Abstract: The invention provides mutants of GAS57 (Spy0416) which are unable to cleave IL-8 and similar substrates but which still maintain the ability to induce protection against S. pyogenes. The invention also provides antibodies which specifically bind to GAS57 and which inhibit its ability to cleave IL-8 and similar substrates. The mutants are useful, inter alia, in vaccine compositions to induce protection against S. pyogenes. The antibodies are useful, e.g., as therapeutics for treating S. pyogenes infections.

Abstract: Provided herein are Mycobacterium smegmatis porin nanopores, systems that comprise these nanopores, and methods of using and making these nanopores. Such nanopores may be wild-type MspA porins, mutant MspA porins, wild-type MspA paralog porins, wild-type MspA homolog porins, mutant MspA paralog porins, mutant MspA homolog porins, or single-chain Msp porins. Also provided are bacterial strains capable of inducible Msp porin expression.

Abstract: It is an object of the present invention to provide a mutant streptavidin with a reduced affinity for natural biotin, and also to provide a modified biotin having a high affinity for the mutant streptavidin with a reduced affinity for natural biotin. According to the present invention, there is provided a reagent kit for use in treatments or diagnoses, which comprises: (a) a mutant streptavidin with a reduced affinity for natural biotin or biocytin; and a modified biotin having a high affinity for the above-described mutant streptavidin.

Abstract: The present invention provides a method for diagnosing and detecting diseases associated with colon. The present invention provides one or more proteins or fragments thereof, peptides or nucleic acid molecules differentially expressed in colon diseases (CCAT) and antibodies binds to CCAT. The present invention provides that CCAT is used as targets for screening agents that modulates the CCAT activities. Further the present invention provides methods for treating diseases associated with colon.

Abstract: The invention provides an A? peptide aggregation inhibitor, an A? peptide toxicity reducing agent, and a preventive and/or therapeutic agent for Alzheimer's disease. The oxidized A? peptide in which one or more amino acid residues of A? peptide have been oxidized (excluding an oxidized A? peptide in which only Met has been oxidized).

Abstract: Disclosed is a polypeptide containing an extracellular domain of a synaptogenic protein, and a method for manufacturing a nerve cell, a complex containing a biotin tagged at the C-terminus of the polypeptide, an artificial synapse inducer for coupling the composite to a streptavidin (SAV)-coated substrate and a nerve cell. The complex tagged with a biotin at the C-terminus of the polypeptide containing the extracellular domain of the synaptogenic protein, such as neuroligin-1, can display activity by being attached to the SAV-coated substrate to adjust the orientation thereof without help of a supported lipid bilayer. The complex containing an additional RFP between the extracellular domain and the biotin of the synaptogenic protein not only facilitates easier mass-production, quantification, and tracking, but also displays activity of a normal synaptogenic protein, thereby inducing excitatory or inhibitory synaptic differentiation by being fixed to the substrate and added to the nerve cell culture.

Abstract: The present invention provides compositions and methods relating to IL-1Rrp2 requiring proteins.

Abstract: Compounds are provided having inter alia good duration of action, high potency and/or convenient dosing regimens including once weekly administration. The compounds are engineered polypeptides which incorporate an albumin binding domain in combination with one or more biologically active polypeptides. Also provided are pharmaceutical compositions and methods of treatment for diseases and disorders including lipodystrophy, dyslipidemia, hyperlipidemia, overweight, obesity, hypothalamic amenorrhea, Alzheimer's disease, leptin deficiency, fatty liver disease or diabetes (including type I and type II). Additional diseases and disorders which can be treated by the compounds and methods described herein include nonalcoholic steatohepatitis (NASH) and nonalcoholic fatty liver disease (NAFLD), metabolic syndrome X and Huntington's Disease.

Abstract: The present invention provides peptidomimetic macrocycles capable of modulating growth hormone levels and methods of using such macrocycles for the treatment of disease.

Abstract: The present invention relates to compositions comprising GLP-2 protein or variants thereof linked to extended recombinant polypeptide (XTEN), isolated nucleic acids encoding the compositions and vectors and host cells containing the same, and methods of making and using such compositions in the treatment of GLP-2-related conditions.

