Sapu Nano  announced new biomarker data identifying a molecular signature that predicts sensitivity to Sapu003, the company’s intravenous Deciparticle^™ formulation of everolimus. These data will be presented at the 2025 San Antonio Breast Cancer Symposium (SABCS) Dec 9-12. This work describes the first prospective biomarker framework for intravenous everolimus and establishes a foundation for mTOR therapy targeted to the patient populations most likely to benefit.

The analysis, which evaluated more than 9,000 patient tumor samples across 20 cancer types, revealed that tumors exhibiting a High-RICTOR / Low-RPTOR gene-expression pattern show a significantly greater dependency on mTOR signaling and are therefore, more likely to respond to potent mTOR inhibition delivered by IV Sapu003.

The biomarker analysis demonstrated that:

• Tumors with elevated RICTOR (mTORC2 activation) and suppressed RPTOR (limited mTORC1 scaffolding) show heightened reliance on mTORC2-AKT survival signaling.
• These tumors exhibit increased glycolytic flux, elevated metabolic stress markers, and reduced compensatory feedback, making them vulnerable to systemically distributed everolimus.
• This phenotype/genotype was strongly enriched in:
  • HR+/HER2- breast cancer
  • Lung adenocarcinoma
  • Gastric cancer
  • Renal cell carcinoma
  • Ovarian cancer
  • AML and T-cell malignancies

Across multiple datasets, patients with this signature had significantly worse survival with standard therapy, but showed predicted sensitivity to Sapu003.

This enables, for the first time, biomarker-enriched patient selection for an mTOR inhibitor.

“Up to now mTOR inhibitor therapy has lacked an empirical patient selection strategy beyond tumor type,” said Dr. Seymour Fein, Chief Medical Officer of Sapu Nano. “The High-RICTOR/Low-RPTOR signature gives us, for the first time, a molecular map of which patients are most likely to benefit. The potential for targeting a more sensitive patient population combined with the consistent pharmacokinetic profile of Sapu003 administered intravenously creates an entirely new therapeutic opportunity for mTOR-driven cancers.”