TriSalus Life Sciences^®, an immunotherapy company on a mission to extend and improve the lives of patients with liver and pancreatic tumors, today highlighted a series of updates from clinical and pre-clinical studies that help support the company’s immunotherapy platform approach for treating liver and pancreatic tumors.

Since acquiring its first therapeutic candidate in 2020, TriSalus™ has initiated two Phase I clinical trials and numerous pre-clinical studies with leading cancer institutes across the U.S. These studies are evaluating the company’s immunotherapy platform, which integrates an investigational class C TLR9 agonist, SD-101, and the proprietary Pressure-Enabled Drug Delivery™ (PEDD™) method of administration to overcome critical treatment barriers that can prevent immunotherapeutic uptake in hard-to-treat tumors.

“Patients with liver and pancreatic tumors can experience poor outcomes due to tumor-induced immunosuppression and high intratumoral pressure that often prevent therapeutics, such as immunotherapy drugs, from reaching their targets. Existing treatment approaches, including direct needle injections and intravenous immunotherapy alone, often fail to address these barriers in a comprehensive way. By engineering new approaches to meet these challenges, we may be able to improve the treatment paradigm for liver and pancreas tumor patients,” said Steven C. Katz, MD, FACS, Chief Medical Officer at TriSalus.

Dr. Katz continued, “The TriSalus immunotherapy platform combines the well-studied, investigational immunotherapy, SD-101, administered via PEDD™, an innovative vascular delivery method leveraged by FDA-cleared devices. Pre-clinical and early clinical data from studies examining this novel approach are promising and give us hope that we will be able to offer liver and pancreas tumor patients a better chance of responding more reliably to immunotherapy. While our approach is highly innovative, the delivery technology has been used in over 16,000 cases and SD-101 has been studied through Phase 2 trials in other indications. As such, we are building upon reassuring safety data for both SD-101 and PEDD™ and hope that, by integrating the two into a single platform, we can enable better responsiveness to systemic immunotherapy.”

Clinical Development Update for Liver and Pancreas Immunotherapy Platform

Pressure-Enabled Regional Immuno-Oncology (PERIO-01) Clinical Study

In June, the Pressure-Enabled Regional Immuno-Oncology™ (PERIO™-01) clinical trial’s Principal Investigator, Dr. Sapna Patel, an Associate Professor and Director of the Uveal Melanoma Program and Melanoma Fellowship Program at the University of Texas MD Anderson Cancer Center, delivered an oral presentation at the 20^th Congress of the International Society of Ocular Oncology. During this presentation, Dr. Patel discussed the innovative approach being taken in the PERIO-01 trial and reviewed early data that supports the safety of SD-101 and immunologic effects within liver tumors at various dose levels.

The PERIO-01 clinical trial (NCT04935229) seeks to evaluate whether the TriSalus immunotherapy platform approach can improve the performance of systemic checkpoint inhibitors in patients with uveal melanoma with liver metastases, a rare form of eye cancer that frequently spreads to the liver. The clinical trial is underway at leading academic medical centers, including MD Anderson Cancer Center, Columbia University Irving Medical Center, Thomas Jefferson University Hospital, Massachusetts General Hospital, and University of Pittsburgh Medical Centers. Since enrollment of the first patient in the PERIO-01 trial, TriSalus has fully enrolled patients at four dose levels in Cohort A, which is evaluating the safety of SD-101, and started enrollment for Cohort B to evaluate the safety of SD-101 in combination with nivolumab, a checkpoint inhibitor.

Early data from the PERIO-01 study, also presented at the Society for Immunotherapy of Cancer’s Tumor Immune Microenvironment Workshop, suggest SD-101 delivered via PEDD™ has enabled immunologic activity within the liver metastases’ tumor microenvironment in metastatic uveal melanoma patients. This data bolsters evidence that suggests this integrated approach may support better immune checkpoint inhibitor performance in uveal melanoma patients and other intrahepatic indications, within the liver and potentially at other disease sites. These clinical data resonate well with a newly published pre-clinical study in Cancer Gene Therapy that suggests administering a class C TLR9 agonist via PEDD™ can improve responsiveness to systemic checkpoint inhibition for liver tumors through elimination of a highly immunosuppressive cell type known as myeloid derived suppressor cells (MDSC).

