Oncotelic Therapeutics Identifies Biomarker Signature Predicting Tumor Sensitivity to IV Sapu003

Oncotelic Therapeutics, Inc. (OTCQB: OTLC) announced that its 45% owned joint venture, Sapu Nano, has identified a High-RICTOR/Low-RPTOR molecular signature that predicts tumor sensitivity to Sapu003, the company's intravenous Deciparticle formulation of everolimus. This biomarker framework represents the first prospective selection strategy for IV everolimus and will be presented at the 2025 San Antonio Breast Cancer Symposium. The findings are based on analysis of more than 9,000 tumor samples across 20 cancer types, providing substantial evidence for the signature's predictive value.

Data from the research indicate that mTORC2-dominant tumors exhibit heightened mTOR dependency and predicted sensitivity to Sapu003. These tumors include HR+/HER2- breast cancer, lung adenocarcinoma, gastric cancer, renal cancer, ovarian cancer, acute myeloid leukemia (AML), and T-cell malignancies. The identification of this biomarker signature is significant because it could enable clinicians to select patients most likely to benefit from Sapu003 treatment, potentially improving therapeutic outcomes while avoiding unnecessary treatment for patients unlikely to respond.

Sapu003 overcomes limitations of oral everolimus through higher tissue penetration, reduced gastrointestinal accumulation, and preserved metabolic specificity. The intravenous formulation represents an advancement in mTOR inhibitor delivery, addressing challenges that have limited the effectiveness of oral formulations. The biomarker discovery aligns with precision medicine approaches that seek to match specific treatments with patients based on molecular characteristics of their tumors.

The company's latest news and updates relating to OTLC are available in its newsroom at https://ibn.fm/OTLC. The full press release containing additional details about this biomarker discovery can be viewed at https://ibn.fm/bIpA4. This development represents progress toward more personalized cancer treatment strategies that could benefit patients with various malignancies. The identification of predictive biomarkers for targeted therapies continues to be a critical focus in oncology research, as it enables more efficient clinical development and potentially improves patient outcomes through better treatment selection.