Oncotelic Therapeutics Doses First Patient in Phase 1b Trial of Sapu003 for Advanced Solid Tumors
Oncotelic Therapeutics and Sapu Nano announced the first patient dosed in a Phase 1b trial of Sapu003, an IV formulation of everolimus, aiming to improve delivery and reduce toxicity for advanced mTOR-sensitive solid tumors.
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, marking a milestone in the development of a potentially safer and more effective alternative to oral everolimus.
The open-label, dose-escalation study is designed to evaluate safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity across multiple patient cohorts. These include HR-positive/HER2-negative breast cancer and other tumor types. Sapu003 is developed as a weekly IV formulation intended to overcome limitations associated with oral everolimus, such as variable absorption and dose-limiting toxicity. The study's results could provide critical insights into the drug's potential to improve outcomes for patients with limited treatment options.
This development is significant because oral everolimus, while effective in certain cancers, has challenges including inconsistent absorption and significant side effects that often limit its use. Sapu003's IV formulation aims to deliver more consistent drug levels and potentially reduce toxicity, which could broaden its applicability and improve patient quality of life. The trial's focus on mTOR-sensitive tumors, including breast cancer, addresses a high unmet need, as mTOR pathways are frequently dysregulated in cancer.
Oncotelic Therapeutics is a clinical-stage biopharmaceutical company specializing in oncology and immunotherapy. The company leverages its proprietary AI-enabled PDAOAI platform for research and biomarker discovery. Additionally, Oncotelic holds a 45% interest in GMP Bio, a joint venture advancing a complementary pipeline of therapeutic candidates. The company benefits from the extensive patent portfolio of its CEO, Dr. Vuong Trieu, who has filed over 500 patent applications and holds 75 issued patents.
For more information about the trial, visit the full press release at https://ibn.fm/JuGIs. Updates on Oncotelic Therapeutics are available in the company’s newsroom at https://ibn.fm/OTLC. This announcement underscores the ongoing efforts to improve cancer treatment through innovative drug delivery methods.