Abstract: Organs-on-chips are microfluidic devices for culturing living cells in micrometer sized chambers in order to model physiological functions of tissues and organs. Engineered patterning and continuous fluid flow in these devices has allowed culturing of intestinal cells bearing physiologically relevant features and sustained exposure to bacteria while maintaining cellular viability, thereby allowing study of inflammatory bowl diseases. However, existing intestinal cells do not possess all physiologically relevant subtypes, do not possess the repertoire of genetic variations, or allow for study of other important cellular actors such as immune cells. Use of iPSC-derived epithelium, including IBD patient-specific cells, allows for superior disease modeling by capturing the multi-faceted nature of the disease.

Abstract: The present invention relates to anti-HBsAg antibodies, antibody fragments, and their uses for the prevention and treatment of hepatitis B virus infection and associated diseases.

Abstract: The disclosure provides a method for treating a subject afflicted with a tumor derived from a small cell lung cancer (SCLC) having a high tumor mutational burden (TMB) status comprising administering to the subject a monotherapy comprising an anti-PD-1 antibody or a combination therapy comprising an anti-PD-1 antibody and an anti-CTLA-4 antibody. The present disclosure also provides a method for identifying a subject suitable for treatment with an anti-PD-1 antibody or a combination therapy comprising an anti-PD-1 antibody and an anti-CTLA-4 antibody comprising measuring a TMB status of a biological sample of the subject. A high TMB status identifies the patient as suitable for treatment with an anti-PD-1 antibody or antigen-binding portion thereof. The TMB status can be determined by sequencing nucleic acids in the tumor and identifying a genomic alteration, e.g., a somatic nonsynonymous mutation, in the sequenced nucleic acids.

Abstract: The present disclosure relates to pharmaceutical compositions and methods for treating a disease or condition associated with opening of Cx43 hemichannels in astrocytes or osteocytes, preferably for treating an inflammatory disease or condition or a neurodegenerative disease such as spinal cord injury.

Abstract: Methods are provided for identifying biomarker proteins that exhibit differential expression in subjects with a first lung condition versus healthy subjects or subjects with a second lung condition. Also provided are compositions comprising these biomarker proteins and methods of using these biomarker proteins or panels thereof to diagnose, classify, and monitor various lung conditions. The methods and compositions provided herein may be used to diagnose or classify a subject as having lung cancer or a non-cancerous condition, and to distinguish between different types of cancer (e.g., malignant versus benign, SCLC versus NSCLC).

Abstract: The disclosure provides antibody molecules that bind to TCR V? regions and multispecific molecules comprising said antibody molecules. Additionally, disclosed are nucleic acids encoding the same, methods of producing the aforesaid molecules, pharmaceutical compositions comprising aforesaid molecules, and methods of treating a cancer using the aforesaid molecules.

Abstract: A process for analysing chromosome regions and interactions relating to immunoresponsiveness.

Abstract: Described herein are methods for treating nephrotic syndrome using an anti-CD20 antibody. In one embodiment, that anti-CD20 antibody is Obinutuzumab.

Abstract: Provided herein are methods of treating B7-H1-expressing tumors comprising administering an effective amount of MEDI4736 or an antigen-binding fragment thereof.

Abstract: Methods and kits for identifying an increased risk of developing preeclampsia in a pregnant woman based on expression pattern of non-coding RNAs in body fluids are provided. In particular, the methods provide information for identifying a pregnant woman as being at risk of developing preeclampsia by analyzing the pattern of non-coding RNAs in body fluids during early stages of pregnancy.

Abstract: A method for reducing the viscosity of a pharmaceutical formulation is provided that utilizes a viscosity-reducing concentration of an excipient selected from the group consisting of the n-acetyl arginine, n-acetyl lysine, n-acetyl proline and mixtures thereof in combination with a therapeutiv protein. A stable pharmaceutical formulation is also provided.

