Oncotelic Therapeutics (OTCQB: OTLC) together with Sapu Nano has announced the publication of a peer-reviewed study in Biomedicines detailing preclinical data for Sapu003, an intravenous Deciparticle formulation of everolimus. The study, which covers absorption, distribution, metabolism, excretion (ADME), pharmacokinetics, tissue distribution, GLP toxicology, and cGMP manufacturing data, supports the ongoing Phase 1 clinical evaluation of Sapu003 in patients with advanced solid tumors.
The published findings demonstrate that the formulation overcomes pharmacokinetic limitations associated with oral everolimus while preserving the drug’s metabolic profile. Key results include reduced gastrointestinal drug exposure compared with oral everolimus, no treatment-related gastric pathology in repeat-dose GLP toxicology studies, and the successful development of a reproducible cGMP manufacturing process suitable for clinical production. The company noted that this comprehensive preclinical package supports continued clinical development of Sapu003 and validates its Deciparticle platform for transforming hydrophobic therapeutics into intravenous medicines.
The Deciparticle platform is designed to address challenges in drug delivery for poorly water-soluble compounds, a common issue in oncology. Everolimus, an mTOR inhibitor, is currently approved in oral form for several cancers but has limitations including variable absorption and gastrointestinal side effects. The intravenous formulation aims to provide more consistent drug exposure and potentially reduce side effects, improving patient outcomes.
Oncotelic Therapeutics is a clinical-stage biopharmaceutical company focusing on oncology and immunotherapy products for high-unmet-need cancers and rare pediatric indications. The company benefits from a robust portfolio of inventions by its CEO, Dr. Vuong Trieu, who has filed over 500 patent applications and holds 75 issued U.S. patents. Oncotelic also owns 45% of GMP Bio, a joint venture advancing its own pipeline of drug candidates, and develops PDAOAI, a proprietary AI platform for drug discovery and manufacturing.
For more information about Oncotelic, visit www.oncotelic.com. The full press release is available at https://ibn.fm/hocuZ.
