Abstract: This invention provides a method of treating a subject afflicted with active lupus arthritis comprising periodically administering to the subject an amount of laquinimod or pharmaceutically acceptable salt thereof effective to treat the subject. This invention also provides laquinimod or pharmaceutically acceptable salt thereof for use in treating a subject afflicted with active lupus arthritis. This invention further provides a pharmaceutical composition comprising an amount of laquinimod or pharmaceutically acceptable salt thereof for use in treating a subject afflicted with lupus arthritis.

Abstract: Engineered multivalent and multispecific binding proteins that bind IL-1? and/or IL-17 are provided, along with methods of making and uses in the prevention, diagnosis, and/or treatment of disease.

Abstract: The present invention provides liquid formulations of SYNAGIS® or an antigen-binding fragment thereof that immunospecifically bind to a respiratory syncytial virus (RSV) antigen, which formulations exhibit stability, low to undetectable levels of aggregation, and very little to no loss of the biological activities of SYNAGIS® or an antigen-binding fragment thereof, even during long periods of storage. In particular, the present invention provides liquid formulations of SYNAGIS® or an antigen-binding fragment thereof which immunospecifically binds to a RSV antigen, which formulations are substantially free of surfactant, inorganic salts, and/or other common excipients. Furthermore, the invention provides method of preventing, treating or ameliorating symptoms associated with RSV infection utilizing liquid formulations of the present invention.

Abstract: The invention relates to human targets of interest (TOI), anti-TOI ligands, kits compositions and method.

Abstract: The invention relates to human targets of interest (TOI), anti-TOI ligands, kits compositions and method.

Abstract: In certain embodiments, the present invention, the present invention provides a method of treating a cancer in a subject, comprising: (a) administering to the subject a predetermined dosage of an anti-CTLA4 antibody; (b) detecting the level of the anti-CTLA4 antibody in a sample of the subject; and (c) increasing the dosage of the anti-CTLA4 antibody in the subject if the level of the anti-CTLA4 antibody from step (b) is below a threshold exposure level, such that the cancer is treated.

Abstract: The present invention provides compositions and methods of use in the treatment/prevention of chlamydial infection and/or diseases and disorders associated with chlamydial infection in a subject.

Abstract: The invention provides a method for producing a host cell protein-(HCP) reduced antibody preparation from a mixture comprising an antibody and at least one HCP, comprising an ion exchange separation step wherein the mixture is subjected to a first ion exchange material, such that the HCP-reduced antibody preparation is obtained.

Abstract: The invention relates to fully human monoclonal antibodies, and fragments thereof, that bind to the chemokine Regulated upon Activation, Normal T-cell Expressed, and Secreted (RANTES, CCL5), thereby modulating the interaction between RANTES and one of more of its receptors, such as, e.g., CCR1, CCR3, CCR4 and CCR5, and/or modulating the biological activities of RANTES. The invention also relates to the use of these or any anti-RANTES antibodies in the prevention or treatment of immune-related disorders and in the amelioration of one or more symptoms associated with an immune-related disorder.

Abstract: Methods of treating disorders in which TNF? activity is detrimental via biweekly, subcutaneous administration of human antibodies, preferably recombinant human antibodies, that specifically bind to human tumor necrosis factor ? (hTNF?) are disclosed. The antibody may be administered with or without methotrexate. These antibodies have high affinity for hTNF? (e.g., Kd=10?8 M or less), a slow off rate for hTNF? dissociation (e.g., Koff=10?3 sec?1 or less) and neutralize hTNF? activity in vitro and in vivo. An antibody of the invention can be a full-length antibody or an antigen-binding portion thereof. Kits containing a pharmaceutical composition and instructions for dosing, and preloaded syringes containing pharmaceutical compositions are also encompassed by the invention.

Abstract: The invention provides a method for producing a host cell protein-(HCP) reduced antibody preparation from a mixture comprising an antibody and at least one HCP, comprising an ion exchange separation step wherein the mixture is subjected to a first ion exchange material, such that the HCP-reduced antibody preparation is obtained.

Abstract: The invention relates to human targets of interest (TOI), anti-TOI ligands, kits compositions and method.

Abstract: It has been found out that among antibodies showing reactivity with wild type TGF-?, antibodies less reactive with G79A-substituted TGF-? have an excellent growth-suppressing effect on cancer cells having a mutated Ras gene. Further, it has been found out that most of these antibodies have an activity of inhibiting EGFR tyrosine phosphorylation and/or an induction-suppressing activity on vascular endothelial cells.

