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DISCORVER GOLIVER THERAPEUTICS

THE CELL THERAPY AND THE REGENERATIVE MEDICINE OF TOMORROW

Goliver Therapeutics

GOLIVER THERAPEUTICS is a spin-off from the INSERM and University of Nantes (CRTI UMR1064-ITUN-Nantes Hospital), focused on developing cell-based Advanced Therapy Medicinal Products (ATMP) to respond to an urgent unmet medical need in transplantation.

GOLIVER THERAPEUTICS aims to become a Worldwide leader inregenerative medicine in providing the first cell-based therapy product for life-threatening liver failures.

Date of creation : April 2017.

The Solution That Goliver Therapeutics Provides

GoliverTX solution is based on the remarkable and unique ability of the liver to regenerate after injuries (the myth of Prometheus)

->It is manufactured from pluripotent stem cells, which have unlimited self-renewal ability and can be differentiated

into hepatocytes, the metabolic cells of the liver.

After injection into the patient, the hepatocytes will support liver metabolism and regeneration with the therapeutic benefit of:

Patient recovery without liver graft

 ""Therapeutic bridge” to liver transplant.


The cell therapy is transient :

 After patient healing (or liver transplant), there is no further need of the injected therapeutic cells

➜ Immunosuppression to avoid cell rejection is short-term.

THE GOLIVERTX TEAM

CORE TEAM


Tuan Huy NGUYEN (PhD)Co-Founder, Former researcher at INSERM, Expert in the field of liver cell & gene therapy and regenerative medicine, Former head of the GenoCellEdit Platform (CRISPR/cas) SFR Bonamy-Inserm CRTI UMR1064

Michel COIGNARD VP Finance, Co-Founder, Former CFO Alcatel, General Foods, Trailer

Julie CANOVAS Chief Technological Officer, former Technology Transfer Project Manager at GSK

Angélique FOURRIER R&D Scientist, PhD in Regenerative medicine with hepatocyte-derived pluripotent stem cells

Frédéric DELBOS : R&D engineer, expertise in liver-directed regenerative medicine with pluripotent stem cells and pre-clinical studies

Malika GANTIER : PhD Student in collaboration with the INSERM Unit - CRTI UMR 1064 (Research Center in Transplantation and Immunology)

Nathalie NGUYEN : Administrative and Financial Manager

Prof. Thierry GUSTOT : Directeur Médical de la Transplantation Hépatique: Hôpital Erasme, Bruxelles, Belgique; Editor of J. Hep. Reports

Patrick CASSAGNE : Fundraising from Business angels, CEO CASSAGNE et Associés

Didier COQUOZ : Director of Regulatory Affairs, CEO Copexis

 Prof. Faouzi SALIBA : Director of Clinical Development, Hepatologist and Transplant critical care intensivist, Coordinator of  FULMAR trial

 Thomas Zadrozny : EU Project Manager

 Franck Merly : Chief Operating Officer - Innovation R&D, PhD in Cellular and Molecular Biology, expertise in innovation strategy for health technologies

Prof. Anne Mouré: R&D scientist, PhD in cell therapy and bioartificial pancreas

 Anne-Sophie GARY : R&D scientist, PhD in Regenerative Medicine, University Laval, Quebec, Canada


Business Development Advisory Board


Didier HOCH: Chairman : Chairman of the Supervisory Board Pherecydes Former Chairman of the Sanofi Pasteur MSD

Maryvonne HIANCE: VP Business Development : Co-Founder Vice Chairman of the Board and Director for Public Affairs of OSE immunotherapeutics, President of the « HealthTech Investor Days » committee and Vice Chairman of France Biotech

Prof. Thierry GUSTOT : Directeur Médical de la Transplantation Hépatique - Hôpital Erasme, Bruxelles, Belgique; Editor of J. Hep. Reports

Tuan Huy NGUYEN (PhD): CEO and CSO : Co-Founder, Former researcher at INSERM, Expert in the field of liver cell & gene therapy and regenerative medicine

Michel COIGNARD VP Finance: Co-Founder, Former CFO Alcatel, General Foods, Trailer


Scientific Advisory Board


Anne WEBER-BENAROUS (PhD) Former Director INSERM unit Pioneer in stem cell-based liver therapy, Coordinator of Liv-ES and Innovaliv European FP7 projects (2008-2014)

Prof. Didier SAMUEL: Dean of the Paris Sud Faculty of Medicine, Director of the Inserm Unit 1193, Paul-Brousse Hospital, Centre Hépato-Biliaire, Villejuif, France

Prof Alberto Sanchez-Fueyo MD-PhD, Academic Head of Liver Sciences : King’s College London, Expert in Liver Immunotherapy and Transplantation, ORCID 0000-0002-8316-3504

Fabien MONCAUBEIG: BIP Partners, Former Head of EMEA Bioprocess and Cell culture Services, PALL Life Science

Prof. Faouzi SALIBA Prof. Hepatology : Hepatologist and Transplant critical care intensivist, Coordinator of  FULMAR trial

Prof. Thierry GUSTOT: Head Liver Transplant: Erasme Hospital, Bruxelles, Belgium, Editor of J. Hep reports


OTHER ADVISORS AND COLLABORATORS


 L. Nguyen: Business development : , CEO Bionure, Former CEO of Sensorion

 L. Selig: Business development : CEO CYTOO, co-founder of Hybrigenics

 D. Franco: clinical development co-founder, VP of the French National Academy of Surgery, former Head visceral surgery unit, former ANSM expert

 JC. Duclos-Vallée: clinician collaborator : CHB Paul Brousse Hospital (Villejuif), coordinator of RHU iLite

 A.Dubart-Kupperschmitt: scientific collaborator : U1193 INSERM, Leader of Stem cell and Liver Team

 L. Vallier: scientific collaborator: Cambridge University, expert in pluripotent stem cell

LIVER DISEASES

Acute liver failure
Acute liver failure
Genetic diseases
Genetic diseases
Cancers
Cancers
Cirrhosis
Cirrhosis
NASH (nonalcoholic steatohepatitis)
NASH (nonalcoholic steatohepatitis)
more

THE CONSEQUENCES

The liver is the most complex and metabolically organ (>500 functions) in the body: synthesis, secretion, regulation and detoxification. Severe fulminant live diseases are life-threatening and current solutions are unsatisfactory.

