On June 29, 2026 Oncotelic Therapeutics, Inc. ("Oncotelic" or the "Company") (OTCQB: OTLC) and Sapu Nano reported the publication of a peer-reviewed scientific manuscript validating its proprietary Deciparticle nanoparticle platform through the successful development of Sapu003, the Company’s investigational intravenous everolimus formulation currently being evaluated in an ongoing Phase 1b clinical trial.
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The publication, "Intravenous Everolimus Formulation (Sapu003) for Clinical Trials," has been published in the International Journal of Molecular Sciences and provides the first comprehensive description of the Deciparticle platform, including formulation design, scalable cGMP manufacturing, product characterization, stability, and preclinical evaluation.
Publication Citation
Min SH, Forero K, Putnam W, Anderson J, Hoff R, Lopp J, Trieu V, Ho K, Lee C. Intravenous Everolimus Formulation (Sapu003) for Clinical Trials. International Journal of Molecular Sciences. 2026;27(13):5775. doi:10.3390/ijms27135775.
Everolimus is a well-established inhibitor of the mammalian target of rapamycin (mTOR) approved for the treatment of multiple cancers. However, because of its poor aqueous solubility and limited oral bioavailability, clinical use has historically been restricted to oral administration. Sapu003 was developed using the Deciparticle platform to enable intravenous delivery through a stable nanoparticle formulation.
The publication reports several significant achievements, including:
Development of a stable intravenous everolimus formulation with mean particle sizes below 20 nanometers.
A robust, scalable cGMP manufacturing process capable of producing clinical-grade material with high batch-to-batch reproducibility.
Favorable product stability following lyophilization and refrigerated storage.
Successful formulation of multiple hydrophobic therapeutic compounds, demonstrating the broader applicability of the Deciparticle platform beyond everolimus.
Potent preclinical antitumor activity supporting continued clinical development of Sapu003.
"The publication of this work represents an important milestone for Sapu Bioscience," said Vuong Trieu, Ph.D., CEO and Chairman of Oncotelic. "Independent peer review validates not only the scientific foundation supporting Sapu003, but also the broader Deciparticle platform. We believe this technology has the potential to address one of the longstanding challenges in drug development-enabling intravenous delivery of poorly water-soluble therapeutic compounds through a scalable and reproducible manufacturing process."
Unlike many formulation technologies developed for a single product, the published research demonstrates that the Deciparticle platform is compatible with wide range of hydrophobic molecules, including rapalogs, macrocyclic compounds, immunosuppressants, and selected peptide therapeutics. The Company believes this broad formulation capability may support future pipeline expansion and collaborative development opportunities.
Sapu003 is currently being evaluated in an ongoing Phase 1b open-label dose-escalation study in patients with advanced mTOR-sensitive solid tumors. The study is assessing the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of weekly intravenous Sapu003 administered in combination with exemestane.
"The publication marks the successful translation of the Deciparticle platform from laboratory research to clinical-stage manufacturing," added Dr. Trieu. "As our Phase 1b clinical study progresses, we look forward to further evaluating the potential of Sapu003 while continuing to expand the application of the Deciparticle platform to additional therapeutic programs."
About Sapu003
Sapu003 is an investigational intravenous formulation of everolimus developed using Sapu Bioscience’s proprietary Deciparticle nanoparticle platform. The program is designed to overcome the formulation limitations associated with oral everolimus while enabling predictable intravenous administration for the treatment of patients with advanced cancers.
About Deciparticle
Deciparticle is Sapu Bioscience’s proprietary nanoparticle formulation platform designed to enable intravenous delivery of poorly water-soluble therapeutic compounds. The technology combines amphiphilic polymer design with scalable cGMP manufacturing to generate stable nanoparticle formulations suitable for clinical development. The platform has demonstrated compatibility across multiple classes of hydrophobic therapeutic agents and is being evaluated for broader pharmaceutical applications.
(Press release, Oncotelic, JUN 29, 2026, View Source [SID1234668995])