On November 21, 2022 TriSalus Life Sciences, Inc. ("TriSalus") (the "Company"), an oncology therapeutics 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 a presentation for investors with additional information 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, NOV 21, 2022, View Source [SID1234624286]).
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"We are commercializing our TriNav Infusion System (TriNav) and developing SD-101 to potentially enable more patients with liver and pancreatic tumors to benefit from immunotherapeutics and the current standard of care," said Mary Szela, President and Chief Executive Officer of TriSalus. "Today we are providing recent clinical data from our SD-101 studies so investors can better understand the progress to date and the potential upside that our company can generate."
"The initial findings from these studies offer encouraging data supporting TriSalus’ proprietary Pressure-Enabled Drug Delivery ("PEDD") method," said Steven C. Katz, MD, FACS, Chief Medical Officer at TriSalus. "This promising clinical data demonstrate that SD-101 delivered via TriNav may support broad immune effects in liver tumors and eliminate myeloid-derived suppressor cells ("MDSC"). Importantly, the data further substantiates the potential of our therapeutic platform to significantly improve immunotherapy outcomes for patients with liver and pancreatic tumors."
Highlights of the presentation include:
Data is consistent with the hypothesis that TriNav can achieve high SD-101 levels in the liver with limited systemic exposure using the PEDD method.
SD-101 delivered via TriNav is associated with evidence of induction of immunostimulatory cytokines in the blood and has demonstrated reductions in liver tumor monocytic MDSC levels.
To date, 27 patients have been treated with 123 infusions of SD-101 in the PERIO trials, with no serious cytokine adverse events related to SD-101 or serious adverse events related to TriNav or PEDD.
The Company expects PERIO 01 and PERIO 02 Phase 1 response data in December 2022. The studies continue to enroll at higher SD-101 dose levels in combination with checkpoint inhibitors.
The full presentation has been filed with the Securities and Exchange Commission ("SEC") and is accessible on TriSalus’ investor relations page at View Source
About TriSalus and Its Proposed Business Combination with MedTech
TriSalus is an oncology therapeutics 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 highly effective 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 intra-tumoral pressure through modulation of pressure and flow to increase delivery of therapeutic agents.
As previously announced on November 14, 2022, TriSalus has entered into a definitive merger agreement with MedTech (the "Merger Agreement"), a publicly traded special purpose acquisition company 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 first 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.