Oncotelic Therapeutics (OTCQB: OTLC) together with Sapu Nano, announced publication of a peer-reviewed study in Biomedicines detailing the preclinical data supporting Sapu003, its intravenous Deciparticle(TM) formulation of everolimus. The publication outlines the program’s absorption, distribution, metabolism, excretion (“ADME”), pharmacokinetics, tissue distribution, GLP toxicology and cGMP manufacturing data, supporting the ongoing Phase 1 clinical evaluation of Sapu003 in patients with advanced solid tumors. According to the company, the formulation is designed to overcome pharmacokinetic limitations associated with oral everolimus while preserving the drug’s metabolic profile.
The published findings also describe 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 said the comprehensive preclinical package supports continued clinical development of Sapu003 and further validates its Deciparticle platform for transforming hydrophobic therapeutics into intravenous medicines.
To view the full press release, visit https://ibn.fm/TVYf7
About Oncotelic Therapeutics
Oncotelic Therapeutics, Inc. 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
NOTE TO INVESTORS: The latest news and updates relating to OTLC are available in the company’s newsroom at https://ibn.fm/OTLC
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