$NTHISep 28, 2026, 8:00 AM ETAI processed
NeOnc (NTHI) schedules FDA End-of-Phase 1 meeting for NEO212 on Nov 17, 2026
AI Summary
NeOnc said it will meet with the FDA in person on Nov. 17, 2026 for an End-of-Phase 1 meeting to seek feedback on NEO212’s patient population, trial design, endpoints, dose selection and potential registrational/accelerated approval pathway. The meeting follows Phase 1 dose escalation (DLT at 810 mg; recommended Phase 2 dose 610 mg) and reported encouraging, but anecdotal, durable responses in two patients (one recurrent GBM partial response with ~60% shrinkage and 21 months disease control; one lung-to-brain metastasis with ~16 months stable disease).
Positives
- In-person FDA End-of-Phase 1 meeting scheduled for Nov 17, 2026 to discuss NEO212 development
- Recommended Phase 2 dose (RP2D) set at 610 mg after Phase 1 dose escalation
- Phase 1 reported durable individual patient outcomes including ~60% tumor reduction and 21 months disease control in recurrent GBM
Negatives
- Dose-limiting toxicity observed at 810 mg caused discontinuation of escalation
- Reported clinical activity is from individual patients and does not establish efficacy
- FDA feedback could require additional clinical, nonclinical or manufacturing work and does not guarantee agreement on trial design or approval