The present invention relates to methods and compositions for monitoring, diagnosis, prognosis, and determination of treatment regimens in subjects suffering from or suspected of having a renal injury. In particular, the invention relates to using a one or more assays configured to detect a kidney injury marker selected from the group consisting of Cancer antigen CA 15-3, C-C Motif chemokine 18, C-C Motif chemokine 24, Cathepsin D, C-X-C Motif chemokine 13, C-C motif chemokine 8, Interleukin-2 receptor alpha chain, Insulin-like growth factor-binding protein 3, Interleukin-11, Matrix Metalloproteinase-8, Transforming growth factor alpha, IgG1, and IgG2 as diagnostic and prognostic biomarkers in renal injuries.

An antibody or an antigen-binding fragment can specifically recognize IL-11 thereof. The antibody contains CDR sequence(s) selected from at least one of the following or an amino acid sequence having at least 95% identity thereto: heavy chain variable region CDR sequences: SEQ ID NOs: 1-33 and light chain variable region CDR sequences: SEQ ID NOs: 34-66. The antibody can specifically target and bind to IL-11, so as to block binding of IL-11 and an IL-11 receptor.

Disclosed are methods for methods for quantitating and standardizing an anti-inflammatory response of a product and methods for determining the likelihood that a product would produce an anti-inflammatory effect in a subject when administered to the subject. Accordingly, disclosed herein are methods, compositions and kits for characterizing and evaluating the anti-inflammatory effect of products, particularly therapeutic biological products.

The present invention is related to agents capable of binding to and inhibiting or antagonizing the action of IL-11 and/or or IL-11RA for the treatment and/or prevention of abnormal uterine bleeding, which comprises heavy menstrual bleeding, prolonged bleeding, altered bleeding pattern, dysmenorrhea, as well as of the underlying diseases leiomyoma and endometriosis and the use of the agent to inhibit menstruation. Furthermore, the invention provides novel IL-11 antibodies.

In various embodiments, provided are immune response signatures that can be used for the diagnosis, monitoring, and treatment of long-term diseases and inflammatory disorders caused by viral infections. In some embodiments, the viral infection is SARS-CoV-2 infection. In some embodiments, the long-term disease is post-acute sequelae of SARS-CoV-2 infection (PASC).

The present invention is related to agents capable of binding to and inhibiting or antagonizing the action of IL-11 and/or IL-11RA for the treatment and/or prevention of abnormal uterine bleeding, which comprises heavy menstrual bleeding, prolonged bleeding, altered bleeding pattern, dysmenorrhea, as well as of the underlying diseases leiomyoma and endometriosis and the use of the agent to inhibit menstruation. Furthermore, the invention provides novel IL-11 antibodies.

Methods, systems (e.g., computer systems), compositions, and kits are provided for predicting whether an individual will respond to treatment with a TNF inhibitor, for determining a treatment regimen for an individual (e.g. a therapy that does or does not include administration of a TNF inhibitor), and for treating an individual. The subject methods include measuring an expression level of an RGS1 expression product and/or an expression level of an IL11 expression product in a biological sample from an individual. In some cases, the methods include a step of calculating a TNF inhibitor signature score from measured expression levels (e.g., calculating a geometric mean of the expression levels of an RGS1 expression product and an IL11 expression product). After comparing measured expression levels and/or a calculated TNF inhibitor signature score with a reference, one can predict whether an individual will respond to treatment with a TNF inhibitor.

The present disclosure provides biomarkers associated with caveolin-1 peptide therapy in subjects with interstitial lung disease. In particular, the present disclosure describes biomarkers such as MYDGF, soluble RAGE, pSMAD2/3, and PDGFR associated with caveolin-1 peptide therapy in subjects with idiopathic pulmonary fibrosis. These biomarkers could be used to determine efficacy, monitoring, and optimal dosing of caveolin-1 peptide therapy in subjects with interstitial lung disease.

The present disclosure provides a whole blood, protein-based diagnostic test for presence and evaluation of aneurysm status. Further, the present disclosure relates to methods of treating aneurysms.

The present disclosure provides a whole blood, protein-based diagnostic test for presence and evaluation of aneurysm status. Further, the present disclosure relates to methods of treating aneurysms.