Abstract: The invention provides peptides and analogs of INGAP and HIP peptides. The peptides and analogs can be used in methods for treating various diseases and conditions. Such diseases and conditions can include impaired pancreatic function, treating a metabolic disease, for example, diabetes, both type 1 and type 2 diabetes, islets induction, expansion and proliferation for transplantation, promoting neuroprotection or nerve regeneration, promoting liver regeneration or inhibiting inflammation.

Abstract: The present invention relates to binding fusion protein compositions comprising targeting moieties linked to extended recombinant polypeptide (XTEN), binding fusion protein-drug conjugate compositions, and XTEN-drug conjugate compositions, isolated nucleic acids encoding the compositions and vectors and host cells containing the same, and methods of using such compositions in treatment of diseases, disorders, and conditions.

Abstract: The present disclosure is directed to an engineered phospholipid or lysophospholipid (e.g., sphingosine 1-phosphate (S1P)) chaperone derived from an Apolipoprotein M (ApoM)-Fc fusion protein having an extended half life in vivo. The disclosed ApoM-Fc fusion protein provides a safe, efficient and effective means of delivering S1P to endothelial cells and to all tissues of the body.

Abstract: The disclosure provides a fusion polypeptide specific for both CD137 and HER2/neu, which fusion polypeptide can be useful for directing CD137 clustering and activation to HER2/neu-positive tumor cells. Such fusion polypeptide can be used in many pharmaceutical applications, for example, as anti-cancer agents and/or immune modulators for the treatment or prevention of human diseases such as a variety of tumors. The present disclosure also concerns methods of making the fusion polypeptide described herein as well as compositions comprising such fusion polypeptide. The present disclosure further relates to nucleic acid molecules encoding such fusion polypeptide and to methods for generation of such fusion polypeptide and nucleic acid molecules. In addition, the application discloses therapeutic and/or diagnostic uses of such fusion polypeptide as well as compositions comprising one or more of such fusion polypeptides.

Abstract: A linker-drug represented by formula (I) or a pharmaceutically acceptable salt or solvate thereof is provided. In formula (I), C is a conjugator, L is a linker unit, D is a toxin unit, and n is an integer ranging from 1 to 4. The structure of the conjugator is represented by formula (II). In formula (II), X is a leaving group, each of R1 and R2 is independently a single bond or —NH—, and Z is substituted aryl, heteroaryl, linear alkyl, cycloalkyl, heterocycloalkyl, or a combination thereof. The antibody is conjugated to the linker unit through a cysteine residue of the antibody. An antibody-drug conjugate (ADC) employing the above linker-drug is also provided.

Abstract: The present disclosure relates to methods of treating, ameliorating or preventing a disorder comprising administering a therapeutically effective amount of a composition comprising a protein which inhibits the ligand of Uniprot # P05112 and/or the ligand of Uniprot # P35225 from binding to their respective receptors to a subject in need thereof. In some embodiments, the disorder is preferably associated with an increase of the Th2 immune response. In some embodiments, administration is preferably locally to the lung in order to treat, ameliorate or prevent allergic asthma, rhinitis, conjunctivitis, lung fibrosis, cystic fibrosis, chronic obstructive pulmonary disease, pulmonary alveolar proteinosis or adult respiratory distress syndrome.

Abstract: The present invention provides a method for diagnosing in a subject Acute Kidney Injury or a related or analogous disease state. The method comprises the steps of a) providing a sample taken from the subject: b) analysing the sample from the subject to determine the level of a biomarker selected from certain atomic species; and c) comparing the level of the biomarker in the sample to a reference level of the biomarker that is characteristic of a healthy subject, eg a subject having normal renal function. An elevated level of the biomarker in the sample relative to the reference level is indicative of Acute Kidney Injury or a related or analogous disease state. The invention also relates to the use of an atomic species selected from those in Table 1 as a biomarker for Acute Kidney Injury or a related or analogous disease state, and test kits comprising an analytical element sensitive to those biomarkers.

Abstract: Disclosed are short DNA aptamers that selectively recognize CD200R1, a protein expressed on the surface of myeloid and lymphoid cells that delivers immune inhibitory signals to modulate inflammation when engaged with its ligand, CD200. Also disclosed is the use of said aptamers as therapeutic agents, for the purpose of decreasing inflammatory response; treatment of spinal cord injury; treatment of an immune related disease such as arthritis, asthma, allergy, infection; as a course of treatment during or after transplantation; or for treatment of an autoimmune disorder such as systemic lupus erythematosus, Parkinson's Disease, or multiple sclerosis.

