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GB13 is a potent treatment for IL13Ra2-expressing GBM and DMG and improves standard-of-care therapy (Exhibit Hall A/B) - Nov 11, 2023 - Abstract #SNO2023SNO_755; Finally, we determined that GB13 works in concert with clinical standard-of-care radiation therapy to increase cell death, compared to radiation alone. Based on this work, we and our clinical collaborators are confident that the current work confirms GB13 has many important characteristics as an exciting therapy, which continues development towards a Phase I clinical trial for both GBM and pediatric DMG.
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Enrollment change, Trial completion date, Trial primary completion date: Phase 3 Randomized, Double-blind, Controlled Study of ICT-107 in Glioblastoma (clinicaltrials.gov) - Apr 3, 2023 P3, N=234, Suspended, Based on this work, we and our clinical collaborators are confident that the current work confirms GB13 has many important characteristics as an exciting therapy, which continues development towards a Phase I clinical trial for both GBM and pediatric DMG. N=414 --> 234 | Trial completion date: Dec 2021 --> Dec 2025 | Trial primary completion date: Dec 2019 --> Dec 2025
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Journal: IL-13Rα2 Status Predicts GB-13 (IL13.E13K-PE4E) Efficacy in High-Grade Glioma. (Pubmed Central) - May 30, 2022 In adults, glioblastoma (GBM) remains largely intractable, with a median survival of approximately 14 months despite standard clinical care of radiation and temozolomide...Direct intratumoral administration of GB-13 via convection-enhanced delivery (CED) significantly decreased tumor burden and resulted in prolonged survival in IL-13Rα2-upregulated orthotopic xenograft models of HGG. In summary, administration of GB-13 demonstrated a promising pharmacological response in HGG models both in vitro and in vivo in a manner strongly associated with IL-13Rα2 expression, underscoring the potential of this IL-13Rα2-targeted therapy in a subset of HGG with increased IL-13Rα2 levels.
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IL-13Rα2 immunoconjugate targeted therapy for H3K27M-mutant midline gliomas (Exhibit Hall D) - Nov 16, 2021 - Abstract #SNO2021SNO_510; Furthermore, we observed enhanced drug tissue retention and volume of distribution after CED, suggesting IL13.E13K-PE4E is capable of covering the target area and remaining at the site of infusion long enough to impart therapeutic effects. In summary, administration of IL13.E13K-PE4E demonstrated a potent pharmacological response in H3K27M DMG and GBM models both in vitro and in vivo in a manner strongly associated with IL13Rα2 expression, underscoring the potential of IL13Rα2 targeted therapy in a subset of these tumors.
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Enrollment change, Trial primary completion date: A Study of ICT-107 Immunotherapy in Glioblastoma Multiforme (GBM) (clinicaltrials.gov) - Oct 10, 2014 P2b, N=124, Active, not recruiting, Not yet recruiting --> Recruiting N=200 --> 124 | Trial primary completion date: Oct 2014 --> Dec 2013
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