공시 • 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. 공시 • May 03
Oncotelic Therapeutics Advances Toward Commercial Launch of Ai-Enabled Robotics Platform Oncotelic Therapeutics, Inc. provided an update on the continued advancement of its proprietary AI platform and robotics integration as it approaches initial commercial deployment. Following the successful integration of approximately 28 million scientific abstracts - representing the totality of scientific knowledge - into its PDAOAI platform, the Company has achieved another milestone to enable real-time application within its jointly developed robotics platform with TechForce Robotics. This integration allows scientific knowledge to be directly embedded into automated workflows operating in regulated environments. The combined platform is designed to improve operational efficiency, reduce reliance on manual processes, and support compliance across pharmaceutical development and manufacturing. Initial deployments are expected in the coming weeks. The Company is also preparing to scale production capabilities to support anticipated demand as it advances toward broader commercialization. 공시 • Apr 01
Oncotelic Therapeutics, Inc. announced delayed annual 10-K filing On 03/31/2026, Oncotelic Therapeutics, Inc. announced that they will be unable to file their next 10-K by the deadline required by the SEC. 공시 • Mar 25
Oncotelic Therapeutics, Inc.'s Sapu Nano Launches Deciparticle Platform and Presents Clinical Pipeline Oncotelic Therapeutics, Inc. announced that its subsidiary Sapu Nano will formally introduce its Deciparticle nanomedicine platform and present its advancing clinical pipeline at BIO-Europe Spring 2026, where the company has been selected as a Presenting Company. The presentation will take place at Event: BIO-Europe Spring 2026, Session: Presenting Company, Location: Theater A, Date: March 25, 2026. During the session, Sapu Nano will unveil its proprietary Deciparticle platform, a next-generation drug delivery technology engineered to optimize tissue distribution, enhance therapeutic index, and enable intravenous delivery of highly hydrophobic oncology agents. The company will highlight two lead clinical candidates: Sapu003 (Everolimus for Injection), Intravenous formulation of everolimus, Designed to overcome limitations of oral exposure and tissue variability, Currently in Phase 1 clinical trials; Sapu006 (Docetaxel for Injection), Advanced formulation of docetaxel leveraging Deciparticle technology, Aimed at improving safety and efficacy versus conventional docetaxel formulations, Entering Phase 1 clinical trials. The presentation will emphasize Platform-level advantages of Deciparticle in sub-20 nm nanomedicine design, Improved pharmacokinetics and tissue targeting capabilities, Reduction of formulation-related toxicities associated with conventional excipients, Broad applicability across multiple hydrophobic drug classes. BIO-Europe Spring is one of the premier global partnering conferences for the life sciences industry, bringing together biotechnology, pharmaceutical, and investment leaders to foster strategic collaborations and advance innovative therapeutics. Sapu Nano is actively seeking strategic partnerships, co-development opportunities, and regional collaborations to accelerate the clinical development and commercialization of its Deciparticle pipeline. 공시 • Dec 16
Oncotelic Therapeutics and Brush and Key Foundation Announce Publication in International Journal of Molecular Sciences Highlighting Context-Dependent Biomarkers in Liver and Pancreatic Cancer Oncotelic Therapeutics, Inc. in collaboration with the Brush and Key Foundation,announced the publication of a peer-reviewed research article in the International Journal of Molecular Sciences titled “Comparative Tumor Microenvironment Analysis for HCC and PDAC Using KMplotter.” Chang, W.-H.; Shah, D.; Myers, S.; Potts, M.; Qazi, S.; Trieu, V. International Journal of Molecular Sciences2025, 26, 11920. The study presents a comprehensive, data-driven analysis of two emerging biomarkers—DNMT3A (DNA methyltransferase 3A) and GMPS (guanine monophosphate synthetase)—across hepatocellular carcinoma (HCC) and pancreatic ductal adenocarcinoma (PDAC). By integrating survival outcomes, transcriptomic profiling, and tumor microenvironment (TME) analyses from more than 7,000 patients, the authors demonstrate that the prognostic significance of these biomarkers is highly context-dependent, shaped by immune composition, metabolic reprogramming, and innate immune sensing pathways. The publication also reflects the educational mission of the Brush and Key Foundation, which supports young scholars through mentored research experiences that bridge scientific inquiry, critical thinking, and professional development. 