Oncotelic Therapeutics, Inc. (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. 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. According to the company, the comprehensive preclinical package supports continued clinical development of Sapu003 and further validates its Deciparticle platform for transforming hydrophobic therapeutics into intravenous medicines. The full press release is available at https://ibn.fm/hocuZ.
Oncotelic Therapeutics is a clinical-stage biopharmaceutical company focused on oncology and immunotherapy products, addressing high-unmet-need cancers and rare pediatric indications. The company’s CEO, Dr. Vuong Trieu, 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. Additionally, Oncotelic develops PDAOAI, a proprietary AI platform for drug discovery and lab automation, which underpins the Deciparticle platform and ongoing work with TechForce Robotics. More information is available at www.oncotelic.com.
