On June 3, 2026 Sapu Nano and Oncotelic Therapeutics (OTCQB:OTLC) reported the expansion of its Phase 1b clinical development program for Sapu003 (Everolimus for Injection) and the appointment of Global Clinical Trials (GCT) as the lead contract research organization supporting international execution of Study SP-03-B101.
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The announcement follows recent regulatory approvals supporting the study expansion and CRO transition and represents an important milestone in the evolution of the Sapu003 clinical program from its initial Australian clinical footprint toward a broader multinational clinical program.
GCT was selected following a competitive evaluation process that assessed international oncology expertise, regulatory capabilities, operational execution, clinical quality systems, and global logistics infrastructure. Following its appointment, GCT successfully completed key regulatory submissions ahead of schedule and has initiated clinical operations, regulatory coordination, site activation activities, investigational product logistics, and study management functions.
The appointment supports the expansion of the SP-03-B101 study beyond Australia into Europe and represents an important step in establishing the clinical, operational, and regulatory infrastructure necessary to support future multinational Phase 3 development. By building an international clinical network early in development, Sapu Nano aims to position Sapu003 for efficient advancement into global registrational studies following successful completion of ongoing clinical evaluation.
SP-03-B101 is an open-label Phase 1b dose-escalation study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of Sapu003 in patients with advanced mTOR-sensitive solid tumors.
"Sapu003 has progressed from concept through formulation development, manufacturing, regulatory approval, and clinical evaluation in a remarkably short period of time," said Dr. Vuong Trieu, Chief Executive Officer. "The expansion of the program beyond Australia and the appointment of GCT provide the international infrastructure necessary to support continued clinical development. We believe these milestones position Sapu003 for broader global evaluation and future registrational studies while expanding access for patients with advanced cancers."
Sapu003 is a proprietary intravenous formulation of everolimus developed using Sapu Nano’s Deciparticle platform technology. The program is designed to address limitations associated with oral everolimus administration, including variable absorption, food effects, and first-pass metabolism, while providing more predictable systemic drug exposure through intravenous delivery.
The Company expects the expanded international footprint and integrated clinical operations platform established through GCT to support continued enrollment, future site expansion, and long-term global development objectives for the Sapu003 program.About Deciparticle
Deciparticle is Oncotelic’s proprietary nanomedicine platform designed to formulate highly water-insoluble therapeutics into ultra-small nanoparticles for intravenous administration. The platform utilizes amphiphilic polymer architectures intended to improve aqueous compatibility, stability, manufacturability, and translational flexibility across multiple therapeutic classes.
(Press release, Sapu Bioscience, JUN 3, 2026, View Source [SID1234666413])