Abstract: The invention provides novel polypeptides useful for co-stimulating T cells, isolated nucleic acid molecules encoding them, vectors containing the nucleic acid molecules, and cells containing the vectors. Also included are methods of making and using these co-stimulatory polypeptides.

Abstract: The present invention relates to a method of detecting metabolic bone disorders using a gene expressed at a high level in osteoclasts, a method of screening for a compound effective for treatment and/or prevention of metabolic bone disorders, and a pharmaceutical composition for treatment and/or prevention of metabolic bone disorders. Specifically, the present invention relates to a method of detecting metabolic bone disorders using expression of the human DC-STAMP gene as an indicator, a pharmaceutical composition containing an antibody which is capable of specifically recognizing human DC-STAMP and suppressing formation of osteoclasts, and so forth.

Abstract: The present invention provides certain improved formulations of proteins. Specifically, the present invention provides use of certain excipients that are useful for stabilization of antibody preparations. Additionally, the novel formulations of the present invention prevents the formation of aggregates or fragments or modifications of protein in solution.

Abstract: The invention describes methods of treating erosive polyarthritis comprising administering a TNF? antibody, or antigen-binding portion thereof. The invention also describes a method for testing the efficacy of a TNF? antibody, or antigen-binding portion thereof, for the treatment of erosive polyarthritis.

Abstract: Concentrated, low-viscosity, low-volume liquid pharmaceutical formulations of proteins have been developed. Such formulations can be rapidly and conveniently administered by subcutaneous or intramuscular injection, rather than by lengthy intravenous infusion. These formulations include low-molecular-weight and/or high-molecular-weight proteins, such as mAbs, and viscosity-lowering agents that are typically bulky polar organic compounds, such as many of the GRAS (US Food and Drug Administration List of compounds generally regarded as safe) and inactive injectable ingredients and FDA approved therapeutics.

Abstract: The invention relates to novel cyclic compounds (cyclic peptides), linkers useful as beta-turn promoters in cyclic peptides, and methods for treatment of malignant cells in vitro or in vivo using one or more linear and cyclic peptides. The peptides can act as integrin interaction inhibitors and may be used in the treatment of cancers as monotherapies or in combination with other anti-cancer agents, such as proteasome inhibitors, inhibitors of autophagy, alkylating agents, MEK inhibitors, FAK/PYK2 inhibitors, and EGFR inhibitors. The invention further concerns a method of predicting the binding of a cyclic or linear HYD1 peptide to a cancer cell by assessing overexpression of biomarkers such as CD44, VLA-4 integrin, basigin, CD138 (syndecan 1), NCAM, ICAM1, ICAM3, and CD59.

Abstract: This invention provides a method that allows selection of antibodies against cells (e.g., tumor cells) in situ using laser capture microdissection. By restricting antibody selection to binders of internalizing epitopes, a panel of phage antibodies was generated that targets clinically represented prostate cancer antigens.

Abstract: Methods of treating disorders in which TNF? activity is detrimental via biweekly, subcutaneous administration of human antibodies, preferably recombinant human antibodies, that specifically bind to human tumor necrosis factor ? (hTNF?) are disclosed. The antibody may be administered with or without methotrexate. These antibodies have high affinity for hTNF? (e.g., Kd=10?8 M or less), a slow off rate for hTNF? dissociation (e.g., Koff=10?3 sec?1 or less) and neutralize hTNF? activity in vitro and in vivo. An antibody of the invention can be a full-length antibody or an antigen-binding portion thereof. Kits containing a pharmaceutical composition and instructions for dosing, and preloaded syringes containing pharmaceutical compositions are also encompassed by the invention.

Abstract: The present invention provides compositions, vaccines, and methods for diagnosing, treating, and preventing influenza infection using a combination of antibodies raised against the influenza hemagglutinin and the matrix 2 ectodomain polypeptides.

Abstract: The present invention provides methods for selecting treatment methods for rheumatoid arthritis based on an objective selection process (algorithm). The present invention also provides methods for treating rheumatoid arthritis with treatment methods selected based on the algorithm disclosed herein. The methods of the present invention provide a more effective means for treating patients with rheumatoid arthritis.

Abstract: The disclosure is directed to predictive methods and personalized therapies for treating psoriatic arthritis (PsA). Specifically, this disclosure relates to methods of treating a patient having PsA by selectively administering an IL-17 antagonist, e.g., an IL-17 antibody, such as secukinumab, to the PsA patient on the basis of that patient being predisposed to have a favorable response to treatment with the IL-17 antagonist. Also disclosed herein are diagnostic methods useful in predicting the likelihood that a patient having PsA will respond to treatment with an IL-17 antagonist, e.g., an IL-17 antibody, such as secukinumab.

