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.
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 implications of this announcement are significant for patients with advanced solid tumors who may benefit from improved drug delivery and reduced gastrointestinal side effects. Oral everolimus is known for its pharmacokinetic limitations and gastrointestinal toxicity; Sapu003’s intravenous formulation could offer a more tolerable and effective treatment option. For the biopharmaceutical industry, the Deciparticle platform represents a novel approach to reformulating hydrophobic drugs, potentially enabling the development of intravenous versions of other oral therapeutics.
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 pipeline includes directly owned drug candidates and those developed through joint ventures. Oncotelic also develops PDAOAI, its proprietary AI platform for drug discovery, lab automation, and AI-assisted GMP manufacturing. The relationship with SAPU Bio, an OEB-5 sterile injectable cGMP manufacturing facility, supports the platform and ongoing joint development work with TechForce Robotics.
The full press release is available at https://ibn.fm/hocuZ. For more information about Oncotelic Therapeutics, visit www.oncotelic.com.
