GeNeuro SA
This article was originally published in Start Up
Executive Summary
Swiss start-up GeNeuro SA aims at an MS cure. The company licensed technology from French infectious-disease specialist bioMérieux SA, whose studies showed the presence of the MS-associated retrovirus (a member of the HERV-W family) may be a major triggering and aggravating factor in MS. GeNeuro's novel approach primarily focuses on the development of therapeutic monoclonal antibodies, which will target and neutralize the pathogenic MSRV/HERV-W proteins and thereby, in theory, prevent the initiation of the inflammatory and autoimmune cascades induced by these proteins in MS.
Targeting endogenous retrovirus expression to treat MS
18 Chemin des Aulx
CH-1228 Plan-les-Ouates
Geneva, Switzerland
Phone: +41 22 794 50 85
Web Site: www.geneuro.com
Contact: François Curtin, MD, CEO
Industry Segment: Biotechnology
Business: CNS drug development
Founded: March 2006
Founders: Jesus Martin-Garcia; Christophe Mérieux; Hervé Perron, PhD, CSO
Employees: 14
Financing: SFr15 million
Investors: Eclosion SA; bioMérieux SA; Institut Mérieux
Board of Directors: Jesùs Martin-Garcia (Eclosion); Benoît Dubuis, PhD (Eclosion); Jean Deleforge, DVM (bioMérieux); Michel Dubois (Institut Mérieux); François Curtin; Hervé Perron
Scientific Advisory Board: Professor Hans-Peter Hartung, Chairman (University of Düsseldorf)
The incidence of many CNS disorders, such as multiple sclerosis, is growing, and existing therapeutics largely focus on the treatment of symptoms. Swiss start-up GeNeuro SA focuses on human endogenous retrovirus (HERV) expression, which is associated with the CNS disease process.
Mobile genetic elements make up about half the human genome and around 8% of the human genome is represented by HERV, and this genetic material is usually dormant. Around 75% of patients with multiple sclerosis express the MS-associated retrovirus (MSRV), a member of the HERV-W family. Researchers at GeNeuro believe that expression of an MSRV protein could be a causal factor in the disease, based on preclinical and human studies, and targeting it could prevent the damage to the nerves associated with MS and so reduce or prevent neurological damage and disability.
"We believe that the protein product from this endogenous retrovirus triggers inflammation in MS, and so if we can neutralize expression and stop the inflammatory process at its start, before the myelin coat around the nerves is damaged, we may be able to treat MS symptoms, and even prevent disease progression," says François Curtin, GeNeuro's CEO.
Founded in March 2006 as a spin-out from bioMérieux SA, GeNeuro's headquarters are located in Geneva, with a subsidiary, GeNeuro Innovation SAS, in Lyon to coordinate preclinical research. The trigger for the spin-out was a change in strategy at bioMérieux.
"While the company's research into therapeutics based on HERV seemed promising, bioMérieux decided to reorientate its business toward diagnostics, so the lead scientist, Hervé Perron, now our CSO, decided to found GeNeuro to continue to develop the technology," says Curtin.
GeNeuro's lead product is a monoclonal antibody targeted against MSRV, and preclinical studies have shown evidence that this approach could reduce the inflammation and neurodegeneration in the MS disease process. The company's initial focus will be in relapsing-remitting and progressive forms of MS, but if it proves effective in active disease, it could also be useful in clinically isolated syndrome (CIS), which can progress to MS.
Following a green light from a Swiss ethics committee, GeNeuro is finalizing the CTA dossier for the MSRV monoclonal antibody, and expects to begin clinical trials in healthy volunteers and patients during the first quarter of 2011.
Around 40% of patients with schizophrenia also have MSRV antigens in their blood, and GeNeuro is collecting animal and epidemiological data to try to establish a causal role in the disease.
"Treatments for schizophrenia to date are only symptomatic, and we see this as a large area of unmet medical need. Neutralizing antibodies against HERV-W could meet this need, and we hope to begin clinical trials as soon as late 2012 or early 2013," says Curtin.
In addition to MS and schizophrenia, GeNeuro is working on at least two other indications, though the company has not yet disclosed these.
The company has created a network of patents to protect its intellectual property, with more than 25 families of patents around HERV-W, including sequences, products, diagnostics and therapeutics, and it is looking to expand its coverage to include other families and other disease areas. GeNeuro's technology and pipeline is based on technology out-licensed from bioMérieux and the French National Inst. Health & Med. Res. (INSERM) as well as on GeNeuro's own patents.
Multiple sclerosis is a focus for many major pharmaceutical companies, including Merck Serono SA, Novartis AG, Biogen Inc., Teva Pharmaceutical Industries Ltd., Sanofi, Bayer HealthCare Pharmaceuticals AG and Genzyme Corp., which all have active R&D pipelines or marketed products to treat the symptoms of MS, or to try to modify the disease process through immunosuppression or immunomodulation.
"While immunomodulators are effective, there is a knock-on risk with immunosuppression, for example cancers and infections, especially with long-term treatment. As the endogenous viruses have no physiological function in humans, we don't expect any impact on the immune system with our approach," says Curtin.
There are no other companies targeting HERV-W, according to Curtin, though a number of academic groups are now studying endogenous viruses.
"Our key achievement during 2010 was to complete the GMP production of the monoclonal antibodies for the clinical trial and finalize the preclinical package – and this was on time and within budget, which is a real accomplishment for a team of our size," says Curtin.
Now that it has a comprehensive preclinical dossier, the company is actively looking for pharmaceutical companies to partner its MS product once it has moved into clinical trials. GeNeuro is also looking to in-license complementary technologies and products. During 2011, GeNeuro plans to move its MS program into clinical trials, consolidate the preclinical package of the schizophrenia program, and begin development of two additional indications, as well as setting up initial discussions with partners.
Eclosion SA, a Geneva-based company that supports start-ups, along with Institut Mérieux provided SFr12 million in August 2008, which was earmarked to support the progression of the lead project through to its first clinical trial. The company has received a total of SFr15 million to date. GeNeuro has 14 full-time employees, and Curtin expects the company to grow by around 20% during 2011.
"We may seek further private funding, but this will depend on any partnerships that we make for our multiple sclerosis program," says Curtin. "We want to grow, but we also want to remain flexible, and we want to monitor the progress of the current research programs to adapt the expansion."
Curtin joined GeNeuro in autumn 2009, and comes from a career in clinical development and business development at Merck Serono.
"I was attracted to GeNeuro by its science – as a scientist, I found the key role of these endogenous viruses in triggering and progressing disease very exciting. My experience at Merck Serono means that I know the field and the challenges, and I look forward to moving the company forward. One of the challenges we face is that we are bringing a completely new approach to the treatment of multiple sclerosis and schizophrenia, so we will have to educate patients and physicians. However, if we see the same results in humans as we have seen in preclinical models, the reward will be considerable." – Suzanne Elvidge