Abstract: The present application discloses high-concentration monoclonal antibody formulations suitable for subcutaneous administration, e.g. via a pre-filled syringe. In particular, it discloses a formulation comprising a spray dried monoclonal antibody at a concentration of about 200 mg/mL or more suspended in a non-aqueous suspension vehicle where the viscosity of the suspension vehicle is less than about 20 centipoise. Also disclosed are: a subcutaneous administration device with the formulation therein, a method of making the formulation, a method of making an article of manufacture comprising the suspension formulation, use of the formulation in the preparation of a medicament, and a method of treating a patient with the formulation.

Abstract: Described herein are human antibody agents and multi-specific binding agents that specifically bind human CD 19, in particular, native human CD 19. Also provided herein are methods of using the same or compositions thereof for the detection, prevention and/or therapeutic treatment of diseases characterized by CD 19 expression, in particular, B cell lymphomas and leukemias.

Abstract: The present invention relates to anti-PD-L1 antibodies, bispecific antibodies containing one domain with specificity to PD-L1, and to immunocytokines comprising an anti-PD-L1 antibody fused to a cytokine, such as IL-2. The present invention also provides methods of treatment, uses and pharmaceutical compositions comprising the antibodies, bispecific antibodies and immunocytokines.

Abstract: Methods for the production of immunogenic compositions containing a non-natural amino acid are disclosed. The non-natural amino acid can be a site for attachment of antigens, such as bacterial capsular polysaccharides, to make immunogenic conjugates. Bio-orthogonal attachment chemistry incorporated into the non-natural amino acids allows for more efficient and potent antigen presentation to the immune system, simplified purification, and more well-defined structure of these semi-synthetic immunogens.

Abstract: The invention relates to PD-1 binding agents that do not block the interaction of PD-1 with its ligands, and the use of such binding agents in the treatment, prevention and detection of disease.

Abstract: The present disclosure, among other things, provides low-viscosity, high concentration therapeutic protein agent formulations.

Abstract: The present invention relates to anti-interleukin-36 receptor (anti-IL-36R1) antibody formulations for administration to a subject.

Abstract: The present disclosure relates to composition and methodology for using the CD2 receptor to block viral replication, such as HIV-1 infection. In one embodiment, viral target cells such as blood CD4 T cells can be rendered resistant to HIV through stimulation of the CD2 receptor with either an antibody, a ligand, or a small molecule that binds to the CD2 receptor. Pre-stimulation of CD2 can be used to enhance the anti-HIV immunity and used to promote immune response from HIV infection or from an anti-HIV vaccine.

Abstract: Disclosed are compositions comprising an isolated chimeric interleukin 6 receptor alpha (IL-6R?) binding protein or cells expressing an isolated chimeric IL-6R? binding protein. The isolated IL-6R? chimeric binding protein and cells expressing the protein may be used in methods of treating cancer and reducing the risk of cytokine release syndrome.

Abstract: Disclosed is to a polypeptide including a mutated Fc region and having functional activity, mediated by the Fc region, that is modified compared with that of a parent polypeptide. The Fc region includes at least one combination of 2 mutations, the combination being selected from among one mutation selected from among a first set of mutations, and at least one mutation selected from among a second set of mutations, and provided that mutation (i) does not take place on the same amino acid as mutation (ii). Also disclosed are use of the polypeptide, compositions including the same, and methods for preparing the polypeptide.

Abstract: The present invention provides a stable liquid formulation of an antibody in phosphate-amino acid based dual buffer system. The antibody formulated in phosphate-amino acid based dual buffer system imparts optimum stability to the antibody, at lower as well as higher concentrations. Further, the antibody formulated in phosphate-amino acid based buffer system has low viscosity and is suitable for therapeutic administration of high concentrations of antibody.

Abstract: This disclosure provides novel broadly neutralizing anti-SARS-CoV-2 antibodies or antigen-binding fragments thereof. The disclosed anti-SARS-CoV-2 antibodies constitute a novel therapeutic strategy in protection from SARS-CoV-2 infections.

Abstract: There is disclosed herein a device for determining the smoking status of a subject, wherein said device comprises a plurality of different specific binding molecules deposited to a solid phase to detect specifically the presence of two or three tobacco smoke exposure biomarkers in a biological sample, said biomarkers consisting of: (i) cotinine and total 4-(methylnitrosamino)-1-(3-, pyridyl)-1-butanol (NNAL); (ii) cotinine and N-acetyl-S-[2-carboxyethyl]-L-cysteine (CEMA); or (iii) cotinine and NNAL and CEMA.

