On October 30, 2025 Oncotelic Therapeutics, Inc. (OTCQB: OTLC), a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat cancer patients by leveraging its novel PDAOAI platform and deep knowledge in nanomedicines and the tumor microenvironment, reported that Sapu Nano will be featuring its investigational intravenous Deciparticle everolimus (Sapu003) have been accepted for presentation at the 2025 San Antonio Breast Cancer Symposium (SABCS), to be held December 9-12, 2025, at the Henry B. Gonzalez Convention Center, San Antonio, Texas. Sapu Nano is the developer of DeciparticleTM and is part of Sapu family of companies and a joint venture between Oncotelic (OTCQB:OTLC) and Dragon Oversea.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Sapu003 is a novel Deciparticle formulation of everolimus for intravenous administration, designed to overcome the pharmacologic limitations of oral mTOR inhibitors (Afinitor), including poor bioavailability, dose-limiting toxicity, and restricted tumor penetration. Collectively, the accepted abstracts highlight the clinical rationale, molecular biomarkers, and pharmacokinetic justification supporting the ongoing Phase 1 trial of Sapu003 in hormone receptor-positive (HR )/HER2 metastatic breast cancer and RCC and NET.
Renal Cell Carcinoma (RCC): FDA approved oral Everolimus for advanced RCC after failure of sunitinib and/or sorafenib. Approval was based on RECORD-1 randomized phase III (everolimus 10 mg PO daily vs placebo + best supportive care) showing a PFS benefit (median 4.9 vs 1.9 mo; HR 0.33).
Pancreatic NET (pNET): FDA approved Everolimus for Pancreatic NET (pNET). Approval was based on RADIANT-3 (everolimus vs placebo in progressive, advanced pNET), which significantly prolonged PFS.
GI and Lung NET (lNET): FDA approved Everolimus for GI & lung NET. Approval was based on RADIANT-4 (non-functional, well-differentiated, nonresectable/metastatic GI or lung NET), showing a PFS benefit.
Patients and Investigators – please contact Ingenu for trial participation.
Australia Headquarters
22/456 St Kilda Rd
Melbourne 3004 VIC
Australia
Phone: 1300 633 226
Email: [email protected]
Presentation Session:
Thursday, December 11, 2025 | 5:00 PM – 6:30 PM CST
Abstract Number Presentation Number Title
1834 PS4-04-04 High RICTOR / Low RPTOR Gene Expression Signature as a Predictive Biomarker for Intravenous Everolimus Nanoparticle (Sapu003): Rationale for the First in Human Trial
1702 PS4-04-21 Deciparticle Everolimus (Sapu003): From Cytostasis to Cytotoxicity via a Single mPEG Polymer and Clinic-Ready Manufacturing
1811 PS4-06-05 Sapu003: Everolimus for Injection – Pharmacokinetic Rationale for Phase I Evaluation in HR /HER2 Metastatic Breast Cancer
The studies were conducted in collaboration with Southern Oncology Clinical Research Unit (SOCRU), Ingenu CRO, and Medicilon, and reflect a coordinated clinical-translational effort bridging molecular biomarker discovery, pharmacokinetic modeling, and scalable GMP manufacturing of Deciparticle everolimus.
(Press release, Oncotelic, OCT 30, 2025, View Source [SID1234657169])