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. This milestone marks a significant step in addressing the limitations of oral everolimus, such as variable absorption and dose-limiting toxicity.
The open-label, dose-escalation study is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of Sapu003. By administering everolimus intravenously on a weekly basis, the formulation aims to provide more consistent drug exposure and potentially reduce side effects compared to daily oral dosing. According to the press release, the trial will enroll patients across multiple cohorts, with a focus on those who have failed prior therapies.
Oncotelic Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing 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 its internal pipeline, Oncotelic engages in strategic partnerships and joint ventures. The company owns a 45% interest in GMP Bio, a joint venture that advances a complementary pipeline of therapeutic candidates, further strengthening Oncotelic’s position in oncology and rare disease therapeutics. The latest news and updates regarding OTLC are available in the company’s newsroom at https://ibn.fm/OTLC.
The dosing of the first patient in this trial is a key development for Oncotelic, as it progresses Sapu003 toward potential regulatory approval. If successful, Sapu003 could offer a new treatment option for patients with mTOR-sensitive tumors, addressing the unmet need for more effective and tolerable therapies. The trial’s results will be closely watched by the oncology community and investors alike.
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