TriSalus Life Sciences, Inc. announced that data from its Phase 1b PERIO-02 clinical trial was presented in a poster session at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting, taking place May 31-June 4, 2024, in Chicago, Illinois. The PEDD approach is a proprietary delivery mechanism developed by TriSalus that aims to overcome challenges of the tumor microenvironment (TME) by modulating pressure and flow to enhance local drug concentrations in tumors by improving intravascular therapeutic delivery. The PERIO-02 clinical trial is the hepatic arterial infusion (HAI) of nelitolimod with the PEDD method to enhance tumor response in combination with intravenous checkpoint inhibition in adults with Hepatocellular Carcinoma (HCC) or Intrahepatic Cholangiocarcinoma (ICC).

Key Findings from the Phase 1b PERIO-02 Clinical Trial: At the 4 mg dose in cohort C, three of three patients had disease control as best on-treatment response, with one complete response (CR) in the liver (5L ICC), one partial response (PR) (-31%), and one stable disease (SD). For patient 101-017, investigators noted decreases in the target liver lesion (31.3 to 17.5 mm), non-target liver lesion, and extra-hepatic lymph nodes on days 53 and 84 with CR of target liver lesions and stability of extra-hepatic nodal lesions reported on day 154. Median progression-free survival (PFS) in the Cohort C 4 mg dose level is > 120 days.

Median overall survival (OS) for this group has not been reached (range 120-170 days). Immune effects of nelitolimod included increases in liver tumor CD4 and CD8 T cells and an increase in the CD8 T cell:MDSC ratio. Gene expression changes revealed increased T H1 programming as well as increased expression of granzyme A, IFN?, and CXCL10 in both liver tumor and surrounding normal liver.

Changes among plasma marker levels included increased IL-2R and CXCL10 expression, with decreased IL-17A, IDO, and NT5E (CD73). PERIO-02 is an open-label phase 1 trial of nelitolimod given by the PEDD method in HCC and ICC. The study consists of dose-escalation cohorts of nelitolimod alone (Cohort A), with IV pembrolizumab (Cohort B), or IV nivolumab + ipilimumab (Cohort C).

Nelitolimod is delivered over two cycles, with three weekly doses per cycle. Blood, liver tumor, and normal liver biopsies are collected for correlative studies. Details about the presentation can be found below and on the ASCO website.

Additionally, a copy of the poster will be available on the publications page of the TriSalus website.