Abstract: The present invention relates to SH2B adapter protein 3 (SH2B3) for use as a diagnostic marker. Further, the present invention relates to a method for the determination of SH2B3 gene expression.

Abstract: Disclosed is an image analysis method including inputting analysis data, including information regarding an analysis target cell to a deep learning algorithm having a neural network structure, and analyzing an image by calculating, by use of the deep learning algorithm, a probability that the analysis target cell belongs to each of morphology classifications of a plurality of cells belonging to a predetermined cell group.

Abstract: The present invention relates to a biomarker composition for predicting the prognosis of cancer malignancy induced by exposure to microplastics and use thereof, and more particularly, it was confirmed that the expression level of CD44, E-cadherin, N-cadherin, PD-L1, NPAS2, NR1D1, DNMT1, SLC7A2, PCDH7 and CLDN7 was changed in cancer cell lines and animal models treated with polystyrene microspheres which are the one type of microplastic for 4 weeks, and malignancy was induced due to an increase in proliferation, migration and invasion of cancer cells by the change in the expression level of the gene, and 5-year overall survival rates in gastric cancer patients decreased and thus the genes may be provided as a biomarker composition for predicting the prognosis of cancer malignancies by exposure to microplastics.

Abstract: Provided are an organometallic compound represented by Formula 1, an organic light-emitting device including the organometallic compound, and a diagnostic composition including the organometallic compound: M(L1)n1(L2)n2??Formula 1 wherein M, L1, L2, n1 and n2 are each independently the same as defined in the specification.

Abstract: Provided herein are compositions including a CaMKK2 inhibitor and an anti-cancer therapeutic agent and methods of treating cancer in a subject by administering a therapeutically effective amount of the composition to a subject. The subject may be selected for treatment based on an immune cell measurement of a sample from the subject. Methods of treating cancer by administering a therapeutically effective amount of a CaMKK2 inhibitor, and administering a therapeutically effective amount of an anti-cancer therapeutic agent to the subject are also provided. Kits including combination of a CaMKK2 inhibitor and another anti-cancer therapeutic agent are also provided.

Abstract: Immune context scores are calculated for tumor tissue samples using continuous scoring functions. Feature metrics for at least one immune cell marker are calculated for a region or regions of interest, the feature metrics including at least a quantitative measure of human CD3 or total lymphocyte counts. A continuous scoring function is then applied to a feature vector including the feature metric and at least one additional metric related to an immunological biomarker, the output of which is an immune context score. The immune context score may then be plotted as a function of a diagnostic or treatment metric, such as a prognostic metric (e.g. overall survival, disease-specific survival, progression-free survival) or a predictive metric (e.g. likelihood of response to a particular treatment course). The immune context score may then be incorporated into diagnostic and/or treatment decisions.

Abstract: The present invention relates to methods for predicting peptides or polypeptides such as T cell epitopes useful for immunotherapy such as for vaccination. In particular, the present invention relates to methods for predicting whether peptides or polypeptides such as tumor-associated antigens or epitopes, in particular tumor-associated neoantigens or neoepitopes, are immunogenic and, in particular, useful for immunotherapy such as for vaccination. The methods of the invention may be used, in particular, for the provision of vaccines which are specific for a patient's tumor and, thus, in the context of personalized cancer vaccines.

Abstract: The application discloses CD321 as a useful global marker of circulating tumor cells (CTCs) and provides related methods and kits of parts relying on detection of CD321.5.

Abstract: Laboratory test apparatus for conducting a mass spectrometry test on a blood-based sample of a cancer patient includes a classification procedure implemented in a programmed computer that generates a class label. In one form of the test, “Test 1”, if the sample is labelled “Bad” or equivalent the patient is predicted to exhibit primary immune resistance if they are later treated with anti-PD-1 or anti-PD-L1 therapies. In “Test 2” the Bad class label predicts that the patient will have a poor prognosis in response to treatment by either anti-PD-1 or anti-PD-L1 therapies or alternative chemotherapies, such as docetaxel or pemetrexed. “Test 3” identifies patients that are likely to have a poor prognosis in response to treatment by either anti-PD-1 or anti-PD-L1 therapies but have improved outcomes on alternative chemotherapies. A Good class label by either Test 1 or 2 predicts very good outcome on anti-PD-1 or anti-PD-L1 monotherapy.

