Sapu Nano’s Nanoplatform Aims to Unlock ‘Undeliverable’ Drugs

SAN DIEGO, CA – December 03, 2025 – In the high-stakes world of drug development, some of the most potent therapeutic molecules remain sidelined, defeated not by a lack of efficacy but by a simple, stubborn physical property: they don't dissolve in water. This challenge of hydrophobicity has long been a bottleneck, limiting the potential of countless drug candidates. Now, clinical-stage nanomedicine company Sapu Nano has unveiled new data suggesting its proprietary Deciparticle™ platform may offer a versatile and scalable solution to this persistent problem.

Presented at the 2025 San Antonio Breast Cancer Symposium (SABCS), the company's findings demonstrate that its technology can consistently formulate a wide array of structurally diverse hydrophobic drugs into precise, sub-20 nanometer particles suitable for intravenous delivery. This development moves beyond a single-drug solution, positioning the Deciparticle™ platform as a potential engine for reviving stalled pipelines across oncology, immunology, and peptide therapeutics.

The Solubility Barrier: A Persistent Challenge in Drug Development

A significant portion of new chemical entities discovered by pharmaceutical labs are poorly water-soluble. This characteristic severely hampers their clinical utility. When a drug cannot dissolve effectively in the bloodstream, its absorption is erratic, its bioavailability is low, and achieving a consistent, therapeutic concentration in patients becomes a formidable challenge. Consequently, many promising compounds are abandoned early in development, deemed 'undeliverable.'

A prime example is the well-known mTOR inhibitor class of drugs, which includes Everolimus. While effective in certain cancers, oral Everolimus is plagued by bioavailability of only around 10%, meaning 90% of the ingested drug never reaches systemic circulation. This not only limits its overall potency but also contributes to variable patient responses and significant gastrointestinal side effects. The drug's potential is fundamentally capped by its delivery method.

This solubility barrier extends across therapeutic classes, from complex cyclic peptides used as immunosuppressants to novel polyketide antibiotics. The industry has long sought a 'plug-and-play' platform that can reliably overcome this issue without requiring extensive, one-off reformulation for every new molecule. Sapu Nano’s announcement suggests they may be closing in on such a system.

A Modular Engine for Nanomedicine

The core innovation of the Deciparticle™ platform lies in its remarkable chemical versatility and precision. According to data presented at SABCS, the technology successfully formulated multiple classes of hydrophobic agents—including macrolide mTOR inhibitors like Sirolimus and Everolimus, cyclic peptides like Cyclosporine A, linear peptides like Exenatide, and ascomycin macrolactams like Tacrolimus—into uniform nanoparticles.

Crucially, these particles maintain a consistent size profile under 20 nanometers, typically around 15 nm. This dimension is critical for intravenous nanomedicines. Particles in this size range are small enough to evade rapid clearance by the liver and spleen, allowing for longer circulation times and improved potential to accumulate at disease sites, such as tumors, through a phenomenon known as the Enhanced Permeability and Retention (EPR) effect. The SABCS presentation, titled "From Cytostasis to Cytotoxicity," hinted at this enhanced potency, suggesting the delivery system could elevate a drug's effect from merely halting cell growth to actively killing cancer cells.

“With these new data, the Deciparticle™ platform has emerged as a broad, modular nanomedicine engine capable of formulating multiple classes of hydrophobic drugs that were previously constrained by solubility and delivery barriers,” stated Dr. Vuong Trieu, Chief Executive Officer of Sapu Nano, in the company's press release. His statement frames the technology not as a one-off success, but as a repeatable, multi-asset opportunity.

The Strategic Advantage of Integrated Manufacturing

Beyond the novel science, Sapu Nano’s strategic approach distinguishes it within the competitive biotech landscape. The company operates an integrated, ISO-5 certified cGMP (Current Good Manufacturing Practice) facility, a move that vertically integrates drug development from formulation directly to clinical trial supply. This in-house capability is a significant departure from the common biotech model of outsourcing manufacturing to third-party contract organizations (CMOs).

For complex nanomedicines, tech transfer to a CMO is often a costly, time-consuming, and risky process. Ensuring lot-to-lot consistency, particle size control, and sterility is a major technical hurdle. By controlling the entire process—from one-pot bulk drug manufacturing and sterile filtration to automated fill/finish and lyophilization into a stable, clinic-ready powder—Sapu Nano can drastically accelerate development timelines. This model enables high batch reproducibility and supports the company's ambitious goal of filing multiple Investigational New Drug (IND) applications annually.

This integrated infrastructure provides a powerful competitive advantage, potentially making the company an attractive partner for larger pharmaceutical firms looking to de-risk and speed up the development of their own challenging hydrophobic compounds. It represents a blueprint for operational efficiency in a field where manufacturing can often be the highest barrier to clinical progress.

Sapu003: Putting the Platform to the Clinical Test

The first true test of the Deciparticle™ platform is already underway. Sapu Nano’s lead candidate, Sapu003, is an intravenous formulation of Everolimus. The company has received approval from Australia's Human Research Ethics Committee (HREC) to initiate a Phase 1 clinical trial for Sapu003 in patients with advanced HR+/HER2– breast cancer or other mTOR-sensitive tumors who have exhausted standard therapies.

This trial directly targets the shortcomings of the oral drug. By delivering a 100% bioavailable dose intravenously, Sapu003 aims to achieve the consistent and high drug exposure needed for a more powerful anti-tumor effect. Preclinical data suggests this approach could lead to meaningful tumor shrinkage in cases where the oral formulation provides only limited progression-free survival.

Navigating the regulatory pathway for nanomedicines is inherently complex, with agencies like the FDA requiring extensive data on particle characterization, stability, and potential nanotoxicity. However, Sapu Nano’s investment in a cGMP-compliant manufacturing process is designed to proactively address these rigorous requirements. The company's collaboration with established clinical research organizations like SOCRU and Ingenū for the trial further signals a robust and well-planned clinical strategy.

As Dr. Trieu noted, “Sapu003 is only the beginning.” The true measure of the Deciparticle™ platform will be its ability to generate a pipeline of similarly enhanced therapeutics. If successful, this technology could represent a significant step forward in unlocking a vast repository of potent but previously undeliverable drugs, offering new hope for patients across a spectrum of difficult-to-treat diseases.