Regulatory & Certification
NeOnc has successfully obtained both Orphan Drug (OD) and Fast-Track status for our NEO100 and NEO212 formulations, moving them from proof-of-concept to validation study readiness. NEO100 was approved for high-grade glioma and its impact on insulin-resistant gliomas. Our NEO212 gained approval for high-grade gliomas and breast cancer metastasizing to the brain.
Orphan Drug Status
Orphan Drug (OD) status is granted to drug formulations that show promise in treating, preventing, or diagnosing a rare (orphan) disease, defined as affecting a patient population not exceeding 200,000 people. To qualify, the drug must also demonstrate the potential to provide at least equal benefit to currently approved treatments for that disease, without increasing side effects.
When granted, Orphan Drug (OD) status provides significant advantages. Manufacturers can immediately begin human clinical trials and receive seven years of exclusive marketing rights, along with fee reductions and tax incentives. They also gain access to FDA information from Patient-Focused Drug Development (PFDD) meetings. Furthermore, through validation
work, the drug can demonstrate benefits by:
- Showing superior effectiveness or improved effects on serious outcomes.
- Avoiding serious side effects of available therapies.
- Improving diagnosis of serious conditions for better outcomes.
- Decreasing clinically significant toxicity of existing common treatments.
- Addressing emerging or anticipated public health needs.
Then the FDA can also grant the Orphan Drug manufacturer Fast-Tract status which provides the following additional benefits that help dramatically cut the average amount of time and money needed for a traditional drug approval process.
- Enhanced FDA Interaction: Benefit from more frequent meetings and written communication regarding development plans, clinical trial design, and biomarker use.
- Accelerated Pathway Eligibility: Qualify for Accelerated Approval and Priority Review if applicable criteria are met.
- Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met.
- Rolling Review: Submit completed sections of your BLA or NDA for FDA review on an ongoing basis, rather than submitting the entire application at once, streamlining the approval process.
Our Computational &
3D Modeling IP
NeOnc has strategically acquired an intellectual property portfolio focused on AI, 3D bioprinting, and quantum modeling technologies. This acquisition significantly fortifies our drug discovery engine and accelerates our mission to develop therapies for complex neurological cancers.
By creating sophisticated patient-derived 3D brain tumor models and applying proprietary AI and quantum modeling algorithms, we can now perform high-throughput screening of therapeutic candidates with greater speed and accuracy. This technology is designed to de-risk and shorten the preclinical development timeline, allowing us to identify the most promising drug candidates before advancing to clinical testing.
This innovative IP will be integrated into our core R&D operations, supporting our multi-Phase 2 clinical programs and strategic partnerships as we pioneer new paradigms in precision oncology.
Intellectual Property & Scientific Legacy
Our extensive portfolio of domestic and international patents secures NeOnc’s unique and novel drug delivery technology. This aggressive intellectual property strategy ensures our continued ability to innovate and compete effectively in the marketplace.
Our success is built on over a decade and a half of thorough research and product development focused entirely on advancing our novel delivery methodologies and therapeutic formulations for Central Nervous System (CNS)-based disease. That research is supported by a team of physicians from around the world who each have long and proven track records of success in their fields of endeavor, including oncology, neurology, neurosurgery, clinical research, and drug development.
Patents & Claims
Orphan Drug (OD) status is granted to drug formulations that show promise in treating, preventing, or diagnosing a rare (orphan) disease, defined as affecting a patient population not exceeding 200,000 people. To qualify, the drug must also demonstrate the potential to provide at least equal benefit to currently approved treatments for that disease, without increasing side effects.
U.S.
International
14+
Pending
28+
Pending
28+
Issued
65+
Issued
Composition & Method Claims
Issued and Pending Patent Applications*
NEO100 Ultrapure POH – Issued patents expiring in 2031: U.S., Canada, UK, EU and China.
POH Conjugates such as Temozolomide NEO212 or Rolipram NEO214 – Issued patents expiring in 2031: U.S., UK, EU and Japan.
NEO400 POH conjugated to linoleic acid – Anticipated expiration of pending applications expiring in 2031 U.S., EU and China.
NEO412 POH conjugates with fatty acid and a compound such as Temozolomide / Rolipram – Issued patents expiring in 2036: U.S., UK, EU, China, Japan and Australia.
NEO218 POH conjugated to bromopyruvate
NEO216 POH conjugated to Valproic Acid – Anticipated expiration of pending applications expiring in 2038: U.S., EU, and China.
*Note: This does not include all patentsMethod of Treatment Claims
Patents pending applications for indications:
Brain Metastases (US. Patent No. 9,913,838)
Neurofibromatosis (US. Patent No. 9,913,838)
Nasopharyngeal Carcinoma (US. Patent No. 9,987,271)
Product Development and Clinical Pipeline
- NEO100-01/02 POH formulation: Targeting Malignant Glioma (Grade III and IV, IDH1 mutations) and Meningiomas.
- NEO212: A combinatorial formulation of POH and TMZ for treating Glioblastoma Multiforme cancers.
- NEO100-03 Pediatric formulation: Designed for patients with Pediatric High-Grade Gliomas (pHGGs) brain tumors.
