Oncotelic Therapeutics Reports Positive Safety Review for Phase 1b Sapu003 Trial

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, finding no dose-limiting toxicities and recommending 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. The full press release is available at https://ibn.fm/sBbID.

The positive safety review is a critical step for Oncotelic as it advances Sapu003, a nanomedicine formulation of everolimus designed to improve drug delivery and reduce side effects. Everolimus is an mTOR inhibitor used in various cancers, but its oral formulation has limitations including variable bioavailability and toxicity. Sapu003's intravenous administration via the Deciparticle platform aims to enhance tumor targeting and efficacy.

Oncotelic Therapeutics is a clinical-stage biopharmaceutical company focused on oncology and immunotherapy for high-unmet-need cancers and rare pediatric indications. The company benefits from the portfolio of 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 that complement Oncotelic’s strategic position.

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. For more information, visit www.oncotelic.com.

This announcement underscores Oncotelic's progress in bringing novel nanomedicine therapies to patients, with the potential to address significant unmet needs in oncology. The expansion into Europe could accelerate enrollment and provide broader data for the Phase 1b trial, which is evaluating Sapu003 in advanced solid tumors.