PIPELINE

Candidate SD-101

TriSalus is investigating SD-101 as a therapeutic candidate to re-activate the immune system within the liver and pancreas and to enable deeper and more durable responses to other immunotherapeutics (e.g., checkpoint inhibitors) resulting in better patient outcomes.

SD-101 is in clinical development and has not been approved in the US or globally.

Left: Scientific illustration of TriSalus’ investigational candidate SD-101, a single stranded oligonucleotide-based therapy Right: Scientific illustration of SD-101 Mechanism: SD-101 binds to a plasma membrane and is endocytosed. In a late endosome, SD-101 binds to and activates TLR9 which initiates a cascade of events through NF-κB phosphorylation. Gene expression changes reprogram MDSCs to produce and release cytokines.
Top: Scientific illustration of TriSalus’ investigational candidate SD-10, a single stranded oligonucleotide-based therapy Scientific illustration of SD-101 Method Of Action: SD-101 binds to a plasma membrane and is endocytosed. In a late endosome, SD-101 binds to and activates TLR9 which initiates a cascade of events through NF-κB phosphorylation. Gene expression changes reprogram MDSCs to produce and release cytokines. Bottom: Scientific illustration of SD-101 Method Of Action: SD-101 binds to a plasma membrane and is endocytosed. In a late endosome, SD-101 binds to and activates TLR9 which initiates a cascade of events through NF-κB phosphorylation. Gene expression changes reprogram MDSCs to produce and release cytokines.

SD-101 Mechanism of Action to Enable Immunotherapy

SD-101, an investigational agent in development, is a toll-like receptor 9 (TLR9) agonist which is believed to bind to the TLR9 receptors found on suppressive immune cells including myeloid-derived suppressor cells (MDSCs), antigen-presenting immune cells and other immune cells. Toll-like receptors play a key role in the innate immune system and create a bridge to adaptive immunity.1 It is believed that activating TLR9 primes immune cells to promote anti-tumor T-cell function.1,2

Overcoming Immunosuppression
TLR9 agonists have the potential to reprogram and eliminate MDSCs.

Prior Clinical Trials with SD-101

SD-101 has been studied in combination with pembrolizumab (Keytruda®) and other agents in over 300 patients enrolled in various Phase 1 and Phase 2 studies of melanoma, lymphoma, and head and neck squamous cell carcinoma.3,4 It was also studied in the I-SPY2 Trial for patients with high-risk, Stage II/III breast cancer.

Publications & Presentations

Prior clinical trials show immunomodulatory properties of SD-101.

Locally Targeted Delivery 0f SD-101

Traditionally, TLR9 agonists like SD-101 have not been administered intravenously but by direct injection into superficial tumors, making treatment of tumors in deep locations, like the liver and pancreas, difficult. TriSalus will utilize its proprietary Pressure-Enabled Drug Delivery™ (PEDD™) method for intravascular regional delivery of SD-101 to reach these locations.

By infusing SD-101 via our technology, we can administer it to visceral organs and directly to the site of disease. The goal of this approach is to enhance SD-101’s therapeutic index, increase anti-tumor immune activity intended to slow tumor progression and restore, enable or improve responses to immunotherapies for treatment of liver metastases and pancreatic cancer.

Overcoming Intratumoral Pressure

Our intravascular regional delivery technology overcomes physical barriers to delivery.

Ongoing Clinical Trials with SD-101

TriSalus will initially evaluate SD-101 for the treatment of uveal melanoma with liver metastases, hepatocellular carcinoma and intrahepatic cholangiocarcinoma. We intend to develop additional programs looking at a combination of SD-101 and other immuno-oncology agents delivered with Pressure-Enabled Drug Delivery™ (PEDD™) in a range of liver and pancreatic cancers for which limited therapeutic options exist.

Clinical Trials

We are committed to developing treatments to improve outcomes for patients with liver and pancreatic tumors.

CITATIONS

  1. Melisi D, et al. Biomedicines. 2014;2(3):211-228.
  2. Humbert M, et al. Cancer Res. 2018 Jun 15;78(12):3280-3292.3.
  3. Ribas A, et al. Cancer Discov. 2018;8(10):1250-1257.
  4. Frank MJ, et al. Cancer Discov. 2018;8(10):1258-1269.

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