Abstract: Provided herein are methods of treating diseases associated with vascular calcification and/or cardiovascular disease in a subject by using the level of a biomarker, in particular, snail homolog 1 (Snai1), phosphosmad2, phosphosmad3, urinary protein, dickkopf homolog 1 (Dkk1), collagen type 1 alpha 1 (Col1a1), activin (e.g., free activin), runt-related transcription factor 2 (Runx2), alkaline phosphatase (Alp), bone-specific alkaline phosphatase (BSAP), C-terminal type 1 collagen telopeptide (CTX), osterix, Klotho, alpha-smooth muscle actin (alpha-SMA), myocardin (MYOCD), activin receptor type 2A (ActRIIA), axis inhibition protein 2 (Axin2), and/or smooth muscle protein 22-alpha (Sm22-alpha), as an indicator(s) of responsiveness of the subject to the treatment, efficacy of the treatment, or appropriate dosage for the treatment with an activin type II receptor signaling inhibitor.

Abstract: A method of creating skin tissue is described, particularly, an in vitro or ex vivo method for creating skin tissue. The invention extends to the use of agents that disrupt the LINC complex in a skin cell to create the skin tissue, and to using the created tissue in an assay to identify or screen anti-ageing compounds. The invention further extends to model skin tissues per se, uses thereof and to kits for creating such model skin tissues.

Abstract: GDF15 polypeptides, constructs comprising GDF15, and mutants thereof are provided. In various embodiments the GDF15 polypeptides, constructs comprising GDF15, and mutants thereof, can be of use in the treatment or ameliorating a metabolic disorder. In various embodiments the metabolic disease or disorder is type 2 diabetes, obesity, dyslipidemia, elevated glucose levels, elevated insulin levels and diabetic nephropathy.

Abstract: Antibodies that include an antigen binding region that binds to CD137 are provided herein. Also provided herein are bispecific antibodies that include a first antigen binding region that binds to CD137 and a second antigen binding region that binds to an immune checkpoint molecule, an immune stimulatory molecule, or a tumor antigen. Pharmaceutical compositions that include the antibodies and methods of treating cancer are provided.

Abstract: The present invention relates to compositions and methods associated with antibody-bacterial effector translocase protein conjugates. Some aspects of the present invention relate to preventing or treating diseases using the antibody-protective antigen conjugates. Further aspects of the present invention relate to methods of chemically conjugating and synthesizing the antibody-bacterial effector translocase protein conjugates.

Abstract: Provided are various embodiments relating to feline erythropoietin (EPO) polypeptide analogs with one or more additional glycosylation sites and methods of producing and using the same to treat anemia in companion animals. Also provided are various embodiments relating to EPO polypeptides having a mutation in the second binding site, polypeptides comprising an extracellular domain of EPO receptor, and methods of using the same for treating polycythemia in mammals.

Abstract: Methods and systems are disclosed for encoding and decoding data from genetic traits. In one embodiment, the invention provides a method of encoding data from genetic traits. The method comprises encoding genetic traits information, including using quantum dot wavelengths to identify distinct genetic traits, and using numbers of the quantum dots to represent probabilities associated with the traits. In an embodiment, the invention provides a genetic characteristics decoding system for decoding genetic information encoded using quantum dots in a carrier. The decoding system comprises a light source for charging the quantum dots in the carrier; a scanner for scanning the carrier to retrieve information from the charged quantum dots; and a processing system for processing the retrieved information to determine quantum dot wavelengths to identify distinct genetic traits, and to determine numbers of the quantum dots to identify probabilities associated with the genetic traits.

Abstract: The present invention relates to a novel method for the affinity purification of proteins of interest in a single step, based on the lectin activity of the CRD (Carbohydrate Recognition Domain) of a galectin or part of said domain retaining the ability to bind ?-galactosidase derivative.

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 invention provides binding molecules that include an IgM, IgA, IgG/IgM or IgG/IgA antibody with a modified J-chain that includes a binding moiety that antagonizes a T-cell inhibitory signaling pathway, and their uses.

Abstract: The present disclosure provides c-Met antibody drug conjugates (ADCs), including compositions and methods of using such ADCs.

