On April 20, 2023 TriSalus 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"), reported new Phase 1 clinical data presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) ("AACR") 2023 Annual Meeting taking place in Orlando, Florida, from April 14-19, 2023 (Press release, TriSalus Life Sciences, APR 20, 2023, View Source [SID1234630359]).
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The clinical data presented at the AACR (Free AACR Whitepaper) 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.
PERIO-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.
Circulating 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 Company has previously demonstrated in pre-clinical liver metastasis models to be associated with immunosuppression. This data supports the hypothesis that checkpoint inhibitors in combination with SD-101 delivered via the PEDD method can enable broad immune effects, including the depletion of liver MDSCs.
"We believe our approach has the potential to improve outcomes and enhance the quality of life for patients with liver and pancreatic tumors receiving checkpoint inhibitor therapy," said Steven C. Katz, MD, FACS, Chief Medical Officer at TriSalus. "The data presented at the AACR (Free AACR Whitepaper) 2023 Annual Meeting shows that SD-101 has been well tolerated to date when administered via PEDD, at multiple dose levels alone and in combination with checkpoint inhibition. SD-101 infusions have also been associated with encouraging immunologic activity and ctDNA decreases, even at the lower doses, in heavily pre-treated patients. The serious adverse event rate related to treatment to date suggests that our delivery approach may enhance the therapeutic index for SD-101. We look forward to continuing our trials and adding to the growing body of evidence that our proprietary PEDD method is a potentially powerful approach for enabling SD-101 to improve efficacy of systemic immunotherapies like checkpoint inhibitors."