TriSalus Life Sciences Receives Approval from the World Health Organization and the American Medical Association’s Adopted Name Council for “Nelitolimod” as the Nonproprietary Drug Name for SD-101
07 Marzo 2024 - 1:00PM
Business Wire
– Nelitolimod, a class C TLR-9 agonist formerly
called SD-101, is the Company’s therapeutic candidate designed to
overcome biologic barriers in liver and pancreatic tumors
– Nelitolimod is currently being evaluated in
three Phase 1/1b studies in adults with liver and pancreatic
cancers in combination with TriSalus’ proprietary Pressure Enabled
Drug Delivery™ technology
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 that the International Nonproprietary Names (INN)
Expert Committee of the World Health Organization (WHO) and the
United States Adopted Names (USAN) Council have approved the use of
the nonproprietary name of "nelitolimod" for SD-101, a class C
TLR-9 agonist. Nelitolimod is the Company’s novel lead drug
candidate that is currently being studied in three Phase 1/1b
trials for the treatment of uveal melanoma with liver metastases,
hepatocellular carcinoma, intrahepatic cholangiocarcinoma, and
locally advanced pancreatic ductal adenocarcinoma.
“The WHO INN and USAN approval of nelitolimod is an important
milestone in the continued progress we are making with our
nelitolimod program,” said Mary Szela, Chief Executive Officer and
President of TriSalus. “This accomplishment, along with the recent
assignment of a new technology HCPCS Code for our TriNav® Infusion
System, further positions TriSalus to deliver on our mission to
overcome key treatment barriers in liver and pancreatic tumors and
make a meaningful difference in the lives of patients suffering
from cancer.”
TriSalus’ unique approach leverages its innovative delivery
device together with its immunotherapeutic drug to overcome the
mechanical and biologic barriers present in the tumor
microenvironment. This approach has the potential to enable more
durable responses by patients to other immunotherapeutics, thereby
facilitating better patient outcomes. Data from TriSalus’ Phase
1/1b trials indicates that the Company’s approach in liver and
pancreatic tumors is well tolerated with encouraging efficacy and
immune signals, with evidence of nelitolimod being delivered by the
TriNav system into difficult to reach tumors, potentially
overcoming limitations posed by intravenous or direct needle
injection approaches.
Information on nelitolimod will be posted on the USAN website
(www.ama-assn.org/go/usan) and will be published in the Chemical
Abstracts Service and in the U.S. Pharmacopeia. The WHO provides
the INN to the Organization's Member States (at present 191), to
national pharmacopoeia commissions, and to other bodies designated
by WHO’s Member States.
The name, nelitolimod, is ready for use in labelling and
publications. It will serve to identify SD-101 during its lifetime
worldwide. Going forward, TriSalus will use the name in
publications and public statements, at conferences and other
forums, and in corporate-related materials.
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 to 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, which 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
in an effort 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 X (formerly Twitter) and
LinkedIn.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240307072002/en/
For Investor Inquiries: James Young Senior Vice
President, Investor Relations/Treasurer 847.337.0655
james.young@trisaluslifesci.com
For Media Inquiries: Stephanie Jacobson Argot Partners
610.420.3049 TriSalus@argotpartners.com
Grafico Azioni TriSalus Life Sciences (NASDAQ:TLSI)
Storico
Da Gen 2025 a Feb 2025
Grafico Azioni TriSalus Life Sciences (NASDAQ:TLSI)
Storico
Da Feb 2024 a Feb 2025