Nelitolimod sodium is under clinical development by TriSalus Life Sciences and currently in Phase II for Bile Duct Cancer (Cholangiocarcinoma). According to GlobalData, Phase II drugs for Bile Duct Cancer (Cholangiocarcinoma) have a 30% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Nelitolimod sodium’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Nelitolimod sodium overview

Nelitolimod is under development for the treatment of HER2-negative breast cancer, pancreatic ductal adenocarcinoma, metastatic uveal melanoma, hepatocellular carcinoma (HCC), Intrahepatic cholangiocarcinoma (ICC) and metastatic colorectal cancer. The drug candidate is administered by intratumoral, intralesional, intrahepatic, intramuscular, and subcutaneous routes. SD-101 is a toll-like receptor 9 (TLR9) agonist. It is based on immunostimulatory sequences (ISS) technology. The drug candidate is delivered via intrahepatic route by the TriNav Infusion System (TriNav) using the Pressure-Enabled Drug Delivery (PEDD) method of administration.

It was under development for the treatment of solid tumor, high grade lymphoma, low-grade B-cell lymphoma, mantle cell lymphoma, follicular lymphoma, small lymphocytic lymphoma, lymphoplasmacytic lymphoma, B-Cell chronic lymphocytic leukemia, lung cancer, liver cancer, metastatic melanoma, metastatic pancreatic adenocarcinoma and head and neck cancer squamous cell carcinoma, B-cell non-Hodgkin lymphoma, advanced or multiple malignancies. It was also under development for the treatment of non-Hodgkin lymphoma (NHL) or Hodgkin lymphoma (HL), and hepatitis C.

TriSalus Life Sciences overview

TriSalus Life Sciences (TriSalus) is a medical technology company primarily focused on oncology. The company’s main activities involve the development and commercialization of an innovative approach for the treatment of liver and pancreatic tumors. TriSalus’ major products include its Pressure-Enabled Drug Delivery (PEDD) method and its investigational immunotherapeutic, nelitolimod. The company’also offers TriNav and pancreatic retrograde venous infusion system. It is investigating drugs against uveal melanoma liver metastases, pancreatic ductal adenocarcinoma (PDAC), melanoma, head and neck squamous cell carcinoma (HNSCC), lymphoma and breast cancer. The company’s products are designed to address immune dysfunction in liver and pancreatic tumors by combining immunotherapy drugs with highly effective drug delivery technology. TriSalus is headquartered in Westminster, Colorado, the US.

For a complete picture of Nelitolimod sodium’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 12 April 2024

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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.