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.
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.
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Media Contact: press@trisaluslifesci.com Investor Contact: Aaron
Palash / Allison Sobel Joele Frank, Wilkinson Brimmer Katcher +1
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