Portable devices for detection of antibodies against therapeutic drugs

• US 9,903,866 B2
• Filed: 12/13/2016
• Issued: 02/27/2018
• Est. Priority Date: 04/05/2016
• Status: Active Grant

• Current Assignee: Conquerab Inc.
• Original Assignee: Conquerab Inc.
• Inventors: Barbosa, Maria D. F. S.
• Primary Examiner(s): COUNTS, GARY W
• Application Number:
  US15/376,775
• Publication Number:
  US 20170285023A1
• Time in Patent Office: 441 Days
• Field of Search: None
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: G01N 2021/752 Devices comprising reaction zones
• CPC Class Codes: G01N 2021/757 using immobilised reagents
• CPC Class Codes: G01N 21/75 Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated systems in which material is burnt in a flame or plasma G01N21/72, G01N21/73
• CPC Class Codes: G01N 2800/24 Immunology or allergic disorders SLE G01N2800/104
• CPC Class Codes: G01N 2800/50 Determining the risk of developing a disease
• CPC Class Codes: G01N 33/54388 based on lateral flow
• CPC Class Codes: G01N 33/564 for pre-existing immune complex or autoimmune disease , i.e. systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, rheumatoid factors or complement components C1-C9
• CPC Class Codes: G01N 33/6854 Immunoglobulins
• CPC Class Codes: G06F 7/06 Arrangements for sorting, selecting, merging, or comparing data on individual record carriers

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.

Claims

1. 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 a variable region of a therapeutic antibody that is capable of binding to anti-drug antibodies that are 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 contacted with the sample-collecting pad would laterally flow through the conjugate pad and subsequently to the membrane; and

wherein the anti-drug antibodies are human anti-drug antibodies.

2. The portable device of claim 1, further comprising a filter positioned upstream from the sample-collecting pad.

3. The portable device of claim 1, further comprising a liquid reservoir positioned upstream from the sample-collecting pad.

4. The portable device of claim 1, further comprising a filter and a liquid reservoir positioned upstream from the sample-collecting pad.

5. The portable device of claim 1, wherein the constant region is a constant region from a non-human immunoglobulin.

6. The portable device of claim 1, wherein the membrane comprises two or more groups of capture agents, each group positioned at a different location on the membrane.

7. The portable device of claim 1, wherein the anti-drug antibodies are one or more of the antibody isotypes selected from the group consisting of IgG, IgM, and IgE.

8. The portable device of claim 1, wherein the labeled antibodies are capable of binding to anti-infliximab and anti-adalimumab antibodies.

9. The portable device of claim 1, wherein the capture agents comprise the variable regions of adalimumab or infliximab.

10. The portable device of claim 6, wherein the capture agents comprise either the variable region of adalimumab or the variable region of infliximab, wherein the capture agents comprising the variable region of adalimumab are positioned at a different location on the membrane than the capture agents comprising the variable region of infliximab.

11. 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 that are 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 contacted with the sample-collecting pad would laterally flow through the conjugate pad and subsequently to the membrane.

12. The portable device of claim 11, wherein the labeled entities are labeled antibodies.

13. The portable device of claim 11, wherein the therapeutic drug is an antibody.

14. The portable device of claim 11, wherein the therapeutic drug is a variable section of an antibody.

15. The portable device of claim 11, wherein the therapeutic drug is a natural product.

16. The portable device of claim 11, wherein the therapeutic drug is a small molecule drug.

17. The portable device of claim 11, wherein the therapeutic drug is a peptide.

18. The portable device of claim 11, wherein the therapeutic drug is a therapeutic protein.

19. The portable device of claim 11, wherein the therapeutic drug is a small-molecule-biotherapeutic conjugate.