NeOnc Announces NEO212 Clinical Trial Data and Hosts Conference Call

NeOnc Technologies Holdings 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 at Cohort 5 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 has been set at 610 mg. For the Phase 2a metastasis cohort, the starting dose will be 400 mg, 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. 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 platform in an oral formulation, demonstrating NeOnc's drug-engineering capabilities beyond its established intranasal delivery platform. The data validate the Company's ability to optimize CNS penetration and therapeutic exposure across both intranasal and oral modalities. NeOnc intends to request a Type B FDA meeting to review safety, PK/PD, preliminary efficacy, RP2D justification, Phase 2 design modifications, and a potential Accelerated Approval pathway. Supporting regulatory materials, including MedWatch Form FDA 3500A and Form FDA 1571, have been submitted via eCTD, ensuring regulatory transparency and alignment as the program transitions into Phase 2 development.