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DISPOSABLE DEVICE FOR RAPID POINT-OF-CARE DETECTION AND COMPARISON OF ANTIBODY RESPONSES AGAINST THERAPEUTIC PROTEINS IN RHEUMATOID ARTHRITIS PATIENTS

Award Number: R43AR081736
ORGANIZATION: NATIONAL INSTITUTE OF ARTHRITIS & MUSCULOSKELETAL & SKIN DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/20/2022
PERIOD OF PERFORMANCE END DATE: 08/31/2025

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DISPOSABLE DEVICE FOR RAPID POINT-OF-CARE DETECTION AND COMPARISON OF ANTIBODY RESPONSES AGAINST THERAPEUTIC PROTEINS IN RHEUMATOID ARTHRITIS PATIENTS - PROJECT SUMMARY/ABSTRACT The goal of this project is to develop a multiplexed rapid point-of-care diagnostic (“disposable device”) to detect antibodies (“Abs”) against therapeutic monoclonal antibodies (“mAbs”) approved for the treatment of Rheumatoid Arthritis (RA). Patients often develop anti-mAb Abs, which may abrogate the therapeutic mAb efficacy and/or cause adverse events. We have devised a unique use of chimeric proteins as capture reagents in multiplexed disposable devices, which eliminate nonspecific signal during anti-mAb Ab screening, and allows direct comparison of their immunogenicity and risk assessment. The scientific approach is described in granted U.S. patents assigned to ConquerAb Inc. The disposable device allows Ab isotype detection in less than 15 minutes from one drop of blood, and can be used before the next drug infusion (trough mAb concentration) for detection of free anti-mAb Abs, suggesting selection of dose or an alternative treatment. In addition, this disposable device will harmonize Ab detection, allowing integration of patient data generated at different point-of-care facilities (big data). Existing assays for anti-mAb detection, such as enzyme-linked immunosorbent assay (ELISA) require preparation of serum or plasma, sample handling, multiple steps, trained operators, may take days to provide results, and are more prone to errors. In addition, some of those assays may use an acid dissociation step, which unfortunately may denature Abs. Another problem is that the time of sample collection can vary, resulting in samples that have different concentrations of mAbs in complex with anti-mAb Abs, leading to inconsistent results that cannot be validly integrated. For this Phase 1 we propose development of a multiplexed diagnostic for detection of anti-mAb Abs with a proprietary technology. The test strip will also be incorporated into a patented self-contained disposable device, and tested in a clinical study with anonymized RA patients. This is an innovative strategy that can have a major impact in detecting, comparing and mitigating unwanted immunogenicity of protein-based therapies, and also in the utilization of big data for precision medicine.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = -$68 )
2025	2022	CONQUERAB INC.	2701 NW 23RD BLVD APT 156	GAINESVILLE	FL	32605	ALACHUA	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	1	9/4/2025	NEW	-$68
														Subtotal = -$68

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2022	CONQUERAB INC.	747 SW 2ND AVE STE 347	GAINESVILLE	FL	32601	ALACHUA	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	1	8/13/2024	NEW	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2022	CONQUERAB INC.	747 SW 2ND AVE STE 347	GAINESVILLE	FL	32601	ALACHUA	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	1	9/26/2023	NEW	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $258,953 )
2022	2022	CONQUERAB INC.	747 SW 2ND AVE	GAINESVILLE	FL	32601	ALACHUA	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	1	9/19/2022	NEW	$258,953
														Subtotal = $258,953

Grand Total All Awards = $258,885

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DISPOSABLE DEVICE FOR RAPID POINT-OF-CARE DETECTION AND COMPARISON OF ANTIBODY RESPONSES AGAINST THERAPEUTIC PROTEINS IN RHEUMATOID ARTHRITIS PATIENTS

Award Number: R43AR081736

ORGANIZATION: NATIONAL INSTITUTE OF ARTHRITIS & MUSCULOSKELETAL & SKIN DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/20/2022

PERIOD OF PERFORMANCE END DATE: 08/31/2025

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