Oncotelic Therapeutics Publishes Peer-Validated Study on Deciparticle Platform, Advancing Nanoparticle Drug Delivery

Oncotelic Therapeutics (OTCQB: OTLC), in collaboration with Sapu Nano, announced the publication of a peer-reviewed manuscript in the International Journal of Molecular Sciences that validates its proprietary Deciparticle nanoparticle platform. The research highlights the platform's formulation design, scalable cGMP manufacturing process, product stability, and preclinical performance, demonstrating its potential to enable intravenous delivery of poorly water-soluble therapeutic compounds. The study specifically supports the development of Sapu003, an investigational intravenous everolimus formulation currently being evaluated in an ongoing Phase 1b clinical trial for advanced mTOR-sensitive solid tumors.

The Deciparticle platform uses a novel nanoparticle technology to encapsulate hydrophobic drugs, improving their solubility and bioavailability. According to the company, the platform's versatility extends beyond everolimus, offering a delivery solution for other hydrophobic drug candidates. This advancement could address a significant challenge in drug development: the difficulty of administering poorly water-soluble compounds intravenously. The publication provides a comprehensive analysis of the platform's manufacturing scalability, which is critical for commercial viability. The cGMP (current Good Manufacturing Practice) process described in the manuscript ensures that the nanoparticles can be produced consistently and at scale, meeting regulatory standards for clinical use.

Oncotelic CEO Dr. Vuong Trieu, who holds 75 issued U.S. patents, emphasized the importance of this validation for the company's pipeline. The Phase 1b trial of Sapu003 is evaluating safety, pharmacokinetics, and preliminary antitumor activity in combination with exemestane, a standard hormone therapy. The study's results could pave the way for a new treatment option for patients with advanced solid tumors that have become resistant to other therapies. The use of everolimus, an mTOR inhibitor, in an intravenous formulation may improve drug exposure and reduce side effects compared to oral administration, which often suffers from variable absorption.

The publication also bolsters Oncotelic's broader strategy in oncology and rare diseases. The company owns 45% of GMP Bio, a joint venture advancing its own pipeline, and leverages its proprietary AI platform, PDAOAI, for drug discovery and manufacturing automation. The Deciparticle platform is a key component of this strategy, as it can be applied to multiple drug candidates in Oncotelic's pipeline. The company's collaboration with Sapu Bio, an OEB-5 sterile injectable cGMP manufacturing facility, ensures that the platform's production can meet clinical and commercial demands. For more information, visit www.oncotelic.com.

The research was published in the International Journal of Molecular Sciences, a peer-reviewed scientific journal, adding credibility to the findings. This validation is expected to support ongoing and future clinical trials, potentially accelerating the development of new therapies. The full press release is available at https://ibn.fm/gECtl. Oncotelic continues to focus on addressing high-unmet-need cancers and rare pediatric indications, with a pipeline that includes late-stage therapeutic candidates. The company's commitment to innovation is reflected in its extensive patent portfolio and its use of AI to streamline drug development processes.

For investors, the publication marks a milestone in Oncotelic's technology validation, potentially enhancing the company's valuation and partnership opportunities. The platform's ability to enable intravenous delivery of difficult-to-formulate drugs could address a market need, as many promising therapeutic compounds are hydrophobic. The ongoing Phase 1b trial for Sapu003 will provide further data on the platform's clinical utility. As the company continues to advance its pipeline, the Deciparticle platform may become a cornerstone of its drug delivery strategy, offering a competitive edge in the biopharmaceutical industry.