On July 7, 2026 Oncotelic (OTCQB:OTLC), an AI/Robotic native biotechnology company, and its 45% owned subsidiary- Sapu Nano (US) LLC, a clinical-stage biotechnology company developing the proprietary Deciparticle nanomedicine platform, reported that the independent Safety Review Committee (SRC) has completed its review of the initial safety cohort in the Company’s ongoing SP-03-B101 Phase 1b clinical trial evaluating Sapu003, an investigational intravenous formulation of everolimus.

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Following completion of the protocol-defined 28-day dose-limiting toxicity (DLT) evaluation period for the initial three-patient cohort, the SRC concluded that no dose-limiting toxicities (DLTs) were observed and recommended advancing the study to the next planned dose level in accordance with the study protocol.

Sapu003 is currently being evaluated in the SP-03-B101 Phase 1b clinical trial, an open-label, multicenter, Bayesian Optimal Interval (BOIN) dose-escalation study evaluating the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of weekly intravenous Sapu003 in patients with advanced mTOR-sensitive solid tumors. The study is registered on ClinicalTrials.gov (Identifier: NCT07369505).

Following successful completion of the initial safety cohort, the Company has initiated expansion of the SP-03-B101 clinical program into Europe. Additional European clinical sites are expected to participate in the study, broadening patient access, accelerating enrollment, and supporting the global clinical development strategy for Sapu003.

"Successful completion of the initial safety cohort represents an important milestone for the Sapu003 development program," said Dr. Vuong Trieu, CEO of Sapu Nano. "The independent Safety Review Committee’s recommendation to advance to the next dose level provides important clinical validation of the program’s progress. Combined with the expansion of SP-03-B101 into Europe, we believe these milestones position Sapu003 for accelerated clinical development while broadening access for patients with advanced mTOR-sensitive solid tumors."

Peer-Reviewed Publication Supports Clinical Development

The clinical milestone follows the Company’s recent peer-reviewed publication describing the scientific foundation of Sapu003 and the proprietary Deciparticle nanoparticle platform.

Min SH, Forero K, Putnam W, Anderson J, Hoff R, Lopp J, Trieu V, Ho K, Lee C. Intravenous Everolimus Formulation (Sapu003) for Clinical Trials. International Journal of Molecular Sciences. 2026;27(13):5775. doi: 10.3390/ijms27135775.

The publication provides the first comprehensive description of the Deciparticle platform, including formulation discovery, scalable cGMP manufacturing, physicochemical characterization, stability, and preclinical evaluation supporting the ongoing clinical development of Sapu003.

The published work demonstrated:

Development of a stable intravenous everolimus nanoparticle formulation with a mean particle size below 20 nanometers.
Development of a robust, scalable cGMP manufacturing process suitable for clinical production.
Excellent product reproducibility and stability following lyophilization and refrigerated storage.
Broad compatibility of the Deciparticle platform with multiple hydrophobic therapeutic compounds, supporting potential future pipeline expansion.
Potent preclinical antitumor activity supporting advancement into clinical development.

"The progression from peer-reviewed publication to successful completion of our first clinical safety cohort highlights the maturity of both the Sapu003 program and the Deciparticle platform," added Dr. Trieu. "We believe Deciparticle represents a differentiated nanomedicine platform capable of enabling intravenous delivery of numerous poorly water-soluble therapeutic compounds while supporting scalable commercial manufacturing."

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 7, 2026, View Source [SID1234669098])