Sapu Nano Initiates Human Clinical Testing Of Sapu003 To Improve Everolimus Bioavailability In Breast Cancer Treatment

Sapu Nano, developer of Deciparticle™, announced 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. Sapu Nano is part of the Sapu family of companies, established through GMP Biotechnology Limited, a joint venture between Oncotelic Therapeutics, Inc. and Dragon Overseas Capital Limited.

Everolimus is already FDA-approved and marketed under the brand name Afinitor® for several cancers, including advanced breast cancer, kidney cancer, and certain rare tumors. However, when administered orally as a pill, only about 10% of the drug is absorbed by the body, limiting its effectiveness. Using Sapu Nano’s proprietary Deciparticle™ technology, Sapu003 is delivered intravenously, allowing 100% of the drug to reach the bloodstream. Preclinical studies indicate that this approach could be more effective than the current oral version.

Dr. Vuong Trieu, Chief Executive Officer of Sapu Nano, said the HREC approval marks an important milestone. He highlighted the ongoing need for next-generation mTOR inhibitors, noting that current treatments often extend progression-free survival for less than one year and rarely achieve long-term disease control. This Phase 1 trial will determine the optimal dose for future studies, including a planned Phase 3 trial.

Dr. Sud Agarwal, Chief Executive Officer of Ingenu, added that advancing Sapu003 into human trials is a landmark development. By enabling full drug absorption through intravenous delivery, the program has the potential to achieve meaningful tumor shrinkage where oral formulations have been limited. He emphasized the potential of this therapy to improve outcomes and quality of life for breast cancer patients.

In simple terms, Sapu003 offers a new way to deliver an existing cancer drug more effectively. While the oral pill form is largely unabsorbed, the injectable version ensures full drug delivery, which could lead to better tumor reduction and longer-lasting benefits for patients. The Phase 1 trial is the first step in evaluating whether this improved formulation can provide new hope for those battling breast cancer.