On June 3, 2024 TriSalus Life Sciences, Inc. (Nasdaq: TLSI), an oncology company integrating its novel Pressure Enabled Drug Delivery (PEDD) technology with immunotherapy to transform treatment for patients with liver and pancreatic tumors, reported that data from its Phase 1b PERIO-02 clinical trial was presented in a poster session at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2024 Annual Meeting, taking place May 31-June 4, 2024, in Chicago, Illinois (Press release, TriSalus Life Sciences, JUN 3, 2024, View Source [SID1234644067]).

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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).

"The PEDD approach represents a promising new delivery method that addresses the limitations of intravenous infusions or needle injections to deliver therapeutics such as nelitolimod to immune cells throughout and surrounding the tumor microenvironment," said Mary Szela, Chief Executive Officer and President of TriSalus. "The findings from the PERIO-02 clinical trial demonstrate the potential of the PEDD method to treat patients with HCC and ICC and provide initial clinical validation that HAI of nelitolimod is well tolerated with encouraging immunologic activity. We look forward to presenting these data and engaging with the medical community at ASCO (Free ASCO Whitepaper)."

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 Th1 programming as well as increased expression of granzyme A, IFNγ, 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).
"The PERIO-02 data presented by Dr. Sunyoung Lee from the University of Texas MD Anderson Cancer Center illustrate that SD-101 is well tolerated when given by the PEDD method in patients who often have underlying liver disease, in association with encouraging biologic activity. The effects noted in PERIO-02 patients, including liver myeloid derived suppressor cell depletion and broad tumor microenvironment immune stimulation, are consistent with previously reported data in metastatic liver tumors (PERIO-01) and locally advanced pancreatic adenocarcinoma (PERIO-03)," said Steven C. Katz, MD, FACS, Chief Medical Officer at TriSalus.

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 (Free ASCO Whitepaper) website. Additionally, a copy of the poster will be available on the publications page of the TriSalus website.

Title: PERIO-02: Phase 1b Pressure Enabled Regional Immuno-oncology Trial of nelitolimod (SD-101), a Class C TLR9 agonist, delivered via hepatic artery infusion +/- checkpoint inhibition in intrahepatic cholangiocarcinoma and hepatocellular carcinoma
Presenter: Dr. Sunyoung Lee, associate professor of Gastrointestinal (GI) Medical Oncology at the University of Texas MD Anderson Cancer Center
Date: Saturday, June 1, 2024
Session Time: 9:00-12:00 p.m. CT/10:00-1:00 p.m. ET
Poster Session: Developmental Therapeutics—Immunotherapy
Abstract: 2622