A collaborative effort to evaluate treatment of liver and pancreatic tumors

HOUSTON, DENVER and CHICAGO ? The University of Texas MD Anderson Cancer Center and TriSalus Life Sciences today announced a strategic research collaboration to evaluate the treatment of tumors of the pancreas and liver by integrating interventional delivery of SD-101, an investigational toll-like receptor 9 (TLR9) agonist, in combination with checkpoint inhibition immunotherapy.

Under the agreement, MD Anderson and TriSalus will collaborate on studies evaluating the administration of investigational SD-101 intravascularly via TriSalus' Food and Drug Administration (FDA) cleared, proprietary Pressure-Enabled Drug Delivery™ (PEDD™) technology across a range of liver and pancreatic solid tumors.

The initial study will focus on liver metastases from uveal melanoma, followed by studies focused on metastatic disease from pancreatic ductal adenocarcinoma and colorectal cancer. Programs for hepatocellular carcinoma and locally advanced pancreatic ductal adenocarcinoma also are under development. TriSalus will provide funding and technology for the studies.

We're pleased to collaborate with MD Anderson in pursuit of our collective goal to improve outcomes for patients with tumors of the liver and pancreas. The goal of these studies is to augment the potential of existing therapies through novel drug delivery technology and to investigate the strategic modulation of immune microenvironments with investigational candidate SD-101,

Collaborations such as this are an integral part of our development strategy to evaluate treatments to help overcome the challenges inherent to solid tumors and enable a broader population of cancer patients to benefit from immunotherapy."

Steven Katz, M.D., Chief Medical Officer, TriSalus

SD-101 has been evaluated in phase 2 studies in advanced cutaneous melanoma and head and neck cancer. Early data suggests SD-101 augmented responsiveness to checkpoint inhibitors through stimulation of innate immune cells, along with favorable programming of the T cell population. The planned studies under the research collaboration are intended to deliver SD-101 deep into the vasculature of solid tumors using PEDD, a technique not previously possible using standard delivery approaches.

Solid tumors continue to represent one of the single biggest hurdles to successful cancer treatment. High levels of pressure inside solid tumors prevent the delivery of oncology therapeutics, with less than 1% of therapy penetrating solid tumors in some circumstances. TriSalus developed PEDD to deliver immuno-oncology therapeutics directly into the vasculature of solid tumors.

"Tumors in the pancreas and liver are notoriously difficult to treat effectively, and these patients need new therapeutic options. Our collaboration with TriSalus provides a unique opportunity to evaluate immunotherapy in combination with a novel delivery approach," said Sapna Patel, M.D., associate professor of Melanoma Medical Oncology at MD Anderson. "We look forward to our work together to advance new treatments aimed at improving clinical outcomes and the lives of our patients."