TriSalus Life Sciences Presents Data for SD-101 Delivered by TriSalus Infusion System for Pancreatic Adenocarcinoma at the Society for Immunotherapy of Cancer (SITC) Annual Meeting
November 03 2023 - 11:00AM
Business Wire
– New data from PERIO-03 clinical trial indicates PEDD™ method
resulted in modulation of the tumor microenvironment by enabling
performance of a TLR9 agonist in pancreatic tumors –
TriSalus Life Sciences® Inc., (Nasdaq: TLSI), an oncology
company integrating its novel delivery technology with
immunotherapy to transform treatment for patients with liver and
pancreatic tumors, today announced initial positive safety and
feasibility data from a Phase 1 trial at the Society of
Immunotherapy for Cancer (SITC) 2023 Annual Meeting.
TriSalus is studying an investigational class C toll-like
receptor-9 (TLR9) agonist, SD-101, delivered intravascularly using
the Company’s proprietary Pressure-Enabled Drug Delivery™ (PEDD™)
method of administration in three Phase 1 trials (periotrial.com).
In PERIO-03, SD-101 is delivered via PEDD with the TriSalus
Infusion System® using a retrograde venous approach, leveraging
established interventional radiology access techniques.
The TriSalus Infusion System has an expandable SmartValve® and
can interface with standard invasive blood pressure transducers for
continuous pressure monitoring during infusion of a therapeutic.
During infusion, the device blocks retrograde flow and modulates
pressure in the vessel, resulting in the perfusion of the venous
and capillary network isolated by the device.
Early safety and feasibility data from the PERIO-03 locally
advanced pancreatic adenocarcinoma trial revealed that in three
patients who received SD-101 via retrograde venous infusion PEDD at
the lowest dose level (0.5 mg), there were no serious grade 3/4
adverse events related to treatment. This is a first-in-human
experience for use of PEDD and retrograde venous infusion for
delivery of an immunologic agent into pancreatic tumors. Immune
signals pointed to a decrease in myeloid derived suppressor cells
(MDSC) activity in the treated pancreatic tumors, with declines in
MDSC associated genes, including arginase-1, nitric oxide
synthetase-2, and S100A9 (n=3). Signals associated with T cell
activation were also noted in pancreatic tumor biopsy
specimens.
“There is a critical need for novel treatments and approaches in
locally advanced pancreatic cancer. The PERIO-03 trial is a highly
innovative and multidisciplinary approach of delivery of a novel
immunotherapy into the pancreas through pancreatic retrograde
venous infusion,” stated Michael S. Lee, M.D., associate professor
of Gastrointestinal (GI) Medical Oncology at The University of
Texas MD Anderson Cancer Center. “The treatments have been well
tolerated and the translational studies show intriguing changes in
immune markers. We are excited to continue enrolling patients in
this study.”
“These data offer additional validation of our innovative
immunotherapy approach for pancreatic tumors. SD-101 was selected
based on its mechanism of action, which has the potential to
reverse immunosuppression in the pancreas through depletion of MDSC
in concert with broad stimulation of immune cells in the tumor
microenvironment,” said Steven C. Katz, M.D., FACS, Chief Medical
Officer at TriSalus. “TriSalus delivery systems, which use the PEDD
method, are designed to overcome mechanical barriers to
immunotherapy success, which may be underappreciated factors in
limiting performance of TLR agonists in liver and pancreas tumors.
Pancreatic tumors in particular contain very dense stromal tissue,
which may accentuate the mechanical barriers to effective drug
delivery in these patients.”
Overall, the data emerging from PERIO-03 trials indicate
immunologic changes are occurring within the pancreas, with a
favorable safety profile. Additionally, pre-clinical data presented
by TriSalus at SITC indicates that SD-101 administered via PEDD can
enable both intravenously and subcutaneously administered
checkpoint inhibitors.
