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 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 address limitations associated with oral everolimus delivery, including variable absorption and dose-limiting toxicity. The trial marks a significant milestone for Oncotelic, which is focused on developing oncology and immunotherapy products for high-unmet-need cancers and rare pediatric indications.
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 and knowledge integration. Beyond its internal programs, Oncotelic licenses and co-develops select drug candidates through strategic partnerships and joint ventures, including a 45% interest in GMP Bio.
The full press release is available at https://ibn.fm/JuGIs. For more information about Oncotelic, visit their newsroom at https://ibn.fm/OTLC.
