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A Single-Cell Proteomic instrument for Predictive Product Quality Check in Autologous CAR-T Immunotherapies

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44CA210841-04
Agency Tracking Number: R44CA210841
Amount: $1,699,322.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NCI
Solicitation Number: CA18-011
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-06-17
Award End Date (Contract End Date): 2022-05-31
Small Business Information
2711 CENTERVILLE RD STE 400, Wilmington, DE, 19808-1645
DUNS: 078770128
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 (203) 208-4111
Business Contact
Phone: (203) 208-4111
Research Institution
While CAR T therapies have advanced in the clinicthere are still two specific issues using these breakthrough therapies for blood cancersDurable responses in patients are only atand Cytokine Release Syndrome occurs inof treated patientsThese limitationsfor a drug that costs as much as $may cost an additional $for treating adverse events leading to caution for many clinical centers to administer these therapiesIsoPlexis is developing its technology to predict respondersnon respondersand toxicity in patientsdirectly from the CAR T cell therapy product prior to entry in the patientsThis would allow clinical centers to provide improved product release criteria improving CAR T therapy production and potentially increasing patient response while reducing expensive side effectsIsoPlexis recently published in the journal Blood in July ofshowing that across a National Cancer Institute Trial ofNHL patientsonly the IsoCode Single Cell Chip predicted responders and non responderspwhere existing product evaluation technologies like flow cytometry and bulk ELISA did notThe IsoCode s ability to detectsecreted proteins per cell identified unique polyfunctional cells in responding patientsin a metric termed PSIThis published work with Kite Pharma and the NCI also demonstrated the ability to predict certain types of toxicities in combination with in vivo metricsincluding gradeneurotoxicitypand cytokine release syndromepIn its NCI phase II CAR T SBIRIsoPlexis validated this CAR T IsoCode Chipand built and tested the fully automated workflow for the IsoCode Chip on the IsoLight instrumentThe IsoLight is a sample to answer device on which users can processsamples simultaneouslyImages are taken overnight through alaser based optics systemand backend ELISA steps are run in an automated fashionThe CAR T polyfunctional results are directly available in the IsoSpeak software suiteThe instrument is now working and analyzing CAR T samplesIsoPlexisIsoCode Chipfor use in CAR Twas recognized as theInnovation ofby the Scientist Magazineas well as Fierce Life SciencesThe IsoLight instrument was recognized for ease of use by the leading Global Red Dot Design Awardand IsoSpeak was recognized as TopInnovation by Pharma Tech OutlookThe Phase IIB goal advances the IsoLight RUO system and clinically validates the IsoCode and IsoLight across centers delivering an IsoLight Dx to provide the autologous T cell therapy market predictive therapeutic product evaluationAimDevelop automation for manufacturing consumable chip to meet larger production needsAimDevelopment of enterprise software modulesincluding CFR Partcompliance to enable GMP pharmaceutical environment for CAR T product releaseAimDevelop automated IsoLight production and calibration processes verifying with four instruments overmonths to meet IsoLight scalability requirements in CAR T releaseAimAchieve IsoLight clinical validation according to best in class ROCand statistical parametersOne CAR T trial in NHLMoffitt CCa CAR T trial in ALLMemorial Sloan Kettering CCand a CAR T trial in DLBCLStanford CCAdoptive 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 productas cytokines secreted by these cellspost infusionresult in not only therapeutic efficacy but also life threatening immunotoxicityWe have developed a single cellhighly multiplexedbarcoding device that measures all safety and efficacy functional cytokines secretedto meet the need of cancer patients by providing full spectrum potency and toxicity profiling of CAR T cell therapies before infusion as part of the clinical quality control process

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

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