Abstract: The present disclosure relates to anti-CD38 antibodies and their use as therapeutics and diagnostics. The present disclosure further relates to methods of treating autoimmune diseases, such as systemic lupus erythematosus and rheumatoid arthritis. The present disclosure further relates to diagnostic assay methods for identifying patients having autoimmune diseases for treatment.

Abstract: The present invention provides transglutaminase-mediated antibody-drug conjugates with high anti-body-drug ratio (DAR) comprising 1) glutamine-containing tags, endogenous glutamines, and/or endogenous glutamines made reactive by antibody engineering or an engineered transglutaminase (e.g., with altered substrate specifity); and 2) amine donor agents comprising amine donor units, linkers, and agent moieties, wherein the DAR is at least about 5. The invention also provides methods of making and methods of using such higher drug loaded antibody-drug conjugates.

Abstract: The present invention concerns novel and improved antibody-conjugates for targeting CD30. The inventors found that when antibody-conjugates were prepared using a specific mode of conjugation, they exhibit an improved therapeutic index.

Abstract: The present disclosure relates to the treatment of multiple myeloma. Monoclonal antibody MOR202 is efficacious when administered to patient at certain dosage regimens.

Abstract: Provided are an anti-PD-L1/anti-PD-1 natural antibody structure-like heterodimeric bispecific antibody and a preparation thereof. In particular, provided are a highly stable heterodimeric anti-PD-L1/anti-PD-1 bispecific antibody with characteristics of a natural IgG and without mismatches heavy chain-light chain, and a preparation thereof. The bispecific antibody can bind to both target molecules and is more effective in treating a complex disease.

Abstract: This invention provides for a fusion protein between an IL2??? Selective Agonist protein (IL2 Selective Agonist) and a IgG Fc protein using a linker. The IL2 Selective Agonist moiety provides a therapeutic activity by selectively activating the IL2??? form of the receptor, thus selectively stimulating Tregs. The Fc moiety provides a prolonged circulating half-life compared to the circulating half-life of IL-2 or an IL2SA protein.

Abstract: Checkpoint regulator antagonists that bind specifically to TIGIT, PD-1 and/or PD-L1 are disclosed. Also disclosed are methods of making and using the checkpoint regulator inhibitors, including monospecific, bispecific and trispecific checkpoint regulator antagonists thereof.

Abstract: A pharmaceutical composition comprising a PD-1 inhibitor and a Hsp90 inhibitor, or a tautomer, or a pharmaceutically acceptable salt thereof, wherein the Hsp90 inhibitor is 3-(2,4-dihydroxy-5-isopropyl-phenyl)-4-(1-methyl-indol-5-yl)-5-hydroxy-[1,2,4] triazole or 5-hydroxy-4-(5-hydroxy-4-(1-methyl-1H-indol-5-yl)-4H-1,2,4-triazol-3-yl)-2-isopropylphenyl dihydrogen phosphate. Also provided is a method for treating cancer in a subject in need thereof, using the pharmaceutical composition described herein.

Abstract: The present invention relates to immunoglobulins that bind Fc?RIIb+ cells and coengage the antigen on the cell's surface and an Fc?RIIb on the cell's surface, methods for their generation, and methods for using the immunoglobulins.

Abstract: Isolated antibodies that bind to human CD38 and cynomolgus CD38 are disclosed. Also disclosed are pharmaceutical compositions comprising the disclosed antibodies, and therapeutic and diagnostic methods for using the disclosed antibodies.

Abstract: The present invention provides bispecific antibody constructs of a specific Fc modality characterized by comprising a first domain binding to a target cell surface antigen, 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 a composition including a combination of at least one short peptide and at least one peptide dimer, in defined ratio, to which autoantibodies found in elevated levels in schizophrenic patients bind.

Abstract: The invention relates to an isolated immunoglobulin heavy chain polypeptide and an isolated immunoglobulin light chain polypeptide that bind to a protein encoded by the T Cell Immunoglobulin and Mucin Protein-3 (TIM-3). The invention provides a TIM-3-binding agent that comprises the aforementioned immunoglobulin heavy chain polypeptide and immunoglobulin light chain polypeptide. The invention also provides related vectors, compositions, and methods of using the TIM-3-binding agent to treat a disorder or disease that is responsive to TIM-3 inhibition, such as cancer, an infectious disease, or an autoimmune disease.

