OSLO: Lytix Biopharma, a Norwegian immuno-oncology company, today announces the regulatory approval from European authorities to commence 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 responses in patients who have failed prior anti PD 1/PD L1 immune checkpoint therapy.
The clinical trial application (CTA) has now been approved according to the European Clinical Trial Regulation, and the national authorities in Spain, France and Norway have commended the CTA for ATLAS-IT-05.
The approval will enable the expansion of the site network and clinical impact field for LTX-315, mitigate recruitment challenges and drive enrollment in the ATLAS-IT-05 Phase II trial towards completion. The study will be performed at highly recognized sites with intratumoral immunotherapy expertise in the three European countries. It will be led by melanoma experts at each site and follow the same protocol as in the US.
The regulatory application in Europe was submitted in Q2 2022 and six leading clinical sites in Europe are expected to open during the 4th quarter of 2022. Efforts to prepare the sites for initiation of the study and recruitment of patients is ongoing with the aim to complete enrollment in the study in early 2023.
“We are very pleased to have received the regulatory approval to commence studies in three European countries. Lytix has mobilized internal resources and moved extraordinary fast in the face of the need to broaden the impact of this study among clinicians and key opinion leaders. The speed with which we were able to move from the start of this expansion program to this approval speaks to the high level of engagement from the team at Lytix. Now that the European approval has been granted, we are looking forward to and actively preparing for the upcoming start of this clinical study at the European sites,” says CEO and Co-founder of Lytix Biopharma, Øystein Rekdal.