GENEURO SA Defeating neurodegeneration
through Human Endogenous
Retroviruses ("HERVs")
October 2023
Leveraging | Lean and |
unique HERV | experienced |
platform | team |
Three | Delivering |
independent | results in the |
high-potential | short and |
programs | medium term |
Disclaimer
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GeNeuro's lean and experienced team
Jesús Martin-Garcia│MBA
Chief Executive Officer - Co-founder
Prof. David Leppert│MD
Chief Medical Officer
Dr. Hervé Perron│PhD, HDR
Chief Scientific Officer - Co-founder
Dr. Alois B Lang│PhD
Chief Development Officer
Miguel Payró
Chief Financial Officer
Strong track-record in creating value in high technology start-ups
20+ years experience in MS, in charge of R&D and clinical development
Made the initial key discoveries in the field of human endogenous retroviruses while at INSERM and bioMérieux
Over 30 years experience in translational science and drug development
Experience in international groups
- expertise as CFO of a Swiss listed company in the medical sector
More than 20 years of | MBA from Harvard |
experience as founder and | Business School |
investor in successful | Master in Law by |
startups | University of Geneva |
Global Development Team | MD from Zürich University & |
Leader at Roche, then | research fellowships in |
Therapeutic Area Head | neuroimmunology and |
Neuroinflammation at Novartis | neurophysiology at UCSF |
Has published over 120 | PhD in virology and a |
peer-reviewed papers | professorial thesis in |
and patents, mostly on | neuroimmunology |
HERVs | |
Chief of Research & | PhD in Immunology from |
Immunology at Berna | ETH Zürich, post-doctoral |
Biotech, Professor of | work at Zürich University |
Immunology at | Hospital |
University of Bern | |
Previously CFO of | Degree in business |
Groupe Franck Muller & | administration from the |
Unilabs, among others | University of Geneva |
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Defeating neurodegeneration through Human Endogenous Retroviruses ("HERVs")
- GeNeuro is a clinical stage company headquartered in Geneva, with R&D facilities in France
- Founded in 2006 as an Institut Mérieux spin-off, based on 20 years of research on human endogenous retroviruses (HERVs) conducted within Institut Mérieux and bioMérieux
- Leader in the fight against HERV-mediated diseases, supported by a unique network of partnerships with leading Academic Institutions worldwide (NINDS, Karolinska, HHU, CIRI, FondaMental, etc.)
- Three active programs
- Neurodegeneration in Multiple Sclerosis: successful Phase II data with temelimab on key MRI and liquid biomarkers of neurodegeneration
- Ongoing Phase II study of Temelimab against severe neuropsychiatric syndromes post-COVID in CH, I and E
- Amyotrophic Lateral Sclerosis: partnership with NINDS to bring to IND a new diagnostic -> treatment for sporadic ALS
Shareholding structure (December 2022)
GeNeuro is listed on Euronext Paris (ISIN: GNRO) since 2016
P&L and cash balance | 1H | 1H | FY | |
2023 | 2022 | 2022 | ||
(in € '000) | ||||
Income | - | - | - | |
R&D | (5,316) | (3,402) | (8,007) | |
G&A | (1,747) | (1,487) | (3,222) | |
Operating loss | (7,063) | (4,889) | (11,229) | |
Cash & Equivalents | 7,398 | - | 5,593 | |
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Human Endogenous Retroviruses (HERVs)
Ancestral retroviral genomic (DNA) insertions
HERV elements are latent in human genome
- Represent approximately 8% of total human genome
- Genetic transposition leads to variable copy number, with non-ubiquitous copies in individuals
- HERVs are normally latent but may be de-repressed and transcribed to produce viral proteins
Missing link between viral infections and poorly understood autoimmune / neurodegenerative diseases
- Strong epidemiology data associates environmental viruses with diseases such as Epstein Barr Virus (EBV) in MS
- Environmental viruses are not sufficient in disease development
- They can activate HERV genes upon infection of permissive cells
- Pathogenic HERV proteins have been suggested as potential causal factors in autoimmune / neurodegenerative diseases
Sources: Regulatory evolution of innate immunity through co-option of endogenous retroviruses; Science, Vol. 351, Issue 6277 Discovery of unfixed endogenous retrovirus insertions in diverse human populations. Proc Natl Acad Sci U S A. 2016 Human Endogenous Retrovirus Type W Envelope Protein Inhibits Oligodendroglial Precursor Cell Differentiation; Ann Neurol. 2013;74(5)A
Other repeats | DNA |
transposons | |
3% | |
3% | |
Non-LTR | |
Other non-coding | retrotransposons |
35% | |
DNA | |
48% |
Protein-coding | |
HERVs | |
genes | |
8% | |
3% | |
The enemy within:
dormant retroviruses awaken
Engel & Hiebert,
Nature Medicine, 2010
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HERVs: the missing link between viral infection and autoimmune / neurodegenerative diseases ?