Abstract: A method of screening an antibody comprises preparing a serum having a target antibody and a non-target antibody; providing the serum with a first antigen that specifically binds the target antibody to obtain a first mixture; selectively obtaining the first conjugate by separating the first conjugate from the non-target antibody in the first mixture; dissociating the first conjugate, and a redundant non-target antibody adsorbed to the first conjugate into the first antigen, the target antibody and the redundant non-target antibody; removing the first antigen to obtain a second mixture of the target antibody and the redundant non-target antibody; providing the second mixture with a second antigen to form a second conjugate, so that third mixture including the target antibody and the second conjugate may be obtained; and selectively obtaining a target antibody by separating the second conjugate from the target antibody in the third mixture.

Abstract: The present invention provides stable pharmaceutical formulations comprising a human antibody that specifically binds to human programmed death-1 protein (PD-1). In certain embodiments, the formulations contain, in addition to an anti-PD-1 antibody, a buffer, an amino acid, a non-ionic surfactant, and a sugar. The pharmaceutical formulations of the present invention exhibit a substantial degree of antibody stability upon stress and storage.

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: Antigenic surface proteins expressed by Mycobacterium bovis under conditions that mimic the natural environment in a host are described. Use of the identified surface proteins in immunogenic compositions for immunization against M. bovis are also described. Nucleic acid molecules and plasmids encoding the M. bovis surface proteins are further described.

Abstract: The problem to be solved is to provide a humanized anti-IL-6 receptor antibody MRA-containing formulation which is suitable for subcutaneous administration, wherein dimerization or deamidation is prevented during long-term storage. The present application is directed to a stable antibody-containing liquid formulation characterized by containing arginine and histidine buffer. A method of inhibiting deamidation or dimerization of such an antibody in a concentrated liquid formulation includes histidine buffer in the liquid formulation.

Abstract: This disclosure provides a method for inhibiting, delaying, or reducing malignant cell growth in a subject with cancer, comprising administering to the subject a combination therapy comprising an effective amount of an isolated antibody or antigen-binding fragment thereof that specifically binds to semaphorin-4D (SEMA4D) and an effective amount of an epigenetic modulating agent, e.g., a histone deacetylase (HDAC) inhibitor (HDACi) a DNA methyltransferase (DNMT) inhibitor (DNMTi), or any combination thereof. The disclosure further provides a pharmaceutical composition comprising the combination therapy.

Abstract: The present disclosure relates to methods for modulating the level of proteins in a subject or in target cells by priming red blood cells with various agents or conditions that modulate the levels of proteins associated with red blood cells and administering the primed red blood cells to a subject. The disclosed methods represent a novel use of red blood cells primed to express a number of proteins, as cell therapies for numerous diseases or disorders.

Abstract: The present disclosure is directed to methods for tuning the release profile of a biologic disposed in a hydrogel. Parameters that can be used for the tuning include a molar ratio of a nucleophilic group to an electrophilic group, the number of the nucleophilic groups in the first precursor, the number of the electrophilic groups in the second precursor, the molecular weight of the first precursor, the molecular weight of the second precursor, a weight ratio of the biologic and excipient to the hydrogel, a weight percentage of the biologic in a solid state formulation, and a ratio of surface area to volume of the hydrogel. The methods described herein allow the formation of hydrogel with different release profiles suitable for different therapeutic applications.

Abstract: A method and device for the remote eradication of pathogens comprising a light source for emitting UV light in the pathogen killing wave length range, and a tangible transmission medium, which is at least initially resistant to degradation by the UV light. An optical interface between the UV light source and the tangible transmission medium is provided whereby the emitted UV light is collected from the light source and transmitted through the tangible transmission medium, whereby UV light emitted from the tangible transmission medium and directed against a pathogen in proximity thereto is at a power level sufficient to substantially effectively kill the pathogen within a reasonable period of time. The device is used for sanitization of biopsy channels of endoscopes and for treating of pathogens within humans and animals.

