Oncotelic Therapeutics, Inc. (OTCQB: OTLC) announced the publication of a peer-reviewed study in Biomedicines detailing preclinical data supporting Sapu003, its intravenous Deciparticle formulation of everolimus. The study covers absorption, distribution, metabolism, excretion (ADME), pharmacokinetics, tissue distribution, GLP toxicology, and cGMP manufacturing data, supporting the ongoing Phase 1 clinical evaluation in patients with advanced solid tumors.
The formulation is designed to overcome pharmacokinetic limitations associated with oral everolimus while preserving the drug’s metabolic profile. Key findings include reduced gastrointestinal drug exposure compared with oral everolimus, no treatment-related gastric pathology in repeat-dose GLP toxicology studies, and successful development of a reproducible cGMP manufacturing process suitable for clinical production. The company stated that the comprehensive preclinical package supports continued clinical development of Sapu003 and further validates its Deciparticle platform for transforming hydrophobic therapeutics into intravenous medicines.
Oncotelic is a clinical-stage biopharmaceutical company focused on oncology and immunotherapy products, addressing high-unmet-need cancers and rare pediatric indications. The company also develops PDAOAI, its proprietary AI platform for drug discovery, lab automation, and AI-assisted GMP manufacturing. Through Oncotelic’s relationship with SAPU Bio, PDAOAI underpins the platform and ongoing joint development work with TechForce Robotics, Oncotelic’s strategic robotics and automation partner.
The publication of this data is significant for the industry as it addresses a key challenge in oncology: the limitations of oral drug administration, including variable absorption and gastrointestinal side effects. An intravenous formulation of everolimus could offer more predictable dosing and potentially improved efficacy and safety profiles. For patients with advanced solid tumors, this could mean better treatment options with fewer gastrointestinal issues. The successful development of a cGMP manufacturing process also indicates readiness for larger-scale production, accelerating the path to potential regulatory approval.
For investors and business leaders, this news underscores Oncotelic's progress in advancing its pipeline and the potential of its Deciparticle platform. The positive preclinical results reduce technical risk for the Phase 1 trial and may enhance the company's valuation. The data also highlight the growing role of AI and automation in drug development, as Oncotelic leverages its PDAOAI platform for manufacturing and discovery.
To view the full press release, visit https://ibn.fm/hocuZ. For more information about Oncotelic, visit www.oncotelic.com.