Pressure-Enabled Regional Immuno-Oncology (PERIO-02) Clinical Study

In May, TriSalus announced the first patient enrolled in its second immunotherapy platform study, PERIO-02 (NCT05220722). The trial is evaluating SD-101 in adults with locally advanced, metastatic, or unresectable hepatocellular carcinoma and intrahepatic cholangiocarcinoma. Since then, TriSalus has fully enrolled patients in the first dose level of Cohort A, which is evaluating the safety of SD-101 in this patient population. The trial was initiated at MD Anderson Cancer Center with additional sites planned. Cohort B is expected to open over the summer and will test SD-101 via PEDD™ in combination with systemic pembrolizumab, a checkpoint inhibitor. Importantly, testing the therapeutic platform of SD-101 delivered via PEDD™ across multiple indications to enable systemic checkpoint inhibition has the potential to provide data to support the broad application of this innovative approach for patients with liver or pancreas tumors.

Pre-Clinical Studies Leveraging Proprietary Infusion Technology

TriSalus’ clinical leadership team also recently presented new pre-clinical data at the Society of Interventional Radiology (SIR) 2022 Annual Scientific Meeting. In one abstract presentation, TriSalus highlighted data that suggests the PEDD™ method was more effective in delivering SD-101 into liver tissue than direct needle injection. To further support these findings, TriSalus is collaborating with Massachusetts General Cancer Center on an investigator-initiated clinical trial (NCT05128032) to evaluate whether PEDD™ improves the delivery of radioactive microspheres during radioembolization treatment for liver cancer, compared to a standard microcatheter.

In a second abstract presentation at SIR 2022, TriSalus highlighted new data on the development of a trans-venous approach for the regional treatment of pancreatic tumors, called pancreatic retrograde venous infusion (PRVI). This pre-clinical data is the first of its kind to demonstrate that the PRVI approach can improve uptake and tumor response for pancreatic tumors. Unlike the liver, using the arterial systemic for drug delivery in the pancreas poses significant anatomic challenges. TriSalus has developed a novel approach to leverage the PEDD™ method in venous branches using a new FDA-cleared device designed for highly targeted intra-pancreatic delivery of SD-101.

Expanded Strategic Research Collaborations

TriSalus has also announced several strategic collaborations with top-tier cancer institutions and research centers to further efforts to develop innovative treatment options. In January, TriSalus announced a three-year strategic research collaboration with the University of Colorado Anschutz Medical Campus to advance research of immuno-oncology treatments for patients with liver and pancreatic tumors, and in April, the company shared it is developing a new immunotherapeutic research laboratory on the campus of Lifespan Health System to further develop its therapeutic platform. These announcements build upon the strategic research collaboration established in 2021 with the University of Texas MD Anderson Cancer Center to evaluate TriSalus’ platform approach for the treatment of liver and pancreatic tumors.

To learn more about the progress of ongoing research, visit www.trisaluslifesci.com.

About TriSalus Life Sciences

TriSalus Life Sciences^® is an immunotherapy company on a mission to extend and improve the lives of patients living with liver and pancreatic tumors. By integrating an immunotherapeutic with innovative drug delivery technologies, TriSalus’ platform seeks to address two significant barriers that limit the effectiveness of current treatments for liver and pancreatic tumors: immunosuppression and high intratumoral pressure.

The company is studying the ability of SD-101, a potentially first-in-class, investigative TLR9 agonist, to reactivate the immune system within the liver and pancreas to enable more durable responses to other immunotherapeutics (e.g., checkpoint inhibitors) and improve patient outcomes. The platform, which leverages TriSalus’ proprietary Pressure-Enabled Drug Delivery™ (PEDD™) method of administration, modulates pressure and flow within blood vessels to improve the amount of therapy delivered to the tumor. While meaningful progress in these difficult-to-treat diseases will not be easy, TriSalus is focused on advancing science and technological innovation to transform outcomes for patients. To learn more, visit www.trisaluslifesci.com and follow us on Twitter @TriSalusLifeSci and LinkedIn.

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