- Studies to evaluate liver and pancreatic cancers with SD-101, an investigational TLR9 agonist, in combination with checkpoint inhibition immunotherapy
- Studies to deliver investigational SD-101 directly to the site of the disease employing novel Pressure-Enabled Drug Delivery™ (PEDD™)
HOUSTON, DENVER, and CHICAGO, APRIL 8, 2021 – The University of Texas MD Anderson Cancer Center and TriSalus Life Sciences®, an emerging immuno-oncology company committed to transforming outcomes for patients with liver and pancreatic tumors, today announced a strategic research collaboration to evaluate the treatment of tumors of the pancreas and liver by integrating interventional delivery of SD-101, an investigational toll-like receptor 9 (TLR9) agonist, in combination with checkpoint inhibition immunotherapy.
Under the agreement, MD Anderson and TriSalus will collaborate on studies evaluating the administration of investigational SD-101 intravascularly via TriSalus’ Food and Drug Administration (FDA) cleared, proprietary Pressure-Enabled Drug Delivery™ (PEDD™) technology across a range of liver and pancreatic solid tumors. The initial study will focus on liver metastases from uveal melanoma, followed by studies focused on metastatic disease from pancreatic ductal adenocarcinoma and colorectal cancer. Programs for hepatocellular carcinoma and locally advanced pancreatic ductal adenocarcinoma also are under development. TriSalus will provide funding and technology for the studies.
“We’re pleased to collaborate with MD Anderson in pursuit of our collective goal to improve outcomes for patients with tumors of the liver and pancreas. The goal of these studies is to augment the potential of existing therapies through novel drug delivery technology and to investigate the strategic modulation of immune microenvironments with investigational candidate SD-101,” said Steven Katz, M.D., Chief Medical Officer, TriSalus Life Sciences. “Collaborations such as this are an integral part of our development strategy to evaluate treatments to help overcome the challenges inherent to solid tumors and enable a broader population of cancer patients to benefit from immunotherapy.”
SD-101 has been evaluated in phase 2 studies in advanced cutaneous melanoma and head and neck cancer.1,2 Early data suggests SD-101 augmented responsiveness to checkpoint inhibitors through stimulation of innate immune cells, along with favorable programming of the T cell population.3 The planned studies under the research collaboration are intended to deliver SD-101 deep into the vasculature of solid tumors using PEDD™, a technique not previously possible using standard delivery approaches.4
Solid tumors continue to represent one of the single biggest hurdles to successful cancer treatment.5 High levels of pressure inside solid tumors prevent the delivery of oncology therapeutics, with less than 1% of therapy penetrating solid tumors in some circumstances.6,7 TriSalus developed PEDD to deliver immuno-oncology therapeutics directly into the vasculature of solid tumors.
“Tumors in the pancreas and liver are notoriously difficult to treat effectively, and these patients need new therapeutic options. Our collaboration with TriSalus provides a unique opportunity to evaluate immunotherapy in combination with a novel delivery approach,” said Sapna Patel, M.D., associate professor of Melanoma Medical Oncology at MD Anderson. “We look forward to our work together to advance new treatments aimed at improving clinical outcomes and the lives of our patients.”
TriSalus Life Sciences is a revenue generating, emerging immuno-oncology company dedicated to developing immunotherapy treatments for liver and pancreatic tumors using novel delivery technologies to improve patient outcomes. TriSalus intends to pursue multiple solid tumor indications with investigational SD-101 and acquire other immuno-oncology agents to combine with its proprietary Pressure-Enabled Drug Delivery technology for the administration of therapeutics intravascularly into visceral organ solid tumors. In combination with checkpoint inhibitors, TriSalus’ focus is to reprogram the dominant immunosuppressive cell population in liver and pancreatic tumors. This innovative approach in development has the potential to leverage multiple mechanisms that can work together with the goal to overcome inherent immune suppression within the solid tumor microenvironment.
For more information, please visit www.trisaluslifesci.com.
About MD Anderson
The University of Texas MD Anderson Cancer Center in Houston ranks as one of the world’s most respected centers focused on cancer patient care, research, education and prevention. The institution’s sole mission is to end cancer for patients and their families around the world. MD Anderson is one of only 51 comprehensive cancer centers designated by the National Cancer Institute (NCI). MD Anderson is ranked No.1 for cancer care in U.S. News & World Report’s “Best Hospitals” survey. It has ranked as one of the nation’s top two hospitals for cancer care since the survey began in 1990 and has ranked first 16 times in the last 19 years. MD Anderson receives a cancer center support grant from the NCI of the National Institutes of Health (P30 CA016672).
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1.Amin, A. et al. Phase 1b/2, open label, multicenter, study of the combination of SD-101 and pembrolizumab in patients with advanced/metastatic melanoma resistant to anti-PD-1/PD-L1 therapy. J. Clin. Oncol. 37, 9555–9555 (2019).
2.Cohen, E. E. W. et al. Phase 1b/2, open label, multicenter study of intratumoral SD-101 in combination with pembrolizumab in anti-PD-1 treatment naïve patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). J. Clin. Oncol. 37, 6039–6039 (2019).
3.Ribas, A. et al. SD-101 in Combination with Pembrolizumab in Advanced Melanoma: Results of a Phase Ib, Multicenter Study. Cancer Discov. 8, 1250–1257 (2018).
4.Sheth, R. A., Hesketh, R., Kong, D. S., Wicky, S. & Oklu, R. Barriers to Drug Delivery in Interventional Oncology. J. Vasc. Interv. Radiol. 24, 1201–1207 (2013).
5.Jain, R. K. Barriers to Drug Delivery in Solid Tumors. Sci. Am. 8 (1994).
6.Wilhelm, S. et al. Analysis of nanoparticle delivery to tumours. Nat. Rev. Mater. 1, 16014 (2016).
7.Stylianopoulos, T. et al. Coevolution of Solid Stress and Interstitial Fluid Pressure in Tumors During Progression: Implications for Vascular Collapse. Cancer Res. 73, 3833–3841 (2013).
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