Abstract: The monoclonal IgG-type antibodies were suggested comprising variable domains represented by a combination of VHH-derivative with a variable domain of the light chain VL. Said antibodies can comprise amino acid substitutions at positions 44 and 45 (Kabat numbering) or combinations thereof. Antibodies of the invention possess increased affinity and improved aggregation stability.

Abstract: Disclosed herein are Htt repressors and methods and compositions for use of these Htt repressors.

Abstract: The present disclosure relates to methods and computational tools based, at least in part, on computer simulations that identify hot-spot amino acid residues and binding-region amino acid residues of a protein.

Abstract: Bi-specific fusion proteins with therapeutic uses are provided, as well as pharmaceutical compositions comprising such fusion proteins, and methods for using such fusion proteins to repair or regenerate damaged or diseased tissue. The bi-specific fusion proteins generally comprise: (a) a targeting polypeptide domain that binds to a target molecule; and (b) an activator domain that detectably modulates tissue regeneration.

Abstract: The present invention relates generally to stable formulations comprising CTLA4Ig molecules, including lyophilized, and liquid formulations for administration via various routes including, for example, routes such as intravenous (IV) and subcutaneous (SC) for treating immune system diseases and tolerance induction.

Abstract: This disclosure provides an isolated polypeptide comprising no more than 35 amino acids, wherein the amino acid sequence comprises, or alternatively consists essentially of, or alternatively consisting of XXXRYSYXXSYX (SEQ ID NO: 1) and equivalents thereof, wherein X is a basic amino acid and Y is a hydrophobic amino acid. Polynucleotides encoding the polypeptides and antibodies that bind to the polypeptides are also provided. Therapeutic and diagnostic uses are further provided.

Abstract: The present invention relates to new extended release pharmaceutical compositions and methods of use thereof for the treatment of disorders. In certain embodiments, disclosed herein is an extended-release pharmaceutical formulation comprising, in a solid dosage form for oral delivery of between about 100 mg and about 1 g total weight: between about 2 and about 18% of an active ingredient; between about 70% and about 96% of one or more diluents; between about 1% and about 10% of a water-soluble binder and between about 0.5 and about 2% of a surfactant.

Abstract: Compositions and methods for conferring lepidoptericidal activity to bacteria, plants, plant cells, tissues and seeds are provided. Compositions comprising a coding sequence for the Axmi222z toxin polypeptide are provided. The Axmi222z coding sequences can be used in DNA constructs or expression cassettes for transformation and expression in plants and bacteria. Compositions also comprise transformed bacteria, plants, plant cells, tissues, and seeds. In particular, isolated Axmi222z toxin nucleic acid molecules are provided. Additionally, amino acid sequences corresponding to the Axmi222z polynucleotides are encompassed, and antibodies specifically binding to those amino acid sequences. In particular, the present invention provides for isolated nucleic acid molecules comprising nucleotide sequences encoding the amino acid sequence shown in SEQ ID NO:24-26, or the nucleotide sequence set forth in SEQ ID NO:2, 7, 12, and 17, as well as variants and fragments thereof.

Abstract: The present invention relates to compositions and methods for treating autoimmune diseases by administering to a subject a CTLA4 molecule that block endogenous B7 molecules from binding their ligands.

Abstract: The present disclosure provides compositions and methods for treating diseases or conditions associated with an abnormal level or activity of biglycan; disorders associated with an unstable cytoplasmic membrane, for example, due to an unstable dystrophin associated protein complex (DAPC); disorders associated with abnormal synapses or neuromuscular junctions, including those resulting from an abnormal MuSK activation or acetylcholine receptor (AChR) aggregation. Examples of diseases include muscular dystrophies, such as Duchenne's Muscular Dystrophy, Becker's Muscular Dystrophy, neuromuscular disorders and neurological disorders.

