Claims for Patent: 9,903,866

Summary for Patent: 9,903,866

Title:	Portable devices for detection of antibodies against therapeutic drugs
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.
Inventor(s):	Barbosa; Maria D. F. S. (Philadelphia, PA)
Assignee:	ConquerAb Inc. (Philadelphia, PA)
Application Number:	15/376,775
Patent 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.

Details for Patent 9,903,866

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Janssen Biotech, Inc.	REMICADE	infliximab	For Injection	103772	08/24/1998		2035-04-10
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	12/31/2002		2035-04-10
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	02/21/2008		2035-04-10