Sapu Nano Announces Deciparticle™-Led Biomarker Framework Identifying Tumors Most Likely to Respond to IV Sapu003
San Diego, Calif., Dec. 05, 2025 — Sapu Nano today announced new biomarker data identifying a molecular signature that predicts sensitivity to Sapu003, the company’s intravenous Deciparticle™ formulation of everolimus. These findings will be presented at the 2025 San Antonio Breast Cancer Symposium (SABCS), held December 9–12.
This work describes the first prospective biomarker framework for intravenous everolimus and establishes a foundation for targeted mTOR therapy in tumor types most likely to benefit.
Biomarker Signature Identifies Tumors Sensitive to IV Sapu003
The analysis evaluated more than 9,000 patient tumor samples across 20 cancer types and revealed that tumors exhibiting a High-RICTOR / Low-RPTOR gene-expression pattern show significantly greater dependency on mTOR survival signaling — and are therefore more likely to respond to potent mTOR inhibition delivered by IV Sapu003.
Tumors demonstrating this biomarker profile also:
- Show reliance on mTORC2–AKT survival pathways
- Exhibit increased glycolytic flux and metabolic stress markers
- Display reduced compensatory feedback, increasing susceptibility to IV everolimus
This phenotype was strongly enriched in:
- HR+/HER2− breast cancer
- Lung adenocarcinoma
- Ovarian cancer
- Gastric cancer
- Renal cell carcinoma
- AML and T-cell malignancies
Across multiple datasets, patients whose tumors carried this signature had significantly worse outcomes on standard therapy but showed predicted sensitivity to Sapu003. This provides the first molecular roadmap for patient selection with an mTOR inhibitor.
Management Commentary
“Until now, mTOR inhibitor therapy has lacked an empirically grounded patient-selection framework,” said Dr. Seymour Fein, Chief Medical Officer of Sapu Nano. “The High-RICTOR / Low-RPTOR signature gives us, for the first time, a way to identify patients most likely to benefit from mTOR inhibition delivered with consistent systemic exposure. This work creates a precision-medicine path for Sapu003.”
About Sapu003
Sapu003 is an intravenous nanoparticle formulation of everolimus engineered using Sapu Nano’s proprietary Deciparticle™ technology. It is designed to overcome poor bioavailability, GI toxicity, and variable exposure associated with oral everolimus while enabling predictable weekly IV dosing.
About the Deciparticle™ Platform
The Deciparticle™ platform encapsulates hydrophobic molecules into uniform, sub-20 nm nanoparticles for intravenous delivery. The technology improves systemic exposure, reduces GI deposition, and supports precision delivery while maintaining manufacturing readiness at clinical scale.
About Sapu Nano
Sapu Nano is a clinical-stage biotechnology company developing Deciparticle™ nanomedicine therapeutics designed to optimize delivery of hydrophobic oncology agents and peptide-based drugs. The company operates an integrated ISO-5 cGMP manufacturing facility supporting rapid advancement from formulation to clinical trial supply.
For more information, visit www.sapunano.com.