Abstract: The present invention relates to compositions of S-enantiomer enriched oxprenolol and their use in treating cancer and treating or preventing, in cancer patients, cachexia, body weight loss, lean body mass loss and adipose tissue loss, and improving quality of life and prolonging survival of cancer patients.

Abstract: Disclosed herein are methods of treating or reducing incidence of migraine and/or at least one secondary symptom associated with refractory migraine in a subject having refractory migraine comprising administering to the subject a monoclonal antibody that modulates the CGRP pathway. Compositions for use in the disclosed methods are also provided. Antagonist antibody G1 and antibodies derived from G1 directed to CGRP are also described.

Abstract: The present invention provides assays for detecting and measuring the presence or level of anti-TNF? drug therapeutics and autoantibodies in a sample. The present invention is useful for optimizing therapy and monitoring patients receiving anti-TNF? drug therapeutics to detect the presence or level of autoantibodies (e.g., HACA and/or HAHA) against the drug.

Abstract: A process for synthesizing and separating secretory IgA from a mixture of IgA monomer and IgA dimer is provided. The process includes covalently binding affinity tagged or epitope tagged recombinant secretory component to the IgA dimer in the mixture and binding the affinity tagged or an epitope tagged secretory IgA to immobilized moieties on the solid phase support resin to which the affinity tag or epitope tag binds and then eluting the affinity tagged or an epitope tagged secretory IgA with release buffer. A process for synthesizing and separating secretory IgM from a mixture of IgM and other plasma proteins is also provided. The process includes covalently binding affinity tagged or an epitope tagged recombinant secretory component to the IgM in the mixture and binding the affinity tagged or an epitope tagged secretory IgM to immobilized moieties on the solid phase support resin and then eluting the peptide tagged secretory IgM with a release buffer.

Abstract: Natural-KilleifT-Cell Lymphoma (NKTCL) susceptibility prediction, diagnosis and therapy. The invention relates to a method for predicting Natural Killer T-cell Lymphoma (NKTCL) susceptibility and/or diagnosing NKTCL in a subject comprising testing for JAK mutations. The invention also relates to a method of screening for candidate agents capable of treating NKTCL using a cell line comprising at least one JAK mutation. The invention includes an NKTCL animal model comprising at least one JAK mutation. The invention also includes JAK inhibitors for treating NKTCL.

Abstract: The present invention relates to an insulin-like growth factor (IGF) receptor antagonist for use in the treatment of prostate neoplasia, including benign prostatic hyperplasia (BPH), prostate cancer, and particularly CRPC, wherein the antagonist is used in combination with an androgen receptor antagonist. An embodiment of the invention is where the androgen receptor antagonist is enzalutamide.

Abstract: The problems: It is an object of the present invention to provide an immune regulating agent capable of modulating a receptor function concerning immune regulation of DR6, and a method for screening thereof. The object aims to provide: The present invention relates to an immune regulating agent containing a physiologically active substance having an ability to bind specifically to DR6 and an ability to regulate signal transduction induced by specific binding between DR6 and Sdc1, as an active component. The immune regulating agent of the present invention can be used for treating or preventing diseases caused by excessive or abnormal immune response in mammals or diseases for which enhancement of immune function is desired in mammals, as an immune regulating agent based on a hitherto unknown mechanism, capable of regulating signal transduction induced by specific binding between DR6 and Sdc1.

Abstract: Stress, such as from physical, metabolic or psychological trauma, is associated with enduring secondary complications leading to morbidity and/or death in subjects that receive the stress insult. The epigenetic oxidative stress response to a stress insult is characterized by (a) global epigenetic events such as changes in DNA methylation and phosphorylation of Ser10 and acetylation of Lys9/14 residues of histone-3 (b) significant systemic elevations in analytes of oxidative stress in body fluids such as blood or urine and (c) deterioration of clinically relevant parameters such as glycemic control, organ function, lean body mass and rate of healing. The applicant teaches a method of counteracting the grave systemic effects of stress insult with reference to the epigenetic oxidative stress response, by daily subcutaneous bolus injections of nephrilin peptide beginning soon after insult and continuing for seven days.

