Eurostars Project, TLAS, 7121, Immune Therapy Holdings AB

Purpose and goal

ITH and KI have together with clinicians from ECMO unit at Karolinska University Hospital successfully identified and characterized a pro-inflammatory neutrophil population in patients with ARDS, which is responsible for an increased immune response and will be presented in a scientific manuscript for peer review. Additionally, ITH has together with regulatory consultants initiated the CE certification process, meaning that the TLA platform is expected to be eligible for clinical use during 2015.

Results and expected effects

Work package 1 and 2 were successfully completed. Identifying the target cell population in ARDS as well as producing a functional ligand, biotinylated IL-8, was more complicated than anticipated. The IL-8 chemokine synthesized and successfully delivered by Almac Group encountered unforeseen technical problems. The consortium has identified a novel method to confirm clear preclinical demonstration of efficacy before beginning of in vivo clinical trials. Work package 4, commercialization discussions for the TLA platform was initiated during the course of the project.

Approach and implementation

Although some delay was experienced in this project, we have invested time in building up collaboration with significant clinicians important for the feasibility of the clinical study. Since TLA for ARDS is an experimental technology for patients that are severely ill, the planning and context of the clinical program is of increased importance. Work with the regulatory CTA application is ongoing and the Principal Investigator of the project is exploring a multi-center study between ECMO clinic in Bern and Stockholm that can positively affect the inclusion rate of the clinical study.