George Zavoico

Reni Benjamin

Thomas Yip

- Oncotelic Therapeutics Inc. announced the **advancement of Sapu-003**, a novel IV formulation of everolimus, which has received **approval to start a Phase 1 clinical trial** for breast cancer.  **[908259_c594f7919a4c43ddab0865b46424a8d1_0]** 
- Sapu-003, built on the proprietary Deciparticle™ platform, is designed to deliver **100% of the drug directly to the tumor**, aiming to improve bioavailability and reduce gastric toxicity compared to oral Afinitor®.  **[908259_c594f7919a4c43ddab0865b46424a8d1_0]** 
- The company targets the breast cancer market, estimated at **$30–40 billion** and projected to grow to **$50 billion by 2030**.  **[908259_c594f7919a4c43ddab0865b46424a8d1_0]** 
- Oncotelic anticipates an accelerated development timeline for Sapu-003, aiming for drug approval within **2–3 years**, which is significantly faster than traditional drug development.  **[908259_c594f7919a4c43ddab0865b46424a8d1_0]**

Oncotelic Therapeutics Announces Phase 1 Clinical Trial Approval for Sapu-003

- **Sapu Nano**, a company formed through a joint venture involving **Oncotelic Therapeutics, Inc. (OTLC)**, announced the initiation of a **Phase 1 clinical study in Australia** for **Sapu-003**.  **[908259_8245c1f876eb4edcbaf462c3fbbef971_0]** 
- Sapu-003 is a **novel intravenous Deciparticle™ Everolimus**, an mTOR inhibitor, intended to overcome limitations of oral everolimus in treating advanced HR+/HER2– breast cancer and other mTOR-sensitive tumors.  **[908259_8245c1f876eb4edcbaf462c3fbbef971_0]** 
- The trial is **now open for enrollment** at Australian oncology centers, conducted in collaboration with SOCRU, Ingenū, and Medicilon.  **[908259_8245c1f876eb4edcbaf462c3fbbef971_0]** 
- Oncotelic Therapeutics holds a **45% ownership stake in GMP Bio**, which is part of the Sapu family of companies.  **[908259_8245c1f876eb4edcbaf462c3fbbef971_0]**

Oncotelic Therapeutics' Joint Venture Sapu Nano Initiates Phase 1 Clinical Trial for Sapu-003

- Sapu Nano, a subsidiary of a joint venture involving **Oncotelic Therapeutics (OTLC)**, has received approval from the Australian Human Research Ethics Committee (HREC) to begin patient recruitment for a **Phase 1 human clinical trial of Sapu003**.  **[908259_4ece075c9d384c7283cab6b9ef771f29_0]** 
- Sapu003 is an **injectable Everolimus formulation** developed to treat breast cancer, designed to overcome the limitations of the oral Afinitor® (Everolimus) by achieving **100% bioavailability** through intravenous injection, compared to approximately 10% absorption of the oral form.  **[908259_4ece075c9d384c7283cab6b9ef771f29_0]** 
- This novel intravenous delivery method, utilizing Sapu Nano's proprietary Deciparticle™ technology, aims to deliver Everolimus with full efficacy, potentially leading to more significant tumor shrinkage and improved long-term disease control for breast cancer patients than current oral treatments.  **[908259_4ece075c9d384c7283cab6b9ef771f29_0]**

Oncotelic Therapeutics' Joint Venture Subsidiary Sapu Nano Receives Approval for Sapu003 Clinical Trial

- Oncotelic Therapeutics (OTLC) summarized **two years of significant clinical progress and regulatory validation** across its late-stage pipeline, as of September 12, 2025.  **[908259_db4bb368d19e4a89b57dcd93f215d2e8_0]** 
- Key pipeline advancements include **OT-101 in Phase 3 for pancreatic cancer**, OXi4503 in Phase 2 for AML/MDS and advancing toward Phase 3 design, and AL-101 in Phase 2 for Parkinson's disease and sexual dysfunctions.  **[908259_db4bb368d19e4a89b57dcd93f215d2e8_0]** 
- The company is also advancing **pediatric rare disease programs** with potential for Priority Review Vouchers and a nanomedicine pipeline utilizing the 505(b)(2) pathway.  **[908259_db4bb368d19e4a89b57dcd93f215d2e8_0]** 
- Oncotelic Therapeutics holds a **45% ownership stake in GMP Bio**, a joint venture led by its CEO, Dr. Vuong Trieu, which expands its portfolio in oncology and rare diseases.  **[908259_db4bb368d19e4a89b57dcd93f215d2e8_1]**