New data from PERIO-01 clinical trial indicates PEDD™ method resulted in modulation of the tumor microenvironment and decreased circulating tumor DNA (ctDNA) levels
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), today announced additional Phase 1 clinical data presented at the American Society of Clinical Oncology (ASCO) 2023 Annual Meeting taking place in Chicago, Illinois, from June 2-6, 2023.
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 Mass General Brigham at ASCO reflect important clinical progress of our Phase 1 PERIO-01 trial and builds on the promising data released in April,” said Steven C. Katz, MD, FACS, Chief Medical Officer at TriSalus. “We are pleased that SD-101 in combination with systemic checkpoint inhibition and delivered with TriNav was well tolerated based on a low treatment related serious adverse event rate of 5% and resulted in immune cell activation and natural killer cell expansion. We look forward to moving into Phase 2 later this year and are optimistic about the potential of SD-101 playing an important role in the management of patients with UMLM.”
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 May 12, 2023, 39 patients were enrolled in the PERIO-01 trial, with each having received at least one dose of SD-101. Of the patients with available data, five patients were treatment-naïve and 81% had failed at least one prior line of therapy, including three patients on their sixth-line of treatment.
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 June 3, 2023 at 3:00pm CT.
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 (as amended on April 4, 2023 and May 13, 2023) with MedTech, a publicly traded special purpose acquisition company (as amended, the “Merger Agreement”) in connection with the Business Combination. Upon the closing of the transaction, 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.
For Patients
To learn more about the clinical trial treatment protocol and enrollment, visit http://www.periotrial.com or http://www.clinicaltrials.gov and search NCT04935229, NCT05220722, and NCT05607953.
About MedTech Acquisition Corporation
MedTech is a blank check company formed for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses or entities. MedTech has stated a focus on the medical technology industry in the United States and other developed countries.
Changes and Additional Information in Connection with SEC Filing
The information in this communication has not been reviewed by the U.S. Securities and Exchange Commission (the “SEC”) and certain information may not comply in certain respects with SEC rules. MTAC filed with the SEC a registration statement on Form S-4 (File No. 333-269138) (as amended, the “Registration Statement”), which includes a proxy statement/prospectus of MTAC that will be both the proxy statement to be distributed to holders of MTAC’s common stock in connection with its solicitation of proxies for the vote by MTAC’s stockholders with respect to the Business Combination and other matters as may be described in the Registration Statement, as well as the prospectus relating to the offer and sale of the securities to be issued in the Business Combination. The Registration Statement is not yet effective. The Registration Statement, including the proxy statement/prospectus contained therein, when it is declared effective by the SEC, will contain important information about the Business Combination and the other matters to be voted upon at a meeting of MTAC’s stockholders to be held to approve the Business Combination and other matters (the “Special Meeting”). MTAC may also file other documents with the SEC regarding the Business Combination. MTAC stockholders and other interested persons are advised to read, when available, the Registration Statement, including the proxy statement/prospectus contained therein, as well as any amendments or supplements thereto, because they will contain important information about the Business Combination. When available, the definitive proxy statement/prospectus will be mailed to MTAC stockholders as of a record date to be established for voting on the Business Combination and the other matters to be voted upon at the Special Meeting.
Forward-Looking Statements
This communication contains certain “forward-looking statements” within the meaning of the United States federal securities laws regarding MTAC’s or TriSalus’ expectations, hopes, beliefs, assumptions, intentions or strategies regarding the future including, without limitation, statements regarding: (i) the tolerability of SD-101 infusion with TriNav, (ii) the potential of TriSalus’ proprietary PEDD method to enable SD-101 to have broad immune effects, including depletion of MDSCs, within the liver and systemically, (iii) immunological changes within the liver as evidence of disease control and (iv) expectations for continuing program development. These forward-looking statements generally are identified by words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “strive,” “would,” “will” and similar expressions or the negative or other variations of such statements. These statements are predictions, projections and other statements about future events that are based on various assumptions, whether or not identified in this communication and on the current expectations of MTAC’s and TriSalus’ respective managements and are not predictions of actual performance and, as a result, are subject to risks and uncertainties.
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 SEC. The foregoing list of factors is not exclusive.
MTAC’s other SEC filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those expressed or implied in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and none of MTAC, TriSalus, or any of their respective representatives assume any obligation and do not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. None of MTAC, TriSalus, or any of their respective representatives gives any assurance that either MTAC or TriSalus will achieve its expectations.
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MTAC and TriSalus and their respective directors and executive officers, under SEC rules, may be deemed to be participants in the solicitation of proxies of MTAC’s stockholders in connection with the Business Combination. Investors and security holders may obtain more detailed information regarding the names and interests in the Business Combination of MTAC’s directors and officers in MTAC’s filings with the SEC, including MTAC’s registration statement on Form S-1, which was originally filed with the SEC on November 30, 2020, as amended, MTAC’s 2022 Form 10-K, and the Registration Statement. To the extent that holdings of MTAC’s securities have changed from the amounts reported in the Registration Statement, such changes have been or will be reflected on Statements of Change in Ownership on Form 4 filed with the SEC. Information regarding the persons who may, under SEC rules, be deemed participants in the solicitation of proxies from MTAC’s stockholders in connection with the Business Combination are included in the Registration Statement and will be set forth in the definitive proxy statement/prospectus forming a part of the Registration Statement. Investors and security holders of MTAC and TriSalus are urged to carefully read in their entirety the proxy statement/prospectus and other relevant documents that will be filed with the SEC, when they become available, because they will contain important information about the Business Combination.
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INVESTMENT IN ANY SECURITIES DESCRIBED HEREIN HAS NOT BEEN APPROVED OR DISAPPROVED BY THE SEC OR ANY OTHER REGULATORY AUTHORITY NOR HAS ANY AUTHORITY PASSED UPON OR ENDORSED THE MERITS OF THE OFFERING THEREOF OR THE ACCURACY OR ADEQUACY OF THE INFORMATION CONTAINED HEREIN. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE.
Use of Data
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