MedTech Acquisition announced that it adjourned a shareholder meeting until Aug. 8 at 11 a.m. Eastern. Shareholders will then consider whether to merge with TriSalus Life Sciences, a privately held oncology therapeutics company integrating immunotherapy with disruptive delivery technology to transform the treatment paradigm for patients with liver and pancreatic cancer.
The redemption deadline has been extended to 5 p.m. Eastern Aug. 4.
TriSalus on Monday received notice from the FDA, which acknowledged that preliminary data from the company’s PERIO-01 drug program suggests a tolerable safety profile of SD-101 delivered by TriSalus’ pressure-enabled drug delivery method. The FDA also asked for additional exploration of the optimal SD-101 dose, in a smaller study prior to proceeding with a registrational trial. TriSalus currently expects to have Phase 1 more mature efficacy data at the multiple SD-101 doses for its PERIO-01 clinical trial in the second half of 2023. Based on the FDA’s feedback, TriSalus will move forward with a 40-50 patient study to generate additional efficacy data to determine the optimal SD-101 dose for the PERIO-01 program.
As a result of the FDA Responses, TriSalus said it anticipates that a potential new drug application submission for SD-101 in uveal melanoma with liver metastases is likely to occur beyond 2025. Read more.
