Oncotelic Therapeutics (OTCQB: OTLC), together with Sapu Nano, announced the publication of a peer-reviewed study in Biomedicines detailing preclinical data supporting Sapu003, its intravenous Deciparticle formulation of everolimus. The publication outlines the program's absorption, distribution, metabolism, excretion (“ADME”), pharmacokinetics, tissue distribution, GLP toxicology, and cGMP manufacturing data, supporting the ongoing Phase 1 clinical evaluation of Sapu003 in patients with advanced solid tumors.
According to the company, the formulation is designed to overcome pharmacokinetic limitations associated with oral everolimus while preserving the drug's metabolic profile. The published findings also describe reduced gastrointestinal drug exposure compared with oral everolimus, no treatment-related gastric pathology in repeat-dose GLP toxicology studies, and successful development of a reproducible cGMP manufacturing process suitable for clinical production. The company said the comprehensive preclinical package supports continued clinical development of Sapu003 and further validates its Deciparticle platform for transforming hydrophobic therapeutics into intravenous medicines.
This development is significant because it addresses a key challenge in oncology: the bioavailability and tolerability of oral therapies. Everolimus, an mTOR inhibitor, is approved for certain cancers but its oral administration is associated with variable absorption and gastrointestinal side effects. The intravenous formulation could offer more predictable drug exposure and reduced toxicity, potentially improving outcomes for patients with advanced solid tumors. The Deciparticle platform, if successful, could be applied to other hydrophobic drugs, broadening the scope of intravenous cancer therapies.
Oncotelic Therapeutics is a clinical-stage biopharmaceutical company focused on oncology and immunotherapy products with high unmet need. The company also develops PDAOAI, its proprietary AI platform for drug discovery and manufacturing. The full press release is available at https://ibn.fm/hocuZ.
For more information, visit the company's website at www.oncotelic.com. The latest news and updates relating to OTLC are available in the company's newsroom at https://ibn.fm/OTLC.
