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

Abstract: In one aspect the present invention is directed to mutant Neutrophil gelatinase-associated lipocalin (NGAL) proteins that have the ability to bind to siderophores, such as enterochelin, and to chelate and transport iron, and that are excreted in the urine. Such NGAL mutants, and complexes thereof with siderophores, can be used to clear excess iron from the body, for example in the treatment of iron overload. The NGAL mutants of the invention also have antibacterial activity and can be used in the treatment of bacterial infections, such as those of the urinary tract.

Abstract: The disclosure relates to therapeutic proteins and pharmaceutical compositions comprising said proteins, which have utility in treating various human diseases. In particular aspects, the disclosed therapeutic proteins are useful for treating human gastrointestinal inflammatory diseases and gastrointestinal conditions associated with decreased epithelial cell barrier function or integrity. Further, the disclosed therapeutic proteins are useful for treating human inflammatory bowel disease, including inter alia, Crohn's disease and ulcerative colitis.

Abstract: The present invention provides a method for treating or delaying the onset of an autoimmune condition in a human subject. An effective oral dose of ustekinumab is administered to the subject. Oral administration of ustekinumab also is useful in a method of decreasing innate inflammatory cytokines, such as Interleukin-1? and Tumor Necrosis Factor-?, Th1-like cytokines Interleukin-2 and Interferon-?, Interleukin-17 (Teff), Interleukin-12p70, and increasing Th2-like counter-regulatory cytokine Interleukin-13 in a subject.

Abstract: The present disclosure is directed to methods and kits for using serum biomarkers, including C-X-C Motif Chemokine Ligand 10 (CXCL10), C-X-C Motif Chemokine Ligand 13 (CXCL13), and/or soluble CD27 (sCD27), in predicting and evaluating therapeutic response to Tumor Necrosis Factor (TNF) inhibitor therapy in a patient in need thereof.

Abstract: Recombinant interleukin-11 (rhIL-11) is expressed in yeast, then isolated from aerobic fermentation media by precipitation, solubilization of the precipitate in the presence of a denaturant, and renaturation of the solubilized protein. Renatured rhIL-11 is further purified by cation exchange and hydrophobic interaction chromatography to provide a highly purified rhIL-11 with high biological activity and low rhIL-11 dimer and oxidized rhIL-11 content.

Abstract: The present invention relates to means and methods suitable for risk prediction of chronic kidney disease (CKD) using Pro-Enkephalin or fragments thereof as biomarker. The risk prediction methods of the invention are intended for healthy subjects and for subjects suffering from diseases such as hypertension, cardiovascular diseases and events, diabetes, metabolic syndrome, obesity, or autoimmune diseases. Subject matter of the invention is also a method of predicting the worsening or improvement of kidney function or dysfunction in healthy and diseased individuals.

Abstract: The present invention involves the identification of biomarkers that are predictive of impeding systemic lupus erythematosus (SLE) disease flare. Methods for treating patients so identified are also provided.

Abstract: Methods for selecting and treating patients with active Systemic Lupus Erythematosus (SLE) that are predicted to have an increased likelihood of having a positive response to a treatment with a safe and effective amount of an anti-IL-12/IL-23p40 antibody or an anti-IL-23 antibody, e.g., informs on what patients to treat with the anti-IL-12/IL-23p40 antibody ustekinumab.

Abstract: The invention discloses a fusion protein, a preparation method thereof and application thereof in preparing ophthalmic disease treatment, anti-inflammation and anti-tumor medicament, and belongs to the field of biopharmaceutical technology. The present invention uses a flexible (F) or rigid (R) linker to fuse two polypeptides to respectively obtain two bifunctional fusion proteins, namely two multi-functional fusion protein macromolecules obtained by linking antiangiogenesis polypeptides HM-3, interleukin 4 and immunoglobulin Fc fragments via an amino acid linker, which can improve drug efficacy, prolong half-life and enhance stability, has the characteristics of strong effect, low toxicity and the like, and can be used for the prevention and treatment of solid tumors and various types of inflammations and neovascular ophthalmic diseases. The fusion protein is expressed in a eukaryotic cell by a genetic engineering method and purified by affinity chromatography or the like.

