TriSalus Life Sciences Posts Updated Investor Presentation Highlighting Additional Phase 1 and 1b Clinical Data for Pressure-Enabled Regional Immuno-Oncology™-01 and -02 Studies
TriSalus Life Sciences, an oncology firm, has released new data on its Pressure-Enabled Regional Immuno-Oncology (PERIO) studies for treating liver tumors. The ongoing PERIO-01 and PERIO-02 trials assess SD-101's intravascular delivery using the TriNav Infusion System. Results show a decrease in circulating tumor DNA for uveal melanoma patients treated with SD-101 and nivolumab, indicating potential survival benefits. With 42 patients enrolled as of February 2023, TriSalus anticipates additional data by Q2 2023 and is expanding its clinical sites ahead of Phase 2 programs set for later this year.
- Initial results show decreased circulating tumor DNA in uveal melanoma patients, linked to longer survival.
- 42 patients enrolled in PERIO studies, indicating strong interest and potential demand.
- TriSalus plans to expand clinical sites and expects more data by Q2 2023.
- Uncertain timeline for completion of Phase 2 programs could delay market entry.
- Regulatory approvals for the business combination are pending, creating potential delays.
- Risk that the business combination may not be completed timely or at all.
Data Further Supports the Potential of the Company’s Therapeutic Platform to Improve Immunotherapy Outcomes for Patients with Liver and Pancreatic Tumors
The PERIO™-01 and -02 trials are studying an investigational drug, SD-101, delivered intravascularly by the TriNav® Infusion System (“TriNav®”) using the Company’s proprietary Pressure-Enabled Drug Delivery™ (“PEDD™”) method of administration. The studies are evaluating whether this platform approach can improve the performance of systemic checkpoint inhibitors in treating patients with uveal melanoma with liver metastases, intrahepatic cholangiocarcinoma, and hepatocellular carcinoma.
The latest data from the PERIO™-01 and PERIO™-02 trials, as well as multiple nonclinical studies, are supportive of the PEDD™ method for delivering therapeutics, including SD-101, into high-pressure liver tumors. Specifically, in uveal melanoma patients with liver metastases, when delivered via the PEDD™ method at a 2 or 4 mg dose, SD-101 in combination with nivolumab demonstrated decreases of circulating tumor DNA in the majority of patients, which has been associated with longer overall survival in this population. Emerging data, outlined in the Company’s investor presentation, also supports the hypothesis that SD-101 delivered via the PEDD method, can enable broad immune effects including depletion of liver myeloid derived suppressor cells (“MDSCs”). TriSalus expects data in connection with higher doses by Q2 2023, in addition to data from a separate cohort that combines SD-101 with the combination of nivolumab and ipilimumab.
As of
“The early findings from the Phase 1 PERIO™-01 and Phase 1b PERIO™-02 trials build on our previous findings and reinforce our confidence in the potential of SD-101 combined with TriSalus’ proprietary PEDD™ approach,” said
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.
As previously announced on
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
Changes and Additional Information in Connection with SEC Filing
The information in this communication has not been reviewed by the
Forward-Looking Statements
This communication contains certain “forward-looking statements” within the meaning of
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) risks 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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MTAC and TriSalus and their respective directors and executive officers, under
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
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.
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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
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FAQ
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