NeOnc Technologies Engages Anova Enterprises to Pursue Pediatric Brain Tumor Indication & FDA Fast-Track Status
NeOnc Technologies Holdings, Inc. has recently expanded its engagement of Anova Enterprises to pursue a pediatric indication for NEO100, an enhanced method of delivering pharma-based therapeutics to the brain designed for the treatment of brain and central nervous system (CNS) diseases.
NEO100 is NeOnc’s first therapeutic being developed for pediatric patients diagnosed with Pediatric High-Grade Gliomas (pHGGS) brain tumors. Despite its lower incidence rate of 1.78 per 100,000 children, pHGGS is responsible for more than 40% of all childhood death from brain tumors.
As part of the new pediatric program for NEO100, Anova will prepare the application to obtain FDA Fast-Track and Rare Pediatric designations, and develop a clinical pediatric study plan. The program is expected to build upon the early success researchers have seen in NEO100 studies of adult patients with IDH1 mutated brain tumors (another type of high-grade glioma) and with compassionate use.
“While we recognize there can be significant differences between children and adults when it comes to the effectiveness of drug therapies, our success with NEO100 in adults leads us to believe that we may see similar results in pediatric patients diagnosed with pHGGS,” said NeOnc CEO, Thomas Chen, MD, PhD. “We continue to work with Anova given their strong dedication and success with accelerating the development and availability of promising treatments like ours using their AnovaOS technology platform.”
Anova CEO, Chris Beardmore, added “It is an unfortunate fact that brain tumors are the most common solid tumor and the leading cause of death from cancer in children. While biological understanding of pediatric brain tumors has advanced rapidly, clinical trials have not kept pace. Our team applauds NeOnc for its commitment to bringing the promise of NEO100 to pediatric patients in need, and we are likewise committed to the success of this important program.”
FDA grants Fast-Track status when a drug is shown to treat a serious condition and provides an unmet medical need or therapy that may be potentially better than other available therapies. The criteria includes if the drug will impact survival and day-to-day functioning, or if left untreated, the disease will progress from a less severe condition to a more serious one.
The drug must also show superior effectiveness, significant decrease in serious side effects and the ability to improve the diagnosis of a serious condition. Additionally, it must demonstrate a decrease in clinically significant toxicity over available therapies, and an ability to address emerging or anticipated public health needs.
For adult indications, NEO100 has met these criteria and has already been granted Fast-Track status by the FDA, as well as received FDA classification as an Orphan Drug (OD). OD status is granted by the FDA to a substance that shows promise in treating, preventing or diagnosing an “orphan disease,” that is, diseases that currently affect less than 200,000 people.
OD status provides a seven-year window of exclusive marketing rights, fee reductions, and additional tax incentives. The FDA gathers and shares information from Patient-Focused Drug Development (PFDD) meetings which companies like NeOnc can use in its drug development.
OD status also provides a more streamlined clinical trial process, including not having to perform Phase 1 safety studies, binding, placebo, and randomization criteria. Once sufficient effectiveness and safety data is shown, a New Drug Application (NDA) can be submitted for a Fast-Track review by the FDA.
“In consultation with the FDA under NEO100’s OD and Fast-Track status, we expect to collect sufficient data that demonstrates the important therapeutic value of NEO100 for pHGGS,” said Dr. Chen. “We believe our novel intranasal delivery approach for NEO100 makes a study in a pediatric population easier than other methods. Radiation and chemotherapy for children with high-grade gliomas is complex, time consuming and prognosis remains poor. All this underscores the importance of developing effective therapies that are less invasive and more tolerant for such populations.”
Anova Enterprises, Inc. is accelerating clinical development with its technology platform, AnovaOS, that brings participants in the clinical research process together to speed promising new treatments to market, at reduced cost, and for a larger number of patients. For more information, visit www.anovaevidence.com.
NeOnc is a privately held biotechnology company focused on creating novel drugs and delivery methods for pharma-based therapeutics that target brain and central nervous system diseases. The company’s NEO100 is its first therapeutic that completed Phase 1 clinical trials in April 2019. It is also developing several proprietary chemotherapy agents that have demonstrated positive effects in laboratory tests on various types of cancers. As the result of its extensive research and development efforts, the company has assembled an extensive portfolio of patented intellectual property around these proprietary chemotherapy agents. For more information, visit neonctech.com.
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