparable molecule comprising the wild-type Fc region. The molecules of the invention are particularly useful in preventing, treating, or ameliorating one or more symptoms associated with a disease, disorder, or infection. The molecules of the invention are particularly useful for the treatment or prevention of a disease or disorder where an enhanced efficacy of effector cell function (e.g., ADCC) mediated by Fc?R is desired, e.g., cancer, infectious disease, and in enhancing the therapeutic efficacy of therapeutic antibodies the effect of which is mediated by ADCC.

Abstract: The present invention relates to antibodies or fragments thereof that specifically bind Fc?RIIB, particularly human Fc?RIIB, more particularly the extracellular domain of Fc?RIIB with greater affinity than said antibodies or fragments thereof bind Fc?RIIA, particularly human Fc?RIIA, and block the Fc binding site of Fc?RIIB. The present invention also encompasses the use of an anti-Fc?RIIB antibody or an antigen-binding fragment thereof, as a single agent therapy for the treatment, prevention, management, or amelioration of a cancer, preferably a B-cell malignancy, particularly, B-cell chronic lymphocytic leukemia or non-Hodgkin's lymphoma, an autoimmune disorder, an inflammatory disorder, an IgE-mediated allergic disorder, or one or more symptoms thereof. The present invention also encompasses the use of an anti-Fc?RIIB antibody or an antigen-binding fragment thereof, in combination with other cancer therapies.

Abstract: The present invention discloses novel agents and methods for diagnosis and treatment of melanoma. Also disclosed are related arrays, kits, and screening methods.

Abstract: Disclosed herein are ?-galactosylceramide (?-GalCer) analogs and compositions thereof, methods of activating invariant Natural Killer T (iNKT) cells using said analogs, methods of treating diseases by activating iNKT cells using said analogs, and combination therapy of said analogs.

Abstract: The present invention relates to RSPO-binding agents and methods of using the agents for treating diseases such as cancer. The present invention provides antibodies that specifically bind human RSPO proteins and modulate ?-catenin activity. The present invention further provides methods of using agents that modulate the activity of RSPO proteins, such as antibodies that specifically bind RSPO1, RSPO2, and/or RSPO3 and inhibit tumor growth. Also described are methods of treating cancer comprising administering a therapeutically effect amount of an agent or antibody of the present invention to a patient having a tumor or cancer.

Abstract: Methods for treating a human patient for a cancer or pre-malignant condition that is associated with CD40-expressing cells are provided, where the human patient is heterozygous or homozygous for Fc?RIIIa-158F (genotype V/F or F/F). Also provided are methods of inhibiting antibody production by B cells in a human patient who is heterozygous or homozygous for Fc?RIIIa-158F (genotype V/F or F/F). The methods comprise administering to the human patient a therapeutically or prophylactically effective amount of an anti-CD40 antibody. Methods and kits for identifying a human patient with a cancer or pre-malignant condition that is treatable with an anti-CD40 antibody and which is refractory to treatment with rituximab (Rituxan®), as well as methods and kits for selecting an antibody therapy for treatment of a human patient having a cancer or pre-malignant condition that is refractory to treatment with rituximab (Rituxan®), are also provided.

Abstract: The present invention relates to respirable dry powders that contain respirable dry particles that comprise about 20%-37.5% (w/w) leucine, about 58.6-about 75% (w/w) calcium lactate, and about 3.9-about 5% (w/w) sodium chloride, and methods for treating a subject using the respirable dry powders.

Abstract: The present invention provides a specific binding molecule that binds to Annexin-1 (Anx-A1) for use in the treatment of obsessive compulsive disorder (OCD) or a disease related to OCD. The invention also provides a pharmaceutical composition comprising a specific binding molecule of the invention for use in the treatment of obsessive compulsive disorder (OCD) or a disease related to OCD.