Oncotelic Therapeutics Doses First Patient in Phase 1b Trial of Sapu003 for Advanced Solid Tumors

Oncotelic Therapeutics, Inc. (OTCQB: OTLC), alongside Sapu Nano, announced that the first patient has been dosed in the Phase 1b clinical trial evaluating Sapu003, an investigational intravenous Deciparticle formulation of everolimus for patients with advanced mTOR-sensitive solid tumors. The announcement, made via press release, marks a significant step in addressing limitations of oral everolimus, including variable absorption and dose-limiting toxicity.

The open-label, dose-escalation study is designed to assess safety, tolerability, pharmacokinetics and preliminary anti-tumor activity across patient cohorts including HR-positive/HER2-negative breast cancer and multiple additional tumor types. Sapu003 is developed as a weekly IV formulation intended to overcome challenges associated with oral administration, potentially offering more consistent drug exposure and improved tolerability.

Oncotelic Therapeutics is a clinical-stage biopharmaceutical company focused on oncology and immunotherapy products. The company’s pipeline targets high-unmet-need cancers and rare pediatric indications. In addition to its directly owned drug pipeline, Oncotelic 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 patents. The company also leverages its proprietary AI-enabled PDAOAI platform, which supports research, biomarker discovery, and regulatory processes through advanced data analysis.

Beyond its internal programs, Oncotelic licenses and co-develops select drug candidates through strategic partnerships and joint ventures. The company currently owns a 45% interest in GMP Bio, a joint venture advancing a complementary pipeline of therapeutic candidates that further strengthens its position in oncology and rare disease therapeutics. For more information, visit the company’s newsroom at https://ibn.fm/OTLC.

The dosing of the first patient in this Phase 1b trial represents a critical milestone for Oncotelic, as it moves Sapu003 closer to potentially providing a safer and more effective treatment option for patients with mTOR-sensitive tumors. The trial’s results will be closely watched by investors and the oncology community, given the high unmet need in advanced solid tumors that have limited treatment options after progression on standard therapies.