Sapu Nano has identified a high‑RICTOR/low‑RPTOR gene‑expression signature that predicts sensitivity to its intravenous everolimus formulation, Sapu003. The signature was detected in more than 9,000 tumor samples spanning 20 cancer types, making it the first prospective biomarker framework for an IV everolimus product.
The discovery addresses a long‑standing gap in mTOR‑inhibitor therapy: the lack of a robust patient‑selection strategy. Tumors that carry the signature exhibit poorer survival on standard therapy but are predicted to respond to potent mTOR inhibition delivered by IV Sapu003, potentially accelerating clinical development and improving therapeutic positioning.
Sapu003 is a Deciparticle™ formulation that delivers everolimus intravenously, overcoming the oral formulation’s limitations of poor bioavailability and gastrointestinal toxicity. The Deciparticle platform is versatile, capable of encapsulating other hydrophobic drugs, indicating a broader pipeline potential beyond everolimus.
A senior Sapu Nano executive noted that the signature “provides a molecular map of which patients are most likely to benefit. Targeting a more sensitive patient population combined with the consistent pharmacokinetic profile of IV Sapu003 creates an entirely new therapeutic opportunity for mTOR‑driven cancers.”
The data supporting the biomarker will be presented at the 2025 San Antonio Breast Cancer Symposium (December 9‑12). Sapu003 has already entered Phase 1 trials in Australia for breast cancer, and the biomarker framework will inform patient selection for ongoing and future studies.
This milestone is a material advance in Sapu Nano’s nanoparticle platform strategy and could expand the drug’s market reach beyond current oncology indications, positioning the company to compete more effectively against established mTOR inhibitors such as Afinitor.
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