56 results about "Anti-Drug Antibody" patented technology

The disclosure features methods of reducing or inhibiting an anti-drug antibody response in a subject, as well as methods of reducing or inhibiting unwanted immune cell activation in a subject to be treated with a messenger RNA (mRNA), comprising administering to the subject a mRNA, e.g., a chemically modified messenger RNA (mmRNA), encoding a polypeptide of interest, wherein the mRNA comprises at least one microRNA (miR) binding site for a miR expressed in immune cells, such as miR-126 binding site and/or miR-142 binding site, such that an anti-drug antibody response to the polypeptide or interest, or unwanted immune cell activation (e.g., B cell activation, cytokine secretion), is reduced or inhibited in the subject. The disclosure further provides therapeutic treatment regimens designed to reduce or inhibit AD A or unwanted immune cell activation (e.g., B cell activation, cytokine secretion) in a subject being treated with mRNA-based therapeutics.

The present invention provides assay methods for the determination of one or more anti-drug antibody (ADA) isotypes in a sample. As a non-limiting example, the assays of the present invention are particularly useful for determining different ADA isotypes in samples from ADA-positive patients receiving an anti-TNFα drug such as REMICADE™ (infliximab) or HUMIRA™ (adalimumab). The present invention also provides methods for optimizing therapy and/or reducing toxicity in subjects receiving TNFα inhibitors for the treatment of TNFα-mediated disease or disorders.

The present inventions relates to the monitoring or assaying of anti-bio-agent antibodies, such as anti-drug antibodies (ADA) in patients who may have developed an antibody response in treatments with immunoglobulin bio-agents.

The invention provides a method for the immunological determination of an antibody against a drug antibody in a sample using a double antigen bridging immunoassay comprising a capture drug antibody and a tracer drug antibody, characterized in that the capture drug antibody is a mixture of said drug antibody conjugated to the solid phase at at least two different antibody sites and the tracer drug antibody is a mixture of said drug antibody conjugated to the detectable label at at least two different antibody sites.

The invention relates to blood concentration detection, in particular to a reagent for detecting monoclonal antibody drugs and anti monoclonal antibody drug antibodies and application of the reagent.The reagent comprises a dissociation solution, the dissociation solution is a glycine buffer solution or an acetic acid-sodium acetate buffer solution with the pH value of 2-3 and 8-10 mM, and the dissociation solution contains Tween-20 with the volume fraction of 0.05%-0.1%, 10-15 mug/ml of mouse IgG and/or 10-15 mug/ml of human IgG. The reagent provided by the invention can effectively reduce non-specific reaction, and solves the problems of strong background signal and low signal-to-noise ratio of the existing acid dissociation reagent.

Methods and kits for detecting antibodies (e.g., anti-drug antibodies) specific for abundant body fluid components are provided. Such methods and kits permit the detection of, for example, human serum albumin in human body fluids, such as blood, plasma and serum.

Provided is a method for measuring ADAs appearing in a patient receiving molecular-targeted therapy with a drug or the like in a simpler and more accurate manner.

A method for measuring anti-drug antibodies (ADAs) in an analyte to be measured, the method comprising:

(1) a step of providing a sample comprising an analyte to be measured for ADAs, the step comprising adding a corresponding drug to an analyte to be measured for ADAs to prepare a sample with a drug-ADAs immune complex formed;

(2) a step of contacting the sample prepared in step (1) with a carrier coated with complement Clq, anti-C3d antibody, or anti-Clq antibody;

(3) a step of contacting a labeled or non-labeled antibody to a drug corresponding to the ADAs with the coated carrier prepared in step (2); and

(4) a step of quantifying the drug-ADAs immune complex binding to the complement Clq, anti-C3d antibody, or anti-Clq antibody.

Polyethylene glycol (PEG) is often conjugated with therapeutic proteins to enhance their PK properties. PEG may, however, be immunogenic, and the presence of PEG in food and cosmetics is believed to result in pre-existing anti-PEG antibodies in humans. Polyclonal and monoclonal antibodies reactive to PEG are provided for use in immunogenicity assay development to detect such anti-drug antibodies. Such antibodies exhibit preferential binding based on the size of PEG with molecular weight ranging from 350 daltons to 40 kD. Anti-PEG antibodies of the invention are engineered to comprise human Fc regions to enable non-bridging immunoassay formats.

Assays, methods, reagents and kits for evaluating the level of an antibody against a nucleic acid molecule, e.g., a double-stranded oligonucleotide or RNA molecule (e.g., dsRNA), are disclosed herein.

Methods and compositions for preventing an immune response to an immunogenic therapeutic agent [i.e. anti-drug antibody (ADA), a.k.a. anti-therapeutic antibody (ATA)] are disclosed. One of the disclosed methods comprises administering an effective amount of an immunosuppressant such as an IL-2 signaling pathway inhibitor, including an antagonist, super agonist or partial agonist to the cytokine IL-2, to the IL-2 receptor (IL-2R), or to IL-2R signal transduction molecules. Inhibitors can be in the form of antibodies or antibody fragments, peptide inhibitors, fusion molecule, small molecules, antibody/small molecule conjugates. Administration of a given inhibitor can decrease the incidence and/or magnitude of an immune response or prevent an immune response, including an antibody response, to a potentially immunogenic therapeutic agent in a non-human primate (NHP). Some of the disclosed methods produce a tolerizing effect in NHPs.

Improved assays for the detection and optionally the quantification of anti-drug antibodies (ADAs) in a sample are provided. The disclosed assays include a protein drug capture assay format and a protein drug target capture assay format, each of which have certain advantages over existing assays.