Abstract: Compositions and methods for conferring insecticidal activity to host cells are provided. Compositions comprising a coding sequence for a delta-endotoxin polypeptide are provided. The coding sequences can be used in DNA constructs or expression cassettes for transformation and expression in host cells. Compositions also comprise transformed host cells. In particular, isolated delta-endotoxin nucleic acid molecules are provided. Additionally, amino acid sequences corresponding to the polynucleotides are encompassed, and antibodies specifically binding to those amino acid sequences. In particular, the present invention provides for isolated nucleic acid molecules comprising nucleotide sequences encoding the amino acid sequence shown in SEQ ID NO:4, 5, 6, 13, or 14, or the nucleotide sequence set forth in SEQ ID NO:1, 2, 3, 11, or 12, as well as variants and fragments thereof.

Abstract: The present invention provides a method for inducing chronic elevation of intraocular pressure in the eyes of an animal by introducing into the eyes a cross-linking hydrogel, an animal produced by this method, as well as a screening method useful for identifying compounds capable of modulating intraocular pressure as well as for identifying compounds capable of modulating retinal ganglion cell survival and/or regeneration.

Abstract: Methods of treating peripheral vascular disease comprising administering a protein solution site of a defect at least two proteins from the group IL-1ra, sTNF-RI, sTNF-RII, IGF-I, EGF, HGF, PDGF-AB, PDGF-BB, VEGF, TGF-?1, and sIL-1RII. The solution may also comprise white blood cells, platelets, concentrated bone marrow aspirate, and combinations thereof.

Abstract: Variants of cytotoxic T-lymphocyte antigen 4 (CTLA-4) with high affinity, potency and stability. Formulations of CTLA-4 variants at high concentration for subcutaneous or intravenous administration, e.g. at monthly or less frequent dosage intervals. Use of CTLA-4 variants for treating rheumatoid arthritis and other inflammatory disorders. Fusion of CTLA-4 with IgG Fc having improved stability and longer in vivo half-life.

Abstract: A bioadhesive formulation, comprising gelatin, alginate and a coupling agent, capable of forming a bioadhesive matrix, which is characterized by rapid curing, optimal viscosity, high bonding strength, flexibility, biocompatibility and biodegradability, is disclosed. Further disclosed is such a bioadhesive formulation which further comprises a bioactive agent, and a drug-eluting bioadhesive matrix formed therefrom, the bioadhesive matrix being capable of delivering the bioactive agent to a bodily site. Methods utilizing the bioadhesive formulations and matrices in various biological and medical procedures are also disclosed.

Abstract: The present invention is based on the seminal discovery that targeted immunomodulatory antibodies and fusion proteins can counter act or reverse immune tolerance of cancer cells. Cancer cells are able to escape elimination by chemotherapeutic agents or tumor-targeted antibodies via specific immunosuppressive mechanisms in the tumor microenvironment and such ability of cancer cells is recognized as immune tolerance. Such immunosuppressive mechanisms include immunosuppressive cytokines (for example, Transforming growth factor beta (TGF-?)) and regulatory T cells and/or immunosuppressive myeloid dendritic cells (DCs). By counteracting tumor-induced immune tolerance, the present invention provides effective compositions and methods for cancer treatment, optional in combination with another existing cancer treatment.

Abstract: The present disclosure relates to novel crystalline salt forms of lamivudine, methods for the preparation thereof, pharmaceutical compositions thereof, and their use in the treatment of viruses such as Human Immunodeficiency Virus (HIV) infection.

Abstract: The present disclosure relates to CTLA4 proteins and uses of such proteins, for example to treat diseases associated with the dysregulation of immune responses.

Abstract: The present disclosure relates to methods of treating, ameliorating or preventing a disorder comprising administering a therapeutically effective amount of a composition comprising a protein which inhibits IL-4 and/or IL-13 from binding to their respective receptors to a subject in need thereof. In some embodiments, the disorder is preferably associated with an increase of the Th2 immune response. In some embodiments, administration is preferably locally to the lung in order to treat, ameliorate or prevent allergic asthma, rhinitis, conjunctivitis, lung fibrosis, cystic fibrosis, chronic obstructive pulmonary disease, pulmonary alveolar proteinosis or adult respiratory distress syndrome.