Abstract: The present disclosure relates to heterodimeric fusion proteins comprising two polypeptides, the first polypeptide comprising a first peptide (P1), a linker (L1), and a Fc region (F1), the second polypeptide comprising a second peptide (P2), a linker (L2), and an Fc region (F2), wherein P1 and P2 are each independently selected from GLP-1, GLP-1 analogues, glucagon, glucacon analogues, GIP, GIP analogues, oxyntomodulin, oxyntomodulin analogues, exendin and exendin analogues; wherein F is selected from an IgG Fc, an IgA Fc, an IgE Fc, an IgGM Fc, and their analogues; wherein the C-terminals of the peptides are linked, though the Linker L, to the N-terminals of the Fc region F. In one embodiment, the fusion proteins disclosed herein have agonist activity against at least two of the GLP-1 receptor, the GIP receptor, and the glucagon receptor.

Abstract: The present invention relates to a human antibody specific for FcRn that is a receptor with a high affinity for IgG, a production method thereof, a composition for treating autoimmune disease, which comprises the antibody, and a method of treating and diagnosing autoimmune disease using the same. The FcRn-specific antibody according to the present invention can bind to FcRn non-competitively with IgG or the like to reduce serum auto-antibody levels, and thus can be used for the treatment of autoimmune diseases.

Abstract: The invention provides peptides that are useful for treating or preventing, or preventing the progression of a disorder associated with aberrant TDF polypeptide or TDFRP compound target molecule expression or activity, for example a kidney disease or disorder, in a subject. The invention also provides methods of treating a subject having a disorder associated with aberrant TDF polypeptide or TDFRP compound target molecule expression or activity, such as a kidney disease or disorder, comprising administering to the subject an effective amount of the peptides of the invention.

Abstract: The present invention relates to T cell receptors (TCRs) which bind the HLA-A2 restricted FMNKFIYEI (158-166) peptide epitope derived from ? Fetoprotein (AFP). Certain preferred TCRs of the invention demonstrate excellent binding characteristics and specificity profiles for this AFP epitope. T cell receptors of the invention may comprise at least one TCR alpha chain variable domain and/or at least one TCR beta chain variable domain, the alpha chain variable domain which may comprise an amino acid sequence that has at least 90% identity to the sequence of amino acid residues 1-112 of SEQ ID No: 2, and/or the beta chain variable domain which may comprise an amino acid sequence that has at least 90% identity to the sequence of amino acid residues 1-112 of SEQ ID No: 3.

Abstract: The present invention pertains to inter alia therapeutic delivery vesicles, for instance exosomes or microvesicles, comprising polypeptide constructs, methods for producing said therapeutic delivery vesicles, pharmaceutical compositions and medical uses thereof. The therapeutic polypeptide constructs comprised in the extracellular delivery vesicles enable sequestering target molecules of interest, to treat e.g. neuro-inflammatory diseases and cancer.

Abstract: The present invention relates to the use of a non-antibody VEGF antagonist, in the treatment of choroidal neovascularisation secondary to diseases other than age-related macular degeneration and pathologic myopia.

Abstract: The present invention provides stabilized activin IIB receptor polypeptides and proteins capable of binding and inhibiting the activities of activin A, myostatin, or GDF-11. The present invention also provides polynucleotides, vectors and host cells capable of producing the stabilized polypeptides and proteins. Compositions and methods for treating muscle-wasting diseases and metabolic disorders are also provided.

Abstract: The present invention relates to a fibrin sealant kit comprising purified fibrinogen and thrombin. The invention particularly relates to an improved chromatographic process for the purification of thrombin and fibrinogen components devoid of any significant plasminogen and other impurities. The absence of plasminogen facilitates the exclusion of a proteolytic inhibitor (aprotinin) from among the kit components.

Abstract: The present invention relates to a self-cleaving fusion protein including a target protein, a peptide consisting of amino acid sequence represented by LPXTG, a domain of Sortase A having cleaving function, and a tag, which are sequentially positioned from the amino terminal; a nucleic acid encoding the same; an expression vector including the nucleic acid of the present invention; and a cell transformed with the expression vector of the present invention. In addition, the present invention relates to a method for refining a target protein including culturing, dissolving, and purifying the transformed cell, and a method for preparing a therapeutic antibody-drug conjugate by using the purifying method.

Abstract: Provided herein are antibodies that cross-react with hemagglutinin from strains of influenza virus of the same subtype or different subtypes, host cells for producing such antibodies, and kits comprising such antibodies. Also provided herein are compositions comprising antibodies that cross-react with hemagglutinin from strains of influenza virus of the same subtype or different subtypes and methods of using such antibodies to diagnose, prevent or treat influenza virus disease.

