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SantiagoJune 8, 2026 /PRNewswire/ — Sapu Bioscience LLC recently announced the expansion of the Phase 1b clinical development program for Sapu003 (everolimus for injection) and the appointment of Global Clinical Trials (GCT) as the primary Contract Research Organization (CRO) to support the international execution of the SP-03-B101 study.
This announcement follows recent regulatory approvals supporting the study expansion and CRO transition, marking a significant milestone in the Sapu003 clinical program’s shift from its initial clinical footprint in Australia to a broader multinational development strategy.
GCT was selected through a competitive evaluation process that assessed international oncology expertise, regulatory capabilities, operational execution, clinical quality systems, and global logistics infrastructure. Following GCT’s appointment, key regulatory submissions have been completed ahead of schedule, and clinical operations, regulatory coordination, site initiation activities, investigational product logistics, and study management functions have been initiated.
This appointment supports the expansion of the SP-03-B101 study from Australia to Europe and other international regions, representing a critical step in building the clinical, operational, and regulatory infrastructure required for future multinational Phase 3 development. By establishing an international clinical network early in development, Sapu Nano aims to position Sapu003 for efficient progression into global registrational studies upon successful completion of the current clinical evaluation.
SP-03-B101 is an open-label Phase 1b dose-escalation study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of Sapu003 in patients with mTOR-sensitive advanced solid tumors.
“Sapu003 has advanced from concept to formulation development, manufacturing, regulatory approval, and clinical evaluation in a very short timeframe,“ said Dr. Vuong Trieu, Chief Executive Officer. “The expansion of the program beyond Australia and the appointment of GCT provide the necessary international infrastructure to support continued clinical development. We believe these milestones will enable broader global evaluation of Sapu003 and potentially future registrational studies, while also offering more treatment opportunities for patients with advanced cancer.“
Sapu003 is a proprietary intravenous formulation of everolimus developed using Sapu Nano’s Deciparticle™ platform technology. The program aims to address limitations associated with oral everolimus administration, including absorption variability, food effects, and first-pass metabolism, while providing more predictable systemic drug exposure through intravenous delivery.
The company expects that the expanded international footprint and integrated clinical operations platform established with GCT will support continued enrollment, future site expansion, and long-term global development objectives for the Sapu003 program.