Imatinib immunoassay
Inventors
Salamone, Salvatore J. • Courtney, Jodi Blake • Volkov, Alexander
Assignees
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Publication Number
US-8263749-B2
Publication Date
2012-09-11
Expiration Date
Abstract
Novel conjugates and immunogens derived from imatinib and monoclonal antibodies generated by these immunogens are useful in immunoassays for the quantification and monitoring of imatinib or its pharmacologically active salts in biological fluids.
Core Innovation
Immunoassay reagents and antibodies are provided for therapeutic drug monitoring involving imatinib and its pharmacologically active salts. The approach addresses imatinib pharmacokinetic variability in biological fluids by using immunoassay reagents that selectively recognize imatinib and pharmacologically active salts while avoiding misleading signals from related metabolites.
The invention centers on antibodies that bind selectively to imatinib and its pharmacologically active salts without having any substantial cross-reactivity with N-desmethyl imatinib. By reducing cross-reactivity to N-desmethyl imatinib, the immunoassay is enabled to provide accurate readings for therapeutic drug management rather than false results caused by the active metabolite.
Immunogen and conjugate design is based on imatinib-derived immunogens/conjugates having a carrier-linked imatinib derivative with defined spacer/linker variables. The carrier includes a polymer with reactive thiol or reactive amino groups, and the linked compound is defined using an organic spacing group (Y), a terminal functional group (X), and an integer p (0 to 1), to generate monoclonal antibodies and/or polyclonal antibodies screened for selective binding and reduced cross-reactivity.
Claims Coverage
The partial document includes two independent claims: one directed to a selective antibody and one directed to a kit containing assay reagents and the selective antibody. Across these claims, the inventive features include selective binding of imatinib and pharmacologically active salts with no substantial cross-reactivity to specified metabolites, and a defined carrier-linked immunogen/conjugate structure characterized by Y, X, and p with a reactive thiol or amino polymer.
Selective imatinib-binding antibody without substantial cross-reactivity to N-desmethyl imatinib
An antibody that binds selectively to imatinib and its pharmacologically active salts without having any substantial cross-reactivity with N-desmethyl imatinib.
Immunogenic carrier-linked imatinib immunogen defining Y, X and p for antibody generation
An antibody wherein the immunogen is prepared using an immunogenic carrier containing a polymer with a reactive thiol or reactive amino group conjugated to a compound defined by wherein Y is an organic spacing group, X is a terminal functional group capable of binding to said carrier through said amino or thiol group, and p is an integer from 0 to 1.
Kit for determining imatinib or pharmacologically active salts using a carrier conjugate and selective antibody
A kit comprising reagents in separate containers for determining the presence of imatinib or its pharmacologically active salts in a patient sample, including a first reagent that is a conjugate of a carrier containing a polymer with either a reactive thiol or amino group with a compound defined by Y, X and p, and a second reagent being an antibody that binds selectively to imatinib and its pharmacologically active salts without having any substantial cross-reactivity with the pharmacologically inactive metabolites of imatinib.
Conjugate-defined kit reagent and antibody selectivity against inactive imatinib metabolites
The kit wherein the carrier conjugate includes a polymer with a reactive thiol or amino group conjugated to a compound defined by wherein Y is an organic spacing group, X is a terminal functional group capable of binding to said carrier through said amino or thiol group, and p is an integer from 0 to 1, and the antibody lacks substantial cross-reactivity with pharmacologically inactive metabolites of imatinib.
Claim coverage focuses on antibodies that selectively bind imatinib and its pharmacologically active salts while avoiding substantial cross-reactivity to N-desmethyl imatinib or pharmacologically inactive imatinib metabolites, and on assay kits where a defined carrier conjugate reagent is used together with the selective antibody for determining imatinib or its pharmacologically active salts in patient samples.
Stated Advantages
Immunoassay selectivity for imatinib and its pharmacologically active salts without substantial cross-reactivity to N-desmethyl imatinib.
Reduced inaccurate immunoassay readings caused by cross-reactivity with N-desmethyl imatinib.
Support for therapeutic drug monitoring/therapeutic drug management in biological fluids by enabling accurate immunoassay readings.
Documented Applications
Therapeutic drug monitoring/therapeutic drug management in biological fluids for imatinib or its pharmacologically active salts.
Determining the presence of imatinib or its pharmacologically active salts in a patient sample using a kit.
Measuring the amount of imatinib and its pharmacologically active salts in a sample (dependent kit use case).
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