Monday September 28, 2020 0 comments
DENVER and CHICAGO -- TriSalus Life Sciences (TriSalus), an emerging immune-oncology company committed to transforming outcomes for patients with solid tumors, announced its therapeutic clinical development strategy following the successful acquisition of SD-101, an investigational IND-ready immunotherapy, from Dynavax Technologies on Aug. 3, 2020.
SD-101 is an investigational toll-like receptor 9 (TLR9) agonist that has been tested in Phase 2 clinical trials for advanced cutaneous melanoma and head and neck cancer, evaluating efficacy, safety, and the ability to increase responsiveness to checkpoint inhibitors in PD-L1 negative tumors.
By combining SD-101 with TriSalus’ proprietary FDA cleared, drug delivery technologies, TriSalus will deliver the agent into the local vasculature of solid tumors.
The company said it intends to begin evaluating SD-101 in patients with uveal melanoma liver metastases followed by testing in patients with pancreatic ductal adenocarcinoma and colorectal cancer liver metastases.
In addition, a separate program for locally advanced pancreatic ductal adenocarcinoma is in progress.
“Our strategy is to develop a portfolio of immuno-oncology therapeutics and innovative infusion technologies to solve the two key reasons for poor outcomes in pancreatic and liver solid tumors ─ immunosuppression and low therapeutic index,” said Mats Wahlstrom, TriSalus Life Sciences chair.
“The recent acquisition of SD-101 is a strong start to our therapeutics portfolio strategy. We plan to deploy multiple approaches with SD-101 by testing it clinically in a range of liver and pancreatic cancers for which few options currently exist.”
“SD-101 represents an important component of the clinical program, studying the safety and effectiveness on activation of the immune system to help attack solid tumors,” said Mary Szela, TriSalus CEO and president.
“Building on the acquisition of our first therapeutic candidate, we will seek other immuno-oncology products which could benefit from being delivered directly into the disease site through acquisitions, licenses, and partnerships.”
“As an investigational TLR9 agonist, SD-101 has shown promising immunostimulatory capabilities that promote anti-tumor activity in Phase 1b/2 clinical studies,” said Steven Katz, chief medical advisor of TriSalus and chair of its Scientific Advisory Board.
“By using Pressure-Enabled Drug DeliveryTM, (PEDDTM), for intravascular, regional, rather than systemic delivery, our intent is to increase SD-101’s therapeutic index.
“Our clinical development program will initially evaluate SD-101 delivered with PEDD for treatment of uveal melanoma liver metastases. Concurrently, we will develop three additional programs assessing a combination of SD-101 and other immuno-oncology agents delivered with PEDD.”
“Based on the biology of uveal melanoma and the clinical results in cutaneous melanoma, delivery of TLR9 agonists into the liver has been quite challenging,” said Richard Carvajal, director of Experimental Therapeutics and the Melanoma Service at Columbia University Medical Center.
“I am excited about studying the combination of TriSalus’ delivery technology with SD-101 in uveal melanoma liver metastases.”
The company said it will seek a meeting with the FDA to share study designs and clinical plans for the initiation of human clinical studies in uveal melanoma liver metastases, the most common primary intraocular malignancy in adults, representing approximately 85% of all ocular melanomas.
TriSalus was formed to investigate treatments to help stimulate the immune system to overcome immunosuppression by delivering a combination of immuno-oncology therapies directly to the site of disease.
TriSalus is researching this multi-pronged approach to reprogram the immunosuppressive tumor microenvironment, harness the power of tumor killing agents, and deliver these therapies directly to the tumor through its Pressure-Enabled Drug Delivery (PEDD) approach.
The company has identified validated, IND-ready targets to acquire through license agreements, collaborations, or joint ventures. TriSalus said it is initially focused on the goal of successfully treating intractable solid tumors including uveal melanoma liver metastases and pancreatic cancer.