CALABASAS, Calif., June 16, 2026
NeOnc Technologies Holdings, Inc. announced that the Department of Health – Abu Dhabi (DOH) has granted Investigational New Drug (IND) approval for NEO212, the company’s orally administered perillyl alcohol-temozolomide conjugate being developed for patients with aggressive brain cancers. The authorization marks the first international regulatory clearance for NEO212 following the successful completion of its Phase 1 clinical evaluation and opens a new pathway for advancing the program into global Phase 2 development. The milestone strengthens NeOnc’s international clinical strategy while the company continues discussions with the U.S. Food and Drug Administration (FDA) regarding a potential registrational pathway for the investigational therapy.
Phase 1 Results Support Advancement into Phase 2 Studies
The UAE authorization follows the completion of the Phase 1 dose-escalation portion of NeOnc’s ongoing Phase 1/2 clinical study, which established 610 mg as the recommended Phase 2 dose for NEO212. According to the company, the trial generated encouraging early clinical findings, including signs of potential durable disease stabilization in heavily pretreated patients with recurrent glioblastoma (GBM) and brain metastases. These early results support continued evaluation of NEO212 as a potential treatment option for patients facing limited therapeutic choices. NeOnc believes that conducting regulatory and clinical development activities across multiple regions simultaneously could help accelerate the overall development timeline and broaden future patient access to the therapy.
Novel Brain Cancer Therapy Designed to Improve Drug Delivery
NEO212 is a proprietary oral therapeutic that combines the established chemotherapy agent temozolomide with perillyl alcohol in a single molecular conjugate. The therapy has been specifically engineered to improve penetration across the blood-brain barrier, one of the most significant challenges in treating central nervous system cancers. By enhancing delivery of anticancer treatment directly to brain tumors, the company aims to improve therapeutic effectiveness while addressing the limitations of existing treatment approaches. Glioblastoma remains one of the most aggressive and difficult-to-treat cancers, with poor survival outcomes and few effective treatment options available after disease recurrence. NeOnc believes NEO212’s unique design may offer a differentiated approach for patients with advanced brain tumors.
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International Expansion Strengthens NeOnc’s CNS Oncology Pipeline
While the UAE IND authorization represents a significant advancement, patient enrollment cannot begin until additional regulatory requirements are fulfilled, including approval from the DOH Institutional Review Board (IRB) and implementation of protocol and labeling updates. The company emphasized that the authorization permits clinical research activities and does not represent commercial marketing approval. In addition to NEO212, NeOnc has submitted applications for its NEO100 clinical programs, including NEO100-01, NEO100-02, and NEO100-03, which are currently under review by Abu Dhabi health authorities. If approved, these programs would further expand the company’s clinical footprint in the region. With a growing portfolio of CNS-focused therapies and a proprietary drug development platform designed to overcome blood-brain barrier limitations, NeOnc continues to advance innovative treatment strategies for patients with brain cancers and neurological disorders worldwide.
Source: NeOnc Technologies press release
