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Precision quality check of immunotherapeutics via single-cell cytokine mapping

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44CA210841-02
Agency Tracking Number: R44CA210841
Amount: $1,884,667.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: 102
Solicitation Number: PA16-302
Solicitation Year: 2016
Award Year: 2017
Award Start Date (Proposal Award Date): 2017-08-01
Award End Date (Contract End Date): 2019-03-31
Small Business Information
Wilmington, DE 19808-1645
United States
DUNS: 078770128
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (203) 868-9905
Business Contact
Phone: (203) 208-4111
Research Institution

Adoptive transfer of autologous T cells engineered to express chimeric antigen receptorsCARshas emerged
as a promising immunotherapy for patients with hematologic malignanciessuch as CDCARs in leukemias
and lymphomasHoweverchallenges remain in terms of manufacturing consistency and the functional profile
of the CAR T cell productsince infused cellsasliving drugscan be activated and release a variety of
cytokines upon specific antigen recognitionThese secreted cytokines may result in not only therapeutic efficacybut also life threatening immunotoxicitysuch as cytokine release syndrome and neurologic toxicityIt is essential
for cancer patients to have a full spectrum potency and toxicity profiling of CAR T cell products before infusionWe have developed a single cell barcode chipSCBCtechnologywhich enablesaassayingsecreted
proteins per individual live cellba broad range of immune cell functions covering efficacy and safetycis
designed to fit various types of immune cellsdis the first quantitative metric of these proteins per cellanderequires samples sizes totaling onlycellsall critical leaps over flow cytometry based platformsWith the collaboration of two leading CAR T pharmaceutical companiesIsoPlexissingle cell deep profiling has
revealedfor the first timea pre infusion correlate to post infusion patient responseThe SCBC analysis ofpatients with lymphoma demonstrates a significant correlation of the polyfunctional strength of the CAR T cells
with objective responsecomplete or partialto the CAR T cell therapypindicating a powerful metric
of quality assessmentwhere the other gold standard technologies did not detect any significant correlationsBased on the clinical data and the automation progress in our SBIR Phase I grantwe are proposing the following
specific aims in this two year Phase II applicationAIMDevelop automatedflow cellconsumable
compartmentwhich capturesplex single cell cytokine responseto prepare for full automation required by
large CAR T trialmonthsAIMProduce a fully automated cartridge analysis and workflow systemto
allowsamples assayed in parallel with minimal user interactionallowing easy introduction into clinical core
labsmonthsAIMProduce a comprehensive informatics suiteand fully test our automated system and
informatics in twopatient cohort trialsproviding robust and predictive biomarkers for pre infusion CAR T
qualityEstablish MSKCC and UCLA beta sites for post phase II transitionmonthsWith this Phase II submissionwe will deliver the first effective CAR T pre infusion quality check assay to predict
objective response in patientsin an easy to useautomated system that can be used throughout all cellular
immunotherapy trials

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

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