Oncotelic And Sapu Bioscience Expand Global IP Protection For OT-101 Across CNS And Oncology

Oncotelic Therapeutics, Inc. and Sapu Bioscience have announced significant progress in expanding the global intellectual property (IP) protection for OT-101, the company’s proprietary TGF-β antisense therapeutic platform. The expanded IP portfolio strengthens protection across neurology, oncology, and central nervous system (CNS) drug delivery.

OT-101, a TGF-β antisense inhibitor, is a clinical-stage therapy that has been previously evaluated across multiple oncology indications, including glioblastoma and pancreatic cancer. It has also been studied in Acute Respiratory Distress Syndrome (ARDS) and COVID-19-related inflammatory conditions. Building on its oncology foundation, the company is positioning OT-101 as a broader CNS-focused therapeutic platform, supported by targeted delivery technologies and expanded patent coverage.

"OT-101 has a well-established clinical foundation, including prior clinical trials in multiple oncology indications, including glioblastoma, and these new IP milestones significantly expand its long-term potential," said Dr. Vuong Trieu, Chief Executive Officer of Oncotelic Therapeutics. "By securing Parkinson's Disease claims in Australia and strengthening CNS delivery protection in China and Germany, we are building a globally defensible platform that supports both therapeutic use and delivery, while positioning the Company for strategic partnerships and long-term shareholder value creation."

In Australia, patent claims have been allowed specifically covering OT-101 (SEQ ID NO:9) for the treatment of Parkinson’s disease, including associated sleep disorders such as excessive daytime sleepiness and insomnia. The claims include treatment methods, methods of manufacture of medicaments, and CNS delivery routes, such as intrathecal injection and direct intracranial infusion.

Additionally, utility model patents have been granted in China and Germany for a device titled “Device for Delivering Fluid Pharmaceutical Compositions by Intracranial Continuous Infusion.” The Chinese patent (announcement number CN 222693486 U) became effective April 1, 2025, while the German patent (DE 21 2023 000 368.6) extends protection through 2033. These patents provide device-level protection for continuous intracranial infusion technologies applicable to CNS therapeutics.

Together, these developments create an integrated CNS commercialization platform for OT-101, combining therapeutic claims with delivery-device protection. The company believes this expanded IP framework enhances the asset’s strategic value and strengthens its position for future development, partnerships, and commercialization in oncology and neurology.

The company also highlighted its strategy of building a multi-layered global “Patent Wall” around OT-101. This includes protection covering therapeutic uses, CNS delivery methods, device-enabled administration, dosing strategies, combination therapies, and biomarker-driven patient selection. According to the company, this layered IP structure is designed to create long-term defensibility and strengthen OT-101’s commercial potential.