Abstract: The receptor for VISTA is identified (VSIG8) as well as the use of this receptor in the identification or synthesis of agonist or antagonist compounds, preferably antibodies, polypeptides and fusion proteins which agonize or antagonize the effects of VSIG8 and/or VISTA and/or the VSIG8/VISTA binding interaction. These antagonists may be used to suppress VISTA's suppressive effects on T cell immunity, and more particularly used in the treatment of cancer, or infectious disease. These agonist compounds may be used to potentiate or enhance VISTA's suppressive effects on T cell immunity and thereby suppress T cell immunity, such as in the treatment of autoimmunity, allergy or inflammatory conditions. Screening assays for identifying these agonists and antagonist compounds are also provided.

Abstract: A method of treating sarcopenia comprises administering to a subject a composition comprising an anti-AGE antibody. The method may also be used for preventing or delaying the onset of cataracts, preventing or delaying the onset of loss of adipose tissue, increasing health span, and preventing or delaying the onset of lordokyphosis.

Abstract: The present invention concerns binding molecules having a penta- or hexameric ring structure, such as, for example, isolated IgM antibodies with five or six bispecific binding units, and methods and means for making and using the same. The invention further concerns multi-specific binding molecules having a penta- or hexameric ring structure, such as, for example, isolated IgM antibodies with five or six bispecific binding units, and methods and means for making and using the same.

Abstract: The invention provides for a proteomic approach for identification of specific bacterial protein profiles that may be used in the development of methods for the diagnosis of bacterial chronic sinusitis. The invention provides for methods for determining the presence of pathogenic bacteria in the upper respiratory tract of a subject using protein profiles of the pathogenic bacteria. The invention also provides for methods of diagnosing a bacterial infection of the upper respiratory tract of a subject using protein profiles of a pathogenic bacteria. In addition, the invention provides for devices, immunoassays and kits for identifying pathogenic bacteria in the upper respiratory tract.

Abstract: An Interleukin-17 (IL-17) binding molecule, in particular an antibody to human IL-17, more preferably a human antibody to human IL-17 is provided, wherein the hypervariable regions of the heavy and light chains have amino acid sequences as defined, for use in the treatment of an IL-17 mediated disease or disorder, e.g. rheumatoid arthritis.

Abstract: This invention relates generally to molecules that specifically bind bacterial V-tip proteins of the type III secretion system of Gram negative bacteria such as PcrV from Pseudomonas aeruginosa. More specifically, this invention relates to molecules that block the injection of effector molecules into target cells. This invention also relates to molecules that specifically bind to bacterial lipoproteins, such as OprI. The molecules of the present invention are monospecific or multispecific and can bind their target antigen in a monovalent or multivalent manner. The invention also relates generally to molecules that specifically bind bacterial cell surface proteins such as OprI, and to methods of use these molecules in a variety of therapeutic, diagnostic, and/or prophylactic indications.

Abstract: A tamper-resistant pharmaceutical dosage form comprising a pharmacologically active ingredient embedded in a prolonged release matrix, which comprises a prolonged release matrix material selected from the group consisting of nonionic acrylic polymers and waxy materials and which provides prolonged release of the pharmacologically active ingredient, resistance against solvent extraction, resistance against grinding, and resistance against dose-dumping in aqueous ethanol.

Abstract: The present invention relates to methods for the treatment of cancers. In particular, the invention provides methods for treatment of cancer by administering an Aurora kinase inhibitor in combination with an anti-CD30 antibody. The combined administration of the Aurora kinase inhibitor and anti-CD30 antibody can be simultaneous, separate, sequential or consecutive.

Abstract: A fusion polynucleotide including a murine CMV promoter and an intron, a recombinant vector including the fusion polynucleotide and a gene encoding a polypeptide of interest, a recombinant cell including the recombinant vector, and a method of producing a polypeptide of interest using the recombinant vector and/or the recombinant cell.

