NeOnc Technologies Holdings, Inc. (NASDAQ:NTHI) ("NeOnc" or the "Company"), a clinical-stage life sciences company focused on the development of treatments for central nervous system cancers, today announced that it has received written feedback from the U.S. Food and Drug Administration ("FDA") regarding the chemistry, manufacturing and controls ("CMC") development program for NEO212, the Company’s novel temozolomide-perillyl alcohol conjugate.
The written feedback was provided in advance of a Type B End-of-Phase 1 meeting scheduled for July 9, 2026. FDA’s preliminary comments expressly provided NeOnc the option to cancel the meeting if the written responses were sufficiently clear, in which case the written responses would constitute the official record of the meeting. After reviewing the detailed responses, the Company determined that an additional meeting discussion was not required at this stage and canceled the July 9 meeting.
Key elements of the FDA’s written feedback include:
- FDA stated that NeOnc’s proposed approach to CMC development appears reasonable, while identifying additional comparative assessments that may be required if the drug-substance manufacturing process or physical characteristics change during development.
- FDA stated that the general drug-product development plan may proceed in parallel with the Company’s planned late-stage clinical program, subject to the development and submission of appropriate supporting data.
- FDA indicated that a staged stability program supporting clinical development, followed by registration stability studies, is a commonly accepted approach.
- FDA advised that the transition from the current capsule formulation to a tablet formulation should be supported by an in vivo relative bioavailability study.
- FDA identified CMC work to be completed before representative tablet material is used in a confirmatory clinical phase, including finalization of the tablet formulation and manufacturing process, manufacture of at least one GMP batch, establishment of appropriate in-process controls, solid-state and particle-size characterization, and development of an appropriate dissolution method.
NeOnc is incorporating the FDA’s feedback into its NEO212 development plan and is evaluating the associated study design, manufacturing activities, timelines and costs. The Company expects to provide an updated development plan after completing this assessment.
The FDA feedback relates principally to the CMC development of NEO212 and the capsule-to-tablet transition. The written responses do not constitute FDA approval of NEO212 or agreement on the design or adequacy of any future registrational clinical trial. Any future clinical study remains subject to applicable regulatory requirements and continued FDA review.