Abstract: Disclosed herein are isolated humanized monoclonal antibodies that specifically bind Japanese encephalitis virus (JEV) with a binding affinity of about 1.0 nM or less. Nucleic acids encoding these antibodies, expression vectors including these nucleic acid molecules, and isolated host cells that express the nucleic acid molecules are also disclosed. Methods of treating, preventing, and/or ameliorating JEV infection in a subject with JEV also are disclosed. Additionally, the antibodies can be used to detect JEV in a sample, and methods of diagnosing JEV infection, or confirming a diagnosis of JEV infection in a subject, are disclosed herein that utilize these antibodies.

Abstract: The present disclosure relates to monoclonal antibodies that bind poly-?-D-glutamic acid (?DPGA), which is present on the surface of Bacillus anthracis. The disclosure also provides chimeric forms of the monoclonal antibodies, humanized forms of the monoclonal antibodies, and fragments thereof, as well as nucleic acids encoding the antibodies and fragments thereof. Pharmaceutical compositions including such antibodies are also disclosed herein. The disclosure further provides prophylactic, therapeutic, and diagnostic methods of using the disclosed antibodies.

Abstract: The present invention relates to an antibody having specificity for an immunogenic determinant consisting of the pentasaccharide repeating unit of the Clostridium difficile glycopolymer PS-I: ?-L-Rhap-(1?3)-?-D-Glcp-(1?4)-[?-L-Rhap-(1?3)]-?-D-Glcp-(1?2)-?-D-Glcp or a fragment thereof. Said antibody is able to prevent and treat diseases caused by C. difficile. The present invention further pertains to a method of treating or preventing a disease caused by the pathogen Clostridium difficile, which comprises administering to a subject said antibody or a vaccine composition comprising said antibody.

Abstract: The disclosure features over 5000 methylation and acetylation sites identified in human cell line, human serum and mouse tissues, peptides (including AQUA peptides) comprising a methylation or acetylation site of the disclosure, antibodies specifically bind to a methylation or acetylation site of the disclosure, and diagnostic and therapeutic uses of the above.

Abstract: The present invention provides a single domain specific binding molecule having the structure FW1-CDR1-FW2-HV2-FW3a-HV4-FW3b-CDR3-FW4 in which the Framework Regions FW1, FW2, FW3a, FW3b, and FW4, the Complementarity Determining Regions CDR1 and CDR3, and the Hypervariable Regions HV2, and HV4 have amino acid sequences as defined which provide a high affinity anti-human serum albumin (HSA) binding domain.

Abstract: The invention provides stable aqueous pharmaceutical formulations comprising a therapeutic antibody, trehalose, a buffer, and optional surfactant, and having a pH in the range of about 5.5 to about 7.0. The invention also provides methods for making such formulations and methods of using such formulations.

Abstract: Isolated antibodies that specifically bind to an epitope comprised in the stretch of amino acids ranging from amino acid 76 to amino acid 84 of human insulin-like growth factor-1 precursor (SEQ ID NO:1). Use of the novel antibodies for the sensitive and specific detection of insulin-like growth factor-1, in some embodiments while in the presence of high excess concentration of insulin-like growth factor-2, for example in a bodily fluid sample.

Abstract: Chimeric and humanized anti-CD37 antibodies and pharmaceutical compositions containing them are useful for the treatment of B cell malignancies and autoimmune and inflammatory diseases that involve B cells in their pathology.

Abstract: This application discloses anti-P-cadherin antibodies, antigen binding fragments thereof, and antibody drug conjugates of said antibodies or antigen binding fragments. The invention also relates to methods of treating cancer using the antibodies, antigen binding fragments, and antibody drug conjugates. Also disclosed herein are methods of making the antibodies, antigen binding fragments, and antibody drug conjugates, and methods of using the antibodies and antigen binding fragments as diagnostic reagents.

Abstract: The present invention is based, in part, on the identification of novel human anti-PD-1, PD-L1, and PD-L2 antibodies. Accordingly, the invention relates to compositions and methods for diagnosing, prognosing, and treating conditions that would benefit from modulating PD-1, PD-L1, and/or PD-L2 activity (e.g., persistent infectious diseases, autoimmune diseases, asthma, transplant rejection, inflammatory disorders and tumors) using the novel human anti-PD-1, PD-L1, and PD-L2 antibodies described herein.

Abstract: The present disclosure relates to polypeptide variants having modified Fc domains with improved potency and efficacy in activation of complement-dependent cytotoxicity.

