Sapu Nano Reveals the Initial In-Human Clinical Trial of Sapu-003, Intravenous Everolimus (Afinitor(R)) at Australian Translational Breast Cancer Symposium

• The company revealed the trial at the Australia Translational Breast Cancer Research Symposium (“ATBCR”)
• Sapu-003 is an injectable formulation of Everolimus (Afinitor(R)), which aims to offer higher bioavailability and better efficacy than oral versions of the drug
• The trial is conducted alongside partners like the Southern Oncology Clinical Research Unit (“SOCRU”), Ingenū, and Medicilon

Sapu Nano, which is in the Sapu family of companies, which was through GMP Biotechnology Limited, a joint venture between Oncotelic Therapeutics, Inc. (OTCQB: OTLC) and Dragon Overseas Capital Limited, recently revealed the company’s first in-human clinical trial of Sapu-003.

The announcement occurred at the Australian Translational Breast Cancer Research Symposium (“ATBCR”).

Sapu-003 is the first IV Deciparticle(TM) formulation of Everolimus (Afinitor(R)), which is an mTOR inhibitor that’s widely used in oncology to treat various forms of cancer. While oral Everolimus (Afinitor(R)) is effective at treating breast cancer, neuroendocrine tumors, and renal cell carcinoma, broader use has been inhibited due to its low bioavailability and variable systemic exposure.

In contrast, Sapu-003 aims to offer much higher bioavailability, which will allow more of the drug to enter the patient’s system.

The Sapu-003 trial is being conducted in collaboration with the Southern Oncology Clinical Research Unit (“SOCRU”), Ingenū, and Medicilon. These partnerships ensure that the clinical trial is executed precisely, aligns with regulations compliance, and to manage and monitor all aspects of the trial for favorable outcome.

This trial (ACTRN12625001083482) is open to leading oncology centers for enrollment. The eligible participants include both adults with advanced HR+/HER2– breast cancer and those with other mTOR-sensitive tumors that have already tried other standard therapies.

When speaking about Sapu-003 and the trial, CEO of Sapu Nano, Dr. Vuong Trieu said that “Sapu-003 represents a significant advancement in the delivery of mTOR-targeted therapies,”. He also added that “Through the combined expertise of SOCRU, Ingenū, and Medicilon, we are positioned to accelerate development and bring this next-generation treatment option to patients with advanced cancers.”

Oncotelic Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing therapeutics to help fight cancer and pediatric diseases with high unmet medical needs. Oncotelic leverages the portfolio of inventions by its CEO, Dr. Vuong Trieu, who has filed over 500 patent applications with 75 issued patents. The company also enhances its capabilities through strategic partnerships, licensing, and joint ventures — notably its 45% ownership of GMP Bio, led by Dr. Trieu, which is advancing complementary drug candidates that strengthen Oncotelic’s leadership in therapeutics.

For more information, visit the company’s website at www.Oncotelic.com.

NOTE TO INVESTORS: The latest news and updates relating to OTLC are available in the company’s newsroom at ibn.fm/OTLC

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