E!954, TAILOR-2-ALS, TLA Targeted Immunotherapies AB

Purpose and goal:

The project goal is to develop TLA ALS, a completely new treatment strategy for amyotrophic lateral sclerosis (ALS), a rare and fatal neuromuscular disease without a cure. TLA ALS is an immunotherapeutic apheresis column (a blood filter) that specifically removes immune cells that play an important role in the disease picture in ALS from the patient’s blood stream.

The treatment goal is to restore upper motor nerve cells, fine motor skills and muscle tone even in late stage disease. Upon project completion, we will be ready to evaluate TLA ALS in a clinical study in ALS patients. Expected results and effects:

The main results of the project will be: 1) a pre-clinically validated medical device product according to set standards, 2) a validated and scalable manufacturing process ready for technical transfer under Good Manufacturing Practice (GMP) principles, and 3) a clinical trial dossier submitted for approval to initiate a First-in-Man study in ALS patients upon project completion. An additional outcome of the project will be a new technological platform and methodology for antibody-based leukapheresis columns that will be widely replicable to other applications in the future.

Approach and implementation:

The strength of the project lies in the collective expertise and experience of the consortium with regard to biotechnological development. TLA ALS will be developed by TLA (Sweden) in close collaboration with its Dutch partner QVQ. TLA has a proprietary concept for development of leukapheresis devices, and QVQ has unique experience within biotechnological antibody development.

The total project time is 3-years and will be initiated by antibody development at QVQ, followed by development and validation of the TLA ALS medical device product.