Oncotelic Therapeutics (OTCQB: OTLC) and its 45%-owned subsidiary, Sapu Nano (US) LLC, announced that the independent Safety Review Committee has completed its review of the initial three-patient safety cohort in the ongoing Phase 1b SP-03-B101 trial of Sapu003. The committee found no dose-limiting toxicities and recommended advancement to the next planned dose level. The company also announced plans to expand the study into Europe with additional clinical sites to broaden patient access and support enrollment.
This clinical milestone follows the publication of peer-reviewed research describing the scientific foundation of the Deciparticle nanomedicine platform and the intravenous everolimus formulation Sapu003. The company said the publication supports the platform’s scalable manufacturing capabilities, stability and preclinical antitumor activity while reinforcing the ongoing clinical development program. For more details, visit https://ibn.fm/sBbID.
The advancement to the next dose level is a critical step in validating the Deciparticle platform, which aims to improve the delivery and efficacy of existing oncology drugs. Everolimus, an mTOR inhibitor, is currently approved for certain cancers but has limitations due to poor solubility and bioavailability. Sapu003 is designed to overcome these challenges through a nanoparticle formulation that allows intravenous administration.
Oncotelic Therapeutics, a clinical-stage biopharmaceutical company, focuses on oncology and immunotherapy products for high-unmet-need cancers and rare pediatric indications. The company’s pipeline includes directly owned programs and joint ventures. For more information about Oncotelic, visit www.oncotelic.com.
The company also highlighted its proprietary AI platform, PDAOAI, which supports drug discovery, lab automation, and AI-assisted GMP manufacturing. This platform is being developed in collaboration with TechForce Robotics and is integrated into the operations of SAPU Bio, an OEB-5 sterile injectable cGMP manufacturing facility.
The expansion into Europe is expected to accelerate patient enrollment and provide broader access to the investigational therapy. Oncotelic’s CEO, Dr. Vuong Trieu, has filed over 500 patent applications and holds 75 issued U.S. patents, underpinning the company’s innovative approach. The outcomes of this trial could have significant implications for patients with cancers that are resistant to current treatments, as Sapu003 may offer a more effective delivery mechanism for everolimus.
