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NeOnc Technologies Reports Phase 1 Dose-Escalation Results for Dosing and Toxicity and Determination of Recommended Phase 2 Dose for Oral NEO212; Management to Host KOL Conference Call Today at 9 a.m. ET
CALABASAS, Calif., March 04, 2026 (GLOBE NEWSWIRE) -- NeOnc Technologies Holdings, Inc. (Nasdaq: NTHI) (“NeOnc” or the “Company”), a multi-Phase 2
About this update from Neonc Technologies Holdings, Inc.
[{"type":"text","content":"CALABASAS, Calif., March 04, 2026 (GLOBE NEWSWIRE) -- NeOnc Technologies Holdings, Inc. (Nasdaq: NTHI) (“NeOnc” or the “Company”), a multi-Phase 2 clinical-stage biopharmaceutical company developing novel therapies for central nervous system (CNS) cancers, today announced data from the dose-escalation portion of its Phase 1/2 clinical trial for NEO212, the Company’s novel oral bio-conjugated therapy and will host a conference call to discuss the data today at 9:00am ET. NeOnc has formally notified the FDA that the Phase 1 dose-escalation portion of the NEO212-01 Phase 1/2 clinical trial has reached Maximum Tolerated Dose (MTD) at Cohort 5 (810 mg, Days 1–5, 28-day cycle) following a second Dose-Limiting Toxicity. In accordance with protocol-defined stopping rules, dose escalation has been halted, no further patients will be enrolled at 810 mg, and the Recommended Phase 2 Dose (RP2D) has been set at 610 mg (Cohort 4). For the Phase 2a metastasis cohort, the starting dose will be 400 mg (Cohort 3). Notably, although Phase 1 was mainly designed to assess safety, tolerability, and identify the MTD, promising signs of clinical efficacy appeared during this phase of the study. These efficacy signs—including indications of lasting disease control in heavily pretreated patients with recurrent GBM and brain metastases—were observed within the dose-escalation groups. The emergence of measurable anti-tumor activity in Phase 1 offers early clinical confirmation of NEO212’s therapeutic potential and supports the Company’s progress into the Phase 2 segment of the trial. “These early efficacy signals, observed even within a dose-escalation safety study, provide meaningful clinical validation of NEO212’s therapeutic potential,” said Amir Heshmatpour, Chairman and CEO of NTHI. “With RP2D now established, we believe NeOnc is entering Phase 2 with positive clinical momentum and a clear development pathway.” The transition into Phase 2 will focus on further assessing efficacy at the RP2D in specific expansion cohorts, aiming to generate strong clinical data to support potential accelerated development pathways in recurrent CNS cancers. Importantly, this represents the first clinical readout of NeOnc’s bioconjugated temozolomide (TMZ) platform in an oral formulation, demonstrating NeOnc’s drug-engineering capabilities beyond its established intranas...