Abstract: Provided are monoclonal antibodies and antigen-binding fragments thereof that bind to, and inhibit the activity of, CD47, as well as monoclonal antibodies and antigen binding fragments thereof that compete with the former for binding to CD47. Also provided are combinations of any of the foregoing. Such antibody compounds are variously effective in 1) treating tissue ischemia and ischemia-reperfusion injury (IRI) in the setting of organ preservation and transplantation, pulmonary hypertension, sickle cell disease, myocardial infarction, stroke, and other instances of surgery and/or trauma in which IRI is a component of pathogenesis; 2) in treating autoimmune and inflammatory diseases; and 3) as anti-cancer agents that are toxic to susceptible cancer cells, promoting their phagocytic uptake and clearance, or directly killing such cells.

Abstract: Provided are monoclonal antibodies and antigen-binding fragments thereof that bind to, and inhibit the activity of, CD47, as well as monoclonal antibodies and antigen binding fragments thereof that compete with the former for binding to CD47. Also provided are combinations of any of the foregoing. Such antibody compounds are variously effective in 1) treating tissue ischemia and ischemia-reperfusion injury (IRI) in the setting of organ preservation and transplantation, pulmonary hypertension, sickle cell disease, myocardial infarction, stroke, and other instances of surgery and/or trauma in which IRI is a component of pathogenesis; 2) in treating autoimmune and inflammatory diseases; and 3) as anti-cancer agents that are toxic to susceptible cancer cells, promoting their phagocytic uptake and clearance, or directly killing such cells.

Abstract: Compositions and methods for treating MM are provided herein.

Abstract: The disclosure relates to a protein composed of a first polypeptide or polypeptide domain having a first specific binding activity for Cytotoxic T-lymphocyte Antigen 4 (CTLA-4) expressed on a T-cell cell surface and a second specific binding activity for Glucose Transporter 2 (GLUT2) or an extracellular ectodomain thereof expressed on a pancreatic ?-cell surface, wherein binding of the first polypeptide or polypeptide domain to CTLA-4 induces a CTLA-4 specific agonist response in the T-cell, and binding of the second polypeptide or polypeptide domain to GLUT2 or an ectodomain thereof does not inhibit GLUT2 glucose transporter function, wherein said agonist response in the T-cell induces a response that reduces immunoreactivity against pancreatic ?-cells.

Abstract: The present invention relates to ?v?8 antagonists, anti-?v?8 antibodies or immunoconjugates for reducing TGF? activation in an individual. Further provided are compositions comprising one of the ?v?8 antagonists, anti-?v?8 antibodies or immunoconjugates, methods for using the compositions, and related subject matter.

Abstract: Provided are monospecific and bispecific antibodies that are useful as anti-neoplastic agents and that bind specifically to human IGF-1R and human ErbB3. Exemplary antibodies inhibit signal transduction through either or both of IGF-1R and ErbB3. Exemplary polyvalent proteins comprise at least one anti-IGF-1R binding site and at least one anti-ErbB3 binding site. In certain embodiments the binding sites may be linked through an immunoglobulin constant region. AntiErbB3 and anti-IGF-1R antibodies (e.g., monoclonal antibodies) are also provided.

Abstract: The invention provides anti-oncostatin M receptor-? (OSMR) antigen binding proteins. e.g., antibodies and functional fragments, derivatives, muteins, and variants thereof. OSMR antigen binding proteins interfere with binding of OSM and/or IL-31 to OSMR. In some embodiments, anti-OSMR antigen binding proteins are useful tools in studying diseases and disorders associated with OSMR and are particularly useful in methods of treating diseases and disorders associated with OSMR and binding of OSM and/or IL-31 to OSMR.

Abstract: The disclosure provides humanized anti-OX40 antibodies. Also provided are methods of making such antibodies, and methods of use, e.g., treatment of cancer.

Abstract: Provided herein is a method of diagnosing muscle specific tyrosine kinase specific autoimmune myasthenia gravis in an individual. Generally, in the method a level of muscle specific tyrosine kinase binding to B cells is determined in a sample from an individual. A significant increase in the level of muscle specific tyrosine kinase reactive B-cells compared to that in a healthy individual indicates the presence of muscle specific tyrosine kinase autoimmune myasthenia gravis. Also provided is a fluorophore-muscle specific tyrosine kinase conjugate and a kit comprising the same useful to test the frequency of muscle specific tyrosine kinase binding B cells expressing specific markers, for diagnosis or as biomarker for muscle specific tyrosine kinase autoimmune myasthenia gravis.

