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Imcyse plans first human trial of disease-modifying MS vaccine

This article was originally published in Scrip

Belgium start-up Imcyse believes it has a promising candidate for a disease-modifying multiple sclerosis vaccine. The company is planning a first-in-human study of the product in September, it told Scrip.

Even though treatment options for multiple sclerosis patients have improved vastly in recent years, there is still no cure for the disease. Even next-generation drugs like Biogen Idec's Tecfidera (dimethyl fumarate) only treat symptoms of the progressive disorder, rather than halting or reversing its course. A product that can cure the disease would therefore be of great interest to both patients and the pharmaceutical industry.

Imcyse is targeting CD4+ T-cells, which trigger an immune reaction and are implicated in autoimmune diseases such as MS,

"If we can act on an early event, we could modulate the immune system," explained Imcyse chief scientific officer Jean-Marie Saint-Remy. Imcyse's vaccine effectively switches off the immune response, in part by converting pathogenic CD4+ cells to beneficial cytolytic CD4+ cells.

But unlike other approaches, Imcyse's product doesn't cause blanket immunosuppression, so shouldn't lead to the same side-effects as other MS drugs such as immune deficiency, Dr Saint-Remy believes.

In addition, the vaccine could also have an anti-inflammatory effect, with preliminary animal results suggesting this could lead to regeneration of the myelin sheaths around nerve fibers that are damaged in MS, according to the company.

If this is also true in humans, this means that, as well as potentially halting disease progression, the vaccine could also reverse damage already done. But this remains to be tested, with Dr Saint-Remy describing the upcoming 30-patient clinical trial as "quite a challenge".

Leuven-based Imcyse is developing its platform in several other applications: cancer, allergic asthma, graft rejection, gene therapy, and other autoimmune diseases such as type 1 diabetes.

In diabetes, it is collaborating with pharma giant GlaxoSmithKline, and hopes to start a first clinical trial in 2015.

It is still early days for Imcyse, which was founded in 2010 and carried out its first funding round in November 2012, raising €5m ($6.9m). It will need more money, and perhaps partners, to keep progressing.

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