TriSalus Begins Enrollment in PERIO-01 Trial of Pressure-Enabled Drug Delivery for SD-101 to Treat Uveal Melanoma Liver Metastases

September 7, 2021—TriSalus Life Sciences, an emerging immuno-oncology company focused on treatment for liver and pancreatic tumors, announced that the first patient was enrolled in the Pressure-Enabled Regional Immuno-Oncology clinical study, PERIO-01, evaluating the administration of SD-101, an investigational toll-like receptor 9 (TLR9) agonist, in adults with metastatic uveal melanoma.

The study is designed to evaluate the intravascular administration of SD-101 into uveal melanoma liver metastasis lesions in combination with checkpoint inhibitors using the pressure-enable drug delivery (PEDD) approach. The study will enroll up to 52 patients in phase 1 and will be initiated at multiple cancer centers across the United States.

The trial’s Principal Investigator will be Sapna Patel, MD, Associate Professor of Melanoma Medical Oncology at The University of Texas MD Anderson Cancer Center in Houston, Texas. Additional investigators include Richard Carvajal, MD, Director of the Melanoma Service at Columbia University Irving Medical Center in New York, New York, and Marlana Orloff, MD, at Thomas Jefferson University Hospital in Philadelphia, Pennsylvania.

According to the company, the TriSalus TriNav infusion system is FDA cleared for the PEDD approach. TriNav is designed to overcome the inherent intratumoral pressure of solid tumors and will be used for intravascular delivery of SD-101 in this trial.

TriNav is a flexible, ultrathin therapy delivery system with SmartValve technology, a self-expanding, nonocclusive one-way microvalve. This system for the PEDD approach has demonstrated the ability to overcome intratumoral pressure in solid tumors and potentially improve distribution and penetration of therapy during transcatheter arterial chemoembolization and transcatheter arterial radioembolization procedures.

TriSalus stated that TLR9 agonists, such as SD-101, are believed to play a key role in the innate immune system and create a bridge to adaptive immunity by binding to the TLR9 receptors found on suppressive immune cells including myeloid-derived suppressor cells and antigen-presenting immune cells. By infusing SD-101 directly to the site of disease, the goal of this approach is to enhance SD-101’s therapeutic index; increase antitumor immune activity intended to slow tumor progression; and restore, enable, or improve responses to immunotherapies such as checkpoint inhibitors for treatment of liver metastases.