Oncotelic Therapeutics Announces Phase 1 Trial Enrollment for Novel Intravenous Everolimus Formulation in Australia

Oncotelic Therapeutics, through its joint venture GMP Biotechnology Ltd. with Dragon Overseas Capital Ltd., has announced that patient enrollment is now open for a Phase 1 clinical trial of Sapu-003, a novel intravenous Deciparticle formulation of everolimus. The trial represents the first clinical investigation of an intravenous Deciparticle formulation of everolimus, an mTOR inhibitor commonly used in breast cancer and other malignancies.

The significance of this development lies in the potential advancement of cancer treatment delivery systems. Traditional formulations of mTOR inhibitors like everolimus have faced limitations in administration and bioavailability. The Deciparticle technology platform aims to overcome these challenges by creating stable intravenous formulations that could potentially improve drug delivery efficiency and patient outcomes.

The clinical trial, registered under ACTRN12625001083482, is being conducted in collaboration with SOCRU, Ingenū, and Medicilon at leading oncology centers across Australia. The study will enroll patients with advanced HR+/HER2– breast cancer or other mTOR-sensitive tumors, targeting populations where mTOR inhibition has demonstrated clinical benefit but where improved delivery methods could enhance therapeutic effectiveness.

Dr. Vuong Trieu, CEO of Sapu Nano and Oncotelic, emphasized the importance of this development, stating that Sapu-003 represents a significant advance in the delivery of mTOR-targeted therapies. The partnerships with multiple research organizations aim to accelerate development and bring this next-generation treatment to patients with advanced cancers more efficiently.

The trial's initiation follows recent presentation of research data at the 8th Australian Translational Breast Cancer Research Symposium (ATBCR 2025), where Sapu Nano presented its poster detailing the Sapu-003 formulation and its progression into clinical studies. This timing underscores the ongoing scientific interest in improving cancer therapeutic delivery systems.

For investors and stakeholders following Oncotelic's progress, additional information is available through the company's newsroom at https://ibn.fm/OTLC. The broader implications of this trial extend beyond immediate clinical applications, potentially establishing new standards for intravenous formulation of targeted cancer therapies and opening pathways for improved treatment regimens across multiple cancer types where mTOR inhibition shows promise.

The advancement of Sapu-003 into clinical trials represents an important milestone in cancer therapeutics, particularly for patients with advanced HR+/HER2– breast cancer who may benefit from more effective delivery of mTOR inhibitors. Success in this Phase 1 trial could pave the way for broader applications of the Deciparticle technology platform across oncology and potentially other therapeutic areas where improved drug delivery remains a critical challenge.