TriSalus Life Sciences®? Inc. announced initial positive safety and feasibility data from a Phase 1 trial at the Society of Immunotherapy for Cancer (SITC) 2023 Annual Meeting. TriSalus is studying an investigational class C toll-like receptor-9 (TLR9) agonist, SD-101, delivered intravascularly using the Company?s proprietary Pressure-Enabled Drug Delivery?

(PEDD?) method of administration in three Phase 1 trials. In PERIO-03, SD-101 is delivered via PEDD with the TriSalus Infusion System® using a retrograde venous approach, leveraging established interventional radiology access techniques. The TriSalus Infusion System has an expandable SmartValve® and can interface with standard invasive blood pressure transducers for continuous pressure monitoring during infusion of a therapeutic.

During infusion, the device blocks retrograde flow and modulates pressure in the vessel, resulting in the perfusion of the venous and capillary network isolated by the device. Early safety and feasibility data from the PERIO-03 locally advanced pancreatic adenocarcinoma trial revealed that in three patients who received SD-101 via retrograde venous infusion PEDD at the lowest dose level (0.5 mg), there were no serious grade 3/4 adverse events related to treatment. This is a first-in-human experience for use of PEDD and retrograde venous infusion for delivery of an immunologic agent into pancreatic tumors.

Immune signals pointed to a decrease in myeloid derived suppressor cells (MDSC) activity in the treated pancreatic tumors, with declines in MDSC associated genes, including arginase-1, nitric oxide synthetase-2, and S100A9 (n=3). Signals associated with T cell activation were also noted in pancreatic tumor biopsy specimens. Overall, the data emerging from PERIO-03 trials indicate immunologic changes are occurring within the pancreas, with a favorable safety profile.

Additionally, pre-clinical data presented by TriSalus at SITC indicates that SD-101 administered via PEDD can enable both intravenously and subcutaneously administered checkpoint inhibitors. TriSalus will also present data from its PERIO-01 trial for uveal melanoma liver metastases at a SITC late breaker session on November 4 at 11:25 am PT. Pressure-Enabled Regional Immuno-Oncology (PERIO) clinical trials: The Pressure-Enabled Regional Immuno-Oncology (PERIO) clinical trials are studying an investigational class C toll-like receptor-9 agonist, SD-101, delivered intravascularly by TriSalus?

TriNav® Infusion System (TriNav) using the Company?s proprietary Pressure-Enabled Drug Delivery? (PEDD?) method of administration in three Phase 1 trials. The PERIO-01 Phase 1 clinical study for uveal melanoma with liver metastases (UMLM), is studying SD-101 delivered via PEDD with TriNav in combination with intravenous checkpoint inhibitors.

The PERIO-02 Phase 1b clinical study for hepatocellular carcinoma and intrahepatic cholangiocarcinoma, is studying SD-101 delivered via PEDD with TriNav in combination with intravenous checkpoint inhibitors. The PERIO-03 Phase 1 clinical study for locally advanced pancreatic adenocarcinoma, is studying SD-101 delivered via PEDD with TriNav in combination with intravenous checkpoint inhibitors.