Abstract: The present invention relates to biomarkers associated with multiple sclerosis (MS), particular GLX molecules, and teven more particular GLX-related glycosaminoglycans (GAGs) and GLX-related proteoglycans (PGs).

Abstract: The invention relates to an agent having immunomodulatory properties for the prevention and/or treatment of autoimmune diseases, said agent comprising one or more C3-C8 carboxylic acids and their physiologically acceptable salts and/or C1-C8 alkyl esters, and their use as immunomodulatory agents for use in prevention and/or treatment of autoimmune related diseases and immune-mediated chronic inflammatory diseases, and dietary supplements with immunomodulating effect comprising one or more C3-C8 carboxylic acids and their physiologically acceptable salts and/or esters comprising C1-C8 alkyl alcohols.

Abstract: The disclosure provides a pharmaceutical composition containing an anti-IgE antibody that suppresses the production of allergen-specific IgE antibodies and methods of use thereof.

Abstract: Lyophilization methods for preparing protein formulations for long-term storage at room temperature or improved stability at refrigeration storage are provided. Specifically, the present application provides lyophilization methods to obtain a target percentage of residual moisture of a lyophilized product, such as 3-5% residual moisture. The secondary drying of the lyophilization can be conducted under controlling rate of desorption under a temperature which is similar to the shelf temperature of the primary drying. Alternatively, the lyophilization can be conducted without a distinguished secondary drying step.

Abstract: The invention encompasses formulations and methods for the production thereof that permit the delivery of concentrated protein solutions. The inventive methods can yield a lower viscosity liquid formulation or a higher concentration of therapeutic or nontherapeutic proteins in the liquid formulation, as compared to traditional protein solutions.

Abstract: The invention encompasses formulations and methods for the production thereof that permit the delivery of concentrated protein solutions. The inventive methods can yield a lower viscosity liquid formulation or a higher concentration of therapeutic or nontherapeutic proteins in the liquid formulation, as compared to traditional protein solutions.

Abstract: The invention relates to stable formulations of antibodies against human programmed death receptor PD-1, or antigen binding fragments thereof. In some embodiments the formulations of the invention comprise between 5-200 mg/mL anti-PD-1 antibody, or antigen binding fragment thereof. The invention further provides methods for treating various cancers with stable formulations of the invention. In some embodiments of the methods of the invention, the formulations are administered to a subject by intravenous or subcutaneous administration.

Abstract: Methods for treating a disorder associated with immunoglobulin E (IgE) in a subject with antibodies capable of binding to the C?mx domain of a membrane-bound IgE. The subject can be administered with at least two doses of the antibody, the two doses being at least three months apart.

Abstract: Uses of IL-13 antagonists for treating atopic dermatitis are provided. Also provided are methods of treating atopic dermatitis and methods of reducing the severity of atopic dermatitis by administering IL-13 antagonists.

Abstract: The invention is directed to the removal of serum gal-3 from circulation by plasmapheresis, comprising at least in part donor apheresis, using gal-3 binding agents in either a fixed bed, or in a form easily removed, such as by being complexed with magnetic particles. This method, on its own, brings a sharp reduction and relief from the inflammation and fibroses that can be induced by circulating gal-3. The process may be combined with the administration of gal-3 binding agents, such as modified citrus pectin, to further lower unbound gal-3 levels, to the point where gal-3 in the tissues may be addressed. This method may also be combined with removal of TNF receptors to provide an effective treatment for cancer.

Abstract: The invention is directed to the removal of serum gal-3 from circulation by plasmapheresis, comprising at least in part donor apheresis, using gal-3 binding agents in either a fixed bed, or in a form easily removed, such as by being complexed with magnetic particles. This method, on its own, brings a sharp reduction and relief from the inflammation and fibroses that can be induced by circulating gal-3. The process may be combined with the administration of gal-3 binding agents, such as modified citrus pectin, to further lower unbound gal-3 levels, to the point where gal-3 in the tissues may be addressed. This method may also be combined with removal of TNF receptors to provide an effective treatment for cancer.

Abstract: Embodiments of the disclosure concern methods and compositions for delivering therapeutic, diagnostic or interventional moieties, such as complex and simple entities such as biologies, including at least cells, for example. The methods employ targeted delivery by employing at least one ALCAM-binding moiety on the therapeutic, diagnostic or interventional moiety to be delivered. In specific cases, the ALCAM-binding moiety is present on or with the therapeutic moiety in multiple iterations. In certain embodiments, the ALCAM-binding moiety comprises at least one SRCR domain from CD6 and a stalk, such as from CD6, of the secretable or molecular form thereof.

