NeOnc Technologies Gets UAE IND Approval for NEO212

Calabasas, Calif. - NeOnc Technologies Holdings, Inc. (Nasdaq: NTHI), a clinical-stage biopharmaceutical firm, has received Investigational New Drug (IND) status from the Department of Health (DOH) in Abu Dhabi for its lead oncology candidate, NEO212. This regulatory milestone marks the company's first international clearance for the asset as it transitions into Phase 2 development.

NEO212 is an orally administered perillyl alcohol-temozolomide conjugate specifically engineered to cross the blood-brain barrier. The drug is currently being developed to address aggressive brain tumors, including recurrent glioblastoma and brain metastases. The company is concurrently pursuing regulatory discussions with the U.S. FDA regarding a potential registrational pathway.

Key Highlights:

• Phase 1 Success: The recent dose-escalation study successfully established 610 mg as the recommended dose for the Phase 2 clinical trials.
• International Expansion: The Abu Dhabi DOH authorization facilitates a new international clinical pathway, complementing ongoing U.S.-based development.
• Pipeline Progress: NeOnc has also filed applications for several NEO100 clinical programs in the UAE, currently awaiting regulatory decisions.

While the DOH has cleared the clinical research path, NeOnc must still secure approval from the Institutional Review Board (IRB) and finalize protocol amendments and product labeling before patient enrollment can begin in the region.