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 research details the platform’s formulation design, scalable cGMP manufacturing process, product stability and preclinical performance, demonstrating its potential to enable intravenous delivery of poorly water-soluble therapeutic compounds. This development is significant because it addresses a major challenge in drug development: many promising therapeutic compounds are hydrophobic and difficult to administer effectively. The Deciparticle platform could expand the arsenal of treatable diseases by allowing these compounds to be delivered intravenously.
The publication specifically validates the platform through the development of Sapu003, an investigational intravenous everolimus formulation currently being evaluated in an ongoing Phase 1b clinical trial. Everolimus is a well-known mTOR inhibitor used in cancer therapy, but its oral formulation has limitations in bioavailability and dosing. An intravenous formulation could offer more predictable pharmacokinetics and potentially improved efficacy. The Phase 1b study is a dose-escalation trial in patients with advanced mTOR-sensitive solid tumors, assessing safety, pharmacokinetics and preliminary antitumor activity in combination with exemestane.
The broader implications of this research extend beyond everolimus. Oncotelic stated that the Deciparticle platform has applications for additional hydrophobic drug candidates. This means the platform could serve as a delivery system for a wide range of poorly soluble drugs, potentially accelerating the development of new therapies and improving existing ones. For the pharmaceutical industry, this technology could reduce the time and cost associated with formulating difficult-to-deliver compounds.
For patients, particularly those with advanced cancers, the successful development of Sapu003 could provide a more effective treatment option with better control over drug exposure. The ability to deliver drugs intravenously may also enable combination therapies that are not feasible with oral formulations. For investors, this validation strengthens Oncotelic’s position in the nanoparticle drug delivery space and adds credibility to its broader pipeline.
Oncotelic Therapeutics is a clinical-stage biopharmaceutical company focused on oncology and immunotherapy products, addressing high-unmet-need cancers and rare pediatric indications. The company 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 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 the platform and ongoing joint development work with TechForce Robotics.
For more information, visit www.oncotelic.com.
To view the full press release, visit https://ibn.fm/gECtl.
