Live News • Jun 30
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 • Jun 29
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. Announcement • Jun 17
TechForce Robotics Advances Phase 2 Deployment Of PUR-E Autonomous Clean Room Support Robot At SAPU Bio OEB-5 Sterile Injectable cGMP Facility TechForce Robotics, Inc. announced the advancement of Phase 2 objectives under its joint development collaboration with Oncotelic Therapeutics, Inc., marked by the deployment of PUR-E, TechForce’s autonomous clean room support robot, within SAPU Bio's OEB-5 sterile injectable cGMP facility. The deployment is intended to support the evaluation of robotics and automation opportunities within sterile manufacturing and regulated operational environments. The Phase 2 deployment follows the completion of Phase 1 objectives, which focused on materials logistics and internal transport operations using TechForce's LIM-E autonomous GMP support robot. Phase 2 expands the initiative into OEB-5 clean room and sterile injectable manufacturing operations within the SAPU Bio cGMP environment. PUR-E is designed to support designated clean room operations through autonomous transport, shelving-based supply movement, operational observation activities, and routine support tasks. TechForce and Oncotelic are utilizing the system to evaluate automation opportunities across sterile manufacturing operations and associated cGMP workflows. Within SAPU Bio's OEB-5 sterile injectable cGMP facility, PUR-E joins LIM-E as part of the ongoing robotics and automation initiative, supporting sterile manufacturing workflows and the evaluation of future electronic batch record (EBR) opportunities within the regulated environment. The deployment is part of an ongoing joint development initiative focused on robotics, automation, and AI-driven operational technologies for high-containment pharmaceutical manufacturing environments. TechForce and Oncotelic expect to continue exploring additional automation opportunities under their ongoing joint development collaboration. PUR-E is part of TechForce Robotics' Robotics-as-a-Service Provider (RaaSP) platform, which delivers autonomous robotics solutions through a subscription-based operational model that includes deployment, maintenance, support, software updates, training, and ongoing system management. Available features, integrations, deployment configurations, and operational capabilities may vary depending on customer requirements, regulatory considerations, and operating environments. Announcement • Jun 09
Oncotelic Therapeutics, Inc. Showcases Pdaoai Capability in Advancing Drug Development Oncotelic Therapeutics, Inc. announced that its proprietary PDAOAI drug discovery and development platform will be featured inside the Product & Engineering keynote at Qdrant Vector Space Day 2026, taking place on June 11, 2026 at The Midway in San Francisco. The segment will detail how Oncotelic has successfully compressed the discovery of drug development for two product candidates, historically ranging from four to seven years and hundreds of millions of dollars per program in the pharmaceutical industry, to less than 2 years at a fraction of the cost, using PDAOAI running on Qdrant infrastructure. Oncotelic has already demonstrated this acceleration. Within a single 24-month execution window, the Company advanced two drug candidates, SAPU 003 and SAPU 006, through Sapu Nano (US) LLC, its 45% owned subsidiary through GMP Biotechnology, Limited (GMP Bio), from concept to Investigational New Drug (IND) filing, completing formulations, toxicology, and preclinical studies; building a clinical manufacturing facility from greenfield to GMP certification; and shipping clinical trial materials for first-in-human use. Manifold Folding: A Breakthrough in Semantic Retrieval. Oncotelic’s novel “manifold folding” technique helps reshape the high-dimensional embedding space to cluster related concepts tightly while separating unrelated ones, delivering smaller search regions, higher retrieval precision, and substantially reduced LLM hallucination. 28 Million PubMed Abstracts on Qdrant. PDAOAI indexes the totality of published human biomedical knowledge — the full publicly available PubMed corpus, approximately 28 million biomedical abstracts — live on Qdrant Cloud, using hybrid search, payload filtering, HNSW indexing, and quantization for production-scale retrieval. Shell Sampling Built on Qdrant Primitives. Oncotelic’s “shell sampling” pattern, built on Qdrant’s prefetch and cosine primitives, retrieves a bounded ring of semantically related abstracts, rather than just the closest matches returned by standard vector search. VP - Technology Mike Potts will detail the technique in a forthcoming Qdrant developer-community webinar. Announcement • May 15
Sapu Nano And Oncotelic Therapeutics, Inc. Announce First Patient Dosed In Phase 1b Trial Of Sapu003, An Intravenous Deciparticle Formulation Of Everolimus Sapu Nano and Oncotelic Therapeutics, Inc. announced that the first patient has been dosed in the Phase 1b clinical trial of Sapu003, the Company’s investigational intravenous Deciparticle formulation of everolimus. The trial: SP-03-B101- Sapu003 in Patients with Advanced mTOR-sensitive Solid Tumors, (NCT07369505), is a Phase 1b, open-label, dose-escalation trial designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of Sapu003 in patients with advanced mTOR-sensitive solid tumors. The investigational product is administered intravenously over 30 minutes once weekly in 4-week cycles. The study includes two cohort patients. Cohort A enrolls patients with HR-positive/HER2-negative breast cancer, receiving Sapu003 in combination with aromatase inhibitor and Cohort B enrolls patients with renal cell carcinoma, neuroendocrine tumors, TSC-associated tumors, or hepatocellular carcinoma, receiving Sapu003 as monotherapy. Dose escalation follows a Bayesian Optimal Interval design, with planned dose levels of 5 mg/m², 7.5 mg/m², and 10 mg/m², and an optional lower dose cohort of 3.5 mg/m² if required for safety. Sapu003 was designed to re-engineer everolimus, as a weekly IV Deciparticle formulation, with the goal of improving exposure control and expanding the therapeutic potential of mTOR inhibition. The Sapu003 program has also been featured at the 2025 San Antonio Breast Cancer Symposium, held December 9–12, 2025. The Sapu003 program is being developed in collaboration with Southern Oncology Clinical Research Unit, iNGENu CRO, and Shanghai Medicilon, supporting the clinical, translational, pharmacokinetic, and manufacturing development of Sapu003. 