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 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 said the comprehensive preclinical package supports continued clinical development of Sapu003 and further validates its Deciparticle platform for transforming hydrophobic therapeutics into intravenous medicines.
This news is important because it addresses a key challenge in cancer therapy: many potent anticancer drugs are hydrophobic and poorly soluble, limiting their bioavailability when administered orally. The Deciparticle platform enables intravenous delivery, potentially improving drug exposure and reducing side effects. For patients with advanced solid tumors, this could mean more effective treatment with fewer gastrointestinal complications. The successful cGMP manufacturing also paves the way for scalable production, which is critical for clinical and commercial success.
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, and develops PDAOAI, a 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 ongoing joint development work with TechForce Robotics.
The full press release is available at https://ibn.fm/hocuZ. For more information about Oncotelic, visit www.oncotelic.com.
