Oncotelic Therapeutics (OTCQB: OTLC), together with Sapu Nano, announced the publication of a peer-reviewed manuscript in the International Journal of Molecular Sciences validating its proprietary Deciparticle nanoparticle platform. The platform was demonstrated through the development of Sapu003, an investigational intravenous everolimus formulation currently being evaluated in an ongoing Phase 1b clinical trial. The publication details the platform's formulation design, scalable cGMP manufacturing process, product stability, and preclinical performance, while highlighting its potential to enable intravenous delivery of poorly water-soluble therapeutic compounds.
The research underscores the broader applicability of the Deciparticle platform beyond everolimus, including other hydrophobic drug candidates. Sapu003 is currently being evaluated in a Phase 1b dose-escalation study in patients with advanced mTOR-sensitive solid tumors to assess safety, pharmacokinetics, and preliminary antitumor activity in combination with exemestane. For more details, the full press release is available at https://ibn.fm/gECtl.
Oncotelic Therapeutics is a clinical-stage biopharmaceutical company focused on developing oncology and immunotherapy products for high-unmet-need cancers and rare pediatric indications. The company's drug pipeline is complemented by innovations from its CEO, Dr. Vuong Trieu, who has filed over 500 patent applications and holds 75 issued U.S. patents. Oncotelic also owns 45% of GMP Bio, a joint venture advancing its own pipeline of drug candidates. Additionally, the company develops PDAOAI, its proprietary AI platform for drug discovery, lab automation, and AI-assisted GMP manufacturing, which underpins the Deciparticle platform through its relationship with SAPU Bio and its strategic partnership with TechForce Robotics. For more information, visit www.oncotelic.com. The latest news and updates relating to OTLC are available in the company's newsroom at https://ibn.fm/OTLC.
This validation represents a significant step in addressing the challenge of delivering poorly water-soluble drugs intravenously, potentially expanding treatment options for patients with solid tumors. The Deciparticle platform's ability to enable scalable cGMP manufacturing further enhances its commercial viability. The ongoing Phase 1b trial of Sapu003 will provide critical data on safety and efficacy, which could pave the way for broader applications of the platform in oncology and beyond.