The enemy within:
dormant retroviruses awaken
Engel & Hiebert,
Nature Medicine, 2010
Viruses from our environment can activate HERV expression from our DNA in target cells /organs (dependent on virus- specific tropism)
HERV proteins may continue to be expressed long after the initial viral trigger is resolved
Some HERV proteins have well documented pathogenic properties and may play a key role in neurodegenerative and autoimmune diseases
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Existing IP portfolio & constant efforts to protect new discoveries place GeNeuro in a strong competitive position
- Mérieux Group & GeNeuro have been working for more than 25 years in the HERV field
- Key granted patents on temelimab filed from 2008 (NCE) to 2014 (on progression)
- Strong IP development strategy to continue protecting temelimab beyond 2034 (2039 w. SPC)
- 17 families of patents in HERV-W including the following 3 broad categories:
MSRV* ligand | ||
SEP 16 family | TLR4 family | 3 successive families |
Background including | Antibody against TLR4 | Product patents, therapeutic |
HERV-W sequences | HERV-W Envelope agonist | compositions & disease areas |
* previous name of HERV-W ENV |
- New anti-HERV-K patent co-owned with and in-licensed from NIH, filed in 2017
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GeNeuro seeks to deliver results
from three programs in areas of high unmet medical need
Program | Indication | Status | Pre-clinical Phase I | Phase II | Phase III |
HERV
Biology
applied to
Nervous
System
Diseases
Neurodegeneration | Finalization of | ||||||
/ remylenation in | Phase II | Results | Phase III | ||||
Multiple Sclerosis | strategy | ||||||
Completed | Presented | ||||||
Temelimab | With partners or | ||||||
Karolinska/ASC trial | ECTRIMS | independently | |||||
MAb against | Oct. 2022 | ||||||
Pivotal | |||||||
HERV-W ENV | Neuropsychiatric | Biomarker- | |||||
Phase II | Results | ||||||
syndromes | based 6-month | ||||||
launched | expected | ||||||
of Long-COVID | Phase II trial | ||||||
2Q2024 | |||||||
GNK301 | Sporadic | Preclinical POC | GMP | Biomarker- | |||
Amyotrophic | production | based | |||||
achieved through | and formal | ||||||
MAb against | Lateral Sclerosis | 6-month Phase | |||||
NINDS | preclinical | ||||||
(ALS) | I/II | ||||||
partnership | package to | IND | |||||
trial | |||||||
HERV-K ENV | IND | ||||||
Program launch subject to completion of additional funding
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Temelimab status against neurodegeneration in MS
A novel pathway to specifically target neurodegeneration and disability progression in MS
Phase II results open path to combination trial of temelimab with high-efficacyanti-inflammatory drug
In partnership discussions
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Despite effective treatments against relapses,
80% of MS patients suffer disability progression over time
• 2.8 million people worldwide suffer from MS
• 80% of them suffer from disability progression despite the availability of efficacious anti-inflammatory drugs
• HERV-WENV protein (W-ENV) is consistently found in MS brains
• W-ENV contributes to neurodegeneration through the activation of microglia and the inhibition of the brain's remyelination capacity
• Neutralizing W-ENVis an attractive strategy against neurodegeneration, which is the key market opportunity for the next decade in MS
Benign MS Primary Progressive MS
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GeNeuro SA published this content on 20 October 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 20 October 2023 09:52:03 UTC.
