Sapu003 Designed to Overcome Limitations of Afinitor®, FDA-Approved Oral Everolimus, Delivering Full Strength of Everolimus via Intravenous Injection
AUSTRALIA, Sydney, Sept. 24, 2025 (GLOBE NEWSWIRE) — Sapu Nano, developer of Deciparticle™, today announced it 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. 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.
Everolimus is an FDA-approved drug (Afinitor®) for various cancers, including advanced breast cancer, kidney cancer, and certain rare tumors. In oral pill form, only about 10% of the drug is absorbed by the body, limiting its effectiveness. Using Sapu Nano’s proprietary Deciparticle™ technology, Sapu003, delivered intravenously, allows 100% of the drug to reach the bloodstream. Preclinical studies suggest this approach could be more effective than the current approach.
“We are extremely pleased to receive approval from HREC to proceed with human clinical trials,” said Sapu Nano CEO, Dr. Vuong Trieu. “Despite advances in treatment, a critical unmet need for next generation mTOR inhibitors remains. 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, CEO, 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, potentially giving 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. By delivering it intravenously, 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.
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