Oncotelic Therapeutics, Inc. (OTCQB: OTLC) and Sapu Nano announced 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 for international execution of Study SP-03-B101. The move follows recent regulatory approvals supporting study expansion and marks the transition of the Sapu003 program from an Australia-based clinical effort toward a broader multinational development strategy, including planned expansion into Europe.
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. The company said GCT has already completed key regulatory submissions ahead of schedule and initiated clinical operations, site activation and study management activities. Sapu003 is an intravenous formulation of everolimus developed using Sapu Nano’s Deciparticle platform, which is designed to improve drug delivery and provide more predictable systemic exposure than oral administration while supporting future global registrational studies.
The expansion of the Sapu003 program represents a significant milestone for Oncotelic as it seeks to address high-unmet-need cancers and rare pediatric indications. The company is a clinical-stage biopharmaceutical firm focused on oncology and immunotherapy products, leveraging a robust portfolio of inventions from its CEO, Dr. Vuong Trieu, who has filed over 500 patent applications and holds 75 issued patents. Oncotelic also utilizes its proprietary AI-enabled PDAOAI platform to support research, biomarker discovery, and regulatory processes.
Beyond its internal programs, Oncotelic licenses and co-develops select drug candidates through strategic partnerships and joint ventures, including a 45% interest in GMP Bio, which advances a complementary pipeline of therapeutic candidates. The appointment of GCT as the global CRO is expected to accelerate the clinical development of Sapu003, bringing it closer to potential registration and commercialization. For more information, view the full press release here.
