Company Overview

GeNeuro is a clinical stage pharmaceutical company developing a new approach to the treatment of autoimmune diseases, including multiple sclerosis (MS) and Type 1 Diabetes (T1D) associated with pathogenic proteins expressed by human endogenous retroviruses (HERV), viral genes that account for 8% of human DNA.

This novel approach is the result of 25 years of research on endogenous retroviruses, including 15 within Institut Mérieux and INSERM, before the creation of GeNeuro in 2006. This research has allowed us to uncover and understand the action of a factor potentially causative of multiple sclerosis, the envelope protein (Env), which is produced by a pathogenic member of the human endogenous retrovirus-W family (pHERV-W). The presence of pHERV-W Env in brains of MS patients may be an important driver of the neurodegenerative phenomena characterizing this disease.

GeNeuro has developed temelimab, a humanized monoclonal antibody targeting pHERV-W Env, which has completed a 270-patient Phase IIb clinical trial (CHANGE-MS) in multiple sclerosis. By neutralizing the pathogenic HERV-W Env protein rather than targeting the patient's immune system, temelimab has proven to have a coherent impact across all key markers associated with disease progression, such as diminishing brain atrophy, reducing the number of black holes (permanent damage) and maintaining MT signal (an experimental measure of myelin integrity). Moreover, these benefits were prominent in the inactive sub-population of patients in this study, precisely the group of MS patients that are sub-optimally treated with currently available therapies. These results, obtained by targeting a pathogenic HERV-encoded protein, support a completely new mechanism of action as a cause of MS progression. The results generated from the CHANGE-MS study suggest that temelimab should be further studied, both as a single agent on progressive MS populations without active inflammation, as well as synergistically with existing immune-modulatory MS drugs in active, relapsing MS patients.

GeNeuro is developing its platform against other autoimmune diseases, such as type 1 diabetes for which a 60-patient one-year Phase lla with temelimab in adults was launched in April 2017. Six-month results obtained in the fall 2018 confirmed the safety of this approach, the primary endpoint of the study in this new patient population, as well as pharmacodynamic markers such as a reduction in the number of hypoglycemic episodes. Full one-year results are expected in 2Q2019, as a stepping stone to entering the juvenile T1D population, where there are currently no disease modifying therapies and a very high unmet medical need. 

To capture the full therapeutic potential of its approach against pathogenic HERV-encoded proteins, GeNeuro is developing new therapeutics, currently at preclinical stage, against other diseases mediated by pHERV-W Env, such as inflammatory psychosis, as well as against diseases mediated by pathogenic Env proteins encoded by other HERV families. In research generated by the National Institute of Neurological Disorders and Stroke (NINDS, part of the NIH), the Env protein encoded by a member of the HERV-K family has been found to be associated with a significant proportion of patients with the sporadic form of amyotrophic lateral sclerosis and to be capable of generating a motor-neuron disease phenotype in genetic, knock-in animal models. GeNeuro has signed a research partnership with the NIH and in-licensed all the IP covering the development of an antibody program to block the activity of pHERV-K Env. GeNeuro expects to begin clinical trials of its anti-HERV-K Env antibody in patients with sporadic ALS by mid-2020.

GeNeuro SA is a member of the Swiss Biotech Association, a member of the BioAlps community and has the CTI (Commission for Technology and Innovation) start-up label.

GeNeuro Innovation SAS is member of the French Lyon Biopôle.

More about the pipeline
More about the multiple sclerosis
More about the schizophrenia