# Personalized precision dosing of anti-TNF biologic therapies

> **NIH NIH R44** · ABREOS BIOSCIENCES, INC. · 2020 · $841,118

## Abstract

Biologics are increasingly used in the treatment of autoimmune and inflammatory diseases. Monoclonal antibody
(mAb) drugs that target tumor necrosis factor alpha (TNF-a), such as Remicade (infliximab), are blockbuster
drugs—global sales of infliximab were close to $6B in 2016. However, post-approval studies have revealed
inefficiencies in the use of these anti-TNF-a biologics; some patients do not respond to mAb therapies upon
induction, whereas others lose response over time. Primary causes of dosing inefficiency include a rigid dosing
schedule and the frequent development of anti-drug antibody (ADA) responses in treated patients. The clinical
data strongly point to the need for therapeutic dose monitoring of mAb drugs to ensure an optimal therapeutic
window in every patient. While laboratory-based test methods are available, there are no point-of-care tests for
measuring the concentration of either infliximab or ADAs. The goal of this project is to develop lateral flow
immunoassays (LFAs) for rapid measurement of free infliximab and ADA levels in finger-stick blood samples.
Our proprietary technology uses small peptide mimetics (Veritopes™) of the antigen as a specific capture reagent.
Our tests are based on ligand-binding activity, and are thus expected to detect the parent mAb drug (infliximab),
as well as new biosimilars (infliximab-dyyb, infliximab-abda). We previously qualified the technical feasibility of
Veritope-based LFAs for the detection of rituximab concentration in patient serum. The objectives of this project
are to: 1) generate Veritope specific for infliximab and implement the peptide in a LFA for the measurement of
free infliximab levels in blood at the point-of-care, 2) Demonstrate ADA detection for infliximab using a
complement point-of-care LFA that incorporates an initial acid dissociation step, and 3) validate free drug and
ADA LFA using patient samples. These innovative products will fulfill of an unmet clinical need for a rapid, cost
effective, and accurate dose monitoring assay. Precision dosing through data-driven, personalized regimens will
improve treatment outcomes and maximize the efficient use of infliximab.

## Key facts

- **NIH application ID:** 9888300
- **Project number:** 5R44AI138838-03
- **Recipient organization:** ABREOS BIOSCIENCES, INC.
- **Principal Investigator:** BRADLEY T MESSMER
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $841,118
- **Award type:** 5
- **Project period:** 2018-02-01 → 2021-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9888300

## Citation

> US National Institutes of Health, RePORTER application 9888300, Personalized precision dosing of anti-TNF biologic therapies (5R44AI138838-03). Retrieved via AI Analytics 2026-06-25 from https://api.ai-analytics.org/grant/nih/9888300. Licensed CC0.

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