The present disclosure relates generally to methods and compositions for cancer immunotherapy, and more specifically, liquid markers for predicting effectiveness of cancer therapies. The disclosure features compositions and methods that are useful for predicting the efficacy of cancer treatment (e.g., a checkpoint inhibitor immunotherapy) and, in some embodiments, administering the cancer treatment such as immunotherapy.

Aspects of the present invention relate to the assessment of explant organ viability prior to transplantation. Particularly, although not exclusively, aspects of the present invention relate to biomarkers which can be used to inform a decision as to whether an organ is suitable for transplantation into a recipient. In certain embodiments, the organ is undergoing hypothermic perfusion following retrieval from a donor.

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 are a composition for diagnosing vascular disease including an agent measuring a level of interleukin 12 receptor β2 protein in the blood, and a kit for diagnosing vascular disease including the same. Further, provided is a method for diagnosing vascular disease, the method including the step of measuring a level of interleukin 12 receptor β2 protein in a blood sample separated from an individual suspected of having vascular disease. Furthermore, provided are a composition for preventing or treating vascular disease including an interleukin 12 receptor β2 activity inhibitor, and a method of screening a therapeutic agent for vascular disease, the method including the step of treating smooth muscle cells with a test agent for vascular disease treatment and measuring an expression level of interleukin 12 receptor β2.

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 are methods and systems for determining functional relationships between ex vivo skin models and an inflammatory skin condition. Also provided are methods and systems for identifying modulators of inflammation of skin, as well as the use of modulators identified by such methods or systems for the preparation of cosmetic compositions, personal care products, or both.

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.

The invention relates to panels of biomarkers for diagnosing and/or monitoring the progression of an active mycobacterial infection or for diagnosing the absence of a mycobacterial infection, particularly tuberculosis. Such diagnosis and/or monitoring may be differential diagnosis between active tuberculosis patients and patients with latent, non-progressing tuberculosis or healthy or sick patients, irrespective of whether the patients have been characterised as being sputum smear positive or sputum smear negative, and/or irrespective of whether they have been characterised as being HIV positive or HIV negative. The above pertain in all aspects both to pulmonary and extra pulmonary Mycobacterium tuberculosis infections, with Mycobacterium tuberculosis being the causative organism in tuberculosis.

Diagnostic screening tests that can be used to identify if a patient is a good candidates for an implantable vagus nerve stimulation device. One or more analyte, such as a cytokine or inflammatory molecule, can be measured from a blood sample taken prior to implantation of a vagus nerve stimulator to determine the patient's responsiveness to VNS for treatment of an inflammatory disorder.

Diagnostic screening tests that can be used to identify if a patient is a good candidates for an implantable vagus nerve stimulation device. One or more analyte, such as a cytokine or inflammatory molecule, can be measured from a blood sample taken prior to implantation of a vagus nerve stimulator to determine the patient's responsiveness to VNS for treatment of an inflammatory disorder.