What Sapu Nano does

Sapu Nano is a clinical-stage biotechnology company headquartered in San Diego, California, that develops a proprietary ultra-small nanoparticle drug delivery platform branded Deciparticle™. The platform uses a proprietary amphiphilic polymer system to engineer sub-20 nanometer particles that enable intravenous delivery of water-insoluble therapeutic compounds, with a demonstrated 90% formulation success rate across more than 100 tested active pharmaceutical ingredients spanning macrolide mTOR inhibitors, cyclic and linear peptides, ascomycin macrolactams, and polyketides. The company's lead clinical candidate, SAPU-003, is an intravenous Deciparticle formulation of everolimus that achieves dual mTORC1/mTORC2 inhibition, 100% bioavailability (vs. ~10% for oral everolimus), and up to a 67-fold reduction in gastrointestinal accumulation; it is currently in a Phase 1b dose-escalation trial (SP-03-B101; NCT07369505) in advanced mTOR-sensitive solid tumors including HR+/HER2- breast cancer, renal cell carcinoma, neuroendocrine tumors, TSC-associated tumors, and hepatocellular carcinoma. A second program, SAPU-006 (docetaxel), is advancing toward IND, and additional next-generation Deciparticle candidates, radiosensitizers, and immune-modulating combinations are in preclinical development. Sapu Nano operates an ISO-5 cGMP manufacturing facility in San Diego — the first permitted Deciparticle manufacturing site for lyophilized injectable antineoplastic products — and integrates the PDAOAI AI drug discovery platform (indexing 28 million PubMed abstracts on Qdrant vector infrastructure) for formulation development and biomarker-driven patient selection.

Sapu Nano is structured as a subsidiary within the GMP Biotechnology Limited joint venture, in which Oncotelic Therapeutics (OTCQB: OTLC) holds a 45% stake and Dragon Oversea Capital Limited holds the balance, with integrated management led by CEO Dr. Vuong Trieu (co-inventor of Abraxane and developer of CYNVILOQ), CMO Dr. Seymour Fein, and VP of R&D Dr. Cynthia Lee. The company is pre-revenue and does not commercialize any products; its go-to-market model centers on clinical development followed by licensing, co-development, or strategic pharmaceutical partnerships, executed today through a CRO and manufacturing alliance network spanning Global Clinical Trials, iNGENū, SOCRU, Medicilon, and Sapu Bioscience across the US, Europe, Australia, and Asia. Customer-facing activities are concentrated on scientific conferences (BIO 2026, BIO-Europe Spring 2026, SOT 2026, SABCS 2025), peer-reviewed publication, and companion-diagnostic positioning via the proprietary High-RICTOR/Low-RPTOR biomarker signature.

Name

Sapu Nano

Legal name

Sapu Nano

Website

https://sapunano.com

Company type

Private

Operating status

Operating

Short description

Sapu Nano is a San Diego-based clinical-stage biotech that develops sub-20nm Deciparticle™ nanoparticles for intravenous delivery of water-insoluble oncology drugs. Its lead candidate, SAPU-003 (IV everolimus), is in Phase 1b trials for advanced mTOR-sensitive solid tumors, supported by an ISO-5 cGMP facility and the PDAOAI AI drug discovery platform.

Ownership category

akta.pro rank

Product category

Nanomedicine Drug Delivery

NAICS

Research and Development in Nanotechnology (541713), Pharmaceutical Preparation Manufacturing (325412), Scientific Research and Development Services (5417)

SIC

Pharmaceutical Preparations (2834), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Lead Optimization & Preclinical Candidate Selection (HLAIALAB)

akta.pro secondary industry

Target Identification & Validation Platforms (omics-driven, chemoproteomics, genetic validation) (HLAAAIAI)

Keywords

• Nanomedicine therapeutics
• Sub-20nm drug delivery
• Oncology drug development
• MTOR inhibitors
• Nanoparticle drug delivery

Headquarters

HQ city

San Diego

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Infrastructure, Marketing or Sales

Revenue model

1. Pharmaceutical Development and Licensing: Pre-revenue clinical-stage biotech. The company is developing nanomedicine therapeutics and may generate revenue through licensing agreements, co-development partnerships, or future product commercialization. Oncotelic Therapeutics holds 45% of Sapu Nano via GMP Biotechnology Limited JV.

Go-to-market motion2 records

Distribution channels2 records

Marketing channels4 records

Core offering

Sapu Nano develops sub-20nm Deciparticle™ nanomedicine therapeutics for oncology, with its proprietary amphiphilic polymer platform enabling intravenous delivery of water-insoluble drugs such as macrolide mTOR inhibitors, peptides, and polyketides. The lead clinical candidate SAPU-003 is an intravenous everolimus formulation in Phase 1/2 trials for advanced mTOR-sensitive solid tumors. The company operates an ISO-5 cGMP manufacturing facility and integrates the PDAOAI AI drug discovery platform to accelerate development timelines.

Product overview

Sapu Nano develops sub-20nm Deciparticle™ nanomedicine therapeutics for oncology and rare pediatric diseases. The company operates a modular platform-plus-products model centered on its proprietary Deciparticle™ Platform, which generates ultra-small sub-20nm nanoparticles enabling intravenous delivery of water-insoluble drugs. The lead clinical product, SAPU-003 (Everolimus Deciparticle™), is an intravenous formulation of everolimus currently in Phase 1/2 clinical trials for advanced solid tumors. The platform technology has demonstrated broad applicability across multiple hydrophobic drug classes including macrolide mTOR inhibitors, cyclic and linear peptides, and polyketides, with a cGMP manufacturing facility in San Diego supporting clinical supply. The company also integrates AI through the PDAOAI platform for formulation development and biomarker analysis.