Abstract: The present invention provides methods of treating, stabilizing or lessening the severity or progression of a disease or disorder associated with BTK.

Abstract: The invention provides methods, uses and compositions for the treatment of rheumatoid arthritis. The invention describes methods and uses for treating rheumatoid arthritis wherein a TNF? inhibitor, such as a human TNF? antibody, or antigen-binding portion thereof. Also described are methods for determining the efficacy of a TNF? inhibitor for treatment of rheumatoid arthritis in a subject.

Abstract: The invention provides methods, uses and compositions for the treatment of rheumatoid arthritis. The invention describes methods and uses for treating rheumatoid arthritis wherein a TNF? inhibitor, such as a human TNF? antibody, or antigen-binding portion thereof. Also described are methods for determining the efficacy of a TNF? inhibitor for treatment of rheumatoid arthritis in a subject.

Abstract: The invention relates to engineered polypeptides comprising Fc variants and their uses. More specifically, Fc variants are described exhibiting reduced effector function. These variants cause a benefit for a patient suffering from a disease which could be treated with an antibody for which it is desirable to reduce the effector function elicited by antibodies.

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 antibodies that bind to human GFR?3 and methods of using same. According to certain embodiments of the invention, the antibodies are fully human antibodies that bind to human GFR?3. The antibodies of the invention are useful for the treatment of diseases and disorders associated with one or more GFR?3 biological activities, including the treatment of acute or chronic pain conditions, or inflammatory conditions.

Abstract: The present disclosure provides methods of that include detecting in a biological sample from a patient having or suspected of having cancer the presence of a polypeptide having ROS1 kinase activity or a polynucleotide encoding the same and detecting in the biological sample the presence of a mutant EGFR polypeptide or a polynucleotide encoding the same. In some aspects, the disclosure provides methods of treating a patient for cancer that include determining that a biological sample from a tumor in the patient includes a polypeptide having ROS1 kinase activity or a polynucleotide encoding the same and a mutant EGFR polypeptide or a polynucleotide encoding the same and administering to the patient a therapeutically effective amount of a ROS1 inhibitor and an EGFR inhibitor, thereby treating the patient for cancer.

Abstract: The invention relates to the field of oncology and to chemotherapy resistance and relapse. Thus the invention provides compositions and methods for inhibiting tumorigenicity of senescent cancer cells induced by a chemotherapeutic agent. The invention also provides compositions and methods for inhibiting conversion of non-stem cancer cells (non-CSCs) into tumor initiating cancer stem cells (CSCs) induced by a chemotherapeutic agent.

Abstract: The invention provides methods, uses and compositions for the treatment of rheumatoid arthritis. The invention describes methods and uses for treating rheumatoid arthritis wherein a TNF? inhibitor, such as a human TNF? antibody, or antigen-binding portion thereof. Also described are methods for determining the efficacy of a TNF? inhibitor for treatment of rheumatoid arthritis in a subject.

Abstract: The present invention relates to monoclonal antibodies that bind or neutralize anthrax lethal factor (LF), edema factor (EF), and/or protective antigen (PA). The invention provides such antibodies, fragments of such antibodies retaining anthrax toxin-binding ability, fully human or humanized antibodies retaining anthrax toxin-binding ability, and pharmaceutical compositions including such antibodies. The invention further provides for isolated nucleic acids encoding the antibodies of the invention and host cells transformed therewith. Additionally, the invention provides for prophylactic, therapeutic, and diagnostic methods employing the antibodies and nucleic acids 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 provides anti-N3pGlu A? antibodies or antigen-binding fragment thereof. In addition, the present invention provides the use of the anti-N3pGlu A? antibodies or antigen-binding fragment thereof for the treatment of Alzheimer's disease.

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 invention features methods for preventing or treating CGRP associated disorders such as vasomotor symptoms, including headaches (e.g., migraine, cluster headache, and tension headache) and hot flushes, by administering an anti-CGRP antagonist antibody. Antagonist antibody G1 and antibodies derived from G1 directed to CGRP are also described.

Abstract: The invention provides methods, uses and compositions for the treatment of psoriasis. The invention describes methods and uses for treating psoriasis, wherein a TNF? inhibitor, such as a human TNF? antibody, or antigen-binding portion thereof, is used to treat psoriasis in a subject. Also described are methods for determining the efficacy of a TNF? inhibitor for treatment psoriasis in a subject.

