On February 16, 2023 TriSalus Life Sciences, Inc. ("TriSalus" or the "Company"), an oncology company reported that the process of going public through a business combination transaction (the "Business Combination") with MedTech Acquisition Corporation (Nasdaq: MTAC) ("MedTech" or "MTAC"), today posted an updated investor presentation with new data regarding its ongoing Pressure-Enabled Regional Immuno-Oncology ("PERIO-01" and "PERIO-02") clinical studies for primary and metastatic liver tumors (Press release, TriSalus Life Sciences, FEB 16, 2023, View Source [SID1234627321]). The presentation is available on the investor relations section of the Company’s website.
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The PERIO-01 and -02 trials are 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 studies are evaluating whether this platform approach can improve the performance of systemic checkpoint inhibitors in treating patients with uveal melanoma with liver metastases, intrahepatic cholangiocarcinoma, and hepatocellular carcinoma.
The latest data from the PERIO-01 and PERIO-02 trials, as well as multiple nonclinical studies, are supportive of the PEDD method for delivering therapeutics, including SD-101, into high-pressure liver tumors. Specifically, in uveal melanoma patients with liver metastases, when delivered via the PEDD method at a 2 or 4 mg dose, SD-101 in combination with nivolumab demonstrated decreases of circulating tumor DNA in the majority of patients, which has been associated with longer overall survival in this population. Emerging data, outlined in the Company’s investor presentation, also supports the hypothesis that SD-101 delivered via the PEDD method, can enable broad immune effects including depletion of liver myeloid derived suppressor cells ("MDSCs"). TriSalus expects data in connection with higher doses by Q2 2023, in addition to data from a separate cohort that combines SD-101 with the combination of nivolumab and ipilimumab.
As of February 2023, 42 patients have enrolled in PERIO-01 and PERIO-02 and have been treated with more than 138 infusions of SD-101. TriSalus is continuing to enroll patients in both PERIO-01 and PERIO-02 and is adding additional clinical sites in anticipation of Phase 2 programs in the second half of 2023.
"The early findings from the Phase 1 PERIO-01 and Phase 1b PERIO-02 trials build on our previous findings and reinforce our confidence in the potential of SD-101 combined with TriSalus’ proprietary PEDD approach," said Steven C. Katz, MD, FACS, Chief Medical Officer at TriSalus. "Given the aggressive nature of stage IV uveal melanoma, intrahepatic cholangiocarcinoma, and hepatocellular carcinoma, we believe that the patient enrollment in these studies highlights the potential of SD-101 and PEDD to enable better outcomes when combined with checkpoint inhibitors. These results, which are summarized in our new investor presentation, further support our hypothesis that SD-101, delivered by PEDD, may favorably reprogram the liver tumor microenvironment and reduce or eliminate MDSCs to promote better responsiveness to checkpoint inhibition. Based on the initial data at the lower end of our SD-101 dose range in combination with checkpoint inhibition, we are eager for clinical results at higher dose levels."
About TriSalus and Its Proposed Business Combination with MedTech
TriSalus is an oncology company integrating immunotherapy with disruptive delivery technology to transform the treatment paradigm for patients with liver and pancreatic tumors.
TriSalus’ proprietary platform approach addresses immune dysfunction in liver and pancreatic tumors by combining its drug delivery technology with immunotherapeutics. The TriSalus platform comprises the TriNav Infusion System and SD-101, a class C toll-like receptor 9 (TLR9) agonist. TriNav is an FDA-cleared device that is designed to administer established and emerging therapeutics. SD-101, the Company’s investigational TLR9 agonist, is being delivered via TriNav to selected sites, including tumors in the liver. TriNav is the latest TriSalus asset for the proprietary PEDD method of administration which has been shown to overcome intratumoral pressure through modulation of pressure and flow to increase delivery of therapeutic agents.
As previously announced on November 14, 2022, TriSalus entered into a definitive merger agreement with MedTech, a publicly traded special purpose acquisition company (the "Merger Agreement") in connection with the proposed business combination and related transactions between the parties. Upon the closing of the transaction, which is expected to occur in the second quarter of 2023, the combined company will be a publicly traded company and its common stock is expected to be listed on the NASDAQ Stock Exchange under the ticker "TLSI." The transaction is subject to the satisfaction of the necessary regulatory approvals and customary closing conditions, including the approval of MedTech’s shareholders.