Company Milestones

Prof. Bernard BIHAIN, Doctor of Medicine, Dr. Virginie OGIER, and Dr. Sandrine JACQUENET create the company GENCLIS as a contracted clinical research company. GENCLIS generates between 1 and 1.2 million Euros in revenue, with a profit greater than 20%.
GENCLIS organizes its first capital increase, in order to develop its own range of products. CM-CIC Investissement and the Institut Lorrain de Participation are involved in the capital increase.
GENCLIS is the first company to achieve the production and clinical validation of a recombinant test for the diagnosis of food allergy.This product changes clinical practice in regards to the diagnosis of peanut allergy and is licensed to PHADIA (now THERMO FISHER).The same year, GENCLIS files a patent protecting its discovery of transcription infidelity.
GENCLIS undertakes a program of translational research, aimed at establishing the clinical relevance of its discovery of RNA sequence heterogeneities, or RNA-DNA differences (RDDs).
GENCLIS competes and is awarded first prize (EUR 1 million) on behalf of the fondation INNABIOSANTE for its discovery of RDDs.
The concept of differences between DNA and RNA sequences is established and confirmed by several independent academic groups.
The National Institute of Health (NIH) grant GENCLIS unlimited access to clinical and sequencing data developed under the framework of The Cancer Genome Atlas (TCGA) program (TCGA Database).
GENCLIS obtains the first statistical evidence of a strong association between RDD levels and the severity of triple-negative breast cancer (TNBC).
GENCLIS begins marketing a range of allergenic products through partnerships with Hycor Biomedical (human market) and Galileo Diagnostics (veterinary market).
The measurement of RDD levels opens new perspectives in the detection of the severity of all major cancers.
The first range of SeveridiaTM products aims to predict the risk of recurrence of three cancers – TNBC, clear cell renal cell carcinoma, and bladder carcinoma – which are frequently characterized by the absence of recurrence after resection.

6 Technology Platforms

Statistics
BioInformatics
Informatics
nucleic
acid
engineering
PROTEIN
ENGINEERING
IMMUNOASSAYS
PRECLINICAL
TRIALS
CLINICAL
STUDIES


Head :
Dr Benoit THOUVENOT




Head :
Lionel BONNARD



Head :
Dr Olivier ROITEL



Head:
Dr Christelle RICHARD



Head :
Dr Julie TOMASINA


Head :
Delphine MAURICE

STATISTICS – BIOINFORMATICS – INFORMATICSCreation of information technology tools to process, organize, and visually display data

Statistical analysis (descriptive analysis, selection of variables, discrimination,regression, survival analysis)

Development of software pipelines for data analysis

Analysis of next-generation sequencing (NGS) data
(quality control, alignment, etc.)

Multiple data processing (Omics, ELISA, miRNA, etc.)

Database design and management

NUCLEIC ACID ENGINEERINGDNA/RNA/Plasmid extraction from different sources: biological fluids, cells, tissues (biopsy, paraffin, etc.), food, and bacteria

Nucleic acid quantification

Primers and probe design for PCR and qPCR
PCR, qPCR (ABI 7500® : gene expression level, quantification)

Genotyping

Cloning

Site-directed mutagenesis

Synthetic genes

PROTEIN ENGINEERINGDesign of genes (research of isoforms, sequence alignment, etc.), modeling of 3D protein structure

Recombinant protein production in bacteria (Escherichia coli) and yeast (Pichia pastoris)
in batch mode and fed-batch mode

Purification of natural and recombinant proteins(inclusion bodies and soluble forms)
from complex matrices. Chromatography (Ion exchange, Hydrophobic Interaction,
size-Exclusion, affinity, mixed-mode, reverse phase, etc.)
on Akta Explorer and Xpress

Validation of purified proteins
(purity, stability, activity, immunogenicity, etc.)

IMMUNOASSAYSELISA and Western blot

Study of the feasibility of immunoassay tests

Development and optimization of immunoassay tests (reagents, concentrations, incubation times, etc.)

Study of the robustness of immunoassay tests (quality control, robustness, reproducibility, repeatability, limit of detection, limit of quantification, etc.)

Characterization and quantification of specific and total antibodies

PRECLINICAL TRIALSCell culture (maintenance of lines and gene extinction by RNA interference)

Plethysmograph

Calorimetry

Drafting of project authorization requests

Member of the Lorraine Ethics Committee

CLINICAL STUDIESClinical data collection

Organization and management of serum banks

Design and management of patient and sample databases

Interface between clinicians and researchers

STATISTICS – BIOINFORMATICS – INFORMATICS

List of key skillsCreation of information technology tools to process, organize, and visually display data

Statistical analysis (descriptive analysis, selection of variables, discrimination, regression, survival analysis)

Development of software pipelines for data analysis

Analysis of next-generation sequencing (NGS) data (quality control, alignment, etc.)

