(RTTNews) - Wednesday, NeOnc Technologies Holdings, Inc. (NTHI) announced that the company has received written feedback from the U.S. Food and Drug Administration providing detailed manufacturing and formulation requirements for continued late-stage development of NEO212, a potential treatment for malignant brain tumors and other central nervous system cancers.
The agency stated that the company's approach to chemistry, manufacturing and controls or 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 added 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.
Also, FDA indicated that a staged stability program supporting clinical development, followed by registration stability studies, is a commonly accepted approach.
Further, the agency advised the company that the transition from the current capsule formulation to a tablet formulation should be supported by an in vivo relative bioavailability study.
FDA also 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.
In response, NeOnc stated that it will incorporate FDA's feedback into its NEO212 development plan and is evaluating the associated study design, manufacturing activities, timelines and costs. It would also provide an updated development plan after completing this assessment.
The FDA's feedback comes ahead of a Type B End-of-Phase 1 meeting scheduled for July 9, 2026. However, the company canceled the meeting as the written responses were sufficiently clear and constitute as the official record of the meeting.
Currently, NTHI is trading at $4.03, up 9.51 percent on the Nasdaq.
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