Abstract: Isolated peptides that include one or more antigenic sites of Zika virus (ZIKV) and methods of their use and production are disclosed. The peptides can be used, for example, to detect exposure of a subject to a flavivirus infection, such as a ZIKV infection.

Abstract: The present disclosure relates to a novel recombinant BAF57 fusion protein and the use thereof as a composition capable of effectively preventing or treating inflammatory disease, immune-related disease or cancer. The fusion protein provided in the present disclosure may be delivered into cells, bind to BAF155 or other BAF complex subunit, and act as a competitive inhibitor of BAF57 present in the cell, thereby lowering the expression level of BAF57 by a protein degradation mechanism, thereby effectively preventing, ameliorating or treating various diseases such as inflammatory disease, immune-related disease or cancer.

Abstract: The present invention provides an antibody that can bind to targets with greater affinity. A flexible antibody-like molecule having a nonpeptide hinge part comprising: a group having a nonpeptide hinge part represented by a general formula (I): XY-Asp-Lys-Thr-His-Thr (SEQ ID No. 1)—wherein X represents an amino acid or a peptide composed of 2 to 50 amino acid residues, and Y represents for a group having an alkyleneoxide; and an antibody Fc fragment bound to the group having a nonpeptide hinge part.

Abstract: A process for the preparation of pharmaceutically acceptable immunoglobulin compositions from plasma-derived immunoglobulin fractions which allows the parallel preparation of immunoglobulin compositions enriched in IgG, IgM and IgA. In this process, immunoglobulin contained in Cohn fraction I/II/III or Kistler Nitschmann fraction A+I is resolubilized at conductivities of at least 1 mS/cm, and following removal of contaminating protein the resolubilized immunoglobulin is subjected to anion exchange chromatography to obtain IgG- and IgM/IgA-enriched immunoglobulin compositions. The IgG-enriched immunoglobulin composition is further subjected to treatment with a cation exchange material to obtain an immunoglobulin composition having a reduced properdin content.

Abstract: An immunogenic polypeptide selected from an isolated Clostridium perfringens pilus polypeptide, a variant of the pilus polypeptide; a fragment of the pilus polypeptide; and a fragment of the variant, is useful for the preparation of a vaccine for the treatment or prevention of enteric necrosis in poultry. The isolated Clostridium perfringens pilus polypeptide includes an assembled pilus or the pilus subunits CnaA, FimA and/or FimB.

Abstract: The present invention provides improved methods of protein purification using CEX chromatography. Such methods generally comprise the steps of: contacting a protein of interest (e.g., an antibody) with a cation exchange resin at a first pH, that is less than the pI of the most acidic isoform of the protein of interest, such that the protein of interest binds to the resin; washing the cation exchange resin at a second pH that is greater than the first pH, but less than the pI of the most acidic isoform of the protein of interest; and eluting the protein of interest from the resin at a third pH that is about equal to or less than the first pH. The methods of the invention are particularly useful for the commercial purification of recombinant therapeutic proteins (e.g., antibodies).

Abstract: The present application provides constructs comprising an antibody moiety that specifically binds to a complex comprising a histone H3 peptide and an MHC class I protein. Also provided are methods of making and using these constructs.

Abstract: In certain aspects, the present invention provides compositions and methods for modulating (promoting or inhibiting) growth of red blood cells or a tissue, such as bone, cartilage, muscle, fat, and/or neuronal tissue. The present invention also provides methods of screening compounds that modulate activity of an ActRIIB protein and/or an ActRIIB ligand. The compositions and methods provided herein are useful in treating diseases associated with abnormal activity of an ActRIIB protein and/or an ActRIIB ligand.

Abstract: Antibodies that modulate insulin receptor signaling are provided.

Abstract: Provided is a composition including a combination of at least one short peptide and at least one peptide dimer, in defined ratio, to which autoantibodies found in elevated levels in schizophrenic patients bind.

Abstract: The present invention relates to an anti-CD66c antibody and its use for treating cancer, and more particularly, it is possible to induce T-cell activation or humoral immune response using an antibody specifically recognizing CD66c. A nucleic acid molecule encoding the antibody or antigen-binding fragment thereof, a vector comprising the nucleic acid molecule, a host cell and the antibody or antigen-binding fragment thereof is used for alleviation, prevention, treatment or diagnosis of CD66c-related disease.

Abstract: The present disclosure relates to compositions of insulin-Fc fusion proteins and their use to treat diabetes.