Abstract: The present invention relates to a highly concentrated, stable pharmaceutical formulation of a pharmaceutically active anti-CD20 antibody, such as e.g. Rituximab, Ocrelizumab, or HuMab<CD20>, or a mixture of such antibody molecules for subcutaneous injection. In particular, the present invention relates to formulations comprising, in addition to a suitable amount of the anti-CD20 antibody, an effective amount of at least one hyaluronidase enzyme as a combined formulation or for use in form of a co-formulation. The said formulations comprise additionally at least one buffering agent, such as e.g. a histidine buffer, a stabilizer or a mixture of two or more stabilizers (e.g. a saccharide, such as e.g. ?,?-trehalose dihydrate or sucrose, and optionally methionine as a second stabilizer), a nonionic surfactant and an effective amount of at least one hyaluronidase enzyme. Methods for preparing such formulations and their uses thereof are also provided.

Abstract: The present invention provides glycan-interacting antibodies useful in the treatment and prevention of human disease, including cancer. Such glycan-interacting antibodies include monoclonal antibodies, derivatives and fragments thereof as well as compositions and kits comprising them.

Abstract: The present invention relates to binding agents that specifically bind human MET, binding agents that specifically bind one or more components of the WNT pathway, bispecific agents that bind both human MET and one or more components of the WNT pathway, and methods of using the agents for treating diseases such as cancer.

Abstract: The present invention provides methods for treating hypercholesterolemia. The methods of the present invention comprise administering to patients with heterozygous familial hypercholesterolemia a pharmaceutical composition comprising a PCSK9 inhibitor. In certain embodiments, the PCSK9 inhibitor is an anti-PCSK9 antibody such as the exemplary antibody referred to herein as mAb316P. The methods of the present invention are useful for treating patients with heterozygous familial hypercholesterolemia who are not adequately controlled by maximum tolerated dose statin therapy with or without other lipid lowering therapy.

Abstract: The present invention provides methods for treating hypercholesterolemia. The methods of the present invention comprise administering to a high cardiovascular risk patient a pharmaceutical composition comprising a PCSK9 inhibitor. In certain embodiments, the PCSK9 inhibitor is an anti-PCSK9 antibody such as the exemplary antibody referred to herein as mAb316P. The methods of the present invention are useful for treating high cardiovascular risk patients with hypercholesterolemia and established CHD or CHD risk equivalents that are not adequately controlled by maximum tolerated dose statin therapy.

Abstract: The invention relates to antibodies against human CD39 and use thereof for inhibiting T regulatory cells (Treg) activity. More particularly CD39 antibodies may be used for the treatment or prevention of cancers and infectious diseases.

Abstract: A method of diagnosing metastatic potential of a breast cancer in an individual with breast cancer is described. The method comprises a step of assaying a breast cancer tumour sample from the patient for expression of A Disintegrin And Metalloproteinase 22, (ADAM22), wherein expression of ADAM22 correlates with increased potential for metastasis compared with a patient who is ADAM22 negative. The invention also describes an agent for use in the treatment of metastatic breast cancer in a patient, in which the agent is selected from leucine-rich, glioma-inactivated protein 1 (LGI1) protein (SEQ ID NO:1) and an LGI1 peptide mimic capable of mimicking the ADAM22 binding activity of LGI1 by binding to the LGI1 binding domain of ADAM22 (SEQ ID NO: 4) and which is capable of inhibiting migration of endocrine resistant breast cancer cells.

Abstract: Embodiments concern methods and compositions for treating or preventing a bacterial infection, particularly infection by a Staphylococcus bacterium. Aspects include methods and compositions for providing a passive immune response against the bacteria. In certain embodiments, the methods and compositions involve an antibody that binds Staphylococcal protein A (SpA).

Abstract: A method of treating disorder or condition that relates to intracellular signal transmission of a neurotransmitter, comprising administration of an homeopathically potentized form of antibodies to an antigen, which antigen is a molecule capable of effecting the intracellular signal transmission of a neuroreceptor, in particular dopamine or serotonin.

Abstract: Provided are modified cellulose nanofibers that can be easily formed into a composite with a resin containing a solvent and a resin composition that contains the modified cellulose nanofibers. A method for producing modified cellulose nanofibers is characterized in that a step of obtaining modified cellulose by causing cellulose having hydroxyl groups to react with a resin having an intramolecular polybasic anhydride structure and a step of miniaturizing the modified cellulose are performed in the same step. In this method, the polybasic anhydride structure is a cyclic polybasic anhydride structure obtained by ring formation through dehydration condensation of carboxyl groups in the molecule.