Multiple data processing (Omics, ELISA, miRNA, etc.)

Database design and management

Responsible for platform

Dr Benoit THOUVENOT

Dr Stéphane VERDUN

NUCLEIC ACID ENGINEERING

List of key skillsDNA/RNA/Plasmid extraction from different sources: biological fluids, cells, tissues (biopsy, paraffin, etc.), food, and bacteria

Nucleic acid quantification

Primers and probe design for PCR and qPCR
PCR, qPCR (ABI 7500®: gene expression level, quantification)

Genotyping

Cloning

Site-directed mutagenesis

Synthetic genes

Responsible for platform

Lionel BONNARD

PROTEIN ENGINEERING

List of key skillsDesign of genes (research of isoforms, sequence alignment, etc.), modeling of 3D protein structure

Recombinant protein production in bacteria (Escherichia coli) and yeast (Pichia pastoris) in batch mode and fed-batch mode

Purification of natural and recombinant proteins (inclusion bodies and soluble forms) from complex matrices. Chromatography (Ion exchange chromatography, Hydrophobic Interaction Chromatography, Size-Exclusion Chromatography, affinity, mixed-mode, reverse phase, etc.) on Akta Explorer and Xpress

Validation of purified proteins (purity, stability, activity, immunogenicity, etc.)

Responsible for platform

Dr Olivier ROITEL

IMMUNOASSAYS

List of key skillsELISA and Western blot

Study of the feasibility of immunoassay tests

Development and optimization of immunoassay tests (reagents, concentrations, incubation times, etc.)

Study of the robustness of immunoassay tests (quality control, robustness, reproducibility, repeatability, limit of detection, limit of quantification, etc.)

Characterization and quantification of specific and total antibodies

Responsible for platform

Dr Christelle RICHARD

PRECLINICAL TRIALS

List of key skillsCell culture (maintenance of lines and gene extinction by RNA interference)

Plethysmograph

Calorimetry

Drafting of project authorization requests

Member of the Lorraine Ethics Committee

Responsible for platform

Dr Julie TOMASINA

Dr Marion MICHEL

CLINICAL STUDIES

List of key skillsClinical data collection

Organization and management of serum banks

Design and management of patient and sample databases

Interface between clinicians and researchers

Responsible for platform

Simone BARRAT

Management Team

Bernard Bihain, MD, PhD, CEO

Dr. Bihain created GENCLIS in 2004. After receiving his Doctorate in Medicine from the Free University of Brussels in 1984, Bernard began a surgery internship. In 1988, he left his internship to devote himself exclusively to research as a Postdoctoral Fellow at Columbia University, NY, USA. Thereafter, Dr. Bihain took a position in 1990 as Assistant Professor of Physiology at the University of Louisiana, New Orleans, USA. He was awarded the position of Research Director at INSERM in 1992 and became Professor and Chairman of the Department of Biochemistry, University of Rennes, where INSERM Unit 391 was created in 1994. He then undertook the direction of the Department of Functional Genomics of Genset, a listed genomics company that was acquired by Merck-Serono. Dr. Bihain later became CSO of Valigen, but left this position to focus on the creation of GENCLIS. He has actively contributed to the emergence of genomic technologies. His pragmatism, stemming from his experience as a surgeon, powers the translational activities of GENCLIS. Dr. Bihain has authored over 50 publications in peer-reviewed journals, and his studies are cited in more than 5000 scientific articles.

Sandrine Jacquenet, PhD, Vice President of Allergy

Dr. Jacquenet co-founded GENCLIS in 2004. In charge of the Allergy Service and Research activities since 2005, she was Project Manager for the development and quality control of a milk- and peanut-free margarine produce that has been sold through St. Hubert since 2007. She was also Project Manager for the development of a peanut allergy test licensed to Phadia in 2007. Sandrine is a member of the Task Force on Molecular Allergens of the French Society of Allergology. Previously, she worked at the École Normale Supérieure of Lyon as a Postdoctoral Fellow in Human Virology. Sandrine holds a PhD in Structural, Molecular and Cellular Biology from Henri Poincaré University, Nancy, France.

Virginie Ogier, PhD, Vice President of Oncology

Dr. Ogier co-founded GENCLIS in 2004. With the discovery of the heterogeneity of RNA sequences in 2007, she focused her activities on various applications of this discovery in cancer. From 2004 to 2007, she was Project Manager for different service contracts of GENCLIS. Since 2007, she has led the R&D Cancer division of GENCLIS. Virginie holds a PhD in Structural, Molecular, and Cellular Biology from Henri Poincaré University, Nancy, France.