Abstract: Compositions and methods for conferring pesticidal activity to bacteria, plants, plant cells, tissues and seeds are provided. Compositions comprising a coding sequence for a toxin polypeptide are provided. The coding sequences can be used in DNA constructs or expression cassettes for transformation and expression in plants and bacteria. Compositions also comprise transformed bacteria, plants, plant cells, tissues, and seeds. In particular, isolated toxin nucleic acid molecules are provided. Additionally, amino acid sequences corresponding to the polynucleotides are encompassed, and antibodies specifically binding to those amino acid sequences. In particular, the present invention provides for isolated nucleic acid molecules comprising nucleotide sequences encoding the amino acid sequence shown in SEQ ID NO:3-5, or the nucleotide sequence set forth in SEQ ID NO:2, as well as variants and fragments thereof.

Abstract: The invention relates to inhibitory anti-factor XII/FXIIa antibodies and methods of their use.

Abstract: The invention relates to a stable, pharmaceutically acceptable, aqueous formulation of TNF-binding protein, comprising a TNF-binding protein, a buffer and an isotonicity agent.

Abstract: Compositions and methods for altering cell activity and function by expressing a light-activated ion pump polypeptide in a cell and contacting the cell with light that activates the expressed light-activated ion pump polypeptide. In some aspects of the invention, a light-activated ion pump polypeptide is a modified haloarcula halorhodopsin polypeptide, for example, a modified Halo 57 polypeptide.

Abstract: The present invention provides regulatory polynucleotide molecules isolated from plant proline rich protein genes and linked to a viral enhancer molecule. The invention further discloses compositions, polynucleotide constructs, transformed host cells, transgenic plants and seeds containing the regulatory polynucleotide sequences, and methods for preparing and using the same.

Abstract: The present invention provides therapeutic agents and compositions comprising elastic peptides and therapeutic proteins. Such peptides exhibit a flexible, extended conformation. In some embodiments, the therapeutic protein is a GLP-1 receptor agonist (e.g., GLP-1, exendin), insulin, or Factor VII/VIIa, including functional analogs. The present invention further provides encoding polynucleotides, as well as methods of making and using the therapeutic agents. The therapeutic agents have improvements in relation to their use as therapeutics, including, inter alia, one or more of half-life, clearance and/or persistance in the body, solubility, and bioavailability.

Abstract: The present invention relates to human laminin ?2 chain LG3 domain and active peptides promoting cell adhesion, spreading, migration, and neurite outgrowth. More particularly, it was found that when nerve cells are incubated using human laminin ?2 chain LG3 domain and active peptides in the LG3 domain, cell adhesion, spreading, migration, and neurite outgrowth of nerve cells promote and the promotion of cell adhesion, spreading, migration, and neurite outgrowth of nerve cells are integrin-mediated and achieved by the activation of PKC? and FAK phosphorylation. Thus, the present invention can be very useful for researches on cell adhesion, spreading, migration, and neurite outgrowth activities of cells which are focused on nerve cells and mediated by various extracellular matrix proteins including laminin, manufacture of artificial nerve conduits, burns treatment, wounds treatment, and tissue regeneration.

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

Abstract: Biologically active crosslinked polypeptides with improved properties relative to their corresponding precursor polypeptides, having good cell penetration properties and reduced binding to human proteins; and methods of identifying and making such improved polypeptides.

Abstract: The present invention relates to compositions for delivering carbon monoxide (CO) to cells using heme proteins as carriers. In one embodiment, the present invention relates to the use of MalPEG surface modified hemoglobin to deliver CO to cells.

Abstract: Methods for the treatment of a disorder characterized by excessive proliferation and/or lipid content of sebocytes are disclosed. In one embodiment of the invention, the method comprises administering to a subject in need thereof a therapeutically effective amount of a pharmaceutical composition comprising a small molecule inhibitor targeted to galectin-12 or a nucleic acid-based inhibitor targeted to galectin-12 and a pharmaceutically acceptable carrier, wherein said inhibitor is a non-naturally occurring molecule and administration of said inhibitor produces a decrease in the proliferation and/or lipid content of the sebocytes. Methods for decreasing sebaceous gland size, inhibiting sebocyte proliferation, and/or inhibiting sebocyte lipid content are also disclosed.

Abstract: A method for preventing or treating cardiomyopathy due to energy failure in a subject in need thereof is provided. The method comprises administering to the subject a therapeutically effective amount of a vector which comprises a nucleic acid sequence encoding a gene that can reverse energy failure. An exemplary cardiomyopathy is that which is associated with Friedreich ataxia and an exemplary nucleic acid sequence comprises a nucleic acid that encodes frataxin (FXN).

