Provided is a method of preparing a personalized immunogenic composition, which may be prepared by obtaining genetic sequences from a liquid biopsy, comparing the genetic sequences to a wild-type reference genome to identify mutant sequences, selecting epitopes from the mutant sequences, producing the peptides encoded by the selected epitopes, and incorporating the produced peptides into an immunogenic composition. Obtaining the genetic sequences may include next-generation sequencing of genetic material that has been enriched from the liquid biopsy. Deep sequencing (average coverage of 10,000× and above) may be used to detect gene mutations with rare frequencies. Immunogenicity of selected epitopes may be predicted using various in silico methods and epitopes used in an immunogenic composition may be selected from those selected epitopes with high binding amity to HLA. An immunogenic composition prepared using these methods may be administered to a subject.

EphA2 T-cell epitope are provided herein. The epitopes include peptides corresponding to specific fragments of human EphA2 protein containing one or more T-cell epitopes, and conservative derivatives thereof. The EphA2 T-cell epitopes are useful in an assay, such as an ELISPOT assay, that may be used to determine and/or quantify a patient's immune responsiveness to EphA2. The epitopes also are useful in methods of modulating a patient's immune reactivity to EphA2, which has substantial utility as a treatment for cancers that overexpress EphA2, such as renal cell carcinoma (RCC). The EphA2 epitopes also can be used to vaccinate a patient against EphA2, by in vivo or ex vivo methods.

The present disclosure relates generally to the field of immunological-based assays and describes methods for measuring cell-mediated immuno responsiveness. More particularly, the present disclosure relates to methods, compositions, and kits for measuring cell-mediated immune response activity with enhanced sensitivity and improved storage stability.

The invention provides methods, kits and reagents for diagnosing fibromyalgia (FM) in an individual by determining whether the levels of one or more cytokines in the individual are altered, as compared to control levels. The altered level(s) or patterns of expression of the cytokines measured in the affected individual compared to the level from the control is predictive/indicative of FM in the individual.

The present invention relates to means and methods for determining whether a patient is in need of a PD-L1 inhibitor cotherapy. A patient is determined to be in need of the PD-L1 inhibitor cotherapy if a low or absent ER expression level and an expression level of programmed death ligand 1 (PD-L1) that is increased in comparison to a control is measured in vitro in a sample from the patient. The patient is undergoing therapy comprising a modulator of the HER2/neu (ErbB2) signaling pathway (like Trastuzumab) and a chemotherapeutic agent (like dodetaxel) or such a therapy is contemplated for the patient. Also provided herein are means and methods for treating a cancer in a cancer patient for whom therapy comprising a modulator of the HER2/neu (ErbB2) signaling pathway (like Trastuzumab) and a chemotherapeutic agent (like dodetaxel) is contemplated, wherein the patient is to receive PD-L1 inhibitor cotherapy.

The present invention concerns a composition comprising at least three peptides derived from Mycobacterium tuberculosis antigen Rv2626c, its use in the diagnostic of latently infected Mycobacterium tuberculosis (LTBI) subjects, corresponding methods of use and kits.

A system and method for prediction of immunodominant epitopes is provided herein. MHCII peptidomics was used to discover complex bacterial epitopes and host antigen processing pathways. Novel insights into the features of antigenicity are leveraged to build an algorithm for prediction of immunodominant epitopes. Use of immunodominant epitopes is described.

In vitro method for discriminating latent from active TB. The present invention refers to an in vitro method for the differential diagnosis between active TB, preferably early stages of TB, and LTBI.

The present invention provides novel processes, compositions, and methods for analyzing or assaying the potency and/or functionality of tumor infiltrating lymphocyte (TIL) products for use in therapy, including human cancer therapy, and analyzing or assaying the potency and/or functionality of other polyclonal products, such as marrow infiltrating lymphocyte (MIL) and peripheral blood lymphocyte (PBL) products. Compositions, methods, and kits for preparing and treating cancer using TIL, MIL, and PBL products are also provided.

The present disclosure provides methods of identifying a subject suitable for an immunooncology (I-O) therapy comprising measuring the expression of one or more of STAT1, IFNγ, NECTIN2, and CSFIR. In some aspects, the I-O therapy comprises administering an anti-PD-1 antibody or antigen-binding portion thereof or an anti-PD-L1 antibody or antigen-binding portion thereof to the subject.