• Project to develop companion diagnostic platform to assess and specify disease worsening in patients with multiple sclerosis
• Imcyse to aid in translating results from clinical trial setting into real-world practice
Liège, Belgium, June 22, 2023 – Imcyse, a clinical-stage biopharmaceutical company pioneering the development of a new class of active and specific immunotherapies for the treatment of severe autoimmune diseases, today announced that the company is participating in ‘Clinical impact through AI-assisted MS care’ (CLAIMS), a public-private partnership project funded through the European Innovative Health Initiative (IHI) and involving fifteen partners from nine different countries.
The project, launched at the start of June, has total funding of almost 10 million Euros, contributed by industry partners and the European Commission and will run over the next four years. The goal is to develop a companion diagnostic platform supporting the assessment of disease worsening in patients with multiple sclerosis (MS), making data-driven precision medicine a reality for this group. Powered by deep-learning-based disease subtyping and progression models, this platform aims to enhance the precision of MS care, extending patient quality-adjusted life years and reducing the economic burden for both individuals and society as a whole. As part of the consortium, Imcyse, along with other leading pharmaceutical and biotech companies, will aid in translating results from the highly controlled setting of a clinical trial into real-world clinical practice.
“We are proud to be part of this important project and excited to add Imcyse’s knowledge and the insights we are gathering from our ongoing Phase 1/2 study in patients with relapsing-remitting multiple sclerosis,” commented Denis Bedoret, CEO of Imcyse. “MS is a devastating and highly unpredictable disease that affects everyone differently with a continued high need for effective and safe treatments. With this partnership, we aim to increaseengagement with leading scientists, experts and clinicians in the field while we continue to advance our second clinical program.”
CLAIMS - enhancing the precision of MS care
The CLAIMS, ‘Clinical impact through AI-assisted MS care’, project aims to address the urgent need for a more data-driven and personalized clinical decision-support tool for patients with MS, one that addresses the new insights in disease worsening due to both relapses and disease progression independant of relapses, and as such supports optimal treatment decisions and improved long-term patient outcomes. As such, CLAIM’s mission is to develop, validate, and seek regulatory approval for a companion diagnostic platform that provides a holistic view of each patient. This platform will visualize existing and new biomarker data, as well as predict disease trajectories under different treatment scenarios while accounting for comorbidities. Powered by deep-learning-based disease subtyping and progression models, this platform aims to enhance the precision of MS care, extending the patients’ quality-adjusted life years, and reducing the economic burden on both individuals and society.
Fifteen partners from nine different countries. This diverse consortium brings together a range of multidisciplinary expertise from clinical, scientific, and technical fields. The list of partners includes key medical experts from leading European Hospitals in the field of Multiple Sclerosis, i.e., CHARITE-Universitaetsmedizin Berlin (coordinator), Centre Hospitalier Universitaire de Lille, Casa Di Cura Igea SPA, Vseobecna Fakultni Nemocnice v Praze, Ruhr-Universitaet Bochum and the Technische Universitaet Dresden. Through the European Charcot Foundation, the project ensures that the patient perspective is considered, and that the wider MS community is informed about the project outcomes and how they can improve the patient’s care trajectories. With icometrix (project lead), Nocturne and AALTO university, the consortium also has tremendous experience regarding AI-based medical image analysis and prognostic modelling for MS. Synapse research management partners SL brings over a decade of experience in European research project management to the table, ensuring milestones are met on time and within budget. Importantly, the consortium includes the leading pharmaceutical companies Bristol-Myers Squibb and F. Hoffman La Roche Ltd, and biotech companies IMCYSE and AB Science bring expertise translating results from the highly controlled setting of a clinical trial into real-world clinical practice. The diversity of the consortium is a true asset, ensuring all necessary expertise is available to achieve its challenging goals.
ABOUT MULTIPLE SCLEROSIS (MS)
Multiple sclerosis (MS) induces damage to the proteins protecting the nerves, also called nerve sheath demyelination, which exposes the underlying nerves and can lead to paralysis. Symptoms include muscle weakness, weak reflexes, tremors, and muscle spasms. More than three million people globally have been diagnosed with MS. The disease can affect people as young as 15 years old, and women are twice as likely as men to contract MS. The true cause of the disease is unknown; however, a combination of hereditary and environmental factors is believed to enable the autoimmune attack.
There is no cure for MS. MS treatments typically focus on speeding recovery from attacks, slowing disease progression and managing symptoms. Although current medications are effective in reducing the frequency of disease relapse, they are also associated with significant side effects and compliance challenges. Thus, there remains a major need for new treatments with a more favourable safety profile that can slow or even stop disease progression.
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™, which are synthetic peptides encompassing a T cell epitope and an active thioredox motif. , Imotopes™ generate cytolytic CD4 T-cells that specifically eliminate autoantigen-presenting cells and autoantigen-specific lymphocytes involved in the disease pathways. Imcyse’s approach, sustained over time, may help to prevent and treat diseases with no current therapeutic options and to potentially cure patients without impairing their immune defenses. The company has established proof of concept in several indications and has completed its first clinical trial in type 1 diabetes with promising results and is expecting top-line data from the fully enrolled Phase 2 study in 2024. A clinical Phase 1/2 clinical trial in Multiple Sclerosis (MS) was initiated in April 2022. Beyond type 1 diabetes and MS, Imcyse is developing a pipeline of Imotopes™ for the treatment of several autoimmune diseases in large and rare disease indications. Imcyse was founded as a spin-off from the Catholic University of Leuven and is headquartered in Liège, Belgium.
