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 stated that the publication supports the platform’s scalable manufacturing capabilities, stability, and preclinical antitumor activity while reinforcing the ongoing clinical development program. 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 internal programs, Oncotelic licenses and co-develops select drug candidates through joint ventures; it owns 45% of GMP Bio, a joint venture advancing its own pipeline of drug candidates.
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 ongoing joint development work with TechForce Robotics, the company’s strategic robotics and automation partner. For more information, visit www.oncotelic.com.
The latest news and updates relating to OTLC are available in the company’s newsroom at https://ibn.fm/OTLC.
