Oncotelic Therapeutics, Inc. (OTCQB: OTLC), together with Sapu Nano, announced the publication of a peer-reviewed study in Biomedicines detailing the 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 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 stated that the comprehensive preclinical package supports continued clinical development of Sapu003 and further validates its Deciparticle platform for transforming hydrophobic therapeutics into intravenous medicines. This advancement is significant because everolimus, an mTOR inhibitor, is currently only available orally, which can lead to variable absorption and gastrointestinal side effects. An intravenous formulation could offer more predictable dosing and potentially improve outcomes for patients with advanced solid tumors.
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, visit www.oncotelic.com.
