LOS ANGELES, April 24, 2023 (GLOBE NEWSWIRE) -- NeOnc Technologies Holdings, Inc., a clinical stage medical biotechnology company, has formally secured exclusive worldwide rights from the University of Southern California (USC) to an extensive intellectual property portfolio of proprietary and patented chemotherapy agents and methodologies that have demonstrated positive effects in laboratory tests on various types of cancers and in clinical trials treating malignant gliomas.
Numerous published clinical studies have also shown the patented technology has solved some of the most persistent problems with central nervous system (CNS) therapeutics, particularly in overcoming the blood-brain barrier.
Covering 135 U.S. and international patents issued and applications pending, the licensing agreement is considered the largest IP transfer of its kind for the development and commercialization of chemotherapies related to brain and CNS diseases. The license covers agent composition and methods of use technology, including an enhanced method of delivering pharma-based therapeutics to the brain.
The biotechnology breakthrough is based on more than two decades of advanced research and development led by Thomas Chen, MD, Ph.D., NeOnc’s CEO. Dr. Chen also serves as a professor and director of Surgical Neuro-Oncology at USC’s Keck School of Medicine, which has become one of the nation’s preeminent research-intensive medical schools. Dr. Chen is currently leading the initiation of Phase II clinical trials of NEO100™, one of several proprietary agents included in the license agreement.
“This historic licensing agreement formalizes and further expands upon an extraordinarily productive partnership with USC that has spanned well over a decade and has helped advance promising new treatments for malignant gliomas,” stated Dr. Chen. “We’re looking forward to continuing to work with USC in developing these important therapeutics and bringing them to market.”
The IP licensing transaction was facilitated by the USC Stevens Center for Innovation, the university’s technology transfer office, which has a mission to maximize the translation of USC research into products for public benefit through licenses, collaborations, and the promotion of entrepreneurship and innovation.
“USC is proud of its long and esteemed history of supporting innovation that translates new ideas into tangible positive societal impact,” commented Dr. Steven Moldin, interim executive director of the USC Stevens Center for Innovation. “In further partnership with NeOnc, we hope to bring the benefits of Dr. Chen’s breakthrough research on treating the most challenging of cancers out of the lab and into the hands of physicians where it can have a meaningful impact on people’s health and quality of life.”
Amir Heshmatpour, NeOnc’s executive vice-chairman, commented: “I am excited to be partnering with Dr. Chen and the University of Southern California on this mission of bringing their valuable IP to market. In my over 10 years of partnering with major U.S. academic institutions and their scientific founders in advising them on their public offerings, this IP technology transfer represents the largest patent portfolio monopoly I’ve ever seen.”
Next Steps for NeOnc Technologies
Due to the success of its Phase I clinical trial, NeOnc has been moving forward on a Phase II clinical trials for NEO100. It expects the trials to provide the data it requires for regulatory validation and advance NEO100 toward commercialization.
NeOnc researchers hope the data generated from Phase II will allow NeOnc to seek approval from the FDA to treat IDH1 mutant tumors (Grade IV) with NEO100. The company also expects to show that it has successfully identified a life-extending biomarker and a successful therapy for treating this disease.
NeOnc recently announced it is also pursuing a FDA Fast-Track Status of an indication for NEO100 in the treatment pediatric patients diagnosed with Pediatric High-Grade Gliomas (pHGGs) brain tumors. pHGGs is responsible for more than 40% of all childhood death from brain tumors.
The program is expected to build upon the early success researchers have seen in NEO100 published clinical studies and compassionate use with adult patients with IDH1 mutated brain tumors (another type of high-grade glioma).
For adult indications, the FDA has already granted NEO100 Fast-Track status. The FDA grants such status to drugs that are shown to treat a serious condition and provide an unmet medical need or therapy that may be potentially better than other available therapies. The drug must also show superior effectiveness, significant decrease in serious side effects and the ability to improve the diagnosis of a serious condition. Further, it must demonstrate a decrease in clinically significant toxicity over available therapies, and an ability to address emerging or anticipated public health needs. NEO100 qualifies under all of these criteria.
NEO100 has also received FDA classification as an Orphan Drug (OD). The FDA only grants OD status 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 numerous benefits, including a seven-year window of exclusive marketing rights, fee reductions, and additional tax incentives. The FDA also gathers and shares information from Patient-Focused Drug Development meetings that 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,” noted 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,” added Dr. Chen. “All this underscores the importance of developing effective therapies that are less invasive and more tolerant for such vulnerable populations. Today’s new licensing agreement helps to advance us toward this important goal.”
About NeOnc Technologies Holdings
NeOnc Technologies Holdings is presently 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. As the result of the company’s extensive research and development efforts, it has assembled an extensive portfolio of patented intellectual property. This includes several proprietary chemotherapy agents that have demonstrated positive effects in laboratory tests on various types of cancers and in clinical trials treating malignant gliomas. NEO100™ is the company’s first therapeutic that completed Phase 1 clinical trials in April 2019 and is now advancing to Phase 2.
To learn more about NeOnc, visit neonctech.com.
Important Cautions Regarding Forward Looking Statements
All statements other than statements of historical facts included in this press release are "forward-looking statements" (as defined in the Private Securities Litigation Reform Act of 1995). Generally, such forward-looking statements include statements regarding our expectations, possible or assumed future actions, business strategies, events or results of operations, including statements regarding our expectations or predictions or future financial or business performance or conditions and those statements that use forward-looking words such as "projected," "expect," "possibility" and "anticipate," or similar expressions. The achievement or success of the matters covered by such forward-looking statements involve significant risks, uncertainties, and assumptions. Actual results could differ materially from current projections or implied results.
The Company cautions that statements and assumptions made in this news release constitute forward-looking statements and make no guarantee of future performance. Forward-looking statements are based on estimates and opinions of management at the time statements are made. The information set forth herein speaks only as of the date hereof. The Company and its management are under no obligation, and expressly disclaim any obligation, to update, alter or otherwise revise any forward-looking statements following the date of this news release, whether because of new information, future events or otherwise, except as required by law.
“NEO100” is a registered trademark of NeOnc Technologies Holdings, Inc.
NeOnc Company Contact:
Patrick Walters, President and COO
NeOnc Technologies Holdings, Inc.
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NeOnc Investor Relations:
Ron Both
CMA Investor Relations
Tel (949) 432-7566
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NeOnc Media & ESG Contact:
Tim Randall
CMA Media Relations
Tel (949) 432-7572
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USC Stevens Center for Innovation Contact:
Tran Courtney, Senior Marketing Manager
Tel (213) 821-6065
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