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 to address 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, Oncotelic licenses and co-develops select drug candidates through joint ventures, including a 45% stake in GMP Bio.
Additionally, Oncotelic develops PDAOAI, its 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 ongoing joint development work with TechForce Robotics, Oncotelic’s strategic robotics and automation partner. More information is available at www.oncotelic.com.
The positive safety review marks a significant step forward for Sapu003, potentially offering a new treatment option for cancer patients. The planned European expansion could accelerate enrollment and provide broader access to the investigational therapy. Investors can find the latest news and updates regarding OTLC in the company’s newsroom at https://ibn.fm/OTLC.
