Imcyse Awarded Subsidy from the Walloon Region for Neuromyelitis Optica Spectrum Disorder Study

• Subsidy for €1.1 million over a period of 29 months to support the development of a therapeutic vaccination treatment for Neuromyelitis Optica Spectrum Disorder (NMOSD)
• Funds will be used to demonstrate PoC, establish the clinical relevance of the NMOSD Imotope^TM approach and lead to a Phase I clinical trial
• NMOSD is a rare and severe autoimmune disease of the central nervous system dominated by inflammation of the optic nerve and spinal cord with an estimated incidence between 1-2 per 100,000

Liège, Belgium, July 28, 2020 - Imcyse a clinical-stage biopharmaceutical company pioneering the development of a new class of active, specific immunotherapies for the treatment of severe, chronic autoimmune diseases, today announced that it was awarded a subsidy for €1.1 million over a period of 29 months to support its Neuromyelitis Optica Spectrum Disorder (NMOSD) program. Funding was approved on behalf of the Walloon Region by Willy Borsus, Minister of Economy and Research, and is an example of local support for Imcyse's Imotope^TM technology platform.

Imcyse's program aims to develop a therapeutic vaccination treatment to specifically target immune cells in NMOSD patients. The subsidy will be used to demonstrate Proof of Concept (PoC) both in an animal model and on human cells (Phase 0 study) to select and establish the clinical relevance of the NMOSD Imotope^TM. A clinical Phase I trial in NMOSD patients will follow.

"NMOSD is a rare autoimmune disease with an estimated incidence between 1-2 per 100,000. Due to this, there are few large-scale therapeutic studies ongoing and no present cure. We are therefore, excited that the subsidy awarded to us by the Walloon Region will enable us to study our Imotope^TM technology in this indication. Our technology could offer NMOSD patients a curative therapy in early stage disease intervention", said Thomas Taapken, Imcyse Executive Chairman.

NMOSD, also known as Devic disease, is a chronic disorder of the central nervous system dominated by inflammation of the optic nerve (optic neuritis) and inflammation of the spinal cord (myelitis). Imcyse's technology, Imotopes^TM, presents an opportunity to silence the autoimmune destruction process whereby antibodies attack proteins in the central nervous system, especially aquaporin-4. With the Imotope^TM approach, further disease progression is halted, which would potentially make this novel therapy a first choice in early stage treatment.

"NMOSD is a relatively rare but potentially very disabling neurological condition. Treatments are available, but these are immunosuppressive molecules that block all or part of the immune system. The collaborative project between Imcyse and the Strasbourg Neurology Service aims to find an immunomodulatory and personalized approach to the treatment of NMOSD. Our aim is to deflect the incorrect immune response rather than blocking the entire immunological chain", said Professor Jérôme de Sèze, Head of the Neuroimmunological Department at the Strasbourg University Hospital.

A Phase 0 study on cells from patients with stabilized NMOSD started in June 2020. During the study, Imcyse will select the appropriate Imotope(TM) by generating cytolytic CD4 T cells specific to epitopes of the autoantigen responsible for the disease and identify biomarkers of cCD4 T cells. The study takes place in two French centers and will be conducted in collaboration with Professor Jérôme de Sèze and Dr. Romain Marignier, Neurologist, Hôpital Pierre Wertheimer of the University Clinic of Lyon.

ABOUT IMCYSE
Imcyse is a clinical stage biopharmaceutical company pioneering the development of a new class of active specific immunotherapies for the treatment of severe chronic autoimmune diseases. The company's unique technology platform allows it to locally target immune cells involved in the destruction of the diseased organ. This platform is based on the administration of Imotopes(TM), which are specifically modified peptides, allowing for the generation of cytolytic CD4 T-cells that specifically eliminate antigen-presenting cells and autoantigen specific lymphocytes. Imcyse's approach, sustained over time, helps to prevent and treat diseases with no current therapeutic alternative and to potentially cure patients without impairing immune defense. The company has established proof of concept in several indications and has completed its first clinical trial in type 1 diabetes with promising results. Beyond type 1 diabetes, Imcyse is developing a pipeline of Imotopes(TM) for the treatment of several autoimmune diseases. Founded as a spin-off of the Catholic University of Leuven in 2011, Imcyse subsequently relocated to Liège, Belgium.

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Imcyse S.A.
Thomas Taapken
Executive Chairman
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