(RTTNews) – NeOnc Technologies Holdings, Inc. (NTHI) reported receiving written feedback from the U.S. Food and Drug Administration (FDA) concerning the chemistry, manufacturing, and controls (CMC) program for its investigational drug NEO212.
FDA Feedback Preceding End‑of‑Phase 1 Meeting
NEO212 is a novel temozolomide‑perillyl alcohol conjugate. The FDA’s comments were issued ahead of a scheduled End‑of‑Phase 1 meeting, which NeOnc subsequently cancelled after determining that the written responses were sufficiently clear.
CMC Development Pathway
According to the FDA, NeOnc’s proposed CMC development strategy is reasonable. The agency noted that additional comparative assessments may be required if manufacturing processes or physical characteristics change. The FDA confirmed that the drug‑product development plan can proceed in parallel with late‑stage clinical programs, provided appropriate supporting data are available.
Capsule‑to‑Tablet Transition Requirements
The FDA also indicated that a targeted stability program followed by registration stability studies is an accepted approach. Importantly, the shift from the current capsule formulation to a tablet dosage form should be supported by an in vivo relative bioavailability study. To use representative tablet material in confirmatory clinical phases, the FDA outlined several requirements, including finalizing the tablet formulation and manufacturing process, producing at least one GMP‑grade batch, establishing in‑process controls, performing solid‑state and particle‑size characterization, and developing an appropriate dissolution method.
Next Steps for NEO212
NeOnc is integrating the FDA’s feedback into its NEO212 development plan and is currently evaluating study design, manufacturing activities, timelines, and costs. The company expects to provide an updated development plan once this assessment is complete.
NTHI has reported a trading range of $3.60 to $12.99 over the past year. The stock is currently trading at $3.81, reflecting a 3.76% increase.
