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 were observed and recommended advancing the study to the next planned dose level. Enrollment into the second dose cohort has commenced.
SP-03-B101 is an open-label, multicenter, Bayesian Optimal Interval (BOIN) dose-escalation study evaluating the safety, tolerability, pharmacokinetics, 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, broadening patient access and supporting the global clinical development strategy for Sapu003.
"The independent Safety Review Committee's recommendation to advance to the next dose level provides important clinical validation of the Sapu003 program," said Dr. Vuong Trieu, Chief Executive Officer of Sapu Nano. "Combined with the expansion of SP-03-B101 into Europe, 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 Deciparticle™ 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 and describes a stable intravenous everolimus nanoparticle formulation with a mean particle size below 20 nanometers, identification of mPEG-Chol as the optimal carrier, a scalable cGMP manufacturing process suitable for clinical production, and potent preclinical antitumor activity.
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 Sapu Nano's Deciparticle™
Sapu Nano's Deciparticle™ is a proprietary nanomedicine platform designed to formulate highly water-insoluble therapeutics into ultra-small nanoparticles for intravenous administration. The platform utilizes amphiphilic polymer architectures intended to improve aqueous compatibility, stability, manufacturability, and translational flexibility across multiple therapeutic classes.
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The issuer is solely responsible for the content of this announcement.
About Sapu Nano
Sapu Nano is a biotechnology company developing next-generation nanomedicine platforms to improve drug delivery, enhance therapeutic index, and unlock new clinical potential for established and novel therapeutics, with a primary focus in oncology. For more information, visit www.sapunano.com.
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