Abstract: The invention provides for the removal of a large fraction of contaminants from protein preparations while maintaining a high level of recovery using tentacle anion exchange matrix chromatography medium. Using the methods of the invention, leached affinity chromatography contaminants can be removed from recombinant protein preparations.

Abstract: The present invention provides molecules, such as ISVDs and Nanobodies, that bind to PD1 and LAG3 and, optionally to human serum albumin. These molecules have been engineered so as to reduce the incidence of binding by pre-existing antibodies in the bodies of a subject administered such a molecule. Methods for increasing immune response, treating cancer and/or treating an infectious disease with such molecules are provided.

Abstract: The present invention provides molecules, such as ISVDs and Nanobodies, that bind to PD1 and LAG3 and, optionally to human serum albumin. These molecules have been engineered so as to reduce the incidence of binding by pre-existing antibodies in the bodies of a subject administered such a molecule. Methods for increasing immune response, treating cancer and/or treating an infectious disease with such molecules are provided.

Abstract: Embodiments of the invention include systems and methods for capturing crowd wisdom to be tested for individualized treatment plans. These systems and methods include data mining crowd sourced health related information and unstructured medical narratives and storytelling to identify treatment plans and general techniques that individuals with chronic diseases/symptoms, including but not limited to IBD and other immune invisible neglected and stigmatized diseases, use to improve their general health and wellbeing. A system for testing the treatments effectiveness in a population and then in an individual is also disclosed.

Abstract: The present invention relates to the biomedicine field, in particular to an anti-human PD-L1 humanized monoclonal antibody and its applications. The invention obtains an anti-human PD-L1 humanized monoclonal antibody with good specificity, high affinity and stability by screening, and the antibody can specifically bind to human PD-L1 instead of binding to members of B7 family, and it can bind to active T-cells to strengthen the activation of T-cells, so it can significantly inhibit the growth of tumor.

Abstract: The present invention relates to bispecific antibodies that specific bind to BCMA (B-Cell Maturation Antigen) and CD3 (Cluster of Differentiation 3). Method of making the bispecific antibodies and method of using the bispecific antibodies for the treatment of multiple myeloma are also provided.

Abstract: The present disclosure is generally directed to compositions that include antibodies, e.g., monoclonal, chimeric, humanized antibodies, antibody fragments, etc., that specifically bind one or more epitopes within a CD33 protein, e.g., human CD33 or a mammalian CD33, and use of such compositions in preventing, reducing risk, or treating an individual in need thereof.

Abstract: In certain embodiments, this present invention provides antibodies and Fc fusion proteins with enhanced pharmacokinetics, such as biotinylated antibodies or biotinylated Fc fusion polypeptides.

Abstract: It is intended to provide a method for efficiently and stably producing a heteromultimer by incubating, under a reducing condition, homo variants of plural types of polypeptides in which the alteration of amino acids that form the interface between Fc regions and/or the alteration to destabilize the stability of a heavy chain CH3 region has been introduced in the heavy chain CH3 regions so at to achieve the promotion of the dissociation of the Fc regions and/or the control of the association thereof through the use of charge repulsion.

Abstract: The present invention relates to methods and compositions for modulating T cells. The modulation includes suppressing or inducing regulatory T cells or cytotoxic T cells.

Abstract: Death receptor 5 (DR5) agonist compositions and methods for treating pancreatitis have been developed. The compositions include Tumor Necrosis Factor-related apoptosis-inducing ligand (TRAIL), its analogues, and anti-DR5 agonistic antibodies. In certain embodiments, TRAIL analogs and anti-death receptor 5 agonistic antibodies have analgesic and disease modifying effects on the pancreas.

Abstract: The present invention relates to a novel epitope that converts T cell to type 1 helper T (TH1) cell. Specifically, the present invention relates to an epitope constituting the 56th to 65th amino acids (SEQ ID No. 2) of extracellular domain (ECD) of activation-inducible tumor necrosis factor receptor (AITR), an antibody recognizing the epitope, a polynucleotide encoding the epitope, a polynucleotide encoding the antibody, an expression vector comprising the polynucleotide encoding the epitope or antibody, a transformant introduced with the vector, a composition comprising the antibody for converting T cell to TH1 cell and a method for converting T cell to TH1 cell, a pharmaceutical composition comprising the antibody for preventing or treating cancer, a method for treating cancer using the antibody, a composition comprising the antibody for enhancing immunity, and a method for enhancing immunity using the antibody.