NEO212

July 15, 2026: NeOnc Technologies Holdings, Inc. (NASDAQ: NTHI) reported receiving written FDA feedback on the chemistry, manufacturing and controls (CMC) development plan for NEO212 (a temozolomide–perillyl alcohol conjugate) being developed for malignant brain tumors and other CNS cancers. The feedback was provided ahead of a planned Type B End-of-Phase 1 meeting (scheduled July 9, 2026); NeOnc canceled the meeting after determining the written responses were sufficiently clear and would serve as the official record.

Key FDA points: the proposed CMC approach “appears reasonable,” with potential need for additional comparability assessments if manufacturing process/physical characteristics change; drug-product development may proceed in parallel with planned late-stage clinical work with appropriate supporting data; a staged stability program is acceptable; a capsule-to-tablet transition should be supported by an in vivo relative bioavailability study; and specific CMC work is needed before using representative tablet material in a confirmatory phase (finalizing formulation/process, at least one GMP batch, in-process controls, solid-state/particle-size characterization, and dissolution method development).

NeOnc said it is integrating the feedback and will provide an updated development plan after assessing study design, manufacturing activities, timelines, and costs. The company noted the feedback is not FDA approval or agreement on any future registrational trial design.