On July 22, 2026 Oncotelic Therapeutics, Inc. (OTCQB: OTLC) and Sapu Nano reported the publication of a comprehensive peer-reviewed study in Biomedicines describing the preclinical translational package supporting Sapu003, the Company’s intravenous Deciparticle formulation of everolimus. The publication provides a complete evaluation of the formulation’s absorption, distribution, metabolism, excretion (ADME), pharmacokinetics (PK), tissue distribution, GLP toxicology, and cGMP manufacturing, representing one of the most comprehensive nonclinical evaluations reported for an intravenous formulation of everolimus.
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The study demonstrates that Deciparticle technology successfully transforms everolimus from an oral therapy with well-recognized pharmacokinetic limitations into a clinically manufacturable intravenous formulation while preserving the drug’s intrinsic metabolic characteristics. The findings support the ongoing Phase 1 clinical evaluation of Sapu003 in patients with advanced solid tumors.
The publication integrates multiple components required for clinical translation, including:
Complete ADME characterization
Pharmacokinetic and tissue-distribution studies
Metabolic pathway analysis
Excretion studies
GLP repeat-dose toxicology
cGMP manufacturing and release testing
Product stability and quality characterization
Reduced Gastrointestinal Drug Exposure
Compared with oral everolimus, intravenous Sapu003 produced broad systemic distribution without the marked gastrointestinal accumulation characteristic of oral administration. Repeat-dose GLP toxicology studies demonstrated no treatment-related gastric pathology following intravenous dosing, supporting the potential for improved tolerability.
Clinical-Grade Manufacturing Successfully Demonstrated
The publication also describes the successful development of a reproducible cGMP manufacturing process for Sapu003. These manufacturing studies establish that Deciparticle technology is suitable for clinical production under current Good Manufacturing Practice (cGMP) conditions.
"This publication represents a significant milestone in the clinical translation of the Deciparticle platform," said Vuong Trieu, Ph.D., Chief Executive Officer of Oncotelic Therapeutics. "Rather than describing only a formulation or a pharmacokinetic study, this work brings together the complete scientific package-from cGMP manufacturing and quality control to ADME, pharmacokinetics, tissue distribution, metabolism, and GLP toxicology-that supports the ongoing clinical development of Sapu003."
"Our objective has always been to build a platform capable of transforming challenging hydrophobic therapeutics into clinically practical intravenous medicines. The successful demonstration of reproducible manufacturing together with favorable pharmacokinetic and safety characteristics provides strong validation of the Deciparticle technology."
About the Publication
The manuscript, titled "IV-EVE: EVE for Injection-ADME, Pharmacokinetic and Toxicological Evaluation for Novel Deciparticle EVE Formulation," was published in Biomedicines on July 14, 2026. View Source
Clinical Trial Information
Study Title: SP-03-B101: A Phase 1b Study of Sapu003 (Intravenous Everolimus) in Patients with Advanced mTOR-Sensitive Solid Tumors
ClinicalTrials.gov Identifier: NCT07369505
About Sapu003
Sapu003 is an investigational intravenous formulation of everolimus developed using Sapu Nano’s proprietary Deciparticle nanoparticle platform. Sapu003 is designed to overcome the formulation limitations associated with oral everolimus by enabling intravenous administration with a scalable cGMP manufacturing process. The program is currently being evaluated in the Phase 1b SP-03-B101 clinical trial in patients with advanced mTOR-sensitive solid tumors.
About Deciparticle
Deciparticle is Sapu Nano’s proprietary nanomedicine platform designed to formulate poorly water-soluble therapeutic compounds into stable intravenous formulations. The platform combines amphiphilic polymer technology with scalable cGMP manufacturing to enable the clinical development of challenging hydrophobic therapeutics. In addition to Sapu003, the platform has demonstrated compatibility with multiple classes of hydrophobic molecules, supporting future pipeline expansion and potential strategic collaborations.
(Press release, Oncotelic, JUL 22, 2026, View Source [SID1234669372])