Described herein are compositions for increasing IL-12 production comprising IgG or a fragment thereof or a variant thereof and uses of said compositions for treating cancer and infectious diseases. Also described herein are compositions for decreasing IL-12 production comprising an agent that inhibits signaling mediated by interaction between FcRn and IgG and uses of said compositions for treating autoimmune diseases. Further described herein are methods for assessing efficacy of treatment by monitoring levels of various cytokines in the subject.

In some aspects, the present invention provides methods for predicting whether a subject will develop autoantibodies to an anti-TNFα drug during the course of anti-TNFα drug therapy. In other aspects, the present invention provides methods for predicting the level of an anti-TNFα drug in a subject during the course of anti-TNFα drug therapy. Systems for predicting anti-TNFα drug levels and the likelihood of autoantibody formation during the course of anti-TNFα drug therapy are also provided herein. The present invention further provides methods for predicting a clinical outcome (e.g., endoscopic response) of a subject on anti-TNFα drug therapy.

Provided is an antibody for the treatment or prevention of autoimmune diseases, comprising a heavy chain variable region represented by SEQ ID NO: 1 or SEQ ID NO: 24, and a light chain variable region represented by SEQ ID NO: 6, SEQ ID NO: 11, SEQ ID NO: 13, SEQ ID NO: 15, SEQ ID NO: 17, or SEQ ID NO: 25.

Described herein are compositions and methods for the delivery of microbial therapeutics useful for the treatment of disorders related to intestinal dysbiosis.

The subject invention pertains to systems and methods diagnosing, monitoring and treating women for successful embryo implantation and establishment of pregnancy using peripheral blood cytokine profiling and administration of immune-modulators to establish an implantation-promoting microenvironment in the uterus.

The present invention relates to a novel complex that is formed by linking p40 subunit and EBI3 subunit via a linker and has excellent anti-inflammatory effects and immunomodulatory effects.

The disclosure provides biomarker proteins, a change in the concentration or activity level of which are associated with atypical hemolytic uremic syndrome (aHUS) or clinically meaningful treatment of aHUS with a complement inhibitor. Also provided are compositions and methods for interrogating the concentration and/or activity of one or more of the biomarker proteins in a biological fluid. The compositions and methods are useful for, among other things, evaluating risk for developing aHUS, diagnosing aHUS, determining whether a subject is experiencing the first acute presentation of aHUS, monitoring progression or abatement of aHUS, and/or monitoring response to treatment with a complement inhibitor or optimizing such treatment.

The present invention is related to detecting respiratory diseases using molecular markers as prognostic tool of the evolution of respiratory infection cases. Concretely, during the differential diagnostic of respiratory infections caused by the Syncytial Respiratory Virus and human Metapneumovirus, it will be established the expression pattern of the severity markers of IL-3, IL-33 and IL12p40. The expression pattern of the molecular markers can be defined in biological samplers using ELISA assays, flow cytometry or PCR in real time. The confirmation of the etiological agent of the infection in combination to the pattern definition of the molecular markers IL-3, IL-33 and IL12p40 will indicate a prognostic of the disease severity.

Embodiments provided herein relate to methods, compositions and systems for rapid determination of the bioavailability of a therapeutic biologic in a sample from a subject. In some such embodiments, the presence or absence of a therapeutic biologic in a sample can be determined using an optical sensor

The present invention provides a sensitive and specific indirect homogeneous mobility shift assay using size exclusion chromatography to measure biologics such as vedolizumab and ustekinumab in a patient sample. The assays of the present invention are particularly advantageous for detecting the presence or level of biologics that target complex or large antigens including cell surface proteins, transmembrane proteins, heavily glycosylated proteins, and multimeric proteins, as well as antigens that cannot be purified, impure antigens, and partially or substantially purified antigens. The present invention also provides isolated soluble α4β7 integrin heterodimers and isolated soluble IL-12p40 monomers that are suitable for use in the indirect assays described herein.