Agoura Hills, Calif., July 22, 2026
Oncotelic Therapeutics and Sapu Nano announced the publication of a peer-reviewed study in Biomedicines validating the scientific foundation of the company’s proprietary Deciparticle™ nanomedicine platform, which supports the ongoing Phase 1b clinical development of Sapu003, an investigational intravenous formulation of everolimus for patients with advanced mTOR-sensitive solid tumors. The publication presents one of the most comprehensive nonclinical evaluations performed for an intravenous everolimus formulation, including detailed analyses of absorption, distribution, metabolism, excretion (ADME), pharmacokinetics (PK), tissue distribution, GLP toxicology, product stability, and cGMP manufacturing. The findings demonstrate that Deciparticle™ technology successfully converts everolimus from an oral therapy with known pharmacokinetic limitations into a clinically manufacturable intravenous medicine while preserving the drug’s intrinsic metabolic characteristics, providing strong support for the continued clinical evaluation of Sapu003.
River Study Demonstrates Sustained Clinical ImprovementsPreclinical Studies Demonstrate Improved Drug Delivery and Safety Profile
According to the published research, intravenous Sapu003 achieved broad systemic distribution while avoiding the significant gastrointestinal drug accumulation commonly associated with oral everolimus therapy. Investigators reported that repeat-dose GLP toxicology studies found no treatment-related gastric pathology following intravenous administration, suggesting the potential for improved tolerability compared with conventional oral formulations. The comprehensive translational package also included complete ADME characterization, pharmacokinetic profiling, tissue-distribution studies, metabolic pathway analysis, excretion assessments, and repeat-dose toxicology, providing robust scientific evidence supporting the transition from laboratory development into human clinical testing. These results strengthen confidence that Deciparticle™ can overcome formulation challenges commonly associated with poorly water-soluble therapeutic compounds.
Clinical-Grade Manufacturing Supports Ongoing Phase 1b Development
The publication also confirmed the successful establishment of a reproducible current Good Manufacturing Practice (cGMP) manufacturing process for Sapu003, demonstrating that the Deciparticle™ platform can consistently produce clinical-grade intravenous formulations suitable for regulatory development. Company executives described the publication as an important milestone because it integrates every major component required for clinical translation, including quality control, manufacturing validation, pharmacokinetics, metabolism, tissue distribution, and toxicology within a single scientific report. Sapu003 is currently being evaluated in the Phase 1b SP-03-B101 clinical trial (NCT07369505) involving patients with advanced mTOR-sensitive solid tumors, where researchers are assessing the safety and therapeutic potential of the intravenous formulation. The manufacturing results also demonstrate that the platform can support scalable production for future clinical and commercial development.
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Deciparticle Platform Expands Future Oncology Opportunities
Sapu003 represents the lead clinical candidate developed using Sapu Nano’s proprietary Deciparticle™ nanomedicine platform, which is designed to formulate poorly water-soluble therapeutic compounds into stable intravenous medicines through advanced amphiphilic polymer technology. Beyond everolimus, the platform has demonstrated compatibility with multiple classes of hydrophobic drug molecules, creating opportunities for future oncology programs and strategic development collaborations. Oncotelic Therapeutics is also advancing a broader oncology and immunotherapy pipeline while expanding its capabilities in artificial intelligence-assisted drug discovery, cleanroom automation, and GMP manufacturing through its proprietary PDAOAI platform. With the publication providing extensive scientific validation of Deciparticle™ technology and supporting the ongoing Phase 1b clinical evaluation of Sapu003, the company continues to strengthen its position in the development of innovative nanomedicine-based cancer therapies.
Source: Oncotelic Therapeutics press release
