NeOnc Technologies Holdings, Inc. (Nasdaq: NTHI) has scheduled an in-person End-of-Phase 1 Type B meeting with the U.S. Food and Drug Administration (FDA) for November 17, 2026. The session, located at the FDA's White Oak campus in Silver Spring, Maryland, will focus on the Phase 2 study design and potential regulatory pathways for the company's investigational oral conjugate, NEO212.
The meeting follows the completion of the Phase 1 dose-escalation portion of the NEO212-01 clinical trial. In September 2025, the FDA authorized NeOnc to proceed with the Phase 2a and Phase 2b portions of this trial. During the Phase 1 stage, dose escalation was discontinued after a dose-limiting toxicity occurred at 810 mg, administered once daily on Days 1 through 5 of a 28-day cycle. Consequently, NeOnc selected 610 mg as the recommended Phase 2 dose.
The company reported encouraging clinical activity in individual patients during Phase 1. In one patient with recurrent IDH1 wild-type, MGMT-methylated glioblastoma, treatment with NEO212 resulted in a partial response, including an approximately 60% reduction in tumor size. This was followed by prolonged disease control lasting 21 treatment months. In a second patient with lung cancer metastatic to the brain who had progressed following multiple lines of therapy, including immune checkpoint inhibitors, treatment was associated with stable disease lasting approximately 16 months.
Amir Heshmatpour, Executive Chairman, President and Chief Executive Officer of NeOnc, stated that the meeting will help the company understand FDA feedback on the patient population, study design, and endpoints for the next stage of development. He noted that NeOnc may update its plans after evaluating the agency's feedback. The company intends to discuss its potential registrational development strategy and seek feedback on whether a proposed trial design could support a potential accelerated approval pathway.
NeOnc emphasizes that the scheduling of this meeting does not establish FDA agreement on a trial design, an accelerated approval pathway, or eventual approval of NEO212. While the durability of responses observed in Phase 1 provides clinical rationale for further evaluation, these individual patient outcomes do not establish efficacy and require confirmation in larger studies. NEO212 is an investigational oral conjugate of temozolomide and NEO100 being studied for central nervous system cancers. Clinical efficacy and safety have not been established, and neither product is currently approved by the FDA for commercial use.