Portable devices for detection of antibodies against therapeutic drugs
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Publication Number
US-9903866-B2
Publication Date
2018-02-27
Expiration Date
Abstract
Portable devices for anti-drug antibodies (ADAs) testing are provided. These devices can be used in various applications, including but not restricted to the following: uniform testing of patients for ADAs; selection of therapeutic drug for patient treatment; evaluation of the need to change therapeutic drug or to apply tolerance regimens; selection of patients for clinical trials; comparison of therapeutic drugs marketed for a given disease and also gene therapy; scientific guidance for discovering therapeutic drugs; therapeutic drug development; postmarketing surveillance of therapeutic drugs.
Core Innovation
The invention relates to portable point-of-care or self-testing devices for detecting anti-drug antibodies in samples, including human anti-drug antibodies directed against therapeutic drug classes. The device provides a lateral flow format with a sample-receiving port adjacent to a sample-collecting pad, a conjugate pad comprising labeled antibodies, and a membrane comprising a capture agent.
A central feature is the membrane capture agent comprising a chimeric protein that combines a therapeutic drug and a constant region of an antibody. The therapeutic drug is capable of binding anti-drug antibodies specific to the therapeutic drug, while the constant region is from a different species than the species producing the anti-drug antibodies to be detected.
This species-mismatched constant region is used to reduce non-specific binding/background and to provide improved specificity for functional ADA detection. The described scope includes applications for patient stratification and immunogenicity assessment across biologics and related drug types, and supports standardized immunogenicity comparisons across therapeutic drugs.
Claims Coverage
The document contains two independent claims. Both independent claims cover a portable lateral-flow device with a sample pad and conjugate pad with labeled binding entities, and a membrane capture agent formed by a chimeric protein combining a therapeutic drug with an antibody constant region from a different species, enabling detection of human anti-drug antibodies specific to the therapeutic drug.
Portable lateral-flow device for human anti-drug antibodies
A portable device comprising a sample-receiving port adjacent to a sample-collecting pad, a conjugate pad comprising labeled antibodies capable of binding to a constant region of an anti-drug antibody, and a membrane comprising a capture agent comprising a chimeric protein comprising a therapeutic drug and a constant region of a different antibody, wherein the therapeutic drug is capable of binding to anti-drug antibodies specific to the therapeutic drug, wherein the constant region is from a different species than the species producing the anti-drug antibodies to be detected, wherein a sample laterally flows through the conjugate pad and subsequently to the membrane, and wherein the anti-drug antibodies are human anti-drug antibodies.
Portable lateral-flow device for testing human anti-drug antibodies in tissues and body fluids
A portable device for testing human anti-drug antibodies in tissues and body fluids, comprising a sample-receiving port adjacent to a sample-collecting pad, a conjugate pad comprising labeled entities capable of binding to a constant region of a human anti-drug antibody, and a membrane comprising a capture agent comprising a chimeric protein comprising a therapeutic drug and a constant region of an antibody, wherein the therapeutic drug is capable of binding to human anti-drug antibodies specific to the therapeutic drug, wherein the constant region is from a different species than the species producing the anti-drug antibody to be detected, and wherein a sample laterally flows through the conjugate pad and subsequently to the membrane.
Across both independent claims, the main inventive concept is a portable lateral-flow format that couples labeled binding on a conjugate pad to a membrane capture agent comprising a chimeric protein of therapeutic drug plus an antibody constant region from a different species. This pairing is configured to bind and detect human anti-drug antibodies specific to the therapeutic drug while using the species-mismatched constant region as part of the detection scheme.
Stated Advantages
Provides improved specificity for functional ADA detection while reducing non-specific binding/background by using a constant region from a different species.
Enables standardized immunogenicity comparisons across therapeutic drug classes.
Supports detection of ADAs directed against therapeutic drugs by using capture agents configured with the therapeutic drug and species-mismatched constant regions.
Documented Applications
Patient stratification and immunogenicity assessment based on detecting anti-drug antibodies.
Dosing/tolerance guidance and trial selection for therapeutic drug programs [procedural detail omitted for safety].
Drug comparison and postmarketing surveillance using portable anti-drug antibody detection.
Companion diagnostic use with database access code [procedural detail omitted for safety].
Use for standardized immunogenicity comparisons across therapeutic drug classes, including biologics/biosimilars/biobetters [procedural detail omitted for safety].
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