Abstract: Disclosed herein are drug delivery molecules that comprise a ligand that targets a cell surface molecule; a membrane penetration domain; and a payload binding domain; and pharmaceutical compositions comprising the same. Also disclosed are methods of treating cancer, inhibiting the progression of cancer, preventing cancer metastasis, and delivering a therapeutic compound to the brain in a subject in need thereof, the methods comprising identifying a subject in need thereof; providing a composition comprising the drug delivery molecule as disclosed herein; and administering an effective amount of the composition to the subject.

Abstract: Provided are methods of treating myelodysplastic syndrome (MDS), oligoblastic acute myelogenous leukemia (O-AML), or chronic myelomonocytic leukemia (CMML) using 765IGF-MTX and other IGF-receptor-targeted agents, and formulations for delivering 765IGF-MTX and other IGF-receptor-targeted agents to patients. Also provided are pharmaceutical compositions for use in treating MDS, O-AML, and CMML.

Abstract: The present disclosure relates to a pharmaceutical composition, which comprises an IL-15 protein complex and a citrate buffer solution. In addition, the pharmaceutical composition may also comprise a sugar and a non-ionic surfactant. The pharmaceutical composition in the present disclosure demonstrates a high degree of stability even after being stored at 2-8° C. for several months.

Abstract: A method for producing an antibody-drug conjugate composition, comprising: (i) a step of reacting an antibody with a reducing agent in a buffer to reduce interchain disulfides, and (ii) a step of reacting drug linker intermediates with the antibody having thiol groups obtained in the step (i), wherein the reaction temperature in the step (i) is ?10° C. to 10° C., and the average number of bound drugs in the produced antibody-drug conjugate composition is 3.5 to 4.5, and the content of antibody-drug conjugates in which four drug linkers are bound to heavy-light interchain thiols, in the produced antibody-drug conjugate composition is 50% or more; and an antibody-drug conjugate composition, wherein the content of antibody-drug conjugates wherein the average number of bound drugs is 3.5 to 4.5, and the content of antibody-drug conjugates in which four drug linkers are bound to heavy-light interchain thiols, is 50% or more.

Abstract: The present invention comprises methods of using a humanized monoclonal antibody that binds to the human immunoglobulin heavy chain variable region germline gene VH1-69 to treat B-cell disorders.

Abstract: Methods for diagnosing and treating Alzheimer's disease are provided. In particular, methods of restoring blood-brain barrier integrity and/or promoting vascular reversion in a person suffering from Alzheimer's disease by administering an anti-angiogenic agent or an agent that is capable of restoring tight junction integrity. Methods of preventing or delaying the onset of Alzheimer's disease in a subject are also provided.

Abstract: The invention provides a novel chocolate mass which has a glycemic index of less than 29 (GI<29) and of which the content of added sugar comprises at least 10% galactose and in addition a content of iosmaltulose and/or tagatose. The chocolate mass additionally has a content of vitamin E in the form of a tocotrienol-tocopherol mixture from natural sources, wherein the content of tocotrienols in the chocolate mass is greater than the content of tocopherols.

Abstract: The present invention relates to antibodies and antigen binding fragments thereof which bind to the cytokine receptor IL-22R, particularly human IL-22R. The invention also relates to pharmaceutical compositions comprising said antibodies or antigen binding fragments thereof, and methods of treating psoriasis, psoriatic arthritis or atopic dermatitis.

Abstract: Compositions and methods are described for generating an improved effective immune response against an immunogen in humans. The enhanced immune response, is obtained by using an MVA vector as a prime and an adenovirus vector as a boost and is characterized by a high level of antibody response specific to the immunogen, and an enhanced cellular immune response. The compositions and methods can be used to provide a protective immunity against a disease, such as an infection of one or more subtypes of Ebola and Marburg filoviruses, in humans.

Abstract: Described herein are compositions and methods for the modulation of T-cell tolerance, which can be upregulated or down regulated by concurrent enhancement or inhibition of CEACAM1/TIM3 interactions. As described herein, the discovery that CEACAM1 is a direct ligand of TIM3 and vice versa has been shown in cis and in trans. In addition, as demonstrated herein, CEACAM1 and TIM3 are co-regulated during the course of T-cell activation.

Abstract: Certain embodiments of the disclosure relate to targeted binding agents that specifically bind to JAM-like protein and therein inhibit epithelial damage. Although it is not intended that embodiments of the disclosure be limited by any particular mechanism, it is believed that a possible mechanism by which this can be achieved may include, but are not limited to, either inhibition of binding of JAML to the CAR, inhibition of JAML induced CAR signaling, or increased clearance of JAML from the body of a subject, therein reducing the effective concentration of soluble JAML. In certain embodiment, the specific binding agent is a fully human antibody or chimera that specifically binds to human JAML, such as the JAML D1, and prevents JAML binding to CAR. Certain embodiments of the disclosure contemplate antibodies comprising human IgG type, e.g., IgG1, IgG2, IgG3, and IgG4.

