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. The biomarker framework, to be presented at the 2025 San Antonio Breast Cancer Symposium, represents the first prospective selection strategy for IV everolimus and is based on analysis of more than 9,000 tumor samples across 20 cancer types.
This development is significant because it enables the identification of patients most likely to benefit from Sapu003 treatment, potentially improving clinical outcomes while reducing unnecessary exposure to therapy for those unlikely to respond. Data show that mTORC2-dominant tumors — including HR+/HER2- breast, lung adenocarcinoma, gastric, renal, ovarian, AML and T-cell malignancies — exhibit heightened mTOR dependency and predicted sensitivity to Sapu003.
The identification of this biomarker signature addresses a critical need in oncology for predictive biomarkers that can guide treatment decisions. Currently, many cancer therapies are administered without reliable predictors of response, leading to variable outcomes and potential side effects for patients who derive little benefit. This biomarker framework could help oncologists select patients who are most likely to respond to Sapu003, potentially improving treatment efficacy and patient quality of life.
Sapu003 overcomes limitations of oral everolimus through higher tissue penetration, reduced gastrointestinal accumulation and preserved metabolic specificity. The intravenous formulation represents an advancement in drug delivery that could translate to improved therapeutic outcomes for patients with mTORC2-dominant tumors. The company's latest news and updates relating to OTLC are available in the company's newsroom at https://ibn.fm/OTLC.
The broader implications of this discovery extend to personalized medicine approaches in oncology. By identifying which tumors are dependent on mTOR signaling pathways, clinicians could potentially match patients with therapies targeting those specific pathways. This precision medicine approach aligns with broader trends in cancer treatment toward more targeted, biomarker-driven therapies that improve outcomes while minimizing unnecessary treatment.
For the pharmaceutical industry, this development demonstrates the importance of biomarker research in drug development. Identifying predictive biomarkers early in development can help streamline clinical trials by enrolling patients most likely to respond, potentially accelerating drug approval and reducing development costs. The full press release can be viewed at https://ibn.fm/bIpA4.
The identification of this biomarker signature represents progress toward more personalized cancer treatment. As oncology moves toward precision medicine approaches, biomarkers that predict treatment response become increasingly valuable for optimizing patient care and resource allocation within healthcare systems.
