2022
Intramuscular (IM) INO-5401 + INO-9012 with electroporation (EP) in combination with cemiplimab (REGN2810) in newly diagnosed glioblastoma.
Reardon D, Brem S, Desai A, Bagley S, Kurz S, De La Fuente M, Nagpal S, Welch M, Hormigo A, Forsyth P, Mandel J, Khagi S, Aiken R, Walbert T, Lieberman F, Portnow J, Battiste J, Gillespie E, Lowy I, Skolnik J. Intramuscular (IM) INO-5401 + INO-9012 with electroporation (EP) in combination with cemiplimab (REGN2810) in newly diagnosed glioblastoma. Journal Of Clinical Oncology 2022, 40: 2004-2004. DOI: 10.1200/jco.2022.40.16_suppl.2004.Peer-Reviewed Original ResearchPre-treatment tissueCohort AT cellsLytic potentialAntigen-specific T cellsImmune responsePost-treatment tumor tissuesFlow cytometryMedian OS durationMGMT-unmethylated patientsPD-1 inhibitorsDiagnosed GBM patientsT cell infiltrationAdverse event profileImmune-related markersImmune cell markersRobust immune responseCellular immune responsesWilcoxon rank sum testImmune response suppressionGene expressionPresence of perforinGene expression signaturesRank sum testMedian OS
2020
LTBK-01. INO-5401 AND INO-9012 DELIVERED INTRAMUSCULARLY (IM) WITH ELECTROPORATION (EP) IN COMBINATION WITH CEMIPLIMAB (REGN2810) IN NEWLY DIAGNOSED GLIOBLASTOMA
Reardon D, Brem S, Desai A, Bagley S, Kurz S, De La Fuente M, Nagpal S, Welch M, Hormigo A, Forsyth P, Mandell J, Khagi S, Aiken R, Walbert T, Lieberman F, Portnow J, Batiste J, Carroll N, Sylvester A, Campbell P, Lowy I, Dolgoter A, Boyer J, Kraynyak K, Morrow M, McMullan T, Weiner D, Skolnik J. LTBK-01. INO-5401 AND INO-9012 DELIVERED INTRAMUSCULARLY (IM) WITH ELECTROPORATION (EP) IN COMBINATION WITH CEMIPLIMAB (REGN2810) IN NEWLY DIAGNOSED GLIOBLASTOMA. Neuro-Oncology 2020, 22: ii237-ii237. PMCID: PMC7678727, DOI: 10.1093/neuonc/noaa215.988.Peer-Reviewed Original ResearchCohort AMedian OSAntigen-specific T cell responsesImmune responseRobust systemic immune responsesInterferon-gamma ELISPOTDiagnosed GBM patientsT cell responsesEncoding tumor antigensAdverse event profileNewly diagnosed glioblastomaPeripheral immune responseSystemic immune responsesCheckpoint inhibitionPD-1Diagnosed GBMDiagnosed glioblastomaOverall survivalCohort B.Tumor antigensCD8+T cellsMedian agePrimary endpointCohort BEvent profileINO-5401 and INO-9012 delivered intramuscularly (IM) with electroporation (EP) in combination with cemiplimab (REGN2810) in newly diagnosed glioblastoma (GBM): Interim results.
Reardon D, Brem S, Desai A, Bagley S, Kurz S, De La Fuente M, Nagpal S, Welch M, Hormigo A, Carroll N, Bartra S, Campbell P, Bhatt K, Lowy I, Boyer J, Kraynyak K, Morrow M, McMullan T, Weiner D, Skolnik J. INO-5401 and INO-9012 delivered intramuscularly (IM) with electroporation (EP) in combination with cemiplimab (REGN2810) in newly diagnosed glioblastoma (GBM): Interim results. Journal Of Clinical Oncology 2020, 38: 2514-2514. DOI: 10.1200/jco.2020.38.15_suppl.2514.Peer-Reviewed Original ResearchNewly-diagnosed GBMTumor inflammationCohort AT cell responsesNewly diagnosed glioblastomaWeeks of treatmentCheckpoint inhibitionPD-1Cohort B.Combination therapyPrimary endpointCD8+T cellsPhase I/IICohort BPlatelet countLymphocyte countSafety profileCemiplimabSurvival advantageCohort studyLytic potentialFlow cytometryPatientsGlioblastomaCohortP858 An open-label, multi-center trial of INO-5401 and INO-9012 delivered by electroporation (EP) in combination with cemiplimab in subjects with newly-diagnosed glioblastoma (GBM)
Skolnik J, Reardon D, Brem S, Desai A, Bagley S, Kurz S, de la Fuente M, Nagpal S, Welch M, Sacchetta B, Bartra S, Bredlau A, Lowy I, Kraynyak K, Morrow M, McMullan T, Boyer J. P858 An open-label, multi-center trial of INO-5401 and INO-9012 delivered by electroporation (EP) in combination with cemiplimab in subjects with newly-diagnosed glioblastoma (GBM). Journal For ImmunoTherapy Of Cancer 2020, 8: a8. DOI: 10.1136/lba2019.12.Peer-Reviewed Original ResearchNewly-diagnosed GBMCheckpoint inhibitorsCheckpoint inhibitionOverall survivalCohort ASafety profileClinical efficacyPD-1 checkpoint inhibitorsImmune-related AECycles of temozolomideT cell responsesNewly-diagnosed glioblastomaWeeks of treatmentPreliminary clinical efficacyMulti-center trialInstitutional ethics boardMaintenance temozolomidePD-1Open-labelCohort B.Median agePhase I/IICohort BCemiplimabAdverse events