RegulatoryJun 18, 2026, 05:06 PM
NeOnc Technologies Secures UAE IND Approval for NEO212
AI Summary
NeOnc Technologies Holdings, Inc. announced that the Department of Health – Abu Dhabi (DOH) has granted Investigational New Drug (IND) status for NEO212, its orally administered drug for aggressive brain tumors. This clearance follows the successful completion of Phase 1, which established 610 mg as the recommended Phase 2 dose and showed encouraging early signs of clinical activity. The approval marks a significant international milestone, enabling Phase 2 evaluation in the UAE while the company continues discussions with the U.S. FDA for a potential registrational pathway.
Key Highlights
- UAE Department of Health (DOH) granted Investigational New Drug (IND) status for NEO212.
- NEO212 is an orally administered conjugate for aggressive brain tumors.
- Phase 1 dose-escalation completed, establishing 610 mg as the recommended Phase 2 dose.
- Company reported encouraging early signs of clinical activity in Phase 1 for recurrent glioblastoma.
- Authorization supports advancement of NEO212 into Phase 2 clinical development in the UAE.
- NeOnc is continuing discussions with the U.S. FDA regarding a potential registrational pathway.
- Company also submitted applications for NEO100 clinical programs in Abu Dhabi.
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