Sapu Nano’s Sapu003 Advances to Human Clinical Testing – Transforming Everolimus Delivery with Full Bioavailability for Breast Cancer Patients
San Diego, CA — September 24, 2025 (GLOBE NEWSWIRE) — Sapu Nano, developer of the Deciparticle™ platform, announced 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 intravenous formulation 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.
About Sapu003 (Deciparticle™ Everolimus)
Everolimus is an FDA-approved drug (Afinitor®) used for advanced breast cancer, renal cancer, and several rare tumors. However, the pill form of everolimus results in only about 10% systemic absorption, significantly limiting its therapeutic effectiveness.
Using Sapu Nano’s proprietary Deciparticle™ technology, Sapu003 delivers everolimus intravenously at sub-20 nm size. This approach achieves 100% bioavailability by delivering the full prescribed dose directly into the bloodstream. Preclinical studies indicate that IV delivery could improve drug exposure, tissue penetration, and overall effectiveness relative to oral everolimus.
Executive Commentary
“We are extremely pleased to receive approval from the HREC to proceed with human clinical trials,” said Dr. Vuong Trieu, Chief Executive Officer of Sapu Nano. “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 optimal dose for future studies, including a potential Phase 3 trial.”
Dr. Sud Agarwal, CEO of Ingenu, added: “The approval of Sapu003 to enter human studies 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
Sapu003 represents a new way of delivering a proven cancer drug so it can work more effectively. Unlike the pill form — where only ~10% of the drug reaches circulation — intravenous Deciparticle™ Everolimus delivers the medicine at full strength. This Phase 1 trial is the first step toward understanding whether this enhanced delivery can produce deeper, longer-lasting clinical benefits for breast cancer patients.
About Oncotelic Therapeutics
Oncotelic Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on oncology and immunotherapy. The company develops innovative therapeutics for high-unmet-need cancers and rare pediatric diseases. Oncotelic benefits from the extensive portfolio of inventions created by CEO Dr. Vuong Trieu, who has filed more than 500 patent applications and holds 75 issued patents. The company owns 45% of GMP Bio, the joint venture advancing several complementary therapeutic candidates.