Abstract: The present invention includes compositions and methods for enhancing Th1/Th17 cell responses and decreasing Th2 cell responses. In various embodiments the present invention describes activation of human dendritic cells and enhancement of antigen-specific T cell responses in a Dectin-1-expressing human dendritic cells comprising an anti-Dectin-1-specific antibody or fragment thereof fused with one or more antigens. TLR2 ligands may also be included to enhance the activation and for enhancement of T-cell responses. Further, the invention also includes methods based on the compositions described herein for the treatment of allergy, and asthma.

Abstract: Described are compositions and methods useful for modulating the immune system of a subject. Also included are diagnostic methods for monitoring an immunologic condition. In particular the invention relates to antagonists of interferon proteins and associated methods of use as well as methods to develop neutralizing antibodies against IFN antagonists to treat viral infections.

Abstract: Described are polypeptide dimers comprising two soluble gp130 molecules wherein each of said molecules is fused to an Fc domain of an IgG1 protein and wherein the hinge region of the Fc domain is modified resulting in advantageous properties of the dimer. In a particularly preferred embodiment, the hinge region comprises the amino acid sequence motif Ala234-Glu235-Gly236-Ala237. Moreover, a pharmaceutical composition containing said dimer and various medical uses are described.

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 provides AAV capsid proteins comprising modification of one or a combination of the surface-exposed lysine, serine, threonine and/or tyrosine residues in the VP3 region. Also provided are rAAV virions comprising the AAV capsid proteins of the present invention, as well as nucleic acid molecules and rAAV vectors encoding the AAV capsid proteins of the present invention. Advantageously, the rAAV vectors and virions of the present invention have improved efficiency in transduction of a variety of cells, tissues and organs of interest, when compared to wild-type rAAV vectors and virions.

Abstract: The invention relates to methods of preparing and purifying conjugates between Granulocyte Colony Stimulating Factor and PEG moieties. The conjugates are linked via an intact glycosyl linking group that is interposed between and covalently attached to the peptide and the modifying group. The conjugates are purified using various chromatography methods.

Abstract: The subject invention provides novel soluble PD-1 (sPD-1) proteins, nucleic acids, and fusion constructs thereof, for enhancing humoral and cell-mediated immunity of a subject. Also provided are therapeutic compositions comprising the sPD-1 proteins, nucleic acids, and fusion constructs of the subject invention. In a preferred embodiment, the therapeutic composition is formulated as a vaccine composition. Advantageously, the sPD-1 proteins, nucleic acids, and therapeutic compositions provide protective immunity against pathogenic infection including HIV infection. In addition, the subject invention can be used in the prevention and/or treatment of tumor or cancer.

Abstract: The invention provides methods and compositions for reducing, preventing or reversing cardio toxicity side effects associated with certain therapeutic agents. The invention also provides methods and compositions for treating heart dysfunction including heart failure, and for reversing the effects of myocardial infarction. The various aspects of the invention involve the use of ligand dimers, such as neuregulin dimers, that selectively induce the dimerization of certain EGF receptors in cardiac tissue.

Abstract: Formulations and methods for weight loss and body contouring are disclosed. An illustrative formulation comprises human chorionic gonadotrophin (hCG) and resveratrol. An illustrative method for weight loss and body contouring comprises administering hCG and resveratrol sublingually.

Abstract: The invention relates to the treatment of a hypersensitivity immune response caused by a non-profilin allergen of a profilin-containing plant material (e.g. grass or tree pollen) by bystander suppression with a plant profilin (e.g. Phl p 12, Bet v 2, or Ole e 2) or a variant thereof. Also the invention features a particular variant of Phl p 12 with two of its cysteine residues replaced with another amino acid to increase its pharmaceutical properties.

Abstract: The present invention relates to a method for assembling (monomeric or oligomeric) proteins and peptide structures to multimeric protein or peptide structures. The present invention also provides a method for preparing peptide based polymers by crosslinking such multimeric proteins or peptides obtainable according to the inventive method and their use as polymers, for amphiphilic applications, as protein based detergents, for forming artificial organelles, etc. Disclosed are furthermore novel protein or peptide structures, nucleic acids encoding same and cloning and expression vectors suitable for carrying out the inventive method for assembling multimeric proteins or peptides.