PIPELINE

Colorectal Cancer with Liver Metastases

Scientific illustration of colorectal cancer liver metastases. Colorectal cancer originates in the lower intestines but may spread to the liver.

What is Colorectal Cancer?

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 

Overall, 5-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 diagnosis2 which represents a serious and life-threatening disease with a poor prognosis. Nearly 70% of CRC metastases occur in the liver with the median survival for patients of about 9 months.2 

The TriSalus™ Approach to Studying a Treatment for Colorectal Cancer with Liver Metastases

TriSalus’ CRC with liver metastases clinical program will initially evaluate our investigational TLR9 agonist, nelitolimod (also known as SD-101), delivered deep into the vasculature of the liver tumors using our proprietary, FDA cleared device. Traditionally, TLR9 agonists like nelitolimod are not administered intravenously but by direct injection into superficial tumors, making treatment of liver metastases very difficult.

TriSalus is studying the delivery of nelitolimod directly into the arteries supplying the liver in order to distribute the drug to CRC liver metastases within the organ, irrespective of size, number and location of tumors.  Infusion by the TriSalus device for the Pressure-Enabled Drug Delivery™(PEDD™) method improves targeted delivery of therapy into high-pressure tumors using a standard intraarterial procedure. 

Because immune cells are suppressed throughout the liver and micro-metastases or undetectable additional tumors may be present, tissue that appears normal is also treated with nelitolimod. Importantly, the nelitolimod treatment is being given in combination with a systemic (or intravenous) immunotherapy to enable treatment of tumors within the liver as well as tumors that may be present in other parts of the body.

Nelitolimod is in clinical development and has not been approved in the US or globally.

Platform

Immunomodulatory drugs have the potential to reactivate the immune system.

TriSalus' Pipeline

We are studying the combination of nelitolimod with PEDD to enable immunotherapies in the liver and pancreas. Our clinical research is focused on bringing this potentially transformative treatment platform to patients.

PIPELINE

CITATIONS

  1. American Cancer Society 2020. Published online.
  2. Riihimäki M,et al. Sci Rep. 2016;6:29765. doi:10.1038/srep29765

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