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
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The approval of the nonproprietary name 'nelitolimod' for SD-101 by the WHO INN and USAN Council is a significant step in the clinical development process of an oncology therapeutic. It denotes a level of maturation of the drug as it moves closer to potential commercialization. Nelitolimod, a class C TLR-9 agonist, is designed to target the tumor microenvironment, which is known to be a challenging barrier in the effective treatment of liver and pancreatic cancers.
From a clinical perspective, the combination of nelitolimod with TriSalus’ Pressure Enabled Drug Delivery™ technology, known as the TriNav® Infusion System, aims to enhance drug delivery to tumors that are traditionally resistant to treatment. The preliminary data suggesting tolerability and encouraging efficacy is noteworthy, as it indicates potential in improving the therapeutic landscape for patients with these types of cancer. The designation of a nonproprietary name also facilitates clearer communication within the medical community and may enhance the visibility of the drug in the professional sphere.
As a Medical Research Analyst, the progression of nelitolimod through clinical trials is of particular interest. The Phase 1/1b studies are critical for understanding the safety profile and initial efficacy of the drug in humans. The fact that nelitolimod is being evaluated for multiple types of cancer, including uveal melanoma with liver metastases, hepatocellular carcinoma, intrahepatic cholangiocarcinoma and locally advanced pancreatic ductal adenocarcinoma, suggests a broad potential impact on the oncology market if successful.
The adoption of a nonproprietary name is a procedural milestone that can impact the perception of the drug's readiness for wider clinical use. It is also indicative of the company's commitment to advancing the drug's development. Furthermore, the assignment of a new technology HCPCS Code for the TriNav® Infusion System signifies recognition of the technology's potential utility and may influence reimbursement scenarios in the future, which is a crucial factor for market adoption.
The oncology market is highly competitive, with significant rewards for companies that successfully bring new treatments to market, especially for cancers with high unmet medical needs such as liver and pancreatic cancers. The announcement regarding nelitolimod's nonproprietary name can have positive implications for TriSalus Life Sciences® from a market perspective. It could potentially enhance investor confidence and interest in the company, as it reflects progress in the drug's development pathway.
From an investment standpoint, these developments may be seen as indicators of the company's potential for future growth, especially if further clinical data continue to support nelitolimod's efficacy and safety. However, it is important to note that the drug is still in early-stage clinical trials and there is a long pathway ahead before potential FDA approval and market entry. Investors should consider both the promise of the technology and the inherent risks associated with the clinical development of new therapeutics.
– 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
“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
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.
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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
Source: TriSalus Life Sciences
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