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 study 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.
The full press release is available at https://ibn.fm/hocuZ.
Oncotelic Therapeutics is a clinical-stage biopharmaceutical company focused on developing oncology and immunotherapy products for high-unmet-need cancers and rare pediatric indications. The company benefits from a robust portfolio of inventions created 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, lab automation, and AI-assisted GMP manufacturing. Through its relationship with SAPU Bio, an OEB-5 sterile injectable cGMP manufacturing facility, PDAOAI underpins ongoing joint development work with TechForce Robotics.
For more information, visit www.oncotelic.com. The latest news and updates relating to OTLC are available in the company's newsroom at https://ibn.fm/OTLC.
