other_material
confidence high
sentiment positive
materiality 0.85
NeOnc reports Phase 1 dose-escalation results for NEO212; RP2D set at 610 mg
NEONC TECHNOLOGIES HOLDINGS, INC.
- MTD reached at 810 mg (Cohort 5) with second DLT; dose escalation halted.
- Recommended Phase 2 Dose (RP2D) set at 610 mg; Phase 2a metastasis start at 400 mg.
- Early efficacy signals: partial response in recurrent GBM (~60% tumor reduction after 21 cycles) and stable disease in brain metastasis.
- No clinically meaningful myelosuppression; 39x lower AIC vs TMZ indicating lower toxicity.
- Type B FDA meeting to be requested for accelerated approval pathway.
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