NeOnc Technologies Holdings, Inc. (NASDAQ: NTHI) announced that the U.S. Food and Drug Administration has authorized the company to proceed with Phase IIa/IIb of its NEO212-01 clinical trial, marking a significant milestone for the multi-Phase 2 clinical-stage biopharmaceutical company pioneering therapies for central nervous system cancers.
The FDA's decision follows the successful completion of the Phase I dose-escalation study, which demonstrated that NEO212 could be safely administered at doses up to 810 mg daily on Days 1–5 of a 28-day cycle. Independent review of the recommended Phase II dose is ongoing, with patient enrollment expected to begin before the end of 2025.
Novel Conjugated Chemotherapy Approach
NEO212 represents NeOnc's first oral chemical conjugated chemotherapy drug, uniquely combining Temozolomide (TMZ) – the current standard of care for glioblastoma and other brain cancers marketed as Temodar® – with NEO100, a proprietary form of perillyl alcohol owned and patented by NeOnc. This proprietary conjugation is designed to overcome the limitations of TMZ, including resistance and limited efficacy, by enhancing blood-brain barrier penetration and antitumor activity.
NeOnc believes NEO212 has the potential to replace TMZ as the future standard of care for all brain cancers, representing a transformative leap forward in therapeutic options for patients facing glioblastoma, astrocytoma, and other aggressive CNS malignancies.
Expanding Clinical Network
The NEO212-01 Phase II trial will expand patient enrollment across leading U.S. cancer centers, building on four currently approved and active trial sites: NextGen Oncology, Northwest Medical Specialties, Oncology Physician's Network, and University of Southern California.
In anticipation of expanded Phase II enrollment, NeOnc is preparing activation at a broad network of premier cancer institutions, including Baylor Scott & White, Beverly Hills Cancer Center, Cancer Specialists of North Florida, Cleveland Clinic, Duke University, Inova, New York University Langone, Providence St. John's, RecioMed, Sutter Health, Tampa General Hospital, Vanderbilt University Medical Center, University of Texas Southwestern, and University of California, San Francisco.
Leadership Perspectives
"Receiving FDA authorization to advance NEO212 into Phase II is a defining milestone for NeOnc Technologies," said Amir Heshmatpour, Executive Chairman and President of NeOnc Technologies Holdings, Inc. "This program represents years of innovation combining our proprietary molecule NEO100 with the current standard Temozolomide into a powerful conjugated therapy that we believe can redefine treatment outcomes for brain cancer patients. Our Phase II strategy will expand across the country's leading cancer centers and position NEO212 as the first real replacement for Temozolomide in decades."
Dr. Thomas Chen, Chief Executive Officer and Founder of NeOnc Technologies, added: "From the beginning, our mission has been to give brain cancer patients and their families real hope where few options exist. NEO212 embodies that vision – it is science and compassion fused together. Moving into Phase II is not just a regulatory step forward; it is a step toward changing the future of brain cancer care worldwide."
NIH Grant Support
The clinical advancement comes alongside significant non-dilutive funding support. NeOnc recently received two competitive NIH STTR grants totaling $2.5 million to further advance development of NEO212. The funding includes a $400,000 Phase 1 STTR Grant supporting preclinical feasibility studies of NEO212 in acute myelogenous leukemia, and a $2.1 million Phase 2 STTR Grant focused on expanding NEO212's clinical development into newly diagnosed gliomas.
"Securing $2.5 million in competitive NIH grants during one of the most uncertain federal funding periods reaffirms the scientific and clinical promise of NEO212," said Dr. Chen, who also serves as a brain and spine oncologic surgeon with over 30 years of experience at Keck Medical Center of USC. "As a brain and spine oncologic surgeon for over 30 years at Keck Medical Center of USC, I have witnessed the urgent need for novel, less toxic therapies. These grants are a testament to our research team's commitment and our ability to translate academic science into meaningful treatments."