Abstract: Provided is a cytokine combination for treating a tumor and/or preventing recurrence or metastasis of the tumor. The cytokine combination comprising at least three cytokines selected from the following groups: IL(interleukin)12 or a functional variant thereof, GMCSF (granulocyte-macrophage colony-stimulating factor) or a functional variant thereof, FLT3L (FMS-like tyrosine kinase 3 ligand) or a functional variant thereof, IL2 or a functional variant thereof, IL15 or a functional variant thereof, IL21 or a functional variant thereof, and IL7 or a functional variant thereof. Also provided is a nucleic acid molecule encoding the cytokine combination and a vector thereof, a cell, a pharmaceutical composition, and a application thereof for the manufacture of a drug for treating the tumor and/or preventing recurrence or metastasis of the tumor.

Abstract: A polypeptide comprising the sequence of SEQ. ID NO. 2, 3, 4, 7 or 8. The polypeptide may have the sequence of an immunogenic fragment thereof comprising at least eight amino acids, wherein the immunogenic fragment is not one of SEQ. ID NOS. 6 or 11 to 16. The polypeptide may have a sequence having at least 80% sequence identity to the aforementioned polypeptide or immunogenic fragment. The polypeptide is less than 100 amino acids in length and does not comprise the sequence of any of SEQ. ID NOS. 10, 46, 56, 57 or 59 to 62 and does not consist of the sequence of SEQ ID NO. 58. The polypeptide is useful in the treatment or prophylaxis of cancer.

Abstract: The disclosure provides interleukin 37 (IL-37) fusion proteins, methods of making IL-37 fusion proteins including constructs used to express IL-37 fusion proteins, and methods of using IL-37 fusion proteins. In some embodiments, the IL-37 fusion protein includes amino acids 46-206 of isoform B of IL-37 and a heavy chain portion of an antibody.

Abstract: The present invention provides a bi-functional fusion protein, (AT)a-Fc-(VT)b, simultaneously targeting vascular endothelial growth factor (VEGF) and angiopoietins (ANGs), wherein AT is an ANG binding motif; and VT is a VEGF binding motif, Fragment crystallizable region (Fc) is an N-terminal of Immunoglobulin G (IgG); each of a and b is an integer from 1 to 10. The bi-functional fusion proteins contain two or more domains of human proteins and are of all human sequences, and thus are expected to be non-immunogenic, and potentially can be used therapeutically in human targeting angiogenesis-associated diseases.

Abstract: Fusion compounds and methods of using same are provided which bind and neutralize human receptor activator of nuclear factor kappa-B ligand and are agonistic to parathyroid hormone receptor 1 signaling, said compounds are useful as agents for bone healing or treating conditions associated with bone mass loss or degeneration including treating osteoporosis.

Abstract: The present invention provides an antibody that specifically binds to proprotein convertase subtilisin/kexin type 9 (PCSK9), an antigen-binding fragment of the antibody, and a composition comprising the antibody or the fragment. Also provided are a nucleic acid that encodes the antibody or the fragment, a host cell containing the nucleic acid, and applications of the antibody and fragment in treatment and diagnosis.

Abstract: The present invention relates to polymeric nanoparticles comprising a cytokine or a nucleic acid encoding for a cytokine, pharmaceutical compositions comprising the same, and methods for treating certain diseases comprising administering these polymeric nanoparticles to a subject in need thereof.

Abstract: Specific binding members, particularly antibodies and fragments thereof, which bind to transforming growth factor beta 3 (TGF-?3) are provided, particularly recognizing human and mouse TGF-?3, particularly antibodies and fragments that do not recognize or bind TGF-?1 or TGF-?2. Particular antibodies are provided which specifically recognize and neutralize TGF-?3. These antibodies are useful in the diagnosis and treatment of conditions associated with activated or elevated TGF-?3, including cancer, and for modulating immune cells and immune response, including immune response to cancer or cancer antigens. The anti-TGF-?3 antibodies, variable regions or CDR domain sequences thereof, and fragments thereof may also be used in therapy in combination with chemotherapeutics, immune modulators, or anti-cancer agents and/or with other antibodies or fragments thereof.

Abstract: The present invention provides antibodies, or antigen-binding fragment thereof, which specifically bind to tumor necrosis factor (TNF)-like ligand 1A(TL1A) The invention further provides a method of obtaining such antibodies and nucleic acids encoding the same. The invention further relates to compositions and therapeutic methods for use of these antibodies for the treatment and/or prevention of TL1A mediated diseases, disorders or conditions.

Abstract: The present application provides constructs comprising a single-domain antibody (sdAb) moiety that specifically recognizes cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Also provided are methods of making and using these constructs.