DENVER & FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--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 new Phase 1 clinical data presented at the American Association for Cancer Research (“AACR”) 2023 Annual Meeting taking place in Orlando, Florida, from April 14-19, 2023.
The clinical data presented at the AACR 2023 Annual Meeting relates to the Company’s ongoing Pressure-Enabled Regional Immuno-Oncology (“PERIO-01”) clinical study for uveal melanoma with liver metastases (“UMLM”). The PERIO-01 trial is studying an investigational class C toll-like receptor-9 agonist, SD-101, delivered intravascularly with the TriNav® Infusion System (“TriNav”) using the 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.
PERIO-01 is an open-label, first-in-human Phase 1 trial of SD-101, given by hepatic arterial infusion with TriNav using PEDD™ in UMLM (NCT04935229). The study consists of dose-escalation cohorts of SD-101 (2, 4, or 8 mg) alone or with immune checkpoint inhibition (“ICI”). At data cutoff as of January 14, 2023, based on pooled data from 27 patients enrolled in the PERIO-01 trial, only 3 patients were treatment naïve, and others received 1-7 lines of prior therapy. Within these 27 patients, there has been one treatment-related serious adverse event. The most common treatment related adverse events overall were fatigue (9 events), abdominal discomfort (6 events), and dizziness (3 events) which were all graded as non-serious. Grade 3 liver function test elevations were noted in one subject, which was not clinically serious.
Circulating tumor cell and circulating tumor DNA (“ctDNA”) levels were noted to decrease in 6 out of 13 patients and 6 out of 9 patients, respectively, based on available data. Decreases of ctDNA have been associated with longer overall survival in the stage IV uveal melanoma population. 5 out of 5 patients with available data demonstrated reductions in intratumoral myeloid derived suppressor cells (“MDSCs”), which the Company has previously demonstrated in pre-clinical liver metastasis models to be associated with immunosuppression. This data supports the hypothesis that checkpoint inhibitors in combination with SD-101 delivered via the PEDD™ method can enable broad immune effects, including the depletion of liver MDSCs.
“We believe our approach has the potential to improve outcomes and enhance the quality of life for patients with liver and pancreatic tumors receiving checkpoint inhibitor therapy,” said Steven C. Katz, MD, FACS, Chief Medical Officer at TriSalus. “The data presented at the AACR 2023 Annual Meeting shows that SD-101 has been well tolerated to date when administered via PEDD™, at multiple dose levels alone and in combination with checkpoint inhibition. SD-101 infusions have also been associated with encouraging immunologic activity and ctDNA decreases, even at the lower doses, in heavily pre-treated patients. The serious adverse event rate related to treatment to date suggests that our delivery approach may enhance the therapeutic index for SD-101. We look forward to continuing our trials and adding to the growing body of evidence that our proprietary PEDD™ method is a potentially powerful approach for enabling SD-101 to improve efficacy of systemic immunotherapies like checkpoint inhibitors.”
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 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 and (iii) 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, as amended, 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, as amended; (v) the occurrence of any event, change or other circumstance that could give rise to the termination of the Merger Agreement, as amended; (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, as amended, 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.
Participation in Solicitation
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.
Investors and security holders will be able to obtain free copies of the proxy statement/prospectus and other documents containing important information about MTAC and TriSalus through the website maintained by the SEC at www.sec.gov. Copies of the documents filed with the SEC by MTAC can be obtained free of charge by directing a written request to MedTech Acquisition Corporation at 48 Maple Avenue, Greenwich, CT 06830.
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
The data contained herein is derived from various internal and external sources. Neither MTAC nor TriSalus has independently verified the accuracy or completeness of the information derived from external sources. Any market data in the communication involves a number of assumptions and limitations, and there can be no guarantee as to the accuracy or reliability of such assumptions. Further, no representation is made as to the reasonableness of the assumptions made within or the accuracy or completeness of any projections or modeling or any other information contained herein. Any data on past performance or modeling contained herein is preliminary, subject to change and may not be indicative of actual future performance. MTAC and TriSalus assume no obligation to update the information in this communication.
No Offer or Solicitation
This communication shall not constitute an offer to sell, a solicitation of an offer to buy or a recommendation to purchase any securities, or the solicitation of any proxy, vote, consent or approval in any jurisdiction in connection with the Business Combination, nor shall there be any offer, solicitation or sale of securities in any jurisdiction in which the offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdictions. This communication is restricted by law; it is not intended for distribution to, or use by any person in, any jurisdiction where such distribution or use would be contrary to local law or regulation. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the U.S. Securities Act of 1933, as amended.