NTHI · Neonc Technologies Holdings, Inc.

Summary

NeOnc Technologies Holdings, Inc. announced Phase 1 dose-escalation results for NEO212, determining Maximum Tolerated Dose at 810 mg (Cohort 5) and Recommended Phase 2 Dose at 610 mg (Cohort 4), with promising efficacy signals in recurrent GBM and brain metastases patients. The company plans a Type B FDA meeting to discuss Phase 2 design and potential accelerated approval.

Key takeaways

• Phase 1/2 NEO212-01 trial reached MTD at Cohort 5 (810 mg, Days 1–5, 28-day cycle) after second Dose-Limiting Toxicity
• RP2D set at 610 mg (Cohort 4); Phase 2a metastasis cohort starts at 400 mg (Cohort 3)
• Promising efficacy: partial response in recurrent IDH1 wild-type MGMT-methylated GBM patient stable 21 months post-recurrence
• Stable disease in squamous NSCLC-to-brain metastasis patient on Cycle 16 after 55 months since diagnosis
• No clinically meaningful myelosuppression, hepatic, or renal toxicity observed across 14 patients
• Plans Type B FDA meeting to review RP2D, Phase 2 design, and accelerated approval pathway