TriSalus Publishes Preclinical Data Showing Enhanced Tumor Delivery and Immune Activation with PEDD-Delivered Nelitolimod
Key Insights
TriSalus Life Sciences published preclinical research in Frontiers in Oncology demonstrating that Pressure-Enabled Drug Delivery (PEDD) significantly improved intratumoral distribution of nelitolimod compared to conventional delivery methods.
The study showed PEDD administration reduced immunosuppressive myeloid-derived suppressor cells (search) and increased cytotoxic CD8+ T cell infiltration in the tumor microenvironment.
In murine liver metastasis (search) models, nelitolimod delivered via PEDD significantly reduced tumor growth compared to systemic administration at key study timepoints.
TriSalus Life Sciences has published preclinical research demonstrating that its Pressure-Enabled Drug Delivery (PEDD) technology significantly enhances the delivery and immune activation of nelitolimod, an investigational Toll-like receptor 9 (search) (TLR9 (search)) agonist, in liver tumor (search) models. The study, published in Frontiers in Oncology, provides evidence that improved drug delivery may unlock greater therapeutic potential for immunotherapies in solid tumors (search).
Enhanced Intratumoral Distribution
The research evaluated nelitolimod delivery using the TriNav Infusion System compared with conventional microcatheter delivery in both porcine and murine liver tumor (search) models. PEDD administration resulted in significantly greater distribution of nelitolimod within and around tumors compared with conventional delivery approaches in an Oncopig model of hepatic tumors (search).
The TriNav Infusion System is designed to temporarily overcome elevated intratumoral pressure and reopen collapsed microvasculature to promote distribution of therapeutics within tumors and surrounding tissue, increasing the level of the therapeutic in the tumor.
Immune Microenvironment Modulation
The study revealed encouraging signals of enhanced immune activity with PEDD-delivered nelitolimod. Treatment using PEDD was associated with reduced levels of immunosuppressive myeloid-derived suppressor cells (search) (MDSCs) and increased infiltration of cytotoxic CD8+ T cells (search) within the tumor microenvironment.
These findings suggest that improved therapeutic distribution within tumors may influence both immune activation and anti-tumor activity, supporting the concept that delivery plays a critical role in determining how effectively therapies engage the tumor microenvironment.
Anti-Tumor Efficacy
In murine liver metastasis (search) models, nelitolimod delivered using PEDD significantly reduced tumor growth compared with systemic administration at key time points during the study. This demonstrates the potential clinical relevance of enhanced drug delivery for improving therapeutic outcomes.
"This study highlights the critical role that delivery plays in determining how effectively therapies engage the tumor microenvironment, particularly for immunotherapies designed to activate local immune responses," said Mary Szela, President and Chief Executive Officer of TriSalus Life Sciences.
Platform Technology Implications
The data reinforces TriSalus's strategy of combining PEDD-enabled delivery with locoregional immunotherapy approaches. Szela noted that the findings "illustrate the broader potential of PEDD as a delivery platform capable of enhancing the intratumoral delivery of multiple therapeutic modalities while limiting exposure healthy tissue."
The company believes this approach may help unlock the full potential of immunotherapies and other agents for patients with difficult-to-treat solid tumors (search), including those in the liver. Nelitolimod is being investigated as an immunotherapy intended to stimulate immune responses within tumors, and the study's findings support continued investigation of approaches that combine targeted drug delivery with immune activation.
Clinical Development Status
TriSalus has three FDA-cleared devices that use its proprietary PEDD approach: the TriNav Infusion System and TriNav Infusion System LV for hepatic arterial infusion of liver tumors, and the Pancreatic Retrograde Venous Infusion System for pancreatic tumors. The company is in the final stages of data compilation for several phase 1 clinical trials and will begin exploring partnership opportunities for development.
Patient data generated in phase 1 Pressure-Enabled Regional Immuno-Oncology (PERIO) clinical trials support the hypothesis that nelitolimod delivered via the PEDD technology may have favorable immune effects within the liver and systemically.