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Live News • 3h
Oncotelic Deciparticle Platform Gains Peer-Reviewed Validation Backing Sapu003 Clinical Development Oncotelic Therapeutics reported that a peer-reviewed manuscript has validated its Deciparticle platform through the development of Sapu003, an investigational intravenous everolimus formulation currently in a Phase 1b trial in advanced mTOR-sensitive solid tumors.
The publication indicates that Deciparticle can support intravenous delivery of poorly water-soluble compounds and that its use extends beyond everolimus, tying the platform to both the current Sapu003 program and a broader range of potential drug candidates and partnerships.
Oncotelic’s stock last traded at about US$0.04, with the share price down 44.4% year to date.
This validation gives Oncotelic a clearer technical foundation for its nanoparticle platform. However, a key risk for investors is that any commercial value still depends on clinical outcomes and the company’s ability to convert the platform into pipeline deals or later-stage assets. Announcement • 21h
Oncotelic Therapeutics, Inc. and Sapu Nano Announce Peer-Reviewed Validation of Deciparticle Platform Supporting Clinical Development of Sapu003 Oncotelic Therapeutics, Inc. and Sapu Nano announced the publication of a peer-reviewed scientific manuscript validating its proprietary Deciparticle nanoparticle platform through the successful development of Sapu003, the Company's investigational intravenous everolimus formulation currently being evaluated in an ongoing Phase 1b clinical trial. The publication, "Intravenous Everolimus Formulation (Sapu003) for Clinical Trials," has been published in the International Journal of Molecular Sciences and provides the first comprehensive description of the Deciparticle platform, including formulation design, scalable cGMP manufacturing, product characterization, stability, and preclinical evaluation. The publication reports several significant achievements, including: Development of a stable intravenous everolimus formulation with mean particle sizes below 20 nanometers. A robust, scalable cGMP manufacturing process capable of producing clinical-grade material with high batch-to-batch reproducibility. Favorable product stability following lyophilization and refrigerated storage. Successful formulation of multiple hydrophobic therapeutic compounds, demonstrating the broader applicability of the Deciparticle platform beyond everolimus. Potent preclinical antitumor activity supporting continued clinical development of Sapu003. Unlike many formulation technologies developed for a single product, the published research demonstrates that the Deciparticle platform is compatible with wide range of hydrophobic molecules, including rapalogs, macrocyclic compounds, immunosuppressants, and selected peptide therapeutics. The Company believes this broad formulation capability may support future pipeline expansion and collaborative development opportunities. Sapu003 is currently being evaluated in an ongoing Phase 1b open-label dose-escalation study in patients with advanced mTOR-sensitive solid tumors. The study is assessing the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of weekly intravenous Sapu003 administered in combination with exemestane. The publication marks the successful translation of the Deciparticle platform from laboratory research to clinical-stage manufacturing. As the Phase 1b clinical study progresses, further evaluation of the potential of Sapu003 and expansion of the application of the Deciparticle platform to additional therapeutic programs is anticipated. Announcement • Jun 19
Oncotelic Therapeutics, Inc. Launches AI-Powered GMP Manufacturing Services Platform At BIO International Convention 2026 Oncotelic Therapeutics, Inc. announced the launch of its artificial intelligence powered good manufacturing practices manufacturing services platform at the 2026 BIO International Convention in San Diego, California. The initiative combines the Company's PDAOAI AI platform with advanced robotics — delivered in collaboration with TechForce Robotics, Inc., Oncotelic's strategic robotics and automation partner — and digital manufacturing technologies to support pharmaceutical, biotechnology, and advanced therapeutics companies seeking to modernize GMP operations. As part of the initiative, Oncotelic will demonstrate the integration of intelligent robotic systems and AI-driven manufacturing workflows capable of assisting personnel with routine GMP operations, batch record execution, material handling, manufacturing documentation, and quality management activities. The Platform leverages PDAOAI, Oncotelic's proprietary AI architecture, to support: Electronic batch record generation and management, AI-assisted manufacturing documentation, GMP workflow digitization, Quality and compliance support, Manufacturing process monitoring, Knowledge management and operational intelligence, Integration with intelligent robotic systems through the Company's collaboration with TechForce. The Company believes these capabilities may be particularly valuable for emerging biotechnology companies, contract development and manufacturing organizations, cell and gene therapy developers, radiopharmaceutical manufacturers, and organizations seeking to accelerate technology transfer and manufacturing scale-up activities. In addition to the commercial launch of the Platform, Oncotelic will highlight ongoing progress of its Deciparticle nanomedicine platform, including SAPU003, the Company's clinical-stage intravenous everolimus program currently being evaluated in a Phase 1b clinical study. 