Abstract: The present invention relates to peptides, proteins, nucleic acids and cells for use in immunotherapeutic methods. In particular, the present invention relates to the immunotherapy of cancer. The present invention furthermore relates to tumor-associated T-cell peptide epitopes, alone or in combination with other tumor-associated peptides that can for example serve as active pharmaceutical ingredients of vaccine compositions that stimulate anti-tumor immune responses, or to stimulate T cells ex vivo and transfer into patients. Peptides bound to molecules of the major histocompatibility complex (MHC), or peptides as such, can also be targets of antibodies, soluble T-cell receptors, and other binding molecules.

Abstract: Provided herein are compositions and methods of use relating to a novel class of dendritic cells, referred to herein as ISG+ DC, having anti-tumor activity.

Abstract: A method is provided for treating a cancer patient non-responsive to treatment with a immune checkpoint inhibitor (ICI) by treating the patient with said ICI in combination with an agent that blocks the activity of a dominant factor selected among the plurality of host-driven resistance factors generated in response to treatment of the cancer patient with the ICI, these factors having a fold-change predictive of a non-favorable response of the cancer patient to the treatment with the ICI.

Abstract: Provided are fluorescent microparticles and/or nanoparticles that have a polymeric matrix and at least one porphyrinic macrocycle associated therewith. The porphyrinic macrocycles associated with the presently disclosed fluorescent microparticles and/or nanoparticles are in some embodiments selected from the group consisting of porphyrins (including 17,18-didehydrophorbines), chlorins (including phorbines), bacteriochlorins (including bacteriophorbines), and isobacteriochlorins (including isobacteriochlorins containing a fused “E” ring). In some embodiments, the porphyrinic macrocycles have structures selected from Formulas I and H.

Abstract: A cell encapsulation device for implantation in a body includes one or more cell encapsulation layers, each of the one or more cell encapsulation layers including at least one membrane and a guide tube. The at least one membrane is semipermeable. The least one membrane forms a chamber for encapsulating cells and at least one access port through the at least one membrane. The guide tube extends into the chamber from the at least one access port. The guide tube includes a porous wall along at least a portion of its length. The guide tube is capable of guiding movement of a catheter within the chamber.

Abstract: Antibody molecules that specifically bind to CD138 are disclosed. The antibody molecules can be used to treat, prevent, and/or diagnose disorders, such as multiple myeloma.

Abstract: Bioconjugates and methods of making bioconjugates are provided, wherein the bioconjugates comprise glucose oxidase and nanoparticles that can kill tumor cells. For example, glucose oxidase-iron oxide bioconjugates can produce reactive oxygen species from blood glucose, causing cell death. The use of superparamagnetic iron oxide nanoparticles can provide magnetic resonance imaging guidance to facilitate imaging-guided drug delivery and combine diagnostics with therapy.

Abstract: Aspects of the disclosure relate to improved methods for predicting whether a prostate tissue biopsy obtained from a subject will contain detectable prostate cancer. In some embodiments, the disclosure provides improved prostate antigen standards for quantifying levels of prostate antigens.

Abstract: Methods are provided for assessing risk of developing esophageal adenocarcinoma in a subject using one or more of the following marker genes/proteins: ISG15, LTF, CNDP2, DAD1, SET, UBE2N, S100P, and GPI. Methods are also provided for determining expression of one or more esophageal adenocarcinoma risk factors in a subject. Methods are also provided for treating esophageal adenocarcinoma in a subject, for preventing esophageal adenocarcinoma in a subject, for inhibiting or decreasing proliferation of esophageal adenocarcinoma cells, for inhibiting or decreasing migration of esophageal adenocarcinoma cells, or for increasing susceptibility to cytotoxicity or inducing cell death of esophageal adenocarcinoma cells.

Abstract: The present invention encompasses filamin A (FLNA) binding proteins. Specifically, the invention relates to antibodies to FLNA. An antibody of the invention can be a full-length antibody or an antigen-binding portion thereof. Methods of making and methods of using the antibodies of the invention in methods of diagnosis, monitoring and prognosis of prostate cancer are also provided.

Abstract: Systems and methods for automated, non-supervised, parameter-free segmentation of single cells and other objects in images generated by fluorescence microscopy. The systems and methods relate to both improving initial image quality and to improved automatic segmentation on images. The methods will typically be performed on a digital image by a computer or processor running appropriate software stored in a memory.