Abstract: Natalizumab is a safe and efficacious treatment for inflammatory and autoimmune diseases, such as multiple sclerosis, Crohn's Disease, and rheumatoid arthritis. Chain swapping between natalizumab and IgG4 molecules acts to reduce the level of bivalent natalizumab present following administration of natalizumab, and thus to lower the activity of natalizumab in the patient. Differences in IgG4 levels across patients or within a single patient across time may change the pharmacokinetic profile of natalizumab. Patients with lower levels of IgG4 may experience higher nadir levels of natalizumab during a dosing period. Monitoring IgG4 and/or bivalent natalizumab levels, and determining a dose or dosage period based on the monitoring may improve the safety and/or efficacy of natalizumab therapy.

Abstract: The present disclosure relates to a method for inhibiting cancer tumor growth in a patient by administering to the patient a therapeutic monoclonal antibody specific for a tumor associated antigen in combination with at least one immunostimulatory compound, and at least one immune homeostatic checkpoint inhibitor. Also disclosed are uses, compositions and kits thereof.

Abstract: Provided herein are antibodies specific for TIM3 that can be used to detect cancer cells, in particular, cancer stem cells. The antibodies can also be used in therapeutic compositions for treating cancer and reducing inflammation.

Abstract: Upon administration of rAAV vectors the humoral immune response (neutralizing antibodies) is the first barrier that needs to be overcome. Surprisingly it was found that by using immunoadsorption for depletion of immunoglobulins from the blood (plasma), subjects can be highly efficiently treated with rAAV vectors, i.e. obtain highly efficient transduction after rAAV vector administration, in spite of the presence of high levels of nAb.

Abstract: The present invention provides antibodies and antigen-binding fragments of antibodies that bind to leptin receptor (LEPR), and methods of using the same. According to certain embodiments, the invention includes antibodies and antigen-binding fragments of antibodies that bind LEPR and activate LEPR signaling. In other embodiments, the invention includes antibodies and antigen-binding fragments of antibodies that bind to LEPR and enhance sensitization of LEPR to an antigen. In certain embodiments, the invention includes antibodies and antigen-binding fragments of antibodies that bind LEPR in the presence and absence of leptin. In certain embodiments, the invention includes antibodies and antigen-binding fragments of antibodies that induce signaling in cells expressing LEPR mutants that otherwise exhibit defective or impaired signaling in the presence of leptin.

Abstract: The present technology comprises methods for regulating an the immune system, and in particular methods for the regulation of a specific immune response, including the regulation of lymphocyte activity. Methods of the present technology comprise both the negative and positive modulation of CEACAM1 protein function.

Abstract: Disclosed herein are drug delivery molecules that comprise a ligand that targets a cell surface molecule; a membrane penetration domain; and a payload binding domain; and pharmaceutical compositions comprising the same. Also disclosed are methods of treating cancer, inhibiting the progression of cancer, preventing cancer metastasis, and delivering a therapeutic compound to the brain in a subject in need thereof, the methods comprising identifying a subject in need thereof; providing a composition comprising the drug delivery molecule as disclosed herein; and administering an effective amount of the composition to the subject.

Abstract: The present invention is related to a B-lymphocyte targeting agent for use in a method for the treatment or diagnosis of cardiac insufficiency. Furthermore, it is related to a composition comprising such B-lymphocyte targeting agent and methods for determining whether a patient suffering from cardiac insufficiency is amenable to the use of the B-lymphocyte targeting agent for its treatment.

Abstract: Processes and methods of purifying or separating Single Domain Antigen Binding (SDAB) molecules that include one or more single binding domains (e.g., one or more nanobody molecules), substantially devoid of a complementary antibody domain and an immunoglobulin constant region, using Protein A-based affinity chromatography, are disclosed.

Abstract: Provided herein are biparatopic antigen-binding constructs that specifically bind HER2. The biparatopic antigen-binding constructs comprise one antigen-binding moiety that binds to ECD2 of HER2, a second antigen-binding moiety that binds to ECD4 of HER2, and an Fc. At least one of the antigen-binding moieties is an scFv. The biparatopic antigen-binding constructs can be used in the treatment of cancer.

Abstract: A novel method to reduce B-cell lymphoma cell migration to and engraftment of the spleen in patients with JAM-C positive B-cell lymphomas is described. In certain aspects, a method for identifying and treating JAM-C positive B-cell lymphoma patients with anti-JAM-C antibodies is provided. Recombinant antibody molecules that specifically bind to JAM-C are also disclosed.

