Abstract: Described herein are compositions and kits that comprise an engineered TL1A ligand that displays high stability, minimal binding to decoy receptor DcR3 while retaining functional activity via binding to its cell surface receptor, DR3, and the ability to activate T cells in vitro and in vivo. Methods of making an engineered TL1A ligand and methods of treating a disease or disorder in a subject by administering an engineered TL1A ligand are also provided.

Abstract: The present invention provides monoclonal antibodies that bind to the Activin A type I receptor (ACVR1) protein, and methods of use thereof. In various embodiments of the invention, the antibodies are fully human antibodies that bind to ACVR1. In some embodiments, the antibodies of the invention are useful for inhibiting ACVR1-mediated bone morphogenetic protein (BMP) signal transduction, thus providing a means of treating or preventing a disease, disorder or condition associated with ACVR1.

Abstract: The present invention provides novel biomaterial compositions and methods having a technology to improve retention of hyaluronic acid (HA). The biomaterial compositions utilize small HA binding peptides and extracellular matrix binding (ECM) peptides that are tethered to synthetic biocompatible polymers. When tethered to the polymers, the peptide region allows the polymers to bind to HA and to tissues such as cartilage. The novel biomaterial compositions can be used to coat or chemically modify cartilage or tissues with a biologically compatible polymer having HA binding peptides, which allow HA to bind to the surface of the cartilage or tissues. Methods of using same are also provided.

Abstract: The present invention relates to methods of treating subjects suffering from a pulmonary NTM infection refractory to treatment, for example to antibiotic treatment.

Abstract: Novel compositions that promote hair growth or hair restoration, and compositions that prevent hair loss. Compositions including an iNOS inhibitor as an active ingredient are provided. Advantageous affects for hair growth or hair restoration are obtained when a composition including an iNOS inhibitor as an active ingredient is administered to a mammal. For the iNOS inhibitor, a low-molecular compound, an antibody, or a nucleic acid drug such as an antisense oligonucleotide or siRNA may be used. A method of screening for effective substances for promotion of hair growth or hair restoration or prevention of hair loss is also provided.

Abstract: The present application provides methods and processes for making and using a fibronectin composition, as well as methods for treating ocular conditions and/or disorders with the cellular fibronectin composition described herein.

Abstract: Fusion proteins comprising an extracellular domain of PD1 (programmed cell death protein-1) protein and/or an extracellular domain of PD-L1 (programmed cell death-ligand 1 protein (CD274 or B7-H1)) protein. Portions of the extracellular domains are expressed in specific configurations and purified as protein and used in immunoassays to monitor the circulating levels of biotherapeutic antibodies to these proteins. Also described is a method of determining the amount of circulating levels of a biotherapeutic antibody in a biological sample obtained from a patient, wherein a patient has undergone at least one dose of immunotherapy.

Abstract: This invention discloses a bifunctional TGF-B/immune checkpoint fusion gene and protein with anti-inflammatory activity that represents a new class of therapy for Immune disorders, immune dysregulation, and autoimmune diseases. The bifunctional TGF-B/immune checkpoint fusion gene and protein include: (i) a TGF-B domain consists of TGF-B1 (ii) an immune checkpoint consisting of PD-L1, (iii) a flexible peptide linker that links two TGF-B domains resulting in a dimeric TGF-B construct wherein the dimeric form of the TGF-B ligand is important for its binding and functional activity, and (iv) a rigid peptide linker, wherein the dimeric TGF-B ligand is linked to the immune checkpoint ligand. A unique feature of this invention is the engineering of a dimeric TGF-B1 domain in the TGF-B1/PD-L1 fusion protein which was experimentally shown to be important in its binding to its TFGBR1 receptor and its functional activity.

Abstract: The invention provides methods and compositions for treating a subject having a renal-related disorder, such as chronic kidney disease (CKD), end stage renal failure, diabetes, insulin resistance, kidney hypertrophy, kidney hypotrophy, polycystic kidney disease, proteinuria, hyperglycemia, hyperuricemia, gout, kidney stones, hypertension or hypertensive nephropathy, dyslipidemia, anemia and/or reduced erythropoietin production, iron deficiency or hyperfiltration. The methods and compositions use or contain a composition that reduces or inhibits GDF15 activity.

