Oncotelic Therapeutics, Inc. (OTCQB: OTLC) and Sapu Nano have 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.
This expansion is significant for patients and the oncology community as it accelerates the development of a potentially improved formulation of everolimus. Everolimus is an mTOR inhibitor currently approved orally for certain cancers, but oral administration can lead to variable absorption and side effects. The intravenous formulation aims to provide more consistent drug levels, which could enhance efficacy and reduce toxicity. If successful, Sapu003 could offer a new treatment option for patients with mTOR-sensitive solid tumors, potentially improving outcomes and quality of life.
Oncotelic Therapeutics is a clinical-stage biopharmaceutical company focused on oncology and immunotherapy products. The company’s mission is to address high-unmet-need cancers and rare pediatric indications with innovative, late-stage therapeutic candidates. In addition to its directly owned drug pipeline, Oncotelic benefits from a robust portfolio of inventions created by its CEO, Dr. Vuong Trieu, who has filed over 500 patent applications and holds 75 issued patents. The company also leverages its proprietary AI-enabled PDAOAI platform, which supports research, biomarker discovery, and regulatory processes through advanced data analysis and knowledge integration.
Beyond its internal programs, Oncotelic licenses and co-develops select drug candidates through strategic partnerships and joint ventures. The company currently owns a 45% interest in GMP Bio, a joint venture advancing a complementary pipeline of therapeutic candidates that further strengthens Oncotelic’s position in oncology and rare disease therapeutics.
The appointment of GCT as the global CRO is a key step in executing the multinational study. GCT’s expertise in clinical operations and regulatory submissions is expected to facilitate timely study initiation across multiple countries. For investors, this expansion signals Oncotelic’s commitment to advancing its pipeline and potentially capturing a larger market share in the oncology space. The move also highlights the company’s ability to secure regulatory approvals and execute complex clinical trials, which could de-risk the development path for Sapu003.
For more information, visit the company’s newsroom at https://nnw.fm/OTLC and see the full press release at https://nnw.fm/olX92.