Scientific advisory board

Prof. FRANKLYN G. PRENDERGAST, MD, PhD

Dr. Franklyn G. Prendergast is an Edmond and Marion Guggenheim Professor Emeritus of Biochemistry and Molecular Biology, as well as a Professor of Molecular Pharmacology and Experimental Therapy of Mayo Medical School in Rochester, NY, USA.
Dr. Prendergast received his MD degree with honors from the University of West Indies in Jamaica. After obtaining a Masters in Physiology from the University of Oxford, Dr. Prendergast was awarded a PhD in Biochemistry from the University of Minnesota, Mayo Graduate School.
Dr. Prendergast was Chairman of the Department of Biochemistry and Molecular Biology and Director of Research at Mayo Clinic in Rochester from 1989 to 1992. He served as a member of the Executive Board of Mayo Clinic from 1989 to 1996, as well as a member of the Board of Directors of the Mayo Clinic and Lilly from 1992 to 2009. Currently, he is an Emeritus Member of the Executive Board and Board of Directors of Mayo Clinic and Director Emeritus of the Mayo Clinic Center for Personalized Medicine. Dr. Prendergast has received numerous honors and awards.

Dr. HEINZ BODENMUELLER, PhD

Dr. Bodenmueller is a specialist in the discovery and clinical validation of cancer biomarkers. His main discovery was that of CYFRA21-1, a serum biomarker for therapeutic monitoring and early detection of recurrent non-small cell lung cancer.
Dr. Bodenmueller brings to GENCLIS his experience in the discovery and industrial development of biomarkers, as well as biochemistry expertise developed during a 20-year career in diagnostics at Boehringer Mannheim and Roche. Dr. Bodenmueller has a thorough knowledge of biobank networks and quality control systems. Through Dr. Bodenmueller, GENCLIS has access to diverse and extremely valuable samples.

Prof. JEAN-PIERRE ARMAND, MD

Dr. Armand has dedicated much of his career to new mechanisms of oncogenesis and the early phases of development of innovative molecules. After completing a research fellowship at Columbia University, NY, Dr. Armand joined the Claudius Regaud Institute in Toulouse, where he headed the Department of Medical Oncology until 1984. During the next 23 years, Dr. Armand worked at the Gustave Roussy Institute of Oncology (IGR) in Paris, where he served as Director General of IGR3, Head of the Department of Medical Oncology of IGR2, and Marketing Director for the Department of Innovation and Development at IGR. After 5 years as General Director at the Claudius Regaud Institute, he returned to IGR, where he now serves as Consultant to the Drug Development Department (DITEP). Dr. Armand’s current interests focus on the development of new therapies for patients with treatment failure. He has demonstrated a personal investment in biotech companies specializing in the field of cancer.
Although an expert in the fields of breast oncology, ENT, and neuro-oncology, Dr. Armand’s primary investigatory domain is the early-phase (I and II) development of new anticancer agents. Founder of DITEP in the 1980s, Dr. Armand was the first researcher at IGR to initiate the phase I development of many therapeutics and, more recently, targeted therapies that are currently used in the clinic.

Prof. FRANÇOIS AMALRIC, PhD

A chemist by training, Dr. Amalric began his career as a researcher at the CNRS. After conducting research as a Postdoctoral Fellow at CALTECH, USA, he headed a research team at CRBGC, a CNRS laboratory in Toulouse, France, in 1977. Appointed Professor of Molecular Biology at Paul Sabatier University in Toulouse in 1986, Dr. Amalric took over direction of the Laboratory of Eukaryote Molecular Biology (UPR 9006-CNRS) in 1992, a post he held until 1998. From 1996 to 1997, he also directed the Department of Biology, Health, and Medicine of the Ministry of National Education of Higher Education and Research.
He served as Director of the Institute of Pharmacology and Structural Biology of Paul Sabatier University (IPBS-UMR 5089) until 2008, when he became a Professor Emeritus.
Dr. Amalric initially investigated ribosome biogenesis in eukaryotic cells, followed by the control of cell proliferation in tumor cells. These interests led him to develop a new line of research on growth factors (in particular, FGF2) and to consider the different phenotypes of endothelial cells.
In parallel with his teaching and research activities, Dr. Amalric served as Adviser to the Chairman of the National Cancer Institute (INCa) for Research, as Director of the Department of Cancer Biology from 2005 to 2007, and as a member of several scientific boards, including the Scientific Board of the “Cancer-Bio-Health” Competitivity Pole in Toulouse, over which he has presided since 2009.