TriSalus Life Sciences today announced positive clinical results for its Pressure-Enabled Regional Immuno-Oncology technology.
The company, currently in the process of going public through a SPAC merger, filed a presentation for investors. It features information regarding its ongoing PERIO 01 and PERIO 02 clinical studies. The studies evaluate the TriNav pressure-enabled drug delivery technology for primary and metastatic liver tumors. It delivers SD-101, a class C toll-like receptor 9 (TLR9) agonist.
Last week, TriSalus announced plans to go public through a merger with MedTech Acquisition Corp., a special purpose acquisition company (SPAC).
“We are commercializing our TriNav infusion system and developing SD-101 to potentially enable more patients with liver and pancreatic tumors to benefit from immunotherapeutics and the current standard of care,” said Mary Szela, president and CEO of TriSalus. “Today we are providing recent clinical data from our SD-101 studies so investors can better understand the progress to date and the potential upside that our company can generate.”
About TriSalus’ presentation
In the presentation, TriSalus shared data demonstrating consistency with the hypothesis that TriNav can achieve high SD-101 levels in the liver. It does so with limited systemic exposure using the PEDD method. SD-101 delivered with TriNav also offers evidence of induction of immunostimulatory cytokines in the blood. It demonstrated reductions in liver tumor monocytic myeloid-derived suppressor cells (MDSC) levels.
To date, 27 patients received treatment with 123 infusions of SD-101 in the PERIO trials. None experienced serious cytokine adverse events related to SD-101. Additionally, none reported serious adverse events related to the TriNav or PEDD technologies.
TriSalus expects Phase 1 response data from the trials next month. It plans to continue to enroll at higher SD-101 dose levels in combination with checkpoint inhibitors.
“The initial findings from these studies offer encouraging data supporting TriSalus’ proprietary [PEDD] method,” said Dr. Steven C. Katz, CMO at TriSalus. “This promising clinical data demonstrate that SD-101 delivered via TriNav may support broad immune effects in liver tumors and eliminate [MDSC]. Importantly, the data further substantiates the potential of our therapeutic platform to significantly improve immunotherapy outcomes for patients with liver and pancreatic tumors.”