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Human monoclonal antibody therapy to prevent hepatitis C virus reinfection of liver transplants: advancing lead monoclonal antibodies into clinical trial

Objective

Worldwide, 200 million people are infected with the hepatitis C virus (HCV). An estimated 15 million individuals are living with HCV infection within the EU. The economic, health and societal costs of chronic HCV infection are significant. HCV is the principal cause of death from liver disease and the leading indication for liver transplantation. The only treatment for end-stage liver disease is a liver transplant, yet the transplanted liver becomes rapidly re-infected and is frequently destroyed within 5 years after transplantation. In this cohort of patients current antiviral treatments are too toxic - there is an urgent need to develop safe and effective treatments for use in this setting. Human monoclonal antibodies (MAbs) that target virus entry, are as yet an underutilised and potentially highly effective and safe weapon in the armoury against HCV infection. The consortium has identified MAb leads which, in pre-clinical analyses, potently block HCV infection. HCV exhibits a high degree of genetic and antigenic variability, which enables the virus to escape protective immune responses. Crucially, the lead antibodies identified by the consortium are capable of preventing infection by a wide range of genetically distinct isolates because they target highly conserved epitopes on the virus or host receptor molecules. This limits the chances of virus resistance. Also, each lead antibody targets a unique component of the viral entry pathway, thereby paving the way for powerful combinatorial approaches which maximises clinical potency. HepaMAb harnesses leading expertise in MAb technology, preclinical efficacy and safety testing, biomanufacture and clinical trial to progress at least one anti-viral and one anti-receptor human MAb to phase I/IIa proof of concept clinical trial in the liver transplant setting for the prevention of graft reinfection. We will establish a much-needed therapeutic MAb pipeline for use in this solid organ transplant setting.

Field of science

  • /medical and health sciences/clinical medicine/transplantation

Call for proposal

FP7-HEALTH-2012-INNOVATION-1
See other projects for this call

Funding Scheme

CP-FP - Small or medium-scale focused research project

Coordinator

THE UNIVERSITY OF NOTTINGHAM
Address
University Park
NG7 2RD Nottingham
United Kingdom
Activity type
Higher or Secondary Education Establishments
EU contribution
€ 1 039 196,40
Administrative Contact
Jill Burton (Ms.)

Participants (6)

MOLECULES OF MAN AB
Sweden
EU contribution
€ 728 688
Address
Mossvagen 12
16756 Bromma
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Mats Persson (Dr.)
GENIBET - BIOPHARMACEUTICALS SA
Portugal
EU contribution
€ 1 470 203,60
Address
Avenida Da Republica Quinta Do
2781 901 Oeiras
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Teresa Alves (Dr.)
CEINGE BIOTECNOLOGIE AVANZATE SCARL
Italy
EU contribution
€ 1 145 304
Address
Via Gaetano Salvatore 486
80145 Napoli
Activity type
Research Organisations
Administrative Contact
Alfredo Nicosia (Prof.)
UNIVERSITEIT GENT
Belgium
EU contribution
€ 597 700
Address
Sint Pietersnieuwstraat 25
9000 Gent
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Margo Baele (Dr.)
CONSORCI INSTITUT D'INVESTIGACIONS BIOMEDIQUES AUGUST PI I SUNYER
Spain
EU contribution
€ 586 749
Address
Calle Rossello 149 Puerta Bjs
08036 Barcelona
Activity type
Other
Administrative Contact
Pastora Martinez Samper (Ms.)
UNIVERSITE DE STRASBOURG
France
EU contribution
€ 419 062
Address
Rue Blaise Pascal 4
67081 Strasbourg
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Sandrine Schott-Carriere (Mrs.)