NeOnc Technologies Holdings, Inc. (NTHI) announced it has scheduled an End-of-Phase 1 meeting with the U.S. Food and Drug Administration (FDA) for its cancer drug candidate, NEO212. The meeting will focus on the clinical development plan for the upcoming Phase 2 trial, including study design, patient population, and the potential for an accelerated approval pathway, following the completion of the Phase 1 dose-escalation study which showed encouraging clinical activity.
Key Details
- Event & Date: The in-person End-of-Phase 1 Type B meeting with the FDA is scheduled for November 17, 2026.
- Purpose: To seek FDA feedback on the Phase 2 trial design, endpoints, and potential registrational strategy for NEO212, a therapy for central nervous system (CNS) cancers.
- Phase 1 Progress: The company has completed the dose-escalation portion of its Phase 1 trial and selected a recommended Phase 2 dose of 610 mg. The trial observed encouraging clinical activity, including a partial response in one glioblastoma patient and prolonged disease control in another.