Pipeline

UNMET NEED
In Type 1 diabetes (T1D), the insulin-producing beta cells in the pancreas are destroyed through an autoimmune attack. The loss of beta cells leads to insulin insufficiency and hyperglycemia, with patients eventually requiring lifelong insulin therapy to maintain normal glycemic control.

For the majority of the approximately 9 million juveniles and adults affected worldwide, living with T1D means burdensome round-the-clock self-management including a strict diet, frequent monitoring of blood glucose levels along with lifelong daily insulin injections. But even with modern technologies, controlling blood glucose levels to a level that will eliminate immediate risks, such as hyperglycaemia or hypoglycaemia and serious long-term complications such as organ damage caused by high-blood sugar remains unachievable for most patients.

Despite its global impact and improvements in disease management, there is still no cure for T1D, leaving an urgent need for new advances that can reduce the number or replace daily insulin injections and obtain better overall control.

ABOUT
IMCY-0098, a synthetic peptide based on insulin (one of the proteins to which the body begins to mount an aberrant immune response) is designed to halt the progression of diabetes by stopping the body’s immune system from attacking beta cells. With early intervention, the pancreas’ ability to produce insulin may be preserved, enabling patients to manage the disease with minimal insulin injections and hopefully in some cases without the need for insulin at all.

In a Phase 1b study with 41 newly diagnosed patients, IMCY-0098, was found to be safe and well tolerated, with steady levels of C-peptides detected in some T1D patients up to 6 months following treatment, providing an encouraging signal for the Imotope™ platform. The T1D program was conducted by a European consortium (EXALT) and supported by a European grant of the 7th framework program. Results of the Phase 1b clinical trial were presented at the 55th Annual Meeting of the European Association for the Study of Diabetes (EASD) in September 2019.

STATUS
IMCY-0098 is currently being investigated in a Phase 2 multicenter, randomized, double-blind, placebo-controlled, dose comparison study in patients with recent onset T1D. The IMCY-0098 Proof of Action in Type 1 Diabetes (IMPACT) clinical trial, conducted in collaboration with INNODIA, the largest European T1D network, is evaluating the preservation of beta cell function in patients treated with IMCY-0098.

The study completed recruitment in March 2023 exceeding its recruitment target, with a total of 110 patients enrolled and randomized across 28 clinical sites in Europe, the United States and Australia. Efficacy proof-of-concept data from IMPACT is expected in Q1 2024.

Positive biomarker data, reported in January 2022, from a planned interim analysis conducted by Professor Tim Tree, Ph.D, Department of Immunobiology, King’s College London showed that IMCY-0098 treatment induces an insulin-specific cytolytic CD4+ immune signature, concomitant with prevention of the expansion of insulin-specific pathogenic Th17 T-cells. A promising preliminary result adding to the growing body of evidence supporting the ImotopeTM platform.

The IMPACT clinical trial is supported by the Walloon Region of Belgium under the grant agreement N 8234.

To learn more about T1D and the IMPACT trial visit: https://clinicaltrials.gov/ct2/show/NCT04524949, INNODIA and  T1D UK Consortium.

UNMET NEED
More than three million people globally have been diagnosed with Multiple sclerosis (MS). In MS, the immune system 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.

There is no cure for MS, and 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, leaving a major need for new treatments with a more favorable safety profile that can slow or even stop disease progression. 

ABOUT
IMCY-0141 is a synthetic peptide based on MOG (Myelin Oligodendrocyte Glycoprotein), a dominant autoantigen, designed to stop the progression of MS and the destruction of the myelin sheath protecting the nerves.

IMCY-0141 has shown promising results in several MS pre-clinical models, demonstrating an immune response that supports the proposed mode of action. Notably, in those models, Imotopes^TM also demonstrated induction of a memory response so that the treatment effect was long-lasting after a limited number of administrations.

STATUS
IMCY-0141 is currently being evaluated in a Phase 1/2 clinical trial in adult patients with relapsing-remitting MS. The Phase 1 open-label, dose escalation part of the study will evaluate the safety of three IMCY-0141 dose levels. The Phase 2 expansion arm of the trial will be double-blind and randomized with an adaptive design and will assess immune responses while evaluating the impact on the accumulation of new MRI lesions and following up other disease markers activity. In addition, the Phase 2 part will allow for dose optimization in preparation for registration studies. 

To learn more about MS and the ongoing clinical trial visit: https://clinicaltrials.gov/ct2/show/NCT05417269

UNMET NEED
Neuromyelitis optica spectrum disorder (NMOSD) includes rare, inflammatory autoimmune diseases involving the central nervous system. As a result of severe inflammation or disease relapses, optic nerves and spinal cord can become injured, resulting in significant loss of mobility, vision or other functions. The average age of onset is 40 and if left uncontrolled NMOSD has the potential to cause devastating consequences such as blindness and can be life-threatening.

NMOSD includes a range of distinctive but rare autoimmune diseases, however, NMO typically refers to patients who have a detectable autoantibody to aquaporin-4 (AQP4). These patients represent about 70% of all NMOSD patients.

While just a few years ago there were no approved therapies for NMO patients, over the last few years 3 new therapies providing protection against relapses have been approved and are available to patients. However, these therapies do not cure the disease and are accompanied by significant side-effects, leaving a major unmet need to be tackled.

ABOUT
IMCY-0685 is designed to halt the progression of NMO by stopping the body’s immune system from attacking the central nervous system.

STATUS
With the support of the expertise of The Guthy-Jackson Charitable Foundation, Imcyse is currently preparing the first clinical trial to test this NMO specific Imotope™, with a submission to regulatory authorities anticipated for Q4 2023.

UNMET NEED

Rheumatoid arthritis (RA) is the most common type of autoimmune arthritis affecting more than 25 million people. It is a chronic inflammatory disease that affects primarily the joints manifesting as pain, stiffness and synovitis which leads to progressive joint destruction. Many factors can contribute to the development of RA including genetic, and environmental factors which affect the innate and adaptive immune system. Disease-modifying antirheumatic drugs (DMARDs) and antibodies may be used to try to slow the progression of disease but are associated with significant side effects and are not curative. New safer and more effective treatments are eagerly awaited.

STATUS

In partnership with Pfizer, we are developing novel Imotopes to address this disease.

UNMET NEED

Celiac Disease (CD) is a chronic autoimmune-like disorder, affecting the small intestine, featuring duodenal villous atrophy triggered by gluten ingestion present in foods such as wheat, rye and barley.  Symptoms include gastrointestinal problems such as chronic diarrhoea, abdominal distention, and poor absorption of nutrients. Affecting on average 1% of the population, the management of CD requires lifelong adherence to a strict gluten-free diet (GFD). However, managing such a restrictive diet is challenging, and treatment burden can be high. Currently, there is nothing that truly blocks the effects of the disease and therefore there is a need for better treatments.