NeOnc to hold FDA meeting on NEO212 for glioma program

NeOnc Technologies Holdings, Inc. (Nasdaq: NTHI) said on September 28, 2026 that it has an in-person End-of-Phase 1 Type B meeting scheduled with the FDA on November 17, 2026, to discuss its investigational drug NEO212¹, which is being developed for central nervous system cancers. The company said the meeting will be held at the FDA's White Oak campus in Silver Spring, Maryland¹.

At the meeting, NeOnc said it intends to get FDA input on the NEO212 development program, covering the target patient population, trial design, endpoints, dosing, and what data would be needed to support a future marketing application¹. The company cautioned that holding the meeting does not mean the FDA has agreed to any trial design, an accelerated approval route, or eventual approval of the drug¹.

NeOnc noted that the FDA cleared it in September 2025 to move into the Phase 2a and Phase 2b portions of the NEO212-01 study¹, and that the upcoming meeting comes after the Phase 1 dose-escalation stage wrapped up, with escalation halted after a dose-limiting toxicity appeared at 810 mg given daily on days 1 through 5 of a 28-day cycle, leading the company to pick 610 mg as the recommended Phase 2 dose¹.

On efficacy signals from Phase 1, NeOnc described one glioblastoma patient with IDH1 wild-type, MGMT-methylated disease whose tumor shrank by about 60% and who maintained disease control for 21 months¹. A second patient, with lung cancer that had spread to the brain and had failed multiple prior therapies including checkpoint inhibitors, had stable disease for around 16 months on NEO212¹. The company said these individual results don't prove efficacy and need confirmation in larger trials, but combined with the recommended Phase 2 dose they support moving into the Phase 2 stages of NEO212-01¹. NeOnc said it plans to discuss a possible registrational strategy and ask the FDA whether its proposed design could support accelerated approval¹.