To know more:

Link to ‘CHB Paul-Brousse Hospital” (https://www.centre-hepato-biliaire.org/en/maladies-foie.html)
Link to ‘” American Liver Foundation” (https://liverfoundation.org/for-patients/about-the-liver/diseases-of-the-liver/)
link to TRANSHEPATE (https://www.transhepate.org/)
Link to ELTR (http://www.eltr.org/)
Link to ELPA (https://www.eu-patient.eu/Members/The-EPF-Members/Full-Membership/European-Liver-Patients-organisation–ELPA/)
Link to ERN RARE-LIVER (https://rare-liver.eu/)

LIVER TRANSPLANTATION

50,000 cases/year
Exit
Death
Grafted
Ungrafted

LIVER TRANSPLANT WAITING LIST IN EUROPE AND THE UNITED STATES


Sources: EUROTRANSPLANT, AGENCE DE LA BIOMEDECINE, FRANCE ADOT, ELTR (Europe), OPTN (USA)

Liver transplantation is the only proven cure at end-stage disease when the failing liver can no longer provide a minimum level of vital functions. Nevertheless, the urgent unmet medical need remains. Because of timely unavailability graft, of lifelong immunosuppression-associated complications, and

BECAUSE OF THE SHORTAGE OF ORGANS, AN ALTERNATIVE SOLUTION TO LIVER TRANSPLANT IS TO BE FIND. HOW?

➞ By Developing new generations of Advanced Therapy Medicinal Products (ATMP)
➞ By developing a novel cell therapy using the technology of pluripotent stem cells for regenerative medicine – Health of the Future
➞ By developing industrialization for the pharmaceutical cell drug manufacturing, from the raw biological material to bedside – Industry of the Future -.

GOLIVER THERAPEUTICS IS DEVELOPING THIS HEALTH OF THE FUTURE AND THIS INDUSTRY OF THE FUTURE TO BECOME A MAJOR WORLD LEADER IN LIVER REGENERATIVE MEDICINE

REGENERATIVE MEDICINE

“GOLIVER THERAPEUTICS is pioneering liver regeneration with differentiated human pluripotent stem cells.”

The human body contains more than 100,000 billion cells that die and are replaced any time.

➞ In 1950, the concept of adult stem cells explains the renewal of blood and skin.

➞ In 1957, bone marrow transplant in patients begin (E. Donald Thomas), this is the beginning of cell therapy with stem cells.

➞ The early 2000s saw the acceleration of research on human pluripotent stem cells, a biomedical breakthrough rewarded by the Nobel Prize in Medicine in 2012 (J. Gurdon and S. Yamanaka).

➞ Pluripotent stem cells, of embryonic or induced origin (iPS) resulting from the reprogramming of adult cells to a state similar to embryonic cells, have a huge biomedical and pharmaceutical. potential because they proliferate indefinitely in vitro on culture dish while retaining the ability to differentiate into any cells of the body.

➞ They open the perspective of repairing organs and tissues to cure diseases and injuries.

The first clinical trials have already begun and confirm the biomedical interest of differentiated pluripotent stem cells in treating spinal cord injuries (2010), retinal degenerative diseases (2011), heart failure (2014, Prof. Menasché, G. Pompidou Hospital, France), treating diabetes (2018) and graft-versus-host disease (2018).

To know more :
(Ilic et al, Human embryonic and induced pluripotent stem cells in clinical trials, British Medical Bulletin 2015)

Cell Therapy Product

1

Cell therapy is a promising therapeutic option for liver diseases, as an
alternative to liver transplant.

2

Injection of hepatocytes isolated from donor livers: > 100 patients (since 1994). Target diseases: genetics, acute liver failure, cirrhosis. Results: clinical improvements, healing without graft, therapeutic bridge. But the problem of organ shortage remains, the amount of isolated cells is limited and these cells do not multiply sufficiently in vitro.

3

The drug candidate of GOLIVER THERAPEUTICS is an injectable solution containing hepatocytes produced from human pluripotent stem cells, an unlimited source of body cells grown in the laboratory.

OUR THERAPEUTIC CONCEPT : REPAIR THE LIVER WITHOUT GRAFT

The liver : an unique organ with self-repair and regeneration ability

CONTACT US

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    PARTNERS, COLLABORATORS AND FINANCIAL SUPPORTS OF THE GOLIVER THERAPEUTICS PROJECT


    Co-financing from the European Union (ERDF) of 400 000 € to develop an industrial production process at the scale of one
    billion cells to repair the liver without graft. (2018/2020)

    INFORMATIONS

    GoLiver Therapeutics
    8 quai Moncousu – BP 70721
    44007 Nantes Cedex, France

    Tel: 33 (0)782721251
    Mail: secretariat@golivertx.com