Oncotelic Therapeutics (OTCQB: OTLC) and its 45%-owned subsidiary Sapu Nano (US) LLC announced that the independent Safety Review Committee 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 advancing the trial to the next planned dose level. The company also 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 publication supports the platform’s scalable manufacturing capabilities, stability and preclinical antitumor activity while reinforcing the ongoing clinical development program. For the full press release, visit https://ibn.fm/sBbID.
Oncotelic Therapeutics is a clinical-stage biopharmaceutical company focused on oncology and immunotherapy products for 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. Oncotelic also owns 45% of GMP Bio, a joint venture advancing its own pipeline of drug candidates.
In addition, Oncotelic 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 ongoing joint development work with TechForce Robotics, the company’s strategic robotics and automation partner. For more information, visit www.oncotelic.com.
The positive safety review and planned European expansion mark important steps for Oncotelic as it advances Sapu003 toward potential registration trials. The ability to dose escalate without toxicity signals a favorable safety profile, which could differentiate Sapu003 from other everolimus formulations. Expanding into Europe may accelerate enrollment and provide broader data for regulatory submissions.
Investors and stakeholders can find the latest news and updates on OTLC at the company’s newsroom: https://ibn.fm/OTLC.
