NEO212

September 28, 2026: NeOnc Technologies Holdings, Inc. (NASDAQ: NTHI) said it will meet the FDA in an in-person End-of-Phase 1 Type B meeting on November 17, 2026 to discuss the NEO212 program, including proposed patient population, trial design, endpoints, dose selection, evidence needed for a future marketing application, and whether a proposed trial could support a potential accelerated approval pathway.

NEO212 is an investigational oral conjugate of temozolomide and NEO100 being studied in CNS cancers including recurrent glioblastoma. The meeting follows completion of the Phase 1 dose-escalation portion of the NEO212-01 Phase 1/2 trial. NeOnc said dose escalation stopped after a dose-limiting toxicity at 810 mg once daily on Days 1-5 of a 28-day cycle, and 610 mg was selected as the recommended Phase 2 dose. FDA had authorized the Phase 2a and 2b portions of NEO212-01 in September 2025.

The company highlighted Phase 1 activity in two patients: a recurrent IDH1 wild-type, MGMT-methylated glioblastoma patient had a partial response with about 60% tumor reduction and 21 months of disease control, and a lung cancer brain metastases patient had stable disease for about 16 months. NeOnc said these findings support further Phase 2 evaluation, while noting efficacy remains unconfirmed.