Abstract: Methods for suppressing IgE-mediated anaphylaxis are provided herein, which include administering to a person in need thereof a combination of at least two therapeutic agents selected from the group consisting of an antihistamine, one or more beta-adrenergic agonists, and one or more tyrosine kinase antagonists. Also provided herein are methods of suppressing IgE-mediated anaphylaxis associated with immunotherapeutic desensitization of a subject, and pharmaceutical compositions for suppressing IgE-mediated anaphylaxis.

Abstract: In one aspect, there is provided an antibody or a functional fragment thereof, wherein the antibody or functional fragment thereof is capable of binding specifically to high molecular weight melanoma associated antigen (HMW-MAA), and binding to an Fc? receptor.

Abstract: Methods for treating specific populations of cancer patients, specifically patients suffering from cancer who undergo stem cell transplantation and were classified as positive by a pre-transplant metabolic imaging, by administering to the subject a therapeutically effective amount of a pidilizumab monoclonal antibody.

Abstract: Provided herein are proteins, antibodies, assays and methods useful for modulating growth factor levels and/or activities. In some embodiments, such growth factors are members of the TGF-? superfamily of proteins.

Abstract: Disclosed is a humanized monoclonal antibody that binds to the human immunoglobulin heavy chain variable region germline gene VHI-69. The antibody is derived from Mab G6 and recognizes the same epitope. Moreover, the antibody is used in combination with vaccines to augment an immune response to the antigen.

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 a highly concentrated solution preparation of antagonistic anti-CD40 antibody, in which occurrence of turbidity or insoluble foreign matter attributed to antibodies is suppressed to a level equivalent to that of the conventional low-concentration lyophilized preparation.

Abstract: Antigen binding proteins that bind to human CGRP receptor (CGRP R) are provided. Nucleic acids encoding the antigen binding protein, vectors, and cells encoding the same are also provided. The antigen binding proteins can inhibit binding of CGRP R to CGRP, and are useful in a number of CGRP R related disorders, including the treatment and/or prevention of migraine headaches.

Abstract: The present invention is directed to methods of preventing central nervous system leukemia, treating T-cell acute lymphoblastic leukemia, and treating immune system disorders associated with CCR7-CCL19 mediated signaling. Suitable therapeutic agents for inhibiting CCR7-CCL19 signaling and methods of identifying additional therapeutic agents useful in the methods of the present invention are also disclosed.

Abstract: Provided herein are antibodies that bind to Repulsive Guidance Molecule a (RGMa) and methods of using the antibodies to treat and diagnose neurite degenerative diseases and disorders.

Abstract: Provided are methods of using curcuphenol compounds to increase expression of major histocompatibility complex class I (MHC-I) antigen in cells, particularly on the surface of diseased cells such as cancer cells, and thereby increase the immunogenicity of the cells. Also provided are pharmaceutical compositions that comprise curcuphenol compounds and methods of use thereof, for instance, to treat various cancers, alone or in combination with other therapies.

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

Abstract: The present invention is directed to methods for modulating the Th/Th2 cell balance toward anti-inflammatory cytokine producing cells in a subject comprising decreasing the amount, the expression, or the activity of leptin in a subject sufficient to modulate the Th1/Th2 cell balance toward anti-inflammatory cytokine producing cells. The invention is also directed to methods of treatment of an immune-related disorder in a subject comprising decreasing the amount, the expression, or the activity of leptin in the subject sufficient to treat the immune-related disorder.

Abstract: Agents, compositions, and medicaments that reduce interactions between muscle specific kinase receptor (MuSK) and pathogenic immunoglobulin G4 (IgG4) antibodies specific for the first Ig-like domain of MuSK and methods and uses thereof to reduce such interactions are encompassed herein. Also encompassed are screening assays to identify inhibitors of these pathogenic antibodies, particularly those that reduce binding to MuSK. Agents identified using the screening assays described herein are envisioned for use as therapeutics, alone or in compositions or in medicaments, to improve motor function in subjects afflicted MuSK-MG.

Abstract: The object of the present invention is analogues of peptides or parent proteins, these peptide analogues, comprising at least one aza-?3 aminoacyl residue, and also their uses in pharmaceutical compositions or for the diagnosis of pathologies wherein the aforesaid peptides or parent proteins are involved.

Abstract: The present inventors discovered that by forming a large immune complex comprising antigens containing two or more antigenic binding units (epitopes) and two or more antigen-binding molecules (for example, antibodies), elimination from the plasma of the antigens containing two or more antigenic binding units can be accelerated. Moreover, they found that by using this characteristic and by further using antigen-binding molecules having an ion-dependent antigen-binding activity, elimination of the antigens can further be accelerated and the above problem can be solved.