Abstract: Methods for determining treatments for cancer patients are disclosed.

Abstract: From gene expression analysis with a long-term recurrence-free group and a recurrence metastasis group of stomach cancer, CHRNB2 and NPTXR were identified as drug discovery targets. Tumor growth was successfully inhibited by an antibody medicine or a nucleic acid medicine targeting CHRNB2 or NPTXR. Furthermore, a polyclonal antibody and a monoclonal antibody linking to CHRNB2 or NPTXR are provided. Since these receptor molecules are novel molecular targets, treatment of cases which the existing therapeutic drugs have no effect on is made possible.

Abstract: The present invention relates, in part, to methods of treating a cancer in a subject comprising administering to the subject a therapeutically effective amount of an agent that inhibits one or more biomarkers listed in Table 1 in combination with an immunotherapy.

Abstract: The present invention is based, in part, on the discovery that galectin-1 (Gal1) plays a role in viral-associated PTLD, e.g., EBV-associated PTLD and hypoxia associated angiogenesis disorders. Accordingly, the invention relates to compositions, kits, and method for diagnosing, prognosing, monitoring, treating and modulating viral-associated PTLD, e.g., EBV-associated PTLD and hypoxia associated angiogenesis disorders.

Abstract: An object of the present invention is to provide: an anti-GPC3 antibody that recognizes an epitope different from that for existing antibodies (e.g., GC33 and GC199) and can specifically bind, even in the form of single chain antibody, to GPC3 localized on a cell membrane; CAR comprising the anti-GPC3 single chain antibody; an immunocompetent cell expressing the CAR; a gene of the anti-GPC3 antibody or a gene of the CAR; a vector comprising the anti-GPC3 antibody gene or the CAR gene; a host cell in which the vector has been introduced; a method for specifically detecting GPC3; and a kit for specifically detecting GPC3. An antibody comprising particular heavy chain CDR1 to CDR3 and particular light chain CDR1 to CDR3 defined in claim 1, and specifically binding to a human-derived GPC3 polypeptide specifically binds to GPC3 localized on a cell membrane. CAR-immunocompetent cells prepared on the basis of CAR comprising such single chain antibody are useful for cancer immunotherapy.

Abstract: A method of diagnosing a cancer or a pre-malignant lesion is disclosed. The method comprising determining a level of expression of CD24 on leukocytes comprised in a biological sample of a subject, wherein a level of CD24 on small leukocytes and not on large leukocytes above a predetermined threshold is indicative of the cancer or the pre-malignant lesion. A method of monitoring efficacy of cancer therapy and a kit for diagnosing a cancer or a pre-malignant lesion are also disclosed.

Abstract: Methods for detecting the presence of proteins in a subject are described. The proteins detected can be indicative of acute myeloid leukemia (AML). The proteins can be particularly useful for monitoring minimal residual disease (MRD) in AML.

Abstract: This invention is directed to vaccine compositions and methods of using the same to prevent infection.

Abstract: Methods for treating, preventing and predicting a subject's risk of developing breast cancer are provided.

Abstract: Embodiments of the present invention relate generally to non-invasive methods and tests that measure biomarkers (e.g., tumor antigens) and collect clinical parameters from patients, and computer-implemented machine learning methods, apparatuses, systems, and computer-readable media for assessing a likelihood that a patient has a disease, relative to a patient population or a cohort population. In one embodiment, a classifier is generated using a machine learning system based on training data from retrospective data and subset of inputs (e.g. at least two biomarkers and at least one clinical parameter), wherein each input has an associated weight and the classifier meets a predetermined Receiver Operator Characteristic (ROC) statistic, specifying a sensitivity and a specificity, for correct classification of patients.

Abstract: Aspects of the present disclosure provide methods for determining the eligibility of a subject having a malignancy for treatment with an anti-PD therapeutic agent based on a Combined Positive Score (CPS) for a tumor tissue sample from the subject. Compositions and kits or performing the disclosed methods are also provided.

Abstract: Disclosed are methods for diagnosing CAT1-related diseases, wherein the methods include detecting CAT1 in a cell by a BLV.RBD ligand, or a variant or a fragment thereof. Also disclosed is a BLV.RBD ligand, or a variant or a fragment thereof for use in the treatment of CAT1-related diseases and/or BLV infections.

