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NeOnc Technologies Holdings, Inc. (NTHI) ("NeOnc" or the "Company"), a multi–Phase 2 clinical-stage biopharmaceutical company developing novel therapies for central nervous system (CNS) cancers today announced updated clinical results from its current Phase 1/2a and compassionate care studies involving a cohort of 24 patients with recurrent WHO Grade III/IV isocitrate dehydrogenase 1 (IDH1)–mutant astrocytoma treated with its investigational intranasal agent, NEO100.
Clinical results provided support that treatment with intranasally delivered NEO100 resulted in a significant radiographic response, confirmed by contrast-enhanced and perfusion MRI, in 5 of 24 patients (21%)—a rate that markedly exceeds the <8% response typically observed with salvage therapies for recurrent gliomas. Additionally, results indicated that 44% of patients in this Phase 2a study achieved six-month progression-free survival (PFS-6), surpassing the 21–31% benchmark reported in historical datasets for IDH1-mutant recurrent high-grade gliomas. Furthermore, 8 of 24 patients (33%) remained alive ≥18 months after initiation of NEO100, demonstrating long term survival.
In addition, no significant toxicity was reported with intranasal administration of NEO100, even with prolonged, chronic intranasal administration, underscoring its potential utility as a therapeutic option for this patient population.
Posted In: NTHI
