TriSalus Life Sciences Presents Additional Data for SD-101 Delivered by the Proprietary PEDD Method with the TriNav Device for Uveal Melanoma Liver Metastases at the ASCO 2023 Annual Meeting

TriSalus Life Sciences Inc., (TriSalus or the Company), an oncology company in the process of going public through a business combination transaction (the Business Combination) with MedTech Acquisition Corporation (Nasdaq: MTAC) (MedTech or MTAC), today announced additional Phase 1 clinical data presented at the American Society of Clinical Oncology (ASCO) 2023 Annual Meeting taking place in Chicago, Illinois, from June 2-6, 2023.

TriSalus’ ongoing Phase 1 Pressure-Enabled Regional Immuno-Oncology (PERIO-01) (NCT04935229) clinical study for uveal melanoma with liver metastases (UMLM) is 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. PERIO-01 is evaluating whether this platform approach can improve the performance of systemic checkpoint inhibitors in patients with UMLM.

“The data presented by Dr. Kamaneh Montazeri from Mass General Brigham at ASCO reflect important clinical progress of our Phase 1 PERIO-01 trial and builds on the promising data released in April,” said Steven C. Katz, MD, FACS, Chief Medical Officer at TriSalus. “We are pleased that SD-101 in combination with systemic checkpoint inhibition and delivered with TriNav was well tolerated based on a low treatment related serious adverse event rate of 5% and resulted in immune cell activation and natural killer cell expansion. We look forward to moving into Phase 2 later this year and are optimistic about the potential of SD-101 playing an important role in the management of patients with UMLM.”

Pharmacokinetic data indicate that the strategy of delivering a toll-like receptor-9 agonist with the PEDD method results in high drug levels in the liver, while the drug is undetectable after four hours in the serum in 97% of patients with available data. The immune effects in liver metastases and the blood are consistent with broad tumor microenvironment modulation and the ability of SD-101 to deplete myeloid derived suppressor cells (MDSCs) in the liver.

PERIO-01 is an open-label, first-in-human Phase 1 trial of SD-101, administered by hepatic arterial infusion with TriNav using PEDD in UMLM. The study consists of dose-escalation cohorts of SD-101 (2, 4, or 8 mg) alone or with immune checkpoint inhibition. At the data cutoff as of May 12, 2023, 39 patients were enrolled in the PERIO-01 trial, with each having received at least one dose of SD-101. Of the patients with available data, five patients were treatment-naïve and 81% had failed at least one prior line of therapy, including three patients on their sixth-line of treatment.