TriSalus will also present data from its PERIO-01 trial for
uveal melanoma liver metastases at a SITC late breaker session on
Saturday, November 4 at 11:25 am PT. All TriSalus presentations
from SITC are available here following their respective
sessions.
About Pressure-Enabled Regional Immuno-Oncology (PERIO)
clinical trials
The Pressure-Enabled Regional Immuno-Oncology (PERIO) clinical
trials are 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 in
three Phase 1 trials.
The PERIO-01 Phase 1 clinical study for uveal melanoma with
liver metastases (UMLM), is studying SD-101 delivered via PEDD with
TriNav in combination with intravenous checkpoint inhibitors.
The PERIO-02 Phase 1b clinical study for hepatocellular
carcinoma and intrahepatic cholangiocarcinoma, is studying SD-101
delivered via PEDD with TriNav in combination with intravenous
checkpoint inhibitors.
The PERIO-03 Phase 1 clinical study for locally advanced
pancreatic adenocarcinoma, is studying SD-101 delivered via PEDD
with TriNav in combination with intravenous checkpoint
inhibitors.
About TriSalus Life Sciences
TriSalus Life Sciences® is an oncology company integrating novel
delivery technology with immunotherapy to transform treatment for
patients with liver and pancreatic tumors.
The Company’s platform includes devices that utilize a
proprietary drug delivery technology and a clinical stage
investigational immunotherapy. The Company’s two FDA-cleared
devices use its proprietary Pressure-Enabled Drug Delivery™ (PEDD™)
approach to deliver a range of therapeutics: the TriNav® Infusion
System for hepatic arterial infusion of liver tumors and the
Pancreatic Retrograde Venous Infusion System for pancreatic tumors.
PEDD is a novel delivery approach designed to address the anatomic
limitations of arterial infusion for the pancreas. The PEDD
approach modulates pressure and flow in a manner that delivers more
therapeutic to the tumor and is designed to reduce undesired
delivery to normal tissue, bringing the potential to improve
patient outcomes. SD-101, the Company’s investigational
immunotherapeutic candidate, is designed to improve patient
outcomes by treating the immunosuppressive environment created by
many tumors and that can make current immunotherapies ineffective
in the liver and pancreas. Patient data generated during
Pressure-Enabled Regional Immuno-Oncology™ (PERIO) clinical trials
support the hypothesis that SD-101 delivered via PEDD may have
favorable immune effects within the liver and systemically. The
target for SD-101, TLR9, is expressed across cancer types and the
mechanical barriers addressed by PEDD are commonly present as well.
SD-101 delivered by PEDD will be studied across several indications
to address immune dysfunction and overcome drug delivery barriers
in the liver and pancreas.
In partnership with leading cancer centers across the country –
and by leveraging deep immuno-oncology expertise and inventive
technology development – TriSalus is committed to advancing
innovation that improves outcomes for patients. Learn more at
trisaluslifesci.com and follow us on Twitter and LinkedIn.
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.
Forward Looking Statements
Statements made in this press release regarding matters that are
not historical facts are “forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995.
Because such statements are subject to risks and uncertainties,
actual results may differ materially from those expressed or
implied by such forward‐looking statements. Such statements
include, but are not limited to, statements regarding the benefits
and potential benefits of the Company’s PEDD drug delivery
technology and SD-101 investigational immunotherapy. Risks that
could cause actual results to differ from those expressed in these
forward‐looking statements include risks associated with clinical
development and regulatory approval of drug delivery and
pharmaceutical product candidates, including that future clinical
results may not be consistent with patient data generated during
the Company’s PERIO clinical trials, and other risks described in
the Company’s filings with the Securities and Exchange Commission
under the heading “Risk Factors.” All forward‐looking statements
contained in this press release speak only as of the date on which
they were made and are based on management’s assumptions and
estimates as of such date. The Company undertakes no obligation to
update such statements to reflect events that occur or
circumstances that exist after the date on which they were made
except as required by law.
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For Media and Investor Inquiries: Argot Partners
212.600.1902 TriSalus@argotpartners.com
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