Abstract: The disclosure provides compositions and methods relating to or derived from anti-activin A binding proteins, including antibodies. In particular embodiments, the disclosure provides fully human, humanized, and chimeric anti-activin A antibodies that bind human activin A, activin A-binding fragments and derivatives of such antibodies, and activin A-binding polypeptides comprising such fragments. Other embodiments provide nucleic acids encoding such antibodies, antibody fragments and derivatives and polypeptides, cells comprising such polynucleotides, methods of making such antibodies, antibody fragments and derivatives and polypeptides, and methods of using such antibodies, antibody fragments and derivatives and polypeptides, including methods of treating or diagnosing subjects having activin A-related disorders or conditions including cachexia related to gonadal cancer, other cancers, rheumatoid arthritis, and other diseases.

Abstract: A tissue factor (TF)-targeted antibody-drug conjugate (ADC) and a method for preparing the ADC. The ADC is capable of binding to TF antigen with high specificity, and has high affinity, low immunogenicity, high cytotoxicity, and significant anti-tumor activity.

Abstract: This disclosure belongs to the field of biomedical technology, and particularly refers to a trifunctional molecule and the application thereof. The structure of the trifunctional molecule includes a first functional domain, a second functional domain and a third functional domain. These domains are capable of simultaneously binding to CD19, CD3, and T cell positive (negative) costimulatory factors, thereby producing the first and second signal required for T cell activation. The trifunctional molecule is a recombinant protein peptide chain, which can be produced by a eukaryotic cell expression system. The product has a single structure, simple purification process, high protein yield, and preparation process and product stability. The trifunctional molecule is superior to the anti-CD19/anti-CD3 BiTE bispecific antibody in killing CD19-positive target cells.

Abstract: The disclosure relates to novel regimens for treating psoriasis, which employ a therapeutically effective amount of an IL-17 antagonist, e.g., an IL-17 binding molecule, e.g., an IL-17 antibody, such as the secukinumab antibody, or an IL-17 receptor binding molecule, e.g., an IL-17 receptor antibody.

Abstract: A method of treating a person with a substance abuse disorder, in particular, opioid abuse and psychostimulant abuse with a chemokine receptor antagonist pharmaceutical composition. The antagonist comprising five contiguous amino acids having the general structure: A-B-C-D-E in which A is Ser, Thr, Asn, Glu, or Ile; B is Ser, Thr, Asp, or Asn; C is Thr, Ser, Asn, Arg, or Trp; D is Tyr and E is Thr, Ser, Arg, or Gly. The amino acids are D stereoisomers. The method both relieves a person's symptoms and reduces the person's risks of addiction.

Abstract: The invention relates to methods for generating multipotent mammary stem cells from isolated and cultured human breast luminal cells. The method comprises the steps: 1. isolating and growing normal differentiated cells in vitro; 2. treating the differentiated cells with either a conditioned medium from active fibroblasts or cytokine. The invention also relates to multipotent mammary stem cells, cultures of the multipotent stem cells, differentiated cells, tissues, organs derived from the culture multipotent stem cells isolated by the methods disclosed and therapeutic and other uses for those cells thereof.

Abstract: Compositions for stabilizing and delivering proteins and/or other bioactive agents are disclosed. The bioactive agents are embedded or encapsulated in a crystalline matrix. Typically the bioactive agents are in the form of micro- or nanoparticles. The crystalline matrix confers enhanced stability to the agents embedded therein relative to other microparticulate or nanoparticulate bioactive agents. The carriers are especially useful for stabilizing bioactive macromolecules, such as proteins.

Abstract: Materials and methods for treating potentially chemoresistant tumors (e.g., using DNA-PKcs inhibitors and anti-B7-H1 antibodies) are provided herein.

Abstract: The present invention relates to a brain delivery protein, comprising a target binding antibody which binds to a target in a mammalian brain; two carrier moieties, each of which being capable of monovalent interaction with a protein expressed on a blood brain barrier (BBB) endothelial cell, wherein each of said carrier moieties is linked to a C-terminal end of the target binding antibody. The present invention moreover relates to use of such brain delivery proteins in therapy or diagnosis or for research of e.g. neurodegenerative disorders, and other brain diseases.

