DENVER - TriSalus Life Sciences Inc. (Nasdaq: TLSI), an oncology-focused company, announced that its lead drug candidate, nelitolimod, has been granted nonproprietary name approval by both the World Health Organization (WHO) and the United States Adopted Names (USAN) Council. Nelitolimod, previously known as SD-101, is a class C TLR-9 agonist currently under investigation in three Phase 1/1b clinical trials for treating various liver and pancreatic cancers.
According to TriSalus, the WHO and USAN approval marks a significant milestone for the company's nelitolimod program. This advancement is coupled with the recent assignment of a new technology HCPCS Code for the TriNav Infusion System, which is part of TriSalus's integrated approach to deliver immunotherapy effectively.
TriSalus's CEO and President, Mary Szela, expressed that these developments further position the company to fulfill its mission to address treatment barriers in liver and pancreatic tumors, ultimately aiming to enhance patient outcomes. The company's approach combines its proprietary Pressure Enabled Drug Delivery technology with immunotherapy to potentially deliver more durable responses and better outcomes in patients.
The clinical trials have so far indicated that the combination of nelitolimod with the TriNav system is well tolerated and shows promising efficacy and immune response signals. The technology is designed to deliver nelitolimod directly to hard-to-reach tumors, potentially improving upon limitations associated with traditional intravenous or direct needle injection methods.
Nelitolimod's information will be available on the USAN website and will be published in the Chemical Abstracts Service and U.S. Pharmacopeia. The name will be used globally in labeling, publications, and corporate materials moving forward.
TriSalus Life Sciences is dedicated to transforming treatment for patients with liver and pancreatic tumors through its novel delivery technology and clinical-stage investigational immunotherapy. The company's platform includes FDA-cleared devices that use the proprietary Pressure-Enabled Drug Delivery approach, aiming to improve the delivery of therapeutics to tumors while minimizing exposure to normal tissues.
The information in this article is based on a press release statement from TriSalus Life Sciences.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.