Abstract: Microscale and/or mesoscale condenser arrays that can facilitate microfluidic separation and/or purification of mesoscale and/or nanoscale particles and methods of operation are described herein. An apparatus comprises a condenser array comprising pillars arranged in a plurality of columns, wherein a pillar gap greater than or equal to about 0.5 micrometers is located between a first pillar of the pillars in a first column of the columns and a second pillar of the plurality of pillars in the first column, and wherein the first pillar is adjacent to the second pillar. The first ratio can be characterized by Dx/Dy is less than or equal to a first defined value, wherein Dx represents a first distance across the lattice in a first direction, wherein Dy represents a second distance across the lattice in a second direction, and wherein the first direction is orthogonal to the second direction.

Abstract: Provided herein are compositions and methods for detecting and/or targeting dysfunctional tumor antigen-specific CD8+ T cells in the tumor microenvironment for diagnostic, therapeutic and/or research applications. In particular, dysfunctional tumor antigen-specific CD8+ T cells are detected and/or targeted via their expression of cell surface receptors described herein, such as 4-1BB, LAG-3, or additional markers that correlate with 4-1BB and LAG-3 expression, such as markers differentially expressed on the surface of the T cells.

Abstract: The invention described herein relates to methods of monitoring genotoxic stress in a test subject, specifically by detecting the expression level of microvesicle-associated H2AX from a biological sample.

Abstract: An immunoassay for the detection of an analyte in a sample includes a plurality of moieties capable of binding to the analyte. Capture moieties, which are not specific for the same epitope, are bound to a solid substrate, and at least one epitope-specific detection moiety is bound to a detectable marker. The detectable marker is a large particle marker having a particle size of ?50 nm and ?5000 nm.

Abstract: This invention comprises compositions and methods to detect and treat gastrointestinal diseases.

Abstract: The present invention relates to a method of diagnosing Head and Neck Squamous Cell Carcinoma (HNSCC) in an individual. In addition, the present invention relates to a method of providing a survival prognosis to an individual suffering from Head and Neck Squamous Cell Carcinoma (HNSCC). Moreover, the present invention relates to a kit for performing the above-mentioned methods.

Abstract: The state of protein phosphorylation and glycosylation can be key determinants of cellular physiology such as early stage cancer, but the development of phosphoproteins and/or glycoproteins in biofluids for disease diagnosis remains elusive. Here we demonstrate, for the first time, a strategy to isolate and identify phosphoproteins/glycoproteins in extracellular vesicles (EVs) from human plasma as potential markers to differentiate disease from healthy states. We identified close to 10,000 unique phosphopeptides in EVs by isolating from small volume of plasma samples. Using label-free quantitative phosphoproteomics, we identified 144 phosphoproteins in plasma EVs that are significantly higher in patients diagnosed with breast cancer than in healthy controls. Several novel biomarkers were validated in individual patients using Paralleled Reaction Monitoring for targeted quantitation. Similarly a group of glycoproteins in plasma EVs are identified.

Abstract: Described herein are methods for diagnosing high-risk cancer in a subject by detecting PolySialic Acid (polySia) in a biological sample obtained from the subject, or by detecting polySia and one or more tissue-specific markers in a biological sample obtained from the subject.

Abstract: Disclosed herein are monoclonal antibodies targeting specific tau epitopes, particularly, phosphorylated tau epitopes. Also disclosed are methods of detecting tau protein in a subject, comprising performing an assay using the antibodies or antigen binding fragments thereof on the subject or on a biological sample obtained from the subject. Assay kits containing the disclosed antibodies are also provided. Further, methods of treating or preventing a tauopathy in a subject by administering to the subject tau antibodies or antigen-binding fragments thereof are provided.

Abstract: Methods of testing tumor samples for mutational burden and/or for expression profiles permit the prediction of responsiveness of an individual to immunotherapy comprising PVSRIPO. Those predicted to respond are treated with PVSRIPO and those predicted not to respond are treated with other agents.

Abstract: The present invention relates to biomarkers of lung cancer, particularly to markers that enable distinguishing between subtypes of non-small cell lung cancer (NSCLC), particularly between adenocarcinoma (AC) and squamous cell carcinoma (SCC). In particular, the present invention relates to means and methods for diagnosing, assessing the level of severity and selecting methods of treating NSCLC.

