Oncotelic Therapeutics, Inc. (OTCQB: OTLC), in collaboration with Sapu Nano, has announced the publication of a peer-reviewed manuscript in the International Journal of Molecular Sciences that validates its proprietary Deciparticle nanoparticle platform. The research supports the development of Sapu003, an investigational intravenous everolimus formulation currently being evaluated in an ongoing Phase 1b clinical trial. This publication details the platform’s formulation design, scalable cGMP manufacturing process, product stability, and preclinical performance, highlighting its potential to enable intravenous delivery of poorly water-soluble therapeutic compounds.
The Deciparticle platform addresses a critical challenge in drug development: the delivery of hydrophobic drugs that have limited solubility in water. By encapsulating such compounds in nanoparticles, the platform aims to improve bioavailability and therapeutic efficacy. The company stated that the research also demonstrates broader applications for the platform beyond everolimus, including other hydrophobic drug candidates. This validation could pave the way for more effective treatments in oncology and other therapeutic areas where solubility issues hinder drug development.
Sapu003 is currently being evaluated in a Phase 1b dose-escalation study involving patients with advanced mTOR-sensitive solid tumors. The trial is designed to assess the safety, pharmacokinetics, and preliminary antitumor activity of Sapu003 in combination with exemestane. The successful validation of the platform is a significant step forward for Oncotelic as it seeks to advance its pipeline of innovative therapies.
Oncotelic Therapeutics is a clinical-stage biopharmaceutical company focused on oncology and immunotherapy products, targeting high-unmet-need cancers and rare pediatric indications. The company benefits from a robust portfolio of inventions created by its CEO, Dr. Vuong Trieu, who has filed over 500 patent applications and holds 75 issued U.S. patents. In addition to its directly owned pipeline, Oncotelic licenses and co-develops drug candidates through joint ventures, including a 45% ownership stake in GMP Bio.
The company also develops PDAOAI, a proprietary AI platform for drug discovery, lab automation, and AI-assisted GMP manufacturing. Through its relationship with SAPU Bio, an OEB-5 sterile injectable cGMP manufacturing facility, PDAOAI underpins ongoing joint development work with TechForce Robotics, Oncotelic’s strategic robotics and automation partner. For more information about Oncotelic, visit www.oncotelic.com.
The full press release can be accessed at https://ibn.fm/gECtl. For the latest news and updates regarding OTLC, visit the company’s newsroom at https://ibn.fm/OTLC.
