NeOnc Technologies Receives Rare Pediatric Disease Designation for NEO100 in Treatment of Pediatric-Type Diffuse High-Grade Gliomas

NeOnc Technologies Holdings, Inc. recently announced the US FDA has granted Rare Pediatric Disease Designation (RPDD) to perillyl alcohol (NEO100) for the treatment of pediatric-type diffuse high-grade gliomas, a serious and life-threatening condition affecting children and adolescents.

The designation, issued under Section 529(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), recognizes the urgent need for treatment options for pediatric-type diffuse high-grade gliomas. The FDA’s decision is based on findings that the disease primarily affects individuals from birth to 18 years and meets the statutory definition of a “rare disease or condition.”

“This designation marks a significant milestone in our efforts to develop innovative therapies for children battling this aggressive form of brain cancer,” said Amir Heshmatpour, Executive Chairman, NeOnc Technologies Holdings, Inc. “We remain committed to advancing NEO100 through clinical development to bring new hope to patients and families facing this devastating disease.”

“Receiving the Rare Pediatric Disease Designation for NEO100 is a crucial step forward in our mission to develop effective treatments for children facing diffuse high-grade gliomas,” said Dr. Thomas Chen, CEO and Chief Science Officer of NeOnc Technologies Holdings, Inc. “This designation not only validates the potential of our research, but also strengthens our commitment to delivering innovative therapies that can make a real difference in children’s lives.”

The Rare Pediatric Disease Designation makes NeOnc Technologies eligible to receive a Rare Pediatric Disease Priority Review Voucher (PRV) upon approval of NEO100’s marketing application. The PRV program is designed to encourage the development of new drugs and biologics for rare pediatric diseases by providing companies with an expedited regulatory review process. These vouchers, which are transferable and have been sold in recent years, have significant strategic and financial value, depending on market conditions and demand.

“Currently, there is a dynamic market for PRV’s, which are quite valuable,” added Heshmatpour. “This potential asset further underscores the value of our progress, especially for the patients and families we aim to serve.”

As NeOnc Technologies continues to progress NEO100 through clinical trials, the company remains dedicated to working closely with the FDA and the broader medical community to bring this promising therapy to children in need. The company encourages collaboration with researchers, healthcare providers, and patient advocacy groups to further accelerate advancements in pediatric brain cancer treatment.

NeOnc Technologies Holdings, Inc. is a clinical-stage life sciences company focused on the development and commercialization of central nervous system therapeutics that are designed to address the persistent challenges in overcoming the blood-brain barrier. The company’s NEO drug development platform has produced a portfolio of novel drug candidates and delivery methods with patent protections extending to 2038. These proprietary chemotherapy agents have demonstrated positive effects in laboratory tests on various types of cancers and in clinical trials treating malignant gliomas. NeOnc’s NEO100 and NEO212 therapeutics are in Phase 2 human clinical trials and are advancing under FDA Fast-Track and Investigational New Drug (IND) status. The company has exclusively licensed an extensive worldwide patent portfolio from the University of Southern California consisting of issued patents and pending applications related to NEO100, NEO212, and other products from the NeOnc patent family for multiple uses, including oncological and neurological conditions. For more information, visit neonctech.com.