Our Therapeutic Pipeline

Our clinical research is focused on overcoming the challenges of targeting and treating solid tumors.

TriSalus’ focus is on improving the response rate in solid tumors through studying an innovative, therapeutic approach combining immunomodulation therapy with proprietary intravascular regional delivery with the goal to help overcome the substantial challenges associated with treating solid tumors.

The safety and efficacy of these products have not been established by health authorities. These products are investigational and have not been approved in the US or globally.

Pipeline

Uveal Melanoma Liver Metastases
IND-enabling
Phase 1
Phase 2
Phase 3
SD-101 + PEDDTM HAI + checkpoint inhibitors
 
IND-enabling
Phase 1
Phase 2
Phase 3
SD-101 + PEDDTM HAI + checkpoint inhibitors
Pancreatic Ductal Adenocarcinoma (PDAC)
IND-enabling
Phase 1
Phase 2
Phase 3

Locally advanced PDAC
PEDDTM PRVI + oxaliplatin chemotherapy

ENROLLING   LEARN MORE >

 
IND-enabling
Phase 1
Phase 2
Phase 3
Locally advanced PDAC
PEDDTM PRVI + oxaliplatin chemotherapy

ENROLLING  LEARN MORE >

IND-enabling
Phase 1
Phase 2
Phase 3
Locally advanced PDAC
SD-101 + PEDDTM PRVI + checkpoint inhibitor
 
IND-enabling
Phase 1
Phase 2
Phase 3
Locally advanced PDAC
SD-101 + PEDDTM PRVI + checkpoint inhibitor
IND-enabling
Phase 1
Phase 2
Phase 3
PDAC liver metastases
SD-101 + PEDDTM HAI + checkpoint inhibitor
 
IND-enabling
Phase 1
Phase 2
Phase 3
PDAC liver metastases
SD-101 + PEDDTM HAI + checkpoint inhibitor
Colorectal Cancer Liver Metastases
IND-enabling
Phase 1
Phase 2
Phase 3
Colorectal liver metastases
SD-101 + PEDDTM HAI + checkpoint inhibitor
 
IND-enabling
Phase 1
Phase 2
Phase 3
Colorectal liver metastases
SD-101 + PEDDTM HAI + checkpoint inhibitor

SD-101 Supporting Studies

Melanoma
IND-enabling
Phase 1
Phase 2
Phase 3

Unresectable stage IIIc/IV melanoma (naïve to anti-PD-1/PD-L1 Tx) SD101 + pembrolizumab

LEARN MORE >

 
IND-enabling
Phase 1
Phase 2
Phase 3
Unresectable stage IIIc/IV melanoma (naïve to anti-PD-1/PD-L1 Tx) SD101 + pembrolizumab

LEARN MORE >

IND-enabling
Phase 1
Phase 2
Phase 3

Unresectable stage IIIc/IV melanoma (resistant/refractory to anti-PD-1/PD-L1 Tx) SD101 + pembrolizumab

LEARN MORE >

 
IND-enabling
Phase 1
Phase 2
Phase 3
Unresectable stage IIIc/IV melanoma (resistant/refractory to anti-PD-1/PD-L1 Tx) SD101 + pembrolizumab

LEARN MORE >

Head & Neck Squamous Cell Carcinoma (HNSCC)
IND-enabling
Phase 1
Phase 2
Phase 3
Recurrent unresectable or metastatic (HNSCC) (treatment-naïve) SD-101 + pembrolizumab

LEARN MORE >

 
IND-enabling
Phase 1
Phase 2
Phase 3
Recurrent unresectable or metastatic (HNSCC) (treatment-naïve) SD-101 + pembrolizumab

LEARN MORE >

Lymphoma
IND-enabling
Phase 1
Phase 2
Phase 3

Untreated, low-grade B-cell lymphoma SD-101 + low dose radiation

RESULTS PUBLISHED IN CANCER DISCOVERY JOURNAL LEARN MORE >

 
IND-enabling
Phase 1
Phase 2
Phase 3
Untreated, low-grade B-cell lymphoma SD-101 + low dose radiation

RESULTS PUBLISHED IN CANCER DISCOVERY JOURNAL LEARN MORE >

Breast Cancer
IND-enabling
Phase 1
Phase 2
Phase 3
High risk stage II/III breast cancer SD-101 (pembrolizumab)
ONGOING
 
IND-enabling
Phase 1
Phase 2
Phase 3
High risk stage II/III breast cancer SD-101 (pembrolizumab)
ONGOING
PEDD™ – Pressure-Enabled Drug Delivery™
PRVI – Pancreatic Retrograde Venous Infusion
HAI – Hepatic Arterial Infusion
PDAC – Pancreatic Ductal Adenocarcinoma
TLR9 – Toll-Like Receptor 9
Uveal Melanoma Liver Metastases

Uveal melanoma is the most common primary intraocular malignancy in adults and is considered an ultra-rare cancer,1 with approximately 2,500 patients diagnosed annually in the US.2 In approximately 50 percent of patients, ocular melanoma will spread to distant parts of the body within 15 years after treatment of the primary tumor1,3 with the liver the first site of metastasis in up to 90% of patients.3

TriSalus’ Approach to Studying a Treatment for Uveal Melanoma Liver Metastases

TriSalus’ clinical program for treatment of uveal melanoma liver metastases will initially evaluate our investigational TLR9 agonist, SD-101, delivered deep into the vasculature of the solid tumors using our proprietary, FDA cleared drug delivery technology. TLR9 agonists such as SD-101 are not administered intravenously but by direct injection into the skin or tumors, making treatment of liver metastases very difficult.

