Type 1 Diabetes
With an initial focus on type 1 diabetes (T1D) Imcyse’s lead candidate, IMCY-0098, is a novel insulin-based ImotopeTM. T1D is an autoimmune disease in which beta-cells are destroyed due to an inadequate immune response. Thereby, the pancreas stops producing insulin, the hormone that controls blood-sugar levels. With IMCY-0098, the company aims to intervene early in the autoimmune response to stop the destruction of beta-cells, by this means, the ability of the pancreas to naturally produce insulin is restored.
In a phase 1b study, completed in Q3 2019, IMCY-0098 was found to be safe and well tolerated; early signs of efficacy could also be detected. The T1D program was conducted by a European consortium (EXALT) and supported by a European grant of the 7th framework program. For more information on the T1D EU FP7 program go to http://exalt-fp7.eu 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.
In October 2020, a European Phase 1b/2a clinical trial to evaluate the immune signature of treatment with the ImotopeTM IMCY-0098 and its effect on the preservation of beta-cell function in adult and adolescent patients with a recent onset T1D will start.
The IMPACT Study, IMCY-0098 Proof of ACtion in Type 1 Diabetes, is a multicenter, randomized, double-blind, placebo-controlled study in patients with early T1D. Leading T1D KOL Prof. Dr. Chantal Mathieu with serve as Chief Investigator.
Conducted under an adaptive design approach, the study comprises of two steps. Step one will enroll 24 participants, age 18-45. Step two will enroll 60 participants, both adults and adolescents aged 12-17. The adolescent age group is important since the onset of T1D occurs most often in children and adolescents.
Imcyse is a proud member of INNODIA, a global network of academic institutions, industrial partners and patient organizations bringing their knowledge and experience together to fight T1D. Our aim is to leverage this private public partnership to gain greater access to T1D patient populations, a platform for scientific knowledge exchange and technical approaches to refine treatment with ImotopeTM as a safe and effective therapy to patients with early T1D.
Multiple Sclerosis is Imcyse’s most advanced pre-clinical program. In cases of MS, the body’s own immune system attacks the central nervous system and causes damage, which slows or stops nerve transmission. Imcyse has developed an ImotopeTM based on Myelin oligodendrocyte glycoprotein (MOG) to stop immune attacks to the central nervous system and thereby enable uninterrupted nerve transmission. The efficacy of the selected ImotopeTM has been demonstrated in two EAE pre-clinical models. Clinical studies are currently planned to begin in Q3 2021.
Looking beyond T1D and MS, Imcyse has also initiated a Phase 0 study in neuromyelitis optica spectrum disorder (NMOSD). Furthermore, Imcyse entered into an exploratory research agreement with Pfizer for rheumatoid arthritis (RA). Other early stage, preclinical programs include proof-of-concept studies in allergy, graft vs. host rejection, myasthenia gravis as well as in the prevention of immunogenicity in gene therapy using AAV-Vectors. Recently, Imcyse initiated a new program in celiac disease.
Imcyse’s ImotopeTM technology platform offers numerous competitive, clinical and commercial advantages:
- Long lasting and potentially curative effect: By specifically blocking, in a sustained way, improper immune responses causing the disease, the ImotopeTM technology platform represents a next generation, potentially curative approach to severe, chronic autoimmune diseases for which there is no satisfactory therapeutic alternative.
- Specific and safe: The ImotopeTM effect is specific to the immune responses involved in the disease process and to the target organ. Therefore, the risk of non-specific immunosuppression or of unwanted targeting of other organs is limited. The Imcyse dosing and therapeutic strategy provides all the necessary requirements for a safe medical intervention leading to natural regeneration of damaged cells and organs.
- Cost-effective: The product is a synthetic peptide, administered with adjuvant. Patients only require a few injections in the first year of treatment. The long-lasting effects and prevention of disease progression and elimination of serious complications will dramatically reduce international healthcare budget costs.
- Convenient: The simple and convenient injection administration format will facilitate enhanced patient compliance.
The highly innovative Imcyse approach has a strong IP position with multiple layers of protection: key patents on technology and improvements thereof and composition of matter patents for products in clinical trials (well beyond 2030).
Imcyse has an experienced management team covering R&D, pharma, biotech, BD and finance, a strong immunology-focused research group including an ImotopeTM discovery and lead generation team as well as a peptide chemistry team plus global level scientific and clinical advisory committees.Our business strategy is supported by 3 pillars:
- Research collaborations with internationally-recognized groups, pharmaceutical partner companies and public funding bodies to broaden our pipeline and our IP portfolio
- Commercial partnerships for certain indications
- In-house development and marketing of select indications