Lytix Biopharma (Lytix) announced site activation for the ATLAS-IT-05 study in three European countries. ATLAS-IT-05 is a Phase II combination study evaluating LTX-315 and pembrolizumab in patients with advanced melanoma. The study was initiated at MD Anderson Cancer Center in 2021 and is currently ongoing in the US.

The objective of the study is to document whether LTX-315 in combination with pembrolizumab is effective in inducing tumor responses in patients who have failed prior anti PD 1/PD L1 immune checkpoint therapy. The clinical trial has now been extended to Spain, France and Norway and sites are opened in all three countries. The expansion of the site network will mitigate recruitment challenges, drive enrollment towards completion and extend the clinical impact field for LTX-315.

The European branch of the study is performed at highly recognized sites with intratumoral immunotherapy expertise, led by melanoma experts at each site. It will follow the same protocol as in the US. The regulatory application in Europe was approved in Third Quarter 2022, and efforts to initiate recruitment of patients is ongoing with the aim to complete enrollment in the study in early 2023.