Our approach to the study will deliver SD-101 directly into the artery supplying the liver, with the potential to distribute the drug into uveal melanoma liver metastases, irrespective of size, number, and location of tumors within this organ.

References:

  1. Carvajal, R.D., et al. Br J Opthalmol. 2017, Jan;101(1):38-44.
  2. Massomian, B., et al. J Curr Ophthalmol. 2018;30(2):102-109.
  3. Spagnolo, F., et al. Cancer Treatment Reviews. 2012;38(5):549–53.

Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC) and Liver Metastases

PDAC is the most common tumor arising in the pancreas, accounting for about 85-90% of cases.1 There are usually no symptoms in the disease’s early stages2 and by the time of diagnosis, pancreatic cancer has often grown beyond the limits of surgical therapy and/or to other parts of the body, including nearby lymph nodes, liver, peritoneal cavity, large intestine or lungs.3,4 Pancreatic adenocarcinoma typically has a very poor prognosis with a 5-year relative survival rate of 9% for all stages and 3% for advanced disease.5

TriSalus’ Dual Approach to Studying a Treatment for Locally Advanced PDAC and Liver Metastases

Studying Locally Advanced PDAC Treatment

Unlike the liver, the pancreas does not have a single artery feeding it, making regional intravascular delivery challenging.

TriSalus’ proprietary Pancreatic Retrograde Venous Infusion™ (PRVI™) technique using our PEDD™ with SmartValve™ technology to administer drug into the venous system allows the study for the delivery of investigational SD-101 directly into locally advanced tumors within the pancreas.

Studying PDAC Liver Metastases Treatment

TLR9 agonists such as SD-101 are not administered intravenously but by direct injection into the skin or tumors, making treatment of liver metastases very difficult.

Our approach will study the delivery of investigational agent, SD-101, directly into the artery supplying the liver with the goal to enable distribution of the drug into the PDAC liver metastases, irrespective of size, number, and location of tumors within this organ.

References:

  1. Kim, S.S., et al. CJ Belgian Soc of Rad. 2018;102(1):71,1-8.
  2. National Cancer Institute. “Pancreatic Cancer Treatment (PDQ®) Patient Version”. National Institutes of Health. 17 April 2014; Archived from the original on 5 July 2014. Updated: May 15, 2020.
  3. Ryan, D.P., et al. New England Journal of Medicine. 2014;371(11):1039–1049.
  4. Wolfgang C.L., et al. CA: A Cancer Journal for Clinicians. 2013;63(5):318–348.
  5. “Cancer Facts & Figures 2020” (PDF). American Cancer Society. 2020. Accessed from the original (PDF) on 04 August 2020.
  6. Ribas A., et al. Cancer Discov. 2018;8(10):1250-1257
  7. Katz, S.C., et al. HITM-SURE: Phase Ib CAR-T hepatic artery infusion trial for stage IV adenocarcinoma using Pressure-Enabled Drug Delivery technology. Society of Immunotherapy for Cancer (SITC). 2018; Washington, D.C.

Colorectal Cancer Liver Metastases

Colorectal cancer (CRC) is the fourth most common major cancer in the United States, as approximately 1 in 25 people will be diagnosed with CRC during their lifetime.1,2  Overall, five-year survival rates have increased over time, largely due to increased screening procedures. Despite this, in 20% of cases, CRC has already metastasized at the time of diagnosis3 and represents a serious and life-threatening disease with a poor prognosis. Overall, nearly 70% of CRC metastases occur in the liver3 with the median survival for patients of about 9 months.3  

TriSalus’ Approach to Studying CRC Liver Metastases

TLR9 agonists such as SD-101 are not administered intravenously but by direct injection into the skin or tumors, making treatment of liver metastases very difficult.

Our approach will study the delivery of investigational agent, SD-101 directly into the artery supplying the liver, the goal is to enable distribution of the drug into the CRC liver metastases, irrespective of size, number, and location of tumors within this organ.

References:

  1. National Cancer Institute Surveillance, Epidemiology, and End Results Program, “Cancer Stat Facts: Cancer of Any Site”. 2017. Accessed August 2020.
  2. American Cancer Society, “Colorectal Cancer Facts and Figures 2020-2022”. 2020. Accessed August 2020.
  3. Riihimaki, M., et al. Sci. Rep. 2016;6, 29765.