Oncotelic Therapeutics Publishes Preclinical Data Supporting Intravenous Cancer Therapy

Oncotelic Therapeutics (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.

This advancement is significant because oral everolimus, while effective, has limitations including variable absorption and significant gastrointestinal toxicity. By developing an intravenous formulation, Oncotelic aims to improve drug delivery and patient outcomes. The Deciparticle platform enables the formulation of hydrophobic drugs like everolimus into stable, injectable nanoparticles, potentially expanding the therapeutic index and reducing side effects. The successful development of a cGMP manufacturing process also paves the way for scalable production.

Oncotelic Therapeutics is a clinical-stage biopharmaceutical company focused on oncology and immunotherapy. Its mission is to address high-unmet-need cancers and rare pediatric indications with innovative, late-stage therapeutic candidates. In addition to its directly owned drug pipeline, Oncotelic benefits from the 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. The company also licenses and co-develops select drug candidates through joint ventures, including a 45% ownership in GMP Bio, which is advancing its own pipeline under Dr. Trieu’s leadership.

Oncotelic 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, Oncotelic’s strategic robotics and automation partner. 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.