Late-Breaking Phase 1 Liver Metastasis Data from TriSalus Presented at SITC 2023 Supports Development of Innovative Immuno-oncology Approach for Liver and Pancreas Indications

TriSalus Life Sciences Inc., (Nasdaq: TLSI), an oncology company integrating its novel delivery technology with immunotherapy to transform treatment for patients with liver and pancreatic tumors, today presented additional Phase 1 clinical data during the late-breaker oral presentation session at the Society of Immunotherapy for Cancer (SITC) 2023 Annual Meeting.

The PERIO-01 Phase 1 study for uveal melanoma with liver metastases (UMLM), studied SD-101 delivered via PEDD with the TriNav Infusion System in combination with intravenous checkpoint inhibitors. The data presented today at SITC demonstrate that SD-101 is well tolerated when given by the PEDD method and is associated with immunologic effects both within the liver and systemically, which may enable better outcomes with systemic checkpoint inhibition. The Progression-Free Survival (PFS), Disease Control Rate (DCR), and ctDNA molecular response data in PERIO-01 patients in combination with nivolumab are encouraging for UMLM and for other indications under development. At the optimal biologic dose of SD-101 (2 mg) in combination with nivolumab (n=7), the median PFS was 11.7 months with an 81% DCR.

“We are encouraged to see that SD-101 is well tolerated when given by PEDD, in association with immunologic effects within the liver and systemically, which may enable better outcomes with systemic checkpoint inhibition,” said Steven C. Katz, M.D., FACS, Chief Medical Officer at TriSalus. “The PFS and ctDNA molecular response data in PERIO-01 patients in combination with nivolumab are promising for UMLM and as well as for other indications that we are pursuing.”

“The results of PERIO-01 highlight the importance of getting the biology right and not just pushing a drug to its maximum tolerated dose. The biological effects of SD-101 are best at the lowest dose tested, revealing tumor microenvironment reprogramming and inflammatory cell trafficking from normal to metastatic liver tumors,” said Sapna Patel, M.D., director of the uveal melanoma program at The University of Texas MD Anderson Cancer Center. “This is not seen at higher doses of SD-101, and these findings ensure we are entering the next phase with the optimal dose in combination with checkpoint inhibition, for patients with metastatic uveal melanoma.”