Oncotelic Therapeutics (OTCQB: OTLC), together with Sapu Nano, announced the publication of a peer-reviewed study in Biomedicines detailing preclinical data for Sapu003, its intravenous Deciparticle formulation of everolimus. The study outlines 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 comprehensive preclinical package supports continued clinical development of Sapu003 and further validates the Deciparticle platform for transforming hydrophobic therapeutics into intravenous medicines. The press release can be viewed 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 also develops PDAOAI, its proprietary AI platform for drug discovery, lab automation, and AI-assisted GMP manufacturing. Through Oncotelic’s relationship with SAPU Bio, an OEB-5 sterile injectable cGMP manufacturing facility, PDAOAI underpins the Platform and its ongoing joint development work with TechForce Robotics.
For more information about Oncotelic, visit www.oncotelic.com. Latest news and updates are available in the company’s newsroom at https://ibn.fm/OTLC.
