Oncotelic Therapeutics, Inc. (OTCQB: OTLC) and its 45%-owned subsidiary Sapu Nano (US) LLC announced that the independent Safety Review Committee 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 advancing 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(TM) nanomedicine platform and the intravenous everolimus formulation Sapu003. According to the company, 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 oncology and immunotherapy products, addressing high-unmet-need cancers and rare pediatric indications with late-stage therapeutic candidates. 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 in oncology and rare disease therapeutics.
Additionally, Oncotelic develops PDAOAI, a 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 the platform and ongoing joint development work with TechForce Robotics. For more information, visit www.oncotelic.com.
The positive safety review is a significant step for Oncotelic as it advances Sapu003 through clinical development. The decision to expand into Europe suggests potential for broader patient access and faster enrollment, which could accelerate the timeline for obtaining clinical data. The nanomedicine platform, supported by peer-reviewed research, may offer advantages in drug delivery and stability, positioning Oncotelic favorably in the competitive oncology landscape. Investors and stakeholders will watch for further updates as the trial progresses to higher dose levels and additional sites.