Abstract: The present invention relates to a composition exhibiting a bile-salt hydrolase activity for its use for the treatment or the prevention of giardiasis, said composition comprising a bile-salt hydrolase (BSH) enzyme, a bacterium able to secrete a BSH, a recombinant host cell able to secrete a BSH, or a combination thereof. The present invention also relates to the use of a composition exhibiting a BSH activity for the treatment or the prevention of giardiasis, and to a pharmaceutical composition or a food composition comprising, as an active principle, a BSH, a lactic acid bacterium able to secrete a BSH, or a recombinant host cell able to secrete a BSH.

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: Compounds of formula (I): wherein R1, R2, R3, R4, R5, R6, R7, R8, R14, A and n are as defined in the description.

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: A method is disclosed for obtaining an antibody or antibody fragment to a conformational epitope specific for misfolded inactive human parathyroid hormone and fragments thereof. The method includes the steps of a) immunizing an animal with an immunogen which comprises oxidized parathyroid hormone or an oxidized fragment of parathyroid hormone, or both; and b) recovering an antibody, antibody fragments, or single chain antibody. The complementary determining region of the recovered antibody, antibody fragment or single chain antibody is capable of specifically recognizing a conformational epitope (antigenic determinant) which is present on oxidized parathyroid hormone and fragments thereof only but not regular bioactive human parathyroid hormone.

Abstract: The present invention relates to antibody-containing lyophilized formulations free from reducing sugars, non-reducing sugars, sugar alcohols or polysaccharides as excipients and including one or more amino acid selected from the group consisting of arginine, histidine, lysine, serine, proline, glycine, alanine and threonine or a salt thereof.

Abstract: A novel cell penetrating peptide that transports proteins into cells and/or into nuclei and a pharmaceutical containing the peptide is described.

Abstract: This disclosure provides antibodies that specifically bind to and typically neutralize botulinum neurotoxins (e.g., BoNT/A, BoNT/B, BoNT/E, etc.) and the epitopes bound by those antibodies. The antibodies and derivatives thereof and/or other antibodies that specifically bind to the neutralizing epitopes provided herein can be used to neutralize botulinum neurotoxin and are therefore also useful in the treatment of botulism.

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 bispecific antibody constructs of a specific Fc modality characterized by comprising a first domain binding to BCMA, a second domain binding to an extracellular epitope of the human and/or the Macaca CD3? chain and a third domain, which is the specific Fc modality. Moreover, the invention provides a polynucleotide, encoding the antibody construct, a vector comprising this polynucleotide, host cells, expressing the construct and a pharmaceutical composition comprising the same.

Abstract: Provided is an expression vector having an improved ability to express a gene. Also provided are cells transformed by the expression vector and a method for mass-producing a target protein by using the cells. The expression vector contains a simian virus 40 promoter, a scaffold attachment region or matrix attachment region element, and a chimeric intron. The vector shows an improved ability to express a gene, and thus, can attain a significantly increased expression of a heterogeneous gene.

Abstract: Novel compositions of recombinant human CC10 protein have been generated by chemically modifying the pure protein in vitro. Several new synthetic preparations containing isoforms of chemically modified rhCC10 have been generated by processes that utilize reactive oxygen species and reactive nitrogen species. These preparations contain novel isoforms of rhCC10 which have been characterized with enhanced or altered biological properties compared to the unmodified protein. Preparations containing novel isoforms may be used as standards to identify and characterize naturally occurring isoforms of native CC10 protein from blood or urine and ultimately to measure new CC10-based biomarkers to assess patient disease status. These preparations may also be used to treat respiratory, autoimmune, inflammatory, and other medical conditions that are not effectively treated with the unmodified protein.

Abstract: The invention provides stabilized aqueous pharmaceutical etanercept compositions stabilized with an amino acid and suitable for long-term storage of etanercept, methods of manufacture of these compositions, methods of administration, and kits containing same.

Abstract: Synthetic fragment antigen-binding (Fab) antibodies are disclosed that bind to an N-terminal activation site of BCL-2-associated X-protein (BAX) and inhibit BAX activation. Also disclosed are methods of using the Fabs for measuring inactive monomeric BAX levels, screening for small molecules that bind to an N-terminal activation site of BAX, inhibiting apoptotic cell death, and predicting the ability of a cancer therapy to promote apoptotic cell death.

