Provided herein are methods, kits, and pharmaceutical compositions that include a P13 kinase inhibitor for treating cancers or hematologic disorders.

The present invention relates to a method for determining the potency of DCs, comprising the steps: stimulating dendritic cells by incubation with soluble CD40L and TLR7/8 agonist, measuring the secretion of the marker proteins IL-10 and IL-12 from the stimulated dendritic cells. Thereby it can be determined whether the dendritic cell have a high capability to activate T-cells and Natural Killer (NK) cells. The invention also encompasses a method for stimulating dendritic cells comprising the step of stimulating the dendritic cells with soluble CD40L and TLR7/8 agonist.

The present invention relates to methods, kits, and compositions for detecting and/or diagnosing metastatic potential of cancer cells or for evaluating prognosis in a patient with cancer by detection of the protein expression level of an HLA class I molecule and/or the copy number variation of a polynucleotide encoding the HLA class I molecule. The present invention also relates to the use of the protein expression level of an HLA class I molecule and/or the copy number variation of a polynucleotide encoding the HLA class I molecule as a prognosis biomarker and metastasis predictive biomarker of cancer.

A method for determining predisposition of a subject to developing renal dysfunction (AKI), and to a kit for use in making such a determination is provided. Suitably at least one marker selected from Midkine (MK) or H-FABP present in a blood or urine sample is used in the method.

Disclosed herein are methods of identifying biomarkers (such as genes (e.g., RNA or mRNA), proteins, and/or small molecules) that can be used to predict organ or tissue function or dysfunction. In some embodiments, the methods include ex vivo perfusion of the organ or tissue, collection of samples from the organ or tissue (for example, perfusate, fluids produced by the organ (such as bile or urine), or tissue biopsies) and measuring the level of one or more biomarkers in the sample. It is also disclosed herein that an analysis of biomarkers (such as genes (e.g., RNA or mRNA), proteins, and/or small molecules) present in a biological sample from an organ, tissue, or subject can be used to identify whether the organ, tissue, or subject is at risk for (or has) organ dysfunction or organ failure.

In some aspects, the present invention provides methods for predicting whether a subject will develop autoantibodies to an anti-TNF drug during the course of anti-TNF drug therapy. In other aspects, the present invention provides methods for predicting the level of an anti-TNF drug in a subject during the course of anti-TNF drug therapy. Systems for predicting anti-TNF drug levels and the likelihood of autoantibody formation during the course of anti-TNF 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-TNF drug therapy.

The present invention provides methods for determining the level or status of minimal residue disease (MRD) in a multiple myeloma (MM) patient including analyzing peripheral natural killer (NK), NK-T and T cell distribution and/or activation, and quantifying inflammatory cytokines, chemokines and growth factors in a biological sample obtained from an MM patient to provide a peripheral immune profile; and obtaining a level or status of MRD in the MM patient from the peripheral immune profile, wherein if the peripheral immune profile exceeds a pre-determined threshold, the MM patient is positive for MRD.

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 47 integrin heterodimers and isolated soluble IL-12p40 monomers that are suitable for use in the indirect assays described herein.

In some aspects, the present invention provides methods for predicting whether a subject will develop autoantibodies to an anti-TNF drug during the course of anti-TNF drug therapy. In other aspects, the present invention provides methods for predicting the level of an anti-TNF drug in a subject during the course of anti-TNF drug therapy. Systems for predicting anti-TNF drug levels and the likelihood of autoantibody formation during the course of anti-TNF 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-TNF drug therapy.

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.