The history of GeNeuro

2020

  • Publication in Science Advances by a research consortium led by Fondation FondaMental of a study showing that HERV proteins, which have been previously found in patients with inflammatory psychosis, such as schizophrenia and bipolar disorders, induce glutamate receptor disorganization and behavioral deficits in vitro and in vivo. GeNeuro’s contribution to the study consisted of providing new antibodies that neutralize the HERV-Env protein identified by the consortium’s research work.
  • June: treatment of first patients in its study of phase II in MS at the Karolinska Institutet/Academic Specialist Center of Stockholm, Sweden, after three months delay due to the COVID-19 pandemic.
  • Appointment, effective May 1, 2020, of Prof. David Leppert, MD and Professor of Neurology, as Chief Medical Officer. A recognized expert in the worldwide neurology community, Dr. Leppert has developed pioneering research and worked for over 20 years in clinical development, successfully leading the development of prominent drugs such as ocrelizumab to treat multiple sclerosis (MS) while at Roche, and then leading the development of all neurology clinical trials at Novartis. 
  • Successful completion of a €17.5million international private placement only to certain qualified and institutional investors. GNEH SAS, a subsidiary of Institut Mérieux, participates to the full extent of its €7.5 million credit line. The capital increase extends the company runway with all ongoing programs until mid-2022e.

2019

  • Announced collaboration for a new clinical trial of temelimab in multiple sclerosis (MS) with clinical researchers of Karolinska Institutet and the Academic Specialist Center (ASC), Stockholm, Sweden. This single-center study will be led by Dr. Fredrik Piehl, Professor of Neurology at the Department of Clinical Neurosciences of the Karolinska Institutet, and head of research at the MS clinic at ASC. 
  • Presented at and sponsored the 3rd HERVs & Disease International Workshop on Human Endogenous Retroviruses and Diseases, held November 5-6, 2019, in Lyon, France.
  • Announced that the neuroprotective effects of temelimab in MS patients extend to 96 weeks and that it is safe to use and well tolerated for a prolonged period. These data, from ANGEL-MS, an extension of the Phase 2 CHANGE-MS trial in relapsing-remitting MS (RRMS), were presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS 2019) Congress in Stockholm, Sweden.
  • Publication of a review in Frontiers in Genetics, which has compiled growing evidence of the link between human endogenous retroviruses (HERVs) and many difficult to treat neurological disorders. Although completely incorporated into human DNA millions of years ago, HERVs now represent approximately 8% of the human genome. HERV genes are normally silent but have retained the capacity to be activated and upregulated. 
  • PNAS publication : data supporting the mode of action of its lead product (temelimab) in treating MS was published in the Proceedings of the National Academy of Sciences (PNAS).
  • Announced that the six-month extension of its Phase IIa study of temelimab in Type-1 Diabetes (T1D) confirmed all previously observed positive observations in the trial, meeting its primary objective. GeNeuro believes these data open the door to further development in early-onset T1D pediatric patient population.

2018

  • Published final 1-year results from its 270-patient CHANGE-MS study on RRMS patients, confirming a robust and coherent impact on the key MRI markers associated with disease progression. Moreover, the benefits are also observed in patients with lower inflammatory burden, which are not served by present anti-inflammatory treatments. 
  • Despite positive results, Servier decides to return worldwide rights ex US and Japan for temelimab in MS due to R&D strategic reasons and Servier’s international development priorities. GeNeuro engages in new partnership discussions for its lead MS program. 
  • Announced 6-month results of its T1D trial confirming 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
  • Based on the joint preclinical effort started in 2017, GeNeuro acquires from the US NIH all IP rights to develop a new treatment against Amyotrophic Lateral Sclerosis based on neutralizing the pathogenic HERV-K protein. GeNeuro launches a formal preclinical effort aiming to obtain an IND by mid-2020. 
  • Signing of a financing agreement with GNEH SAS, a subsidiary of Institut Mérieux, to establish a €7.5 million credit line, which extends the company runway with all ongoing programs until mid-2020. 

2017

  • Finalization of the recruitment of patients in the study of Phase IIb CHANGE-MS study in multiple sclerosis, ahead of the schedule, and launch of the open-label extension study (ANGEL-MS),  also funded by Servier, allowing patients who finished the CHANGE-MS study to extend their treatment for two additional years.
  • Announced treatment of the first patient in a Phase IIa study with temelimab in type 1 diabetes. This Australian clinical trial plans to recruit 60 adult patients in more than 10 centers.
  • Signed an agreement with the U.S. NIH to develop a new treatment option against Amyotrophic Lateral Sclerosis. This partnership focuses on antibodies targeting the HERV-K Env protein, a potential cause of the sporadic form of the disease, which accounts for more than 90% of the ALS population.
  • Published 6-month results from its 270-patient CHANGE-MS study on RRMS patients, failing the primary endpoint measuring MRI inflammation markers, but showing promising data on secondary markers of neurodegeneration, to be confirmed by one-year results. 

2016

  • GeNeuro's IPO on Euronext Paris, raising 33 M€ in order to expedite its clinical development in the United States and in new indications, such as type-1 diabetes.
  • Treatment of first patients in its study of phase IIb in MS. The CHANGE-MS clinical trial, funded by Servier, targeted a-260 patient recruitment in 13 European countries.

2015

  • Launched a Phase IIb trial in multiple sclerosis.
  • Completion of a pharmacology study testing high doses of temelimab.

2014

  • Signed a collaboration agreement with Servier for the development of a medicine targeting a potential causal factor of multiple sclerosis.
  • Announced the completion of the Phase IIa trial with good safety results and promising pharmacodynamic responses.

2013 

  • Received authorization from the Swiss Medicine Agency to undertake a Phase IIa trial with a repeated-dose extension for a total of 12 months.
  • Announced the completion of a phase IIa clinical trial with temelimab. During the study, MS patients received the monoclonal antibody temelimab at two different doses.
  • Confirmed the scientific interest in developing temelimab as a treatment for CIDP during a scientific advice meeting with the European Medicines Agency (EMA).

2012

  • Announced the launch of a Phase IIa clinical study with temelimab. The randomized placebo-controlled Phase IIa study tested single ascending doses of temelimab in patients with multiple sclerosis for the first time.

2011

  • Announced the completion of its Phase I clinical study with temelimab. The randomized, double-blind, placebo-controlled, Phase I study of single ascending intravenous doses of temelimab in healthy volunteers demonstrated that temelimab is well tolerated.
  • Swissmedic, the Swiss medicines agency, authorized GeNeuro to start a Phase I trial of the monoclonal antibody temelimab in healthy volunteers. Temelimab is developed for the treatment of multiple sclerosis.

2010

  • Obtained a positive opinion from a German regulatory scientific committee, the Paul Ehrlich Institute, regarding the pre-clinical package for its lead monoclonal antibody temelimab, a humanized monoclonal antibody targeting a human endogenous retrovirus, to treat multiple sclerosis.
  • GeNeuro Innovation SAS obtained the status of Small and Medium Enterprise (SME) awarded by the European Medicines Agency.

2009

  • The French subsidiary GeNeuro Innovation SAS is established in Lyon (France).

2008

  • Obtained funding from Eclosion and Institut Mérieux to expand its operations and advance its drug portfolio towards clinical development.

2006

  • Founded by Dr Hervé Perron, Dr Christophe Mérieux and Jesús Martin-Garcia, with the help of bioMérieux, a leading French diagnostics company, and Eclosion, a Swiss start-up incubator that supports the development of projects in life sciences.