Abstract: Preparations and methods for treating a GD2 positive cancer by administering a preparation comprising an anti-GD2 antibody to a patient, wherein the patient is not concomitantly treated with Interleukin-2 (IL-2), and wherein one or more treatment periods with the antibody may be preceded, accompanied, and/or followed by one or more treatment periods with a retinoid.

Abstract: A method for augmenting expression of a heterologous nucleic acid in a eukaryotic cell or increasing the efficiency of gene expression using any gene expression system is carried out by decreasing expression or activity of an endogenous Interferon-induced protein-16 (IFI16).

Abstract: The invention provides single domain antibodies and derivatives thereof that bind antigens of interest, which are stable, soluble, and do not tend to aggregate. The invention also provides methods for constructing a dAb library and methods for screening dAb libraries to identify the dAb of the invention. The invention also provide methods of treating or preventing conditions by antigen neutralization by administering the dAbs of the invention.

Abstract: This document provides methods and materials involved in reducing venous neointimal hyperplasia (VNH) of an arteriovenous fistula (AVF) or graft. For example, methods and materials for using stem cells (e.g., mesenchymal stem cells), extracellular matrix material, or a combination of stem cells and extracellular matrix material to reduce VNH of AVFs or grafts are provided.

Abstract: This document provides methods and materials involved in modulating a cell's ability to be resistant to apoptosis. For example, methods and materials for exposing cells to KLK6 polypeptides, or increased KLK6 polypeptide activity, to promote resistance to apoptosis are provided. In addition, methods and materials for reducing the ability of KLK6 polypeptides to promote resistance to apoptosis are provided.

Abstract: We provide new monoclonal antibody inhibitors of coagulases for treatment of S. aureus. The monoclonal antibodies are useful in targeting the SC N-terminus and inhibiting SC-ProT activation. The monoclonal antibodies are able to bind to and interfere with, modulate, and/or inhibit the binding interactions between the staphylocoagulase protein and its ligand protein prothrombin in blood and tissues. The antibodies are effective in inhibiting the activation of prothrombin.

Abstract: Biomarkers predictive of responsiveness to integrin beta7 antagonists, including anti-beta7 integrin subunit antibodies, and methods of using such biomarkers are provided. In addition, methods of treating gastrointestinal inflammatory disorders such as inflammatory bowel diseases including ulcerative colitis and Crohn's disease are provided. Also provided are methods of using such predictive biomarkers for the treatment of inflammatory bowel diseases including ulcerative colitis and Crohn's disease.

Abstract: The present invention relates to novel antibodies and fragments that bind to a V-domain Ig Suppressor of T cell Activation (VISTA), and methods of making and using same. Methods of use include methods of treatment of cancer, including leukemias, lymphomas, solid tumors and melanomas.

Abstract: The present invention relates to CD27L antigen binding proteins, such an antibodies, polynucleotides encoding said CD27l antigen binding proteins, antibody drug conjugate compositions, and methods for diagnosing and treating diseases associated with CD27L expression.

Abstract: Campylobacter jejuni is a leading cause of bacterial food-borne diseases in humans, ranging from acute diarrheal disease to neurological disorders. An isolated or purified antibody or fragment thereof specific to C. jejuni is described. The antibody or fragment thereof binds to a flagellar protein and reduces motility of C. jejuni. The antibody or fragment thereof is derived from a heavy chain IgG variable domain fragment (VHH) of a camelid animal immunized with C. jejuni flagellar protein. A multivalent form, as well as a phage format, of the antibody or fragment thereof is described. Methods of reducing presence of C. jejuni in an animal or an animal environment, methods and formulations for treating C. jejuni infection, and method of detecting C. jejuni are also described.

Abstract: Methods for enhancing wound healing, e.g., in diabetic subjects, by administering an antagonist of miR-26a, e.g., an inhibitory nucleic acid that targets miR-26a.

Abstract: The present application relates to the molecular labeling and in vivo imaging of amyloids. Specifically, the present application relates to a polypeptide-based method/vector for targeting amyloids. Such a method/vector enables the transportation of compounds or drugs across blood-brain-barrier of an individual and then binding to amyloids in brain. Particularly, the vector of the present application can transport an imaging group linked to the vector across the blood-brain-barrier, and can binds to amyloids in brain, and thus enables the labeling and imaging of amyloid deposits. When used as an imaging agent for detecting amyloid deposits in body or tissues, the vector may be labeled with suitable optical imaging groups, radioactive isotopes or imaging groups suitable for MRI or CT detection.

