The present disclosure provides antibodies that specifically bind to human FAM19A5 and compositions comprising such antibodies. Also provided herein are methods for treating fibrosis or cancer using the anti-FAM19A5 antibodies.

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.

The present disclosure concerns methods of detecting viral respiratory infections by analyzing biomarkers in a viral transport medium sample. In various embodiments the biomarkers are assessed by measuring mRNA or protein. In certain embodiments the biomarkers are nasal-virus induced molecules.

The current disclosure provides for novel therapeutic methods by identifying cancer patient populations that may be treated effectively by immunotherapies. Accordingly, aspects of the disclosure relate to a method of treating cancer in a subject comprising administering to the subject immune checkpoint blockade (ICB) therapy after the subject has been determined to have increased expression of CXCL13 in a biological sample from the subject.

Means that enables monitoring of an anticancer effect of an anti-CD4 antibody or an anticancer drug targeting an immune checkpoint is disclosed. The method for testing a therapeutic effect of a cancer therapy of the present invention is a method for testing a therapeutic effect of an anticancer drug comprising as an effective ingredient an anti-CD4 antibody or an anticancer drug targeting an immune checkpoint, which method comprises investigation of expression of (1) at least one immune checkpoint receptor, (2) CD8, and (3) at least one cell surface molecule selected from the group consisting of CD44 and CD45RO, on T cells using a sample derived from a patient who received the anticancer drug. Induction of a T cell population which is positive for the immune checkpoint molecule (1) and positive for CD8, and which shows high expression of CD44 and/or high expression of CD45RO, indicates that said anticancer drug is producing a therapeutic effect in said patient.

Methods for monitoring whether a subject will be sensitive or resistant to treatment with an anti-SMAD7 therapy are disclosed. The methods are based on the determining of the amount of CCR9+ FOXP3+ T cells, CCR9+ IFN-gamma+ T cells, CCR9+ IL17A+ T cells, FOXP3+ T cells, IFN-gamma+ T cells, and/or IL17A+ T cells in a sample from the subject. Measurement of T cell populations may be determined by flow cytometry, immunohistochemistry, and/or ELISA.

Compounds having formula I, ##STR00001##
or pharmaceutically acceptable salts, hydrates or N-oxides thereof are provided and are useful for binding to CXCR7, and treating diseases that are dependent, at least in part, on CXCR7 activity. Accordingly, the present invention provides in further aspects, compositions containing one or more of the above-noted compounds in admixture with a pharmaceutically acceptable excipient.

The present invention provides a novel, isolated anti-CXCR4 antibody for use in the diagnosis of cancer. In particular, the antibody of the invention recognizes monomeric and homodimeric CXCR4, but not heterodimeric CXCR4

This disclosure is directed, in part, to a method of determining whether a subject having cancer is at risk for developing metastasis of the cancer. In one embodiment, the method comprises (a) obtaining a biological sample from the subject having cancer; (b) determining CCR5 expression level and/or expression level of at least one of CCR5 ligands in the biological sample; and (c) if the expression level of CCR5 and/or of at least one of CCR5 ligands determined in step (b) is increased compared to CCR5 expression level and/or expression level of at least one of CCR5 ligands in a control sample, then the subject is identified as likely at risk for developing metastasis of the cancer.

A method of diagnosing, monitoring progression of, or monitoring treatment of inflammatory bowel disease comprises determining the levels of CD14.sup.+HLA-DR.sup.hi monocytes or monocytes expressing CCR7 or CCR9 or both CCR7 and CCR9 in a sample obtained from a subject, wherein high levels of CD14.sup.+HLA-DR.sup.hi monocytes or monocytes expressing CCR7 or CCR9 or both CCR7 and CCR9, or increased levels of CD14.sup.+HLA-DR.sup.hi monocytes or monocytes expressing CCR7 or CCR9 or both CCR7 and CCR9 compared to control, indicate the presence or progression of inflammatory bowel disease. Similar methods for diagnosing irritable bowel syndrome are also described. Various companion therapeutic methods and useful binding reagents are also described.