Business
TriSalus Life Sciences Presents New Data at AACR for SD-101 Delivered by the Proprietary PEDD™ Method in Stage IV Uveal Melanoma Patients With Liver Metastases
DENVER & FORT LAUDERDALE, Fla.--(BUSINESS WIRE)-- TriSalus Life Sciences® Inc., (“TriSalus” or the “Company”), an oncology company in the process of going
About this update from Trisalus Life Sciences, Inc.
[{"type":"text","content":" DENVER & FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--\nTriSalus Life Sciences® Inc., (“TriSalus” or the “Company”), an oncology company in the process of going public through a business combination transaction (the “Business Combination”) with MedTech Acquisition Corporation (Nasdaq: MTAC) (“MedTech” or “MTAC”), today announced new Phase 1 clinical data presented at the American Association for Cancer Research (“AACR”) 2023 Annual Meeting taking place in Orlando, Florida, from April 14-19, 2023.\n\n\nThe clinical data presented at the AACR 2023 Annual Meeting relates to the Company’s ongoing Pressure-Enabled Regional Immuno-Oncology (“PERIO-01”) clinical study for uveal melanoma with liver metastases (“UMLM”). The PERIO-01 trial is studying an investigational class C toll-like receptor-9 agonist, SD-101, delivered intravascularly with the TriNav® Infusion System (“TriNav”) using the Pressure-Enabled Drug Delivery™ (“PEDD™”) method of administration. PERIO-01 is evaluating whether this platform approach can improve the performance of systemic checkpoint inhibitors in patients with UMLM.\n\n\nPERIO-01 is an open-label, first-in-human Phase 1 trial of SD-101, given by hepatic arterial infusion with TriNav using PEDD™ in UMLM (NCT04935229). The study consists of dose-escalation cohorts of SD-101 (2, 4, or 8 mg) alone or with immune checkpoint inhibition (“ICI”). At data cutoff as of January 14, 2023, based on pooled data from 27 patients enrolled in the PERIO-01 trial, only 3 patients were treatment naïve, and others received 1-7 lines of prior therapy. Within these 27 patients, there has been one treatment-related serious adverse event. The most common treatment related adverse events overall were fatigue (9 events), abdominal discomfort (6 events), and dizziness (3 events) which were all graded as non-serious. Grade 3 liver function test elevations were noted in one subject, which was not clinically serious.\n\n\nCirculating tumor cell and circulating tumor DNA (“ctDNA”) levels were noted to decrease in 6 out of 13 patients and 6 out of 9 patients, respectively, based on available data. Decreases of ctDNA have been associated with longer overall survival in the stage IV uveal melanoma population. 5 out of 5 patients with available data demonstrated reductions in intratumoral myeloid derived suppressor cells (“MDSCs”), which the Compa...