Oncotelic Therapeutics Advances Sapu003 Phase 1b Trial After Positive Safety Review

Oncotelic Therapeutics, Inc. (OTCQB: OTLC) 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 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.

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 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. Oncotelic also licenses and co-develops drug candidates through joint ventures, including a 45% ownership in GMP Bio, which is advancing its own pipeline of drug candidates.

Additionally, 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 the platform and its ongoing joint development work with TechForce Robotics, Oncotelic’s strategic robotics and automation partner. More information is available at www.oncotelic.com.

The safety review outcome is a critical step for the Sapu003 program, which uses the Deciparticle nanomedicine platform to deliver everolimus intravenously, potentially improving efficacy and reducing toxicity compared to oral administration. The planned European expansion could accelerate patient recruitment and provide broader data for regulatory submissions. For investors, the positive safety data de-risks the program and supports further clinical development. The latest news and updates relating to OTLC are available in the company’s newsroom at https://ibn.fm/OTLC.

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