Oncotelic Therapeutics, Inc. (OTCQB: OTLC), together with Sapu Nano, announced the publication of a peer-reviewed manuscript in the International Journal of Molecular Sciences validating its proprietary Deciparticle nanoparticle platform. The platform was demonstrated through the development of Sapu003, an investigational intravenous everolimus formulation currently being evaluated in an ongoing Phase 1b clinical trial. The publication details the platform’s formulation design, scalable cGMP manufacturing process, product stability and preclinical performance, while demonstrating its potential to enable intravenous delivery of poorly water-soluble therapeutic compounds.
The company said the research also supports broader applications for the Deciparticle platform beyond everolimus, including additional hydrophobic drug candidates. Sapu003 is currently being evaluated in a Phase 1b dose-escalation study in patients with advanced mTOR-sensitive solid tumors to assess its safety, pharmacokinetics and preliminary antitumor activity in combination with exemestane. To view the full press release, visit https://ibn.fm/gECtl.
Oncotelic Therapeutics is a clinical-stage biopharmaceutical company focused on the development of oncology and immunotherapy products. The Company’s mission is to address high-unmet-need cancers and rare pediatric indications with innovative, late-stage therapeutic candidates. In addition to its directly owned and developed drug pipeline, Oncotelic benefits from the 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.
Beyond its internal programs, the Company also licenses and co-develops select drug candidates through joint ventures. Currently, Oncotelic owns 45% of GMP Bio, a joint venture under Dr. Trieu’s leadership and guidance, which is advancing its own pipeline of drug candidates that further complement and strengthen Oncotelic’s strategic position in oncology and rare disease therapeutics. Oncotelic also develops PDAOAI, its proprietary AI platform for drug discovery, lab automation, and AI-assisted GMP manufacturing.
Through Oncotelic’s relationship with SAPU Bio — an OEB-5 sterile injectable cGMP manufacturing facility — PDAOAI underpins the Platform and its ongoing joint development work with TechForce Robotics, Oncotelic’s strategic robotics and automation partner. For more information, please visit www.oncotelic.com.
This validation of the Deciparticle platform is significant because it addresses a key challenge in drug development: the delivery of hydrophobic compounds. By enabling intravenous administration of drugs like everolimus, the platform could improve bioavailability and reduce side effects, potentially expanding treatment options for patients with advanced solid tumors. The ongoing Phase 1b trial will provide further insights into the clinical utility of this approach.