Differentiator

Problem solved

Functional benefit

Products and services

• Deciparticle™ Platform Proprietary sub-20nm nanoparticle drug delivery platform that creates ultra-small particles with enhanced tumor penetration, improved biodistribution, and programmable drug-nanoparticle behavior. The platform enables intravenous delivery of poorly water-soluble therapeutic compounds including macrolide mTOR inhibitors, cyclic peptides, linear peptides, ascomycin macrolactams, and polyketides, with a reported 90% success rate across over 100 tested APIs. Designed for pharmaceutical partners and internal pipeline development.
• SAPU-003 (Everolimus Deciparticle™) Next-generation intravenous mTOR inhibitor delivering 100% bioavailability through sub-20nm Deciparticle™ formulation of everolimus, designed for deeper tumor penetration and improved pharmacokinetics compared to oral formulations. Currently in Phase 1/2 clinical evaluation for advanced mTOR-sensitive solid tumors including HR+/HER2- breast cancer, renal cell carcinoma, neuroendocrine tumors, TSC-associated tumors, and hepatocellular carcinoma. Achieves dual mTORC1 and mTORC2 inhibition with weekly IV dosing and reduced mucositis, pneumonitis, and cytopenia.

Quantifiable outcome

• 67-fold reduction in GI accumulation vs oral everolimus
• +4 more outcomes

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability5 records

Feature7 records

Partnerships

Six partnerships are on record, tiered supporting and core.

• QdrantsupportingTechnology or Integration · 8 June 2026Vector database infrastructure provider for PDAOAI platform, which indexes 28 million PubMed abstracts to support AI-driven drug discovery and formulation development
• Global Clinical Trials (GCT)coreImplementation/ SI/ Consulting Partner · 3 June 2026Appointed as lead CRO to support international execution of Phase 1b clinical trials for Sapu003, including trial operations in Europe
• Medicilon GroupcoreImplementation/ SI/ Consulting PartnerIND-enabling studies partner supporting preclinical development and regulatory filing preparation for Sapu003
• iNGENū CROcoreImplementation/ SI/ Consulting PartnerCRO partner supporting Australian clinical trial coordination, HREC/CTN pathway navigation, and first-in-human study execution
• SOCRU (Southern Oncology Clinical Research Unit)coreImplementation/ SI/ Consulting PartnerClinical research unit partner supporting Phase 1b trial execution and patient enrollment in Australia
• Sapu BiosciencecoreStrategic or Co-development PartnerGMP manufacturing partner providing cGMP production capabilities for Deciparticle formulations and clinical trial supply

Scale indicators9 records

Recent moves7 records

Expansion highlights5 records

Direct peers

• Nanobiotix: Clinical-stage nanoparticle oncology company developing proprietary nanoparticle-based therapeutics (e.g., NBTXR3 radioenhancer). Directly comparable to Sapu Nano as a nanoparticle-platform oncology company targeting solid tumors with a platform-plus-pipeline model.
• Tarveda Therapeutics: Clinical-stage company developing Pentarin nanoparticle conjugates that selectively target solid tumors. Directly comparable to Sapu Nano as a nanoparticle oncology platform with reformulation/re-targeting capability.
• Mersana Therapeutics: Clinical-stage oncology company building nanomedicine-based ADCs (Dolasynthen, Xaluritamig). Comparable to Sapu Nano as a clinical-stage nanomedicine developer targeting oncology with a platform-plus-products model.
• Selecta Biosciences: Clinical-stage company developing ImmTOR nanoparticle tolerogenic platforms and nanoparticle-immunotherapy combinations. Comparable to Sapu Nano as a nanoparticle drug-delivery platform company pursuing oncology and immunology applications.
• Lipocine: Specialty pharmaceutical company reformulating hydrophobic and poorly bioavailable drugs using lipid/nanoparticle delivery technology (e.g., TLANDO). Comparable to Sapu Nano as a delivery-platform reformulation specialist.
• Celsion: Clinical-stage oncology company developing nanoparticle-formulated chemotherapeutics (e.g., ThermoDox, a heat-activated liposomal doxorubicin). Closely comparable as a nanoparticle reformulation specialist in solid tumors.

Emerging players

• CytImmune Sciences: Clinical-stage developer of gold-nanoparticle tumor-targeted therapeutics (CYT-6091, CYT-21625). Comparable to Sapu Nano as an emerging nanoparticle oncology company focused on targeted delivery to solid tumors.

Broad incumbents

• Cardiff Oncology: Clinical-stage oncology company developing therapies for mTOR pathway–driven cancers (onvansertib in KRAS-mutated and mTOR-driven tumors). Comparable as an oncology player targeting overlapping mTOR biology but using small-molecule rather than nanoparticle approaches.
• Novartis: Global pharma that owns Afinitor/Votubia (everolimus), the originator drug Sapu-003 reformulates. Comparable as the incumbent standard-of-care in mTOR-sensitive tumors and a likely strategic partner, licensor, or acquirer.
• Bristol-Myers Squibb (Abraxane franchise): Global biopharmaceutical company that commercialized Abraxane, the first nanoparticle chemotherapy for solid tumors co-invented by Sapu Nano's CEO. Highly relevant as the incumbent that proved the nanoparticle-chemo commercial model the company is iterating on.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks5 records

Key highlights7 records

Customer concentration

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Sapu Nano