On December 2, 2025 Oncotelic Therapeutics, Inc. (OTCQB: OTLC) 45% owned Joint Venture, Sapu Nano, a clinical-stage nanomedicine company, reported new data demonstrating that its proprietary Deciparticle platform enables broad and consistent formulation of structurally diverse hydrophobic therapeutics-including macrolide mTOR inhibitors, cyclic peptides, linear peptides, ascomycin macrolactams, and polyketides-while maintaining a precise sub-20 nm nanoparticle profile suitable for intravenous (IV) delivery.
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These findings, presented at the 2025 San Antonio Breast Cancer Symposium (SABCS), confirm that the Deciparticle technology represents a chemically versatile, cGMP-ready delivery platform with the potential to support an expanding pipeline of oncology and immunology drug products.
Presentation info: PS4-04-21. Deciparticle Everolimus (Sapu003): From Cytostasis to Cytotoxicity via a Single mPEG Polymer and Clinic-Ready Manufacturing. Sheng-Hao Min, Kevin Forero, Johnathan Anderson, William Putnam, Can Evizi, Cassidy McCallum, Robert Hoff, Mark Ostrander, and Kwun Ho.
Deciparticle Platform Demonstrates Broad Formulation Capability Across Therapeutic Classes
New data from a comprehensive screening effort show that Sapu Nano’s optimized polymer reproducibly forms monodisperse nanoparticles (~15 nm) capable of encapsulating multiple classes of hydrophobic drugs:
Macrolide mTOR Inhibitors
All five clinically relevant macrolide immunosuppressants formed stable Deciparticles:
Sirolimus
Temsirolimus
Ridaforolimus
Umirolimus
Everolimus
Differences in substitution at the C-40/C-42 or C-33 positions did not impair nanoparticle formation, highlighting the platform’s tolerance for structural diversity within the macrolide family.
Ascomycin Macrolactams
Tacrolimus formed stable sub-20 nm Deciparticles.
Pimecrolimus, while encapsulated, produced particle sizes above the Deciparticle threshold-defining a steric upper bound for the platform and its suitability for optimized macrolactam design.
Cyclic and Linear Peptides
The Deciparticle platform successfully formulated two medically important peptide classes:
Cyclosporine A (hydrophobic cyclic peptide)
Exenatide (synthetic linear peptide)
These findings demonstrate the platform’s ability to handle both compact hydrophobic macrocycles and amphipathic linear peptides-an important expansion for peptide-based therapeutic pipelines.
Robust and Scalable cGMP Manufacturing
The platform is supported by Sapu Nano’s ISO-5 cGMP facility capable of:
One-pot bulk drug manufacturing
Sterile filtration
Automated fill/finish
Lyophilization into a stable, clinic-ready drug product
High batch reproducibility
Days to weeks post-reconstitution stability
Precision particle-size control with tight lot-to-lot consistency
This cGMP infrastructure enables fast, reliable translation from formulation to Phase 1 supply, supporting multiple INDs annually.
"With these new data, the Deciparticle platform has emerged as a broad, modular nanomedicine engine capable of formulating multiple classes of hydrophobic drugs that were previously constrained by solubility and delivery barriers," said Dr. Vuong Trieu, Chief Executive Officer of Sapu Nano. "This platform advances beyond single-asset value to a multi-asset opportunity across oncology, immunology, and peptide therapeutics. Sapu003 is only the beginning."
About the Deciparticle Platform
The Deciparticle platform is a proprietary nanotechnology engineered to encapsulate hydrophobic molecules as uniform, sub-20 nm nanoparticles for intravenous administration. The platform improves systemic exposure, reduces GI deposition, and supports precision delivery while maintaining manufacturability at clinical scale.
(Press release, Oncotelic, DEC 2, 2025, View Source [SID1234661057])