Abstract: The present invention provides methods of making an in vivo animal model for detecting anti-poly(ethylene glycol) (PEG) antibodies. The methods of the disclosure comprises administering subcutaneously to an animal model a composition comprising antibodies against poly(ethylene glycol) chains with a molecular weight of at least 550 Da to maintain an anti-PEG antibody level within the animal model. The in vivo animal model can be used for testing and screening drugs and other compositions for adverse reactions, bioavailability, and immunogenicity prior to administration to a human subject.

Abstract: The present invention provides a method of promoting local bone growth by administering a therapeutic amount of a Sost antagonist to a mammalian patient in need thereof. Preferably, the Sost antagonist is an antibody or FAB fragment selectively recognizing any one of SEQ ID NOS: 1-23. The Sost antagonist may be coadministered together or sequentially with a matrix conducive to anchoring new bone growth. Orthopedic and Periodontal devices comprising an implantable portion adapted to be permanently implanted within a mammalian body and bearing an external coating of a Sost antagonist are also disclosed, as it a method of increasing bone density by administering to a mammalian patient a therapeutic amount of a Sost antagonist together with an antiresorptive drug.

Abstract: The present application provides methods and processes for making and using a fibronectin composition, as well as methods for treating ocular conditions and/or disorders with the cellular fibronectin composition described herein.

Abstract: Provided by the present invention are a fusion protein binding to a CD47 protein and an application thereof, wherein the fusion protein is capable of binding to a CD47 protein by using a KD value of 1×10?8M or lower. The fusion protein may specifically block the interaction between a CD47 protein and SIRP? without causing a blood coagulation reaction, and may further inhibit the growth and/or proliferation of tumors or tumor cells.

Abstract: The invention relates generally to activatable antibodies that include a masking moiety (MM), a cleavable moiety (CM), and an antibody (AB) that specifically binds to epidermal growth factor receptor (EGFR), and to methods of making and using these anti-EGFR activatable antibodies in a variety of therapeutic, diagnostic and prophylactic indications.

Abstract: The present invention relates to novel monoclonal anti-human-GDF-15 antibodies, pharmaceutical compositions, kits, methods and uses and the cell lines capable of producing the monoclonal antibodies described herein. The present invention further relates to novel antibodies to human GDF-15 capable of inhibiting cancer growth.

Abstract: Methods for treating cancer and/or reducing sternness of cancer stem cells in a subject using a CD14 antagonist, which may be an anti-CD14 antibody.

Abstract: The present invention provides binding proteins, such as antibodies and antigen-binding fragments, which specifically bind to human IL-36 cytokines, IL-36?, IL-36?, and/or IL-36?, and block the IL-36 stimulated signaling pathways. Compositions comprising such binding proteins and methods of making and using such binding proteins are also provided.

Abstract: The present invention provides a method of treating a subject in need thereof comprising classifying the subject into functional group FG1, FG2 or FG3, wherein i) when the subject is classified into the FG1 functional group, (A) the level of OPN or the activity of OPN in said subject is increased; (B) the subject is not treated with a brace; or (C) a combination of (A) and (B); and ii) when the subject is classified into the FG2 or FG3 functional group, (A) the level of OPN or the activity of OPN in said subject is decreased; (B) the subject is treated with a brace; or (C) a combination of (A) and (B).

Abstract: The present disclosure provides compositions and methods for repairing cartilage defects.

Abstract: In certain aspects, the disclosure provides compositions and methods for treating spinal muscular atrophy. For example, in some embodiments, the disclosure provides ALK4:ActRIIB antagonists that may be used to treat spinal muscular atrophy, particularly treating one or more complications of spinal muscular atrophy including, for example, increasing muscle mass muscle strength, and bone mineral density.