Oncotelic Therapeutics' joint venture Sapu Nano presented new data at the 2025 San Antonio Breast Cancer Symposium showing its Deciparticle nanomedicine platform can consistently formulate structurally diverse hydrophobic therapeutics into sub-20 nm nanoparticles suitable for intravenous delivery. The findings confirm Deciparticle as a versatile, cGMP-ready delivery platform backed by ISO-5 manufacturing capabilities that support rapid translation to Phase 1 clinical trial supply.
The platform successfully formulated multiple therapeutic classes including macrolide mTOR inhibitors, cyclic and linear peptides, ascomycin macrolactams and polyketides. This broad formulation capability addresses a significant challenge in drug development, as many promising therapeutic compounds exhibit poor solubility and bioavailability, limiting their clinical potential. The sub-20 nm nanoparticle size is particularly important for intravenous delivery, as smaller particles typically demonstrate improved biodistribution and reduced clearance rates compared to larger formulations.
CEO Dr. Vuong Trieu stated the results position Deciparticle as a modular engine for multiple oncology, immunology and peptide drug candidates, with Sapu003 representing the first of a broader pipeline. The platform's versatility could accelerate development timelines for multiple therapeutic programs by providing a standardized, validated delivery system for hydrophobic compounds that might otherwise face formulation challenges. This is particularly relevant for oncology applications where hydrophobic drugs are common but delivery remains problematic.
The ISO-5 manufacturing capabilities referenced in the announcement refer to cleanroom standards that ensure product quality and consistency, essential for regulatory approval and commercial-scale production. The cGMP-ready status indicates the platform meets current Good Manufacturing Practice requirements, reducing technical and regulatory hurdles as candidates advance through clinical development. This manufacturing readiness could significantly shorten the time between preclinical validation and clinical testing for new drug candidates utilizing the platform.
Oncotelic Therapeutics, a clinical-stage biopharmaceutical company focused on oncology and immunotherapy products, owns 45% of Sapu Nano through its joint venture structure. The company's broader strategy involves addressing high-unmet-need cancers and rare pediatric indications with innovative therapeutic candidates. Additional information about Oncotelic Therapeutics is available through the company's newsroom at https://nnw.fm/OTLC. The full press release detailing the Deciparticle platform data can be accessed at https://nnw.fm/b0Qps.
The implications of this technological advancement extend beyond individual drug candidates to potentially reshape development approaches for hydrophobic therapeutics across multiple disease areas. By providing a standardized, validated delivery platform, Deciparticle could reduce formulation-related failures in drug development pipelines and accelerate the translation of promising compounds into clinical testing. For patients, this could mean faster access to new treatment options, particularly in oncology where hydrophobic drugs represent a significant portion of investigational compounds. For the pharmaceutical industry, such platform technologies offer potential efficiency gains by reducing formulation development timelines and costs across multiple programs.
