NeOnc gets FDA manufacturing feedback for NEO212 tablet transition

NeOnc Technologies Holdings, Inc. (NASDAQ: NTHI) announced it has received written feedback from the U.S. Food and Drug Administration regarding the chemistry, manufacturing and controls development program for NEO212, its temozolomide-perillyl alcohol conjugate for central nervous system cancers.

The written feedback was provided ahead of a Type B End-of-Phase 1 meeting originally scheduled for July 9, 2026. After reviewing the FDA's responses, NeOnc determined a meeting was not required and canceled it. Under FDA practice, the written responses constitute the official record of the meeting.

Key points in the FDA's feedback include a determination that NeOnc's proposed CMC development approach appears reasonable, with additional comparative assessments potentially required if the drug-substance manufacturing process or physical characteristics change. The FDA also indicated that drug-product development may proceed in parallel with the planned late-stage clinical program, subject to submission of supporting data.

On the planned transition from capsule to tablet formulation, the FDA advised that an in vivo relative bioavailability study would be required. The agency also identified several steps to be completed before tablet material can be used in a confirmatory clinical phase, including finalizing the tablet formulation and manufacturing process, producing at least one GMP batch, establishing in-process controls, and developing an appropriate dissolution method.

"It provides greater clarity regarding the manufacturing, formulation and bioavailability work required to support the transition of NEO212 from the current capsule formulation to a tablet intended for late-stage clinical development," said Amir Heshmatpour, Chief Executive Officer of NeOnc.

NeOnc stated it is incorporating the feedback into its NEO212 development plan and evaluating study design, manufacturing activities, timelines, and costs. The company said it expects to provide an updated development plan after completing this assessment. The FDA's written responses do not constitute approval of NEO212 or agreement on the design of any future registrational clinical trial.

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