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Personalized precision dosing of anti-TNF biologic therapies

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 4R44AI138838-02
Agency Tracking Number: R44AI138838
Amount: $1,582,190.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NIAID
Solicitation Number: PA17-302
Solicitation Year: 2017
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-03-07
Award End Date (Contract End Date): 2021-02-28
Small Business Information
San Diego, CA 92122-4126
United States
DUNS: 068800915
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (858) 754-3208
Business Contact
Phone: (858) 534-1783
Research Institution

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.Infliximab is a monoclonal antibody used to treat Crohn’s disease and ulcerative colitis, but there is growing
evidence that some patients are not receiving a therapeutic dose of this agent when given standard doses. This
project will finalize development and fully validate simple lateral flow assay devices that can measure within
minutes how much infliximab is present in a patient’s blood.

* Information listed above is at the time of submission. *

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