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.
TriSalus is an oncology therapeutics company integrating immunotherapy with 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 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 reported on November 14, 2022, TriSalus has entered into a definitive merger agreement with MedTech, 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."
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