Sapu Nano completes Phase 1b safety cohort, gets dose escalation nod

SAN DIEGO, US - Media OutReach Newswire - 9 July 2026 - Sapu Nano (US) LLC, a clinical-stage biotechnology company developing the proprietary Deciparticle™ nanomedicine platform, today announced 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.

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

The issuer is solely responsible for the content of this announcement.

For more information, visit www.sapunano.com.