Abstract: The invention provides vectors, attenuated pathogens, compositions, methods, and kits for use in preventing or treating infection by an infectious pathogen, especially Chlamydia trachomatis. The vectors comprise the plasmid encoded ppg genes from Chlamydia, ppg1, ppg2, ppg3, ppg5, ppg6, ppg7 and/or ppg8, but lack ppg4, a regulator of virulence associated genes. The application also provides attenuated pathogens, especially chlamydia, which are cured of their plasmid and have additional mutations to improve the attenuation, especially mutations in the CT135 gene or in the tryptophan operon (trp promoter, trpA, or trpB). Uses of said nucleic acids and attenuated pathogens for inducing or modulating an immune response in a subject, especially for prevention or treatment of infections, are proposed.

Abstract: The present invention relates to methods of migraine prophylaxis using anti-CGRP receptor antibodies or binding fragments. In particular, methods for preventing or reducing the occurrence of migraine headache in a patient in need thereof comprising administering to the patient an anti-CGRP receptor or binding fragment according to specific dosage regimens are disclosed. Pharmaceutical compositions and administration devices comprising anti-CGRP receptor antibodies or binding fragments for use in the methods are also described.

Abstract: The invention provides a method of treating a degenerative joint disease. The method comprises administering an effective amount of a pharmaceutical composition comprising a diketopiperazine with amino acid side chains of aspartic acid and alanine (DA-DKP). The invention also provides a pharmaceutical product as well as a kit comprising DA-DKP.

Abstract: Biomarkers are provided for detecting, diagnosing and prognosing thymic cancer in individuals having or suspected of having thymic cancer. In addition, kits are provided for measuring expression levels or the presence of the biomarkers associated with thymic cancer for detecting, diagnosing and prognosing thymic cancer. Furthermore, methods are provided for detecting, diagnosing and prognosing thymic cancer in individuals having or suspected of having thymic cancer via the biomarkers.

Abstract: A method of reducing blood glucose in a subject has been developed. In preferred embodiments, the method involves administering to the subject a specific activator of endogenous mitogen-activated protein kinase kinase 6 (MKK3), mitogen-activated protein kinase kinase 6 (MKK4), mitogen-activated protein kinase kinase 6 (MKK6), p38 mitogen-activated protein kinase (p38MAPK), mitogen-activated kinase-activated protein kinase 2 (MK2), or a combination thereof, in an effective amount to reduce blood glucose in a subject. In other embodiments, the method involves administering to the subject a specific activator to increase X-box binding protein 1 (XBP1) phosphorylation on Thr48 and Ser61 in an effective amount to reduce blood glucose in the subject. Methods of identifying agents for reducing blood glucose in a subject are also provided.

Abstract: Endoglin has been identified to play a functional role as a regulator of TGF?1 signaling, particular in TGF?1-mediated calcineurin expression. The present invention features methods of reducing cardiac damage, particularly in a subject undergoing chemotherapy or radiation therapy by administering a composition that inhibits endoglin activity. The present invention also features methods of treating autoimmune diseases, inflammatory diseases, organ transplantation, and conditions association with oxidative stress related to TGF?1-mediated calcineurin expression and reactive oxygen species (ROS) production by administering a composition that inhibits endoglin activity. The present invention also features methods of treating fibrotic diseases by administering a composition that inhibits endoglin activity.

Abstract: The current disclosure provides binding polypeptides (e.g., antibodies), and effector moiety conjugates thereof (e.g., antibody-drug conjugates or ADCs), comprising a site-specifically engineered drug-glycan linkage within native or engineered glycans of the binding polypeptide. The current disclosure also provides nucleic acids encoding the antigen-binding polypeptides, recombinant expression vectors and host cells for making such antigen-binding polypeptides. Methods of using the antigen-binding polypeptides disclosed herein to treat disease are also provided.