TriSalus Life Sciences Announces First Patient Enrolled in PERIO-01 Clinical Trial to Evaluate Delivery of SD-101 via Pressure-Enabled Drug Delivery in Uveal Melanoma Liver Metastases

• Study to evaluate the delivery of SD-101, an investigational TLR9 agonist, in combination with checkpoint inhibitors to treat uveal melanoma liver metastases employing TriSalus’ novel Pressure-Enabled Drug Delivery™ (PEDD™) technology
• Trial sites includes MD Anderson, Columbia University Irving Medical Center and Thomas Jefferson University Hospital

TriSalus Life Sciences^®, an emerging immuno-oncology company committed to transforming outcomes for patients with liver and pancreatic tumors, today announced its first patient enrolled in the Pressure Enabled Regional Immuno-Oncology (PERIO)-01 clinical study evaluating the administration of SD-101, an investigational toll-like receptor 9 (TLR9) agonist, in adults with metastatic uveal melanoma. This study is designed to evaluate the intravascular administration of SD-101 into uveal melanoma liver metastasis lesions in combination with checkpoint inhibitors using the novel Pressure-Enable Drug Delivery (PEDD) approach.

Uveal melanoma is considered an ultra-rare cancer, affecting about 2,500 people in the U.S. every year. Despite this, the disease is the most common primary eye tumor in adults and the second most common form of melanoma. Notably, uveal melanoma patients are at high risk for metastases, with the liver being a site of disease spread in up to 90% of patients, which often results in a rapidly progressive and lethal condition. Currently no therapies provide disease stability or cure. Metastatic uveal melanoma is usually fatal within a year after diagnosis.¹

“The initiation of this study represents a significant milestone for TriSalus, as it marks the first program from TriSalus' platform aimed at improving patient outcomes in liver and pancreatic cancer by delivering SD-101, our TLR9 agonist, directly to the site of disease via our novel drug delivery technology. SD-101 is designed to activate the patient’s own immune cells within the tumor to overcome immunosuppression. We believe that, by combining SD-101 delivered via PEDD with systemic checkpoint inhibition, there is the potential to overcome the specific immunological pathways in the liver that cause treatment failure,” said Steven Katz, M.D., Chief Medical Officer of TriSalus Life Sciences.

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 (MDSCs) and antigen-presenting immune cells.^2,3 By infusing SD-101 directly to the site of disease, the goal of this approach is to enhance SD-101’s therapeutic index, increase anti-tumor immune activity intended to slow tumor progression and restore, enable, or improve responses to immunotherapies such as checkpoint inhibitors for treatment of liver metastases.

TriSalus’ TriNav^® Infusion System, the latest Food and Drug Administration (FDA) cleared technology for the PEDD approach, is designed to overcome the inherent intratumoral pressure of solid tumors and will be used for intravascular delivery of SD-101 in this trial.

“The liver is notoriously a challenging organ to treat effectively, due in part to a uniquely immunosuppressive environment. This trial will allow us the opportunity to investigate the promise of TriSalus’ unique combination of investigational immuno-oncology agents and PEDD technology,” said Katz. “We are eager to advance innovative treatment options to improve clinical outcomes for patients with limited therapeutic options. Importantly, our approach with SD-101 and PEDD represents a therapeutic platform that we will apply across numerous indications within the liver and pancreas.”

The study will enroll up to 52 patients in phase 1 and will be initiated at multiple cancer centers across the U.S. Sapna Patel, M.D., Associate Professor of Melanoma Medical Oncology at The University of Texas MD Anderson Cancer Center, will serve as principal investigator on the trial. Additional investigators include Richard Carvajal, M.D., Director of the Melanoma Service at Columbia University Irving Medical Center and Marlana Orloff, M.D. at Thomas Jefferson University Hospital.

Disclosures

Dr. Patel receives compensation as a consultant on TriSalus’ scientific advisory board. This relationship has been disclosed to MD Anderson in accordance with its Conflict-of-Interest policy.

Dr. Carvajal has received compensation as a consultant for TriSalus. This relationship has been disclosed to Columbia University Irving Medical Center in accordance with its Conflict-of-Interest policy.

Dr. Orloff receives compensation as a consultant on TriSalus’ scientific advisory board. This relationship has been disclosed to Thomas Jefferson University Hospital in accordance with its Conflict-of-Interest policy.

For Patients

To learn more about the clinical trial treatment protocol and enrollment, visit www.clinicaltrials.gov.

About the TriNav Infusion System

TriNav is a flexible, ultra-thin therapy delivery system with SmartValve™ technology, a self-expanding, nonocclusive one-way microvalve. This system for the Pressure-Enabled Drug Delivery approach, has demonstrated the ability to overcome intratumoral pressure in solid tumors and potentially improve distribution and penetration of therapy during Transcatheter Arterial Chemoembolization (TACE) and Transcatheter Arterial Radioembolization (TARE) procedures.

About TriSalus

TriSalus Life Sciences is an emerging immuno-oncology company dedicated to developing immunotherapy treatments for liver and pancreatic tumors using novel delivery technologies to improve patient outcomes. TriSalus is pursuing multiple solid tumor indications with investigational SD-101 and is working to acquire other immuno-oncology agents to pair with its proprietary Pressure-Enabled Drug Delivery infusion system for the administration of therapeutics intravascularly into visceral organ solid tumors. In combination with checkpoint inhibitors, TriSalus’ focus is to reprogram the dominant immunosuppressive cell population in liver and pancreatic tumors. This innovative approach in development has the potential to leverage multiple mechanisms that can work together with the goal of overcoming inherent immune suppression within the solid tumor microenvironment. To learn more, visit us at www.trisaluslifesci.com and follow us on Twitter @TriSalusLifeSci and LinkedIn.

¹ NORD, Clin Ophthalmol. 2017; 11: 279-289; Nat Rev Dis Primers. 2020 Apr; 6, 24, CHBC Primary Research.​

² Melisi, D., et al. Biomedicines. 2014;2(3):211‐228.

³ Ghosh C.C., et al. AACR. (2021).

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The enrollment of the first patient in @TriSalusLifeSci's PERIO-01 clinical trial marks an important milestone in the development of new, innovative treatment options for those living with #uvealmelanoma #livermets.