Abstract: The instant disclosure provides biomarkers and methods for identifying subjects at risk of developing cytokine release syndrome (CRS), neurotoxicity, or both after adoptive immunotherapy to guide preemptive intervention, modified therapy, or the like. For example, adverse event biomarkers may be measured in a subject before pre-conditioning chemotherapy, before immunotherapy (e.g., adoptive immunotherapy infusion comprising a chimeric antigen receptor (CAR) modified T cell), or shortly after pre-conditioning chemotherapy and/or immunotherapy. Exemplary biomarkers include temperature, cytokine levels and endothelial activation biomarkers, such as angiopoietin 2, von Willebrand factor (vWF), ratio of angiopoietin 2 to angiopoietin 1, and ratio of ADAMTS13 to vWF. Also provided are methods of treating subjects identified as at risk of developing cytokine release syndrome (CRS), neurotoxicity, or both to minimize such potential adverse events.

Abstract: The present invention provides novel IgE antibodies useful for inhibiting or preventing metastatic cancer. Also provided are methods to inhibit tumor metastasis by modulating the activity of at least one non-tumor cell, treating a patient to inhibit or prevent tumor metastases of a primary solid tumor, treating metastatic carcinoma, reducing metastasis of carcinoma cells, and reducing the growth kinetics of a primary solid tumor or a metastasized cell or tumor.

Abstract: Disclosed herein are methods and devices for antigen-specific T cell identification or neoantigen identification. Also disclosed herein are devices for separating and isolating antigen-specific T cells or other particles of a certain size from a population of particles of different sizes. Also describe herein are methods and devices for the separation and isolation of barcoded T cells from other nanoparticles containing barcodes for subsequent analysis and further processing of a viable T cell.

Abstract: Methods of using detection of PD-L1 expression by circulating cancer cells in the screening, monitoring, treatment and diagnosis of cancer in subjects are disclosed. The methods are based on assaying one or more of circulating tumor cells (CTCs), epithelial to mesenchymal transition CTCs (EMTCTCs), cancer associated macrophage-like cells (CAMLs), and cancer associated vascular endothelial cells (CAVEs) isolated from a subject having cancer for PD-L1 expression.

Abstract: Disclosed herein are biomarkers for hepatocellular carcinoma and pancreatic cancer. The biomarkers may be laminin gamma 2 monomer, PIVKA-II, AFP, CEA, CA19-9, or combinations thereof. Also disclosed herein are methods of diagnosing, prognosing, classifying risk, and monitoring progression of hepatocellular carcinoma or pancreatic cancer by the detecting the level of laminin gamma 2 monomer, PIVKA-II, AFP, CEA, CA19-9, or combinations thereof.

Abstract: Herein are described methods of treating a human subject having acute myeloid leukemia (AML) that is refractory to induction therapy, wherein an MDM2 inhibitor is administered before or concurrently with chemotherapy, which may comprise induction therapy. Refractory AML may be predicted based on decreased expression of MTF2 in cells from a hematological sample obtained from the subject. Also provided are methods of predicting and treating AML responsive to MDM2/HDM2 inhibitors, based on MTF2 expression. One set of additional biomarkers useful in the predictions comprise one or more of H3K27me3, CD84, CD92, MDM2, NPM1, PRICKLE1, SET, ABCB6, POLQ, POLK, POLH, ARTIMIS, MCM6, CD327, CD90 and PARP1. Another set of additional biomarkers useful in the predictions include at least one of H3K27me3, MDM2, NPM1, SET, CD84 and PRICKLE1. Methods of selecting a patient for treatment with an MDM2 inhibitor before or concurrently with chemotherapy are also provided, along with kits and uses.

Abstract: Described herein are methods of identifying immunologically protective neo-epitopes from the cancer tissue DNA of cancer patients using biophysical principles as well as bioinformatics techniques. The identification of immunologically protective neo-epitopes provides pharmaceutical compositions with a limited number of tumor-specific peptides suitable for personalized genomics-driven immunotherapy of human cancer. Specifically disclosed herein is a method of using the conformational stability of an epitope in an MHC protein-binding groove to predict immunogenicity of peptides in a putative neo-peptide set from a tumor from a cancer patient. Pharmaceutical compositions and methods of administration are also included.