NEO212

September 29, 2026: NeOnc Technologies Holdings (NASDAQ: NTHI) said the FDA will hold an in-person End-of-Phase 1 Type B meeting on November 17, 2026 for NEO212, an oral perillyl alcohol-temozolomide conjugate for aggressive CNS cancers. NeOnc plans to discuss the Phase 2 patient population, trial design, endpoints, dose selection, registrational strategy, and whether a future study could support accelerated approval. NEO212 has completed Phase 1 dose escalation, with a recommended Phase 2 dose of 610 mg and a protocol-defined maximum tolerated dose of 810 mg. The company cited individual-patient observations including about 60% tumor reduction with 21 months of disease control in recurrent IDH1 wild-type, MGMT-methylated glioblastoma and about 16 months of stable disease in lung cancer brain metastasis. The company also said it has UAE IND authorization and previously received FDA written feedback on CMC and a capsule-to-tablet transition.

NEO100: In August, NeOnc reported topline Phase 2a data in recurrent/progressive Grade III-IV IDH1-mutant glioma, with 6-month progression-free survival of 48.9% versus a prespecified 20% benchmark (p=0.0047), median overall survival of 26.09 months, 86.7% alive at 6 months, five of 24 patients still on treatment, and one ongoing partial response beyond 114 days. NeOnc plans to request an FDA Type B meeting on a potential registrational pathway.