On September 24, 2025 Sapu Nano, developer of Deciparticle, reported that it has received approval from Australia’s Human Research Ethics Committee (HREC) to begin enrolling patients in a Phase 1 human clinical trial of Sapu003-an injectable form of Everolimus-for the treatment of breast cancer (Press release, Sapu Bioscience, SEP 24, 2025, View Source [SID1234656203]). Sapu Nano is part of the Sapu family of companies, formed through GMP Biotechnology Limited, a joint venture between Oncotelic Therapeutics, Inc. (OTCQB: OTLC) and Dragon Overseas Capital Limited.
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!
Everolimus is already an FDA-approved drug (sold under the brand name Afinitor) for various cancers, including advanced breast cancer, kidney cancer, and certain rare tumors. However, in oral pill form, only about 10% of the drug is absorbed by the body, which limits how effective it can be. Using Sapu Nano’s proprietary Deciparticle technology, Sapu003 is delivered intravenously (by injection), which allows 100% of the drug to reach the bloodstream. Preclinical studies suggest this approach could be more effective than the current oral version.
"We are extremely pleased to receive approval from the HREC to proceed with human clinical trials," said Sapu Nano Chief Executive Officer Dr. Vuong Trieu. "Despite advances in treatment, there remains a critical unmet need for next generation mTOR inhibitors. Current therapies often extend progression-free survival for less than one year and rarely deliver long-term disease control. This Phase 1 trial will allow us to determine the best dose for future studies, including a Phase 3 trial."
Dr. Sud Agarwal, Chief Executive Officer of Ingenu, added: "The approval of Sapu003 to enter human trials is a landmark moment. By enabling full drug absorption through intravenous delivery, this program has the potential to achieve meaningful tumor shrinkage where oral formulations have been limited. We are proud to support Sapu Nano in advancing this therapy, which may ultimately give breast cancer patients better outcomes and improved quality of life."
What This Means for Patients
Put simply, Sapu003 is a new way of giving an existing cancer drug so it works better. The pill form doesn’t get fully absorbed, only about 10% makes it into the body. By delivering it as an injection, researchers can deliver the medicine at full strength, which could make it more effective at shrinking tumors. This first trial is the starting point to see if this improved version can give breast cancer patients longer-lasting benefits and new hope.