TriSalus' ongoing Phase 1 Pressure-Enabled Regional Immuno-Oncology (PERIO-01) (NCT04935229) clinical study for uveal melanoma with liver metastases (UMLM) is studying an investigational class C toll-like receptor-9 agonist, SD-101, delivered intravascularly by TriSalus' TriNav Infusion System (TriNav) using the Company's proprietary Pressure-Enabled Drug Delivery (PEDD) method of administration. PERIO-01 is evaluating whether this platform approach can improve the performance of systemic checkpoint inhibitors in patients with UMLM.
'The data presented by Dr. Kamaneh Montazeri from
Pharmacokinetic data indicate that the strategy of delivering a toll-like receptor-9 agonist with the PEDD method results in high drug levels in the liver, while the drug is undetectable after four hours in the serum in 97% of patients with available data. The immune effects in liver metastases and the blood are consistent with broad tumor microenvironment modulation and the ability of SD-101 to deplete myeloid derived suppressor cells (MDSCs) in the liver.
PERIO-01 is an open-label, first-in-human Phase 1 trial of SD-101, administered by hepatic arterial infusion with TriNav using PEDD in UMLM. The study consists of dose-escalation cohorts of SD-101 (2, 4, or 8 mg) alone or with immune checkpoint inhibition. At the data cutoff as of
Following receipt of SD-101, patients demonstrated a statistically significant expansion of peripheral natural killer cells, along with evidence of decreased expression of exhaustion markers on these cells. Increases in serum cytokines, including IFNg and IL-18, also supported systemic immune activation. Additionally, decreased levels of ctDNA levels were observed within eight out of 13 evaluable patients. Stable disease was noted as the best on-treatment response for target lesions in 15 out of 25 patients, with one partial response.
These findings, along with reductions of intratumoral MDSCs and decreases in ARG-1 (arginase 1) and IDO-1 (indoleamine 2,3-dioxygenase-1) gene levels, support the hypothesis that SD-101 delivered via PEDD may have favorable immune effects within the liver and systemically.
Overall, the data emerging from the PERIO-01 trial continues to indicate immunologic changes are occurring within the liver, with decreases in ctDNA and disease control observed across a group of heavily pre-treated patients with UMLM, as well as a low treatment-related serious adverse event rate.
The data were also selected for presentation at the Developmental Therapeutics - Immunotherapy Poster Discussion Session on
About TriSalus and Its Proposed Business Combination with
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.
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Many factors could cause actual results or developments to differ materially from those expressed or implied by such forward-looking statements, including but not limited to: (i) the risk that the Business Combination may not be completed in a timely manner or at all, which may adversely affect the price of MTAC's securities; (ii) the risk that the Business Combination may not be completed by MTAC's business combination deadline and the potential failure to obtain an extension of the business combination deadline; (iii) the failure to satisfy the conditions to the consummation of the Business Combination, including the approval of the Merger Agreement, by the stockholders of MTAC, the satisfaction of the minimum cash amount following any redemptions by MTAC's public stockholders, and the receipt of certain governmental and regulatory approvals; (iv) the lack of a third-party valuation in determining whether or not to pursue the Business Combination on the terms set forth in the Merger Agreement; (v) the occurrence of any event, change or other circumstance that could give rise to the termination of the Merger Agreement; (vi) the receipt of an unsolicited offer from another party for an alternative transaction that could interfere with the Business Combination; (vii) the effect of the announcement or pendency of the Business Combination on TriSalus' business relationships, operating results and business generally; (viii) the risk that the Business Combination disrupts current plans and operations of TriSalus; (ix) the outcome of any legal proceedings that may be instituted against TriSalus or MTAC related to the Merger Agreement, or the Business Combination; (x) the ability to maintain the listing of MTAC's securities on the Nasdaq; (xi) changes in business, market, financial, political and legal conditions; (xii) unfavorable changes in the reimbursement environment for TriSalus' products; (xiii) TriSalus' product candidates not achieving success in preclinical or clinical trials or not being able to obtain regulatory approval, either on a timely basis or at all or subject to any conditions that negatively impact TriSalus' ability to commercialize the applicable product candidates; (xiv) TriSalus being unable to continue to grow TriNav sales; (xv) the size of the addressable markets for TriNav and SD-101, if successfully developed and approved by the applicable regulatory authorities, being less than TriSalus currently estimates; (xvi) TriSalus' ability to successfully commercialize any product candidates that it successfully develops and that are approved by applicable regulatory authorities; (xvii) TriSalus' ability to continue to fund preclinical and clinical trials for SD-101; (xviii) TriSalus' ability to partner with other companies; (xix) future economic and market conditions; (xx) the development, effects and enforcement of laws and regulations affecting TriSalus' business or industry; (xxi) TriSalus' ability to manage future growth; (xxii) TriSalus' ability to maintain and grow its market share; (xxiii) the effects of competition on TriSalus' business; (xxiv) the ability of MTAC or the combined company to raise additional financing in connection with the Business Combination or to finance its operations in the future; (xxv) the ability to implement business plans, forecasts and other expectations after the completion of the Business Combination, and identify and realize additional opportunities; (xxvi) costs related to the Business Combination; (xxvii) the failure to realize the anticipated benefits of the Business Combination or to realize estimated pro forma results and the underlying assumptions, including with respect to estimated stockholder redemptions and (xxviii) other risks and uncertainties indicated from time to time in the Registration Statement, including those under the 'Risk Factors' section therein and in MTAC's other filings with the
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