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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: 1R44AI138838-01
Agency Tracking Number: R44AI138838
Amount: $298,851.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NIAID
Solicitation Number: PA17-302
Solicitation Year: 2017
Award Year: 2018
Award Start Date (Proposal Award Date): 2018-02-01
Award End Date (Contract End Date): 2019-01-31
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) 455-9976
Business Contact
Phone: (858) 754-3208
Research Institution

Project SummaryBiologics are increasingly used in the treatment of autoimmune and inflammatory diseasesMonoclonal antibodymAbdrugs that target tumor necrosis factor alphaTNF asuch as Remicadeinfliximabare blockbuster
drugs global sales of infliximab were close to $ B inHoweverpost approval studies have revealed
inefficiencies in the use of these anti TNF a biologicssome patients do not respond to mAb therapies upon
inductionwhereas others lose response over timePrimary causes of dosing inefficiency include a rigid dosing
schedule and the frequent development of anti drug antibodyADAresponses in treated patientsThe clinical
data strongly point to the need for therapeutic dose monitoring of mAb drugs to ensure an optimal therapeutic
window in every patientWhile laboratory based test methods are availablethere are no point of care tests for
measuring the concentration of either infliximab or ADAsThe goal of this project is to develop lateral flow
immunoassaysLFAsfor rapid measurement of free infliximab and ADA levels in finger stick blood samplesOur proprietary technology uses small peptide mimeticsVeritopesof the antigen as a specific capture reagentOur tests are based on ligand binding activityand are thus expected to detect the parent mAb druginfliximabas well as new biosimilarsinfliximab dyybinfliximab abdaWe previously qualified the technical feasibility of
Veritope based LFAs for the detection of rituximab concentration in patient serumThe objectives of this project
are togenerate Veritope specific for infliximab and implement the peptide in a LFA for the measurement of
free infliximab levels in blood at the point of careDemonstrate ADA detection for infliximab using a
complement point of care LFA that incorporates an initial acid dissociation stepandvalidate free drug and
ADA LFA using patient samplesThese innovative products will fulfill of an unmet clinical need for a rapidcost
effectiveand accurate dose monitoring assayPrecision dosing through data drivenpersonalized regimens will
improve treatment outcomes and maximize the efficient use of infliximab Project NarrativeInfliximab is a monoclonal antibody used to treat Crohn s disease and ulcerative colitisbut there is growing
evidence that some patients are not receiving a therapeutic dose of this agent when given standard dosesThis
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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