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, the full press release is available at https://ibn.fm/sBbID.
Oncotelic Therapeutics is a clinical-stage biopharmaceutical company focused on developing 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. Beyond its internal programs, Oncotelic licenses and co-develops drug candidates through joint ventures, including its 45% ownership of GMP Bio. The company also develops PDAOAI, a proprietary AI platform for drug discovery, lab automation, and AI-assisted GMP manufacturing, which underpins its joint development work with TechForce Robotics.
The advancement of Sapu003 highlights the potential of Oncotelic’s Deciparticle platform in delivering therapeutics with improved safety and efficacy. The positive safety review in the Phase 1b trial is a critical step toward providing new treatment options for patients. The planned European expansion aims to accelerate enrollment and bring the therapy to a broader patient population. Investors can find the latest news and updates on OTLC at the company’s newsroom: https://ibn.fm/OTLC.
