regulatory
confidence high
sentiment neutral
materiality 0.50
NeOnc sets Nov 17 FDA End-of-Phase 1 Type B meeting for NEO212; RP2D 610 mg after DLT at 810 mg
NEONC TECHNOLOGIES HOLDINGS, INC.
- FDA End-of-Phase 1 Type B meeting scheduled Nov 17, 2026, in person at FDA's White Oak campus in Silver Spring, Md., covering NEO212 patient population, trial design, endpoints and dose selection.
- Phase 1 dose escalation completed; discontinued after a dose-limiting toxicity at 810 mg (once daily, Days 1-5 of a 28-day cycle); 610 mg selected as recommended Phase 2 dose.
- One patient with recurrent IDH1 wild-type, MGMT-methylated glioblastoma had a partial response with ~60% tumor size reduction and 21 months of disease control.
- A second patient with lung cancer metastatic to the brain, previously progressed on multiple lines including checkpoint inhibitors, had stable disease lasting ~16 months.
- NeOnc will seek FDA feedback on whether a proposed design could support accelerated approval; FDA authorized the Phase 2a/2b portions of NEO212-01 in September 2025.