Sapu Nano’s Sapu003 Advances to Human Clinical Testing - Transforming Everolimus Delivery with Full Bioavailability for Breast Cancer Patients

Rhea-AI Summary

Sapu Nano, part of a joint venture involving Oncotelic Therapeutics (OTCQB: OTLC), has received approval from Australia's HREC to begin Phase 1 human clinical trials for Sapu003, an injectable form of Everolimus for breast cancer treatment.

The key innovation lies in Sapu003's delivery method: While the FDA-approved oral version (Afinitor®) has only 10% bioavailability, Sapu003 uses proprietary Deciparticle™ technology for intravenous delivery, enabling 100% drug absorption. This breakthrough could potentially improve efficacy in treating breast cancer, kidney cancer, and certain rare tumors.

Positive

• Achieved HREC approval for Phase 1 clinical trials, marking significant regulatory progress
• Revolutionary delivery method increases drug bioavailability from 10% to 100% compared to existing oral treatment
• Potential to improve efficacy in multiple cancer types including breast, kidney, and rare tumors
• Building on already FDA-approved drug (Everolimus/Afinitor®), potentially streamlining development process

Negative

• Still in early Phase 1 trials, requiring extensive testing before potential commercialization
• Current therapies only extend progression-free survival for less than one year
• Intravenous delivery may be less convenient for patients compared to oral administration

Sapu003 Designed to Overcome Limitations of Afinitor®, FDA-Approved Oral Everolimus, by Delivering Full Strength of the Drug via Intravenous Injection

SAN DIEGO, Sept. 24, 2025 (GLOBE NEWSWIRE) -- via IBN -- Sapu Nano, developer of Deciparticle™, today 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, formed through GMP Biotechnology Limited, a joint venture between Oncotelic Therapeutics, Inc. (OTCQB: OTLC) and Dragon Overseas Capital Limited.

Everolimus is already an FDA-approved drug (sold under the brand name Afinitor®) for various cancers, including advanced breast cancer, kidney cancer, and certain rare tumors. However, in oral pill form, only about 10% of the drug is absorbed by the body, which limits how effective it can be. Using Sapu Nano’s proprietary Deciparticle™ technology, Sapu003 is delivered intravenously (by injection), which allows 100% of the drug to reach the bloodstream. Preclinical studies suggest this approach could be more effective than the current oral version.

“We are extremely pleased to receive approval from the HREC to proceed with human clinical trials,” said Sapu Nano Chief Executive Officer Dr. Vuong Trieu. “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 best dose for future studies, including a Phase 3 trial.”

Dr. Sud Agarwal, Chief Executive Officer of Ingenu, added: “The approval of Sapu003 to enter human trials 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
 Put simply, Sapu003 is a new way of giving an existing cancer drug so it works better. The pill form doesn’t get fully absorbed, only about 10% makes it into the body. By delivering it as an injection, researchers can deliver the medicine at full strength, which could make it more effective at shrinking tumors. This first trial is the starting point to see if this improved version can give breast cancer patients longer-lasting benefits and new hope.

About Oncotelic Therapeutics

Oncotelic Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development of oncology and immunotherapy products. The Company’s mission is to address high-unmet-need cancers and rare pediatric indications with innovative, late-stage therapeutic candidates.

In addition to its directly owned and developed drug pipeline, Oncotelic benefits from the robust portfolio of inventions created by its CEO, Dr. Vuong Trieu, who has filed over 500 patent applications and holds 75 issued patents. Beyond its internal programs, the Company also licenses and co-develops select drug candidates through joint ventures. Currently, Oncotelic owns 45% of GMP Bio, a joint venture under Dr. Trieu’s leadership and guidance, which is advancing its own pipeline of drug candidates that further complement and strengthen Oncotelic’s strategic position in oncology and rare disease therapeutics.

For more information, please visit: www.oncotelic.com

Oncotelic Cautionary Note on Forward‑Looking Statements

This press release contains forward‑looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements in this release other than statements of historical fact are forward‑looking and are based on current expectations, estimates, and projections about our business and future plans. In some cases, you can identify forward‑looking statements by terms such as “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “project,” “forecast,” “potential,” “continue,” and similar expressions (including the negative of such terms).

Forward‑looking statements in this release include, without limitation: our plans, timelines, and priorities for the OT‑101 program in PDAC and other indications; potential biomarker‑driven development strategies; the advancement, scope, timing, and results of current or future preclinical and clinical studies; regulatory interactions and potential approvals; development or commercialization of any product candidates within the Oncotelic/GMP Bio/Sapu ecosystem; the utility of our PDAOAI platform; future financings, strategic transactions, and/or public offerings involving our joint ventures or affiliates; and other statements that are not historical facts. Actual results may differ materially from those indicated by such forward‑looking statements as a result of various important factors, including, but not limited to: the inherent uncertainties of drug discovery and development; our ability to enroll patients and complete studies on expected timelines; whether preclinical or early clinical findings (including biomarker associations) will be replicated in larger, controlled trials; regulatory developments in the United States and other jurisdictions; competitive developments; our ability to obtain or maintain intellectual property protection; our liquidity and access to capital; the performance of collaborators, suppliers, and manufacturers; and other risks described in our filings with the Securities and Exchange Commission (SEC), including the “Risk Factors” section of our most recent Form 10‑K and subsequent periodic reports.

Forward‑looking statements speak only as of the date of this press release, and we undertake no obligation to update or revise such statements, whether as a result of new information, future events, or otherwise, except as required by law.

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FAQ

What is Sapu003 and how does it differ from Afinitor?

Sapu003 is an injectable form of Everolimus (currently sold as oral Afinitor®) that achieves 100% bioavailability compared to only 10% in the pill form, potentially making it more effective for cancer treatment.

What approval did OTLC receive for Sapu003 in September 2025?

Sapu Nano received approval from Australia's Human Research Ethics Committee (HREC) to begin Phase 1 human clinical trials for Sapu003 in breast cancer treatment.

How does Sapu003's Deciparticle technology improve cancer treatment?

The Deciparticle™ technology enables intravenous delivery of Everolimus, allowing 100% of the drug to reach the bloodstream, compared to only 10% absorption with the oral version.

What types of cancer could Sapu003 potentially treat?

Sapu003 targets multiple cancer types including advanced breast cancer, kidney cancer, and certain rare tumors, similar to the currently approved Afinitor®.

What is the current limitation of existing Everolimus treatment?

Current therapies typically extend progression-free survival for less than one year and rarely achieve long-term disease control.