NeOnc Technologies Secures UAE IND Approval for NEO212, Advancing Oral Brain Cancer Therapy Toward Global Phase 2 Development
核心洞察
NeOnc Technologies received IND clearance from the Abu Dhabi Department of Health for NEO212, its oral perillyl alcohol-temozolomide conjugate for aggressive brain tumors.
The authorization follows successful Phase 1 dose escalation, which established 610 mg as the recommended Phase 2 dose with encouraging signs of durable disease stabilization.
This marks the first international regulatory clearance for NEO212 and adds a parallel clinical pathway alongside ongoing U.S. FDA discussions on a potential registrational pathway.
NeOnc Technologies Holdings (搜索), Inc. (Nasdaq: NTHI), a clinical-stage biopharmaceutical company focused on central nervous system cancers, announced today that the Department of Health – Abu Dhabi (DOH) has granted Investigational New Drug (IND) status for NEO212, the company's orally administered perillyl alcohol-temozolomide carbamate conjugate. The clearance, dated June 16, 2026, represents the first international regulatory authorization for the investigational therapy and paves the way for Phase 2 clinical evaluation in the United Arab Emirates.
The regulatory milestone follows the successful completion of the Phase 1 dose-escalation portion of the company's Phase 1/2 study, which established 610 mg as the recommended Phase 2 dose. In that study, NeOnc reported encouraging early signs of clinical activity, including potential durable disease stabilization, in heavily pretreated patients with recurrent glioblastoma (搜索) (GBM) and brain metastases (搜索).
"This clearance represents an important international milestone for NeOnc and for the NEO212 program," said Amir Heshmatpour, Chief Executive Officer, Executive Chairman and President of NeOnc. "Brain cancers such as glioblastoma (搜索) remain among the most difficult diseases in oncology, and patients urgently need new treatment options. We are grateful to the Department of Health – Abu Dhabi for its rigorous and collaborative review, and we look forward to working with investigators and healthcare institutions in the UAE as we advance NEO212 toward Phase 2 development."
A Novel Approach to Crossing the Blood-Brain Barrier
NEO212 is designed to combine the chemotherapeutic agent temozolomide with perillyl alcohol in a single orally administered conjugate, with the goal of improving drug delivery across the blood-brain barrier — a persistent challenge in treating CNS malignancies. Glioblastoma (搜索) remains one of the deadliest forms of cancer, with limited treatment options and poor long-term survival outcomes.
The company's NEO drug development platform has produced a portfolio of novel drug candidates and delivery methods with patent protections extending to 2038. NeOnc has exclusively licensed an extensive worldwide patent portfolio from the University of Southern California covering NEO100, NEO212, and other products from the NeOnc patent family for multiple uses, including oncological and neurological conditions.
Parallel Regulatory Strategy Across Jurisdictions
The UAE IND clearance adds an international clinical pathway alongside continuing discussions with the U.S. Food and Drug Administration regarding the design of a potential registrational pathway for NEO212. NeOnc believes that parallel regulatory and clinical activities across multiple jurisdictions may accelerate the overall development strategy for the program.
Before patient enrollment can commence in the UAE, NeOnc must satisfy several conditions stipulated by the DOH authorization, including separate approval from the DOH Institutional Review Board (IRB) and amendments to the study protocol, investigator's brochure, and product labeling. The DOH clearance applies specifically to the conduct of clinical research and does not constitute marketing authorization.
Expanding the UAE Clinical Footprint
In addition to the NEO212 authorization, NeOnc has submitted applications to the Department of Health – Abu Dhabi for its NEO100 clinical programs, including NEO100-01, NEO100-02, and NEO100-03, and is currently awaiting regulatory decisions. If approved, these programs would further expand the company's clinical development footprint in the UAE and support its strategy of advancing multiple brain cancer and neurological therapeutic programs in parallel across key international markets.
Both NEO100 and NEO212 therapeutics are currently in Phase II human clinical trials and are advancing under FDA Fast-Track and IND status in the United States.