Abstract: The present invention provides compositions and methods for down-modulating the expression and/or the immuno-suppressive activity of i) the FMRP protein, ii) an mRNA encoding the FMRP protein, and/or iii) the FMR1 gene for the treatment and/or prevention of primary cancer and/or cancer metastasis in a subject in need thereof.

Abstract: Provided in the present invention are a type of anti-human PD-L1 specific nanobodies and VHH chains thereof, coding sequences of the foregoing nanobodies or VHH chains thereof, corresponding expression vectors and host cells, and a method for producing antibodies.

Abstract: The present invention relates to novel humanized anti-IL-4 and IL-13 antibodies and fragments thereof and novel bispecific antibodies and fragments thereof that specifically bind to IL-4 and IL-13. The invention also includes uses of the antibodies to treat or prevent IL-4 and/or IL-13 mediated diseases or disorders, including allergic asthma and dermatitis.

Abstract: A method for treating, remedying, or preventing inflammatory skin disorders by administering a therapeutically effective dose of at least one an antagonist of a calcitonin gene-related peptide receptor in a pharmaceutically acceptable formulation. The method for treating, remedying, or preventing an inflammatory skin disorder by administering topically and to the pre-psoriatic rim a therapeutically effective dose of at least one an antagonist of a calcitonin gene-related peptide receptor in a pharmaceutically acceptable formulation.

Abstract: The present invention provides a method for preparation of a lyophilized formulation of an anti-CD 20 antibody as well as to a lyophilized formulation of an anti-CD 20 antibody, comprising an anti-CD 20 antibody and having a residual moisture content in the range of 1% to 10%. The present invention also relates to the reconstituted formulation obtained by the method described herein, the use of said antibody formulation as a medicament, the use of the lyophilized formulation for the preparation of a medicament and a method of treating a patient.

Abstract: The present invention relates to dimers comprising a first polypeptide and a second polypeptide, wherein each of said first and second polypeptide comprises at least one immunoglobulin single variable domain (1ISVD) and a C-terminal extension comprising a cysteine moiety (preferably at the C-terminus), wherein said first polypeptide and said second polypeptide are covalently linked via a disulfide bond between the cysteine moiety of said first polypeptide and the cysteine moiety of said second polypeptide, in which the dimer outperformed the benchmark constructs, e.g. cognate multivalent and multispecific constructs, in various assays. The present invention provides methods for making the dimers of the invention.

Abstract: The present invention relates to an immunoglobulin preparation comprising immunoglobulin in a mass-volume percentage of at least 4%, wherein the concentration of oxygen dissolved in the preparation at room temperature is less than 40 ?mol/l.

Abstract: Methods for treating Fibrodysplasia Ossificans Progressiva (FOP) are provided. Such methods involve administering to a subject having FOP an effective regime of an activin receptor type 2A (ACVR2A) and/or an activin receptor type 2B (ACVR2B) antagonist or an activin receptor type 1 (ACVR1) antagonist. Antagonists include fusion proteins of one or more extracellular domains (ECDs) of ACVR2A, ACVR2B and/or ACVR1 and the Fc domain of an immunoglobulin heavy chain, and antibodies against ACVR2A, ACVR2B, ACVR1 or Activin A.

Abstract: The present invention provides a method for determining the efficacy of a GPC3-targeting therapeutic agent for a liver cancer patient and a GPC3-targeting therapeutic agent or a preparation which is to be administered to a patient for whom it has been determined that the GPC3-targeting therapeutic agent is effective. The present invention provides, for example, a method for determining that a GPC3-targeting therapeutic agent is effective when the expression level of GPC3 per tumor cell is a predetermined value, and a GPC3-targeting therapeutic agent or a preparation which is to be administered to a patient for whom it has been determined that the GPC3-targeting therapeutic agent is effective.

Abstract: A gene expression platform, which is a combination of a set of genes that are correlated with response to a PD-1 antagonist in multiple tumor types and a normalization gene set, is disclosed. A method and system of using the gene expression platform to derive gene signature biomarkers of anti-tumor response to a PD-1 antagonist and to test patient samples for predictive gene signature biomarkers are also disclosed.