SD-101 is under clinical development by TriSalus Life Sciences and currently in the Phase I and Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect SD-101’s likelihood of approval (LoA) and phase transition for Metastatic Uveal Melanoma took place on 28 Jan 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their SD-101 Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

SD-101 overview

SD-101 is under development for the treatment of breast cancer, pancreatic ductal adenocarcinoma, metastatic uveal melanomat, hepatocellular Ccarcinoma (HCC) and Intrahepatic cholangiocarcinoma (ICC), liver and pancreatic tumor and metastatic colorectal cancer. The drug candidate is administered by intratumoral, intralesional, intramuscular and subcutaneous routes. SD-101 is toll-like receptor 9 (TLR9) agonist. It is an immunostimulatory CpG. The drug candidate is based on immunostimulatory sequences (ISS) technology. 

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, formerly Surefire Medical, is an immune-oncology company which is engaged in developing and commercializing drug delivery infusion systems and medicines to treat solid tumors. The company’s product range includes TriNav, pancreatic and SIS (saline infusion sonohysterography) infusion systems. 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 utilizes its proprietary SmartValve technology which is based on pressure-enabled drug delivery (PEDD) approach to deliver therapeutics. TriSalus Life Sciences is headquartered in Westminster, Colorado, the US.

Quick View SD-101 LOA Data

Report Segments
  • Innovator
Drug Name
  • SD-101
Administration Pathway
  • Intralesional
  • Intramuscular
  • Intratumor
  • Subcutaneous
Therapeutic Areas
  • Infectious Disease
  • Oncology
Key Developers
  • Sponsor Company: TriSalus Life Sciences
  • Originator: Dynavax Technologies
Highest Development Stage
  • Phase II


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 its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.