Oncotelic Therapeutics, Inc. (OTCQB: OTLC), in collaboration with Sapu Nano, announced that the first patient has been dosed in the Phase 1b clinical trial of Sapu003, an investigational intravenous Deciparticle formulation of everolimus. The trial targets patients with advanced mTOR-sensitive solid tumors, including HR-positive/HER2-negative breast cancer and other tumor types.
The open-label, dose-escalation study is designed to assess safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity. Sapu003 is developed as a weekly IV formulation intended to address limitations associated with oral everolimus delivery, such as variable absorption and dose-limiting toxicity. This could represent a significant advancement for patients who may benefit from more consistent drug exposure and reduced side effects.
Oncotelic Therapeutics is a clinical-stage biopharmaceutical company focusing on oncology and immunotherapy products for high-unmet-need cancers and rare pediatric indications. The company leverages a robust portfolio of inventions from its CEO, Dr. Vuong Trieu, who has filed over 500 patent applications and holds 75 issued patents. Additionally, Oncotelic utilizes its proprietary AI-enabled PDAOAI platform to support research, biomarker discovery, and regulatory processes.
Beyond internal programs, Oncotelic licenses and co-develops select drug candidates through strategic partnerships and joint ventures. The company owns a 45% interest in GMP Bio, a joint venture advancing a complementary pipeline of therapeutic candidates that strengthen its position in oncology and rare disease therapeutics.
The initiation of this trial marks a key milestone for Oncotelic and Sapu Nano. If successful, Sapu003 could offer a new treatment option for patients with mTOR-sensitive tumors, potentially improving outcomes through better drug delivery. The dosing of the first patient brings the therapy one step closer to clinical validation.
For more information, the full press release is available at https://ibn.fm/JuGIs. The latest news and updates on OTLC can be found in the company’s newsroom at https://ibn.fm/OTLC.
