On December 15, 2022 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"), reported that it has expanded the reach of its ongoing Pressure-Enabled Regional Immuno-Oncology ("PERIO-01" and "PERIO-02") clinical program (Press release, TriSalus Life Sciences, DEC 15, 2022, View Source [SID1234625325]).
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In recent months TriSalus has opened five new PERIO-01 (NCT04935229) clinical trial sites, at Stanford University Hospitals, University of California Los Angeles, University of Colorado’s Anschutz Medical Campus, University of Washington Medical Center and University of Miami’s Sylvester Comprehensive Cancer Center, in addition to five previously activated sites. The PERIO-01 trial is studying an investigational drug, SD-101, delivered intravascularly by the TriNav Infusion System ("TriNav") using the company’s proprietary Pressure-Enabled Drug Delivery ("PEDD") method of administration. The study is evaluating whether this platform approach with SD-101 and PEDD can improve the performance of systemic checkpoint inhibitors in treating patients with uveal melanoma with liver metastases. In addition to these U.S. sites, TriSalus anticipates opening future PERIOTM-01 clinical trial sites in the United Kingdom, Europe, and Canada.
In parallel, TriSalus opened PERIOTM-02 (NCT05220722) trial sites at Columbia University and University of Colorado Denver, along with Rhode Island Hospital – which was announced last month as part of an expanded research collaboration with Lifespan Health System. The PERIOTM-02 trial, expected to add additional sites in 2023, is evaluating whether this same platform approach with SD-101 and PEDD can improve the performance of systemic checkpoint inhibitors in treating patients with hepatocellular carcinoma or intrahepatic cholangiocarcinoma.
Both the PERIO-01 and PERIO-02 trials, which were initiated at The University of Texas MD Anderson Cancer Center as part of a multi-year strategic collaboration agreement, are studying the ability of SD-101 delivered by the PEDD method of administration to overcome two major challenges in treating patients with liver and pancreatic tumors: immunosuppression and high intratumoral pressure. These two barriers can limit the delivery and efficacy of therapeutics, such as immunotherapy drugs, from reaching their targets and result in poor outcomes.1-5
TriSalus recently shared initial findings from both clinical studies, which indicate the potential of the company’s therapeutic platform to improve immunotherapy outcomes for patients with liver and pancreatic tumors.
The company has also published promising pre-clinical data in Cancer Gene Therapy6 highlighting the potential of SD-101, a toll-like receptor 9 class C ("TLR9C") agonist, to deplete or favorably reprogram myeloid-derived suppressor cells ("MDSCs") that have been shown to contribute to the limited success of immunotherapy in the liver.7 The lead author was Chandra Gosh, PhD, a biomedical scientist and project leader for TriSalus. Pre-clinical data was also presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 37th Annual Meeting, which indicated that SD-101 has a distinct biologic profile relative to other TLR agonists. The pre-clinical findings align with recently released clinical data which supported the potential that SD-101 may reduce MDSCs in patient liver tumors.8-10
"The expansion of the PERIO-01 and PERIO-02 trials represents meaningful progress for our research program—extending trial access to patients across a broader geographic area and increasing the number of partnerships with leading cancer centers," said Steven C. Katz, MD, FACS, Chief Medical Officer at TriSalus. "Further, our pre-clinical work indicates a solid scientific foundation to inform our approach as we seek to advance immunotherapy treatment options for patients with liver and pancreatic tumors. We look forward to building on this momentum for the PERIO programs."