Abstract: Provided is a human antibody having a neutralization activity against a human influenza virus. More specifically, provided is a human antibody which recognizes a highly conserved region in a human influenza A virus subtype H3N2 or a human influenza B virus and has a neutralization activity against the virus. The human antibody is a human anti-human influenza virus antibody, which has a neutralization activity against a human influenza A virus subtype H3N2 and binds to a hemagglutinin HA1 region of the human influenza A virus subtype H3N2, or which has a neutralization activity against a human influenza B virus, and includes, as a base sequence of a DNA encoding a variable region of the antibody, a sequence set forth in any one of SEQ ID NOS: 5 to 12.

Abstract: The present invention encompasses type-I IFN and IFN?-induced PD marker expression profiles, kits, and methods for identifying such IFN?-induced PD marker expression profiles. The type-I IFN and IFN?-induced PD marker expression profiles may also be used in, for example, methods of treating patients having a type-I IFN or IFN?-mediated disorder, methods of monitoring disease progression of patients receiving treatment with a therapeutic agent that binds to and modulates IFN? activity, identifying patients as candidates to receive a therapeutic that binds to and neutralizes IFN? activity, and in diagnosing or providing a prognosis to patients having IFN?-induced disorders.

Abstract: The present invention concerns differential therapeutic treatment of cancer patients based on prognostic antigen/antibody profiles used for predicting (prognosticating) a clinical response (efficacy) and/or adverse event to an immunotherapy for treatment of a malignancy in a subject, and for treating or delaying the onset or relapse of a malignancy in a subject.

Abstract: The present invention provides fully human monoclonal antibodies that specifically bind to GPNMB, and uses thereof. Nucleotide sequences encoding, and amino acid sequences comprising, heavy and light chain immunoglobulin molecules, particularly sequences corresponding to contiguous heavy and light chain sequences spanning the framework regions and/or complementarity determining regions (CDRs) are provided. The present invention also provides immunoconjugates comprising anti-GPNMB antibodies and methods of using such immunoconjugates. The present invention further provides bi-specific antibodies comprising an anti-GPNMB antibody component and an anti-CD3 component, and methods of using such bispecific antibodies.

Abstract: The present invention relates to a pharmaceutical combination that comprises an IGF1R inhibitor and an mTOR inhibitor for the treatment of cancer in a subject; a pharmaceutical composition comprising such a combination; the use of such a combination for the preparation of medicament for the treatment of cancer; a kit comprising such a combination as a combined preparation for simultaneous, separate or sequential use; and a method of treating cancer in a subject, especially a human.

Abstract: Efficacy of a therapeutic to enhance antitumor immunity in a patient is predicted, where the therapeutic is one that targets an immunomodulatory leukocyte membrane protein (ILMP) to enhance immune activity. Peripheral blood sample from the patient is tested for levels of monocytes having specific cell surface markers (CD14+, HLA-DRlow) prior to treatment. Low levels of monocytes of this type (PBM14+HLA-DRlow) indicate a greater likelihood of therapeutic efficacy. In specific exemplary embodiments of the invention, the therapeutic is an antibody to CTLA4, such as ipilimumab or tremelimumab.

Abstract: The present application relates to the combined use of an antigen-binding protein that binds HB-EGF and an EGFR tyrosine kinase inhibitor in medical treatment.

Abstract: The invention relates to human targets of interest (TOI), anti-TOI ligands, kits compositions and method.

Abstract: The invention described herein relates to novel nucleic acid sequences and their encoded proteins, referred to as 158P1D7 and variants thereof, and to diagnostic and therapeutic methods and compositions useful in the management of various cancers that express 158P1D7 and variants thereof.

Abstract: The invention relates to biopolymer-gel based depot systems for prolonged and/or controlled release delivery of biologically active agents, methods for the manufacture of the biopolymer based gel-depots which include a biologically active agent, and uses of such biopolymer gel-depots in therapy. The biopolymer-gel based depot systems comprise a biocompatible polyaminosaccharide and/or protein; a biocompatible phosphate and/or sulphonamide compound; a biologically active agent; an aqueous insoluble alkaline earth metal phosphate; and a biocompatible glycan and/or proteoglycan.

Abstract: The invention provides a method of treating psoriasis in a subject by administering to a subject an antibody capable of binding to the p40 subunit of IL-12 and/or IL-23.