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FlandersBio offers an up-to-date life sciences database with detailed information about all FlandersBio members.

FlandersBio beschikt over een geüpdate life sciences databank met een gedetailleerd overzicht van alle FlandersBio-ledenbedrijven.

Promethera Biosciences

Website: http://www.promethera.com
Email:
Phone: +32 10 39 43 00
FlandersBio Member
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Business Focus

Promethera Biosciences is a global innovator in liver cell-based medicines whose mission is to help patients overcome acute and chronic liver diseases. Our lead clinical program, derived from our patented cell technology platform HepaStem, is designed to benefit from its immune-modulatory and anti-fibrotic properties.

We are a team of international experts operating out of R&D and GMP facilities in Mont-Saint-Guibert, Belgium, and Durham, NC, USA. 

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Company Profile

Promethera Biosciences is a global innovator in liver cell-based medicines whose mission is to help patients overcome acute and chronic liver diseases. Our lead clinical program, derived from our patented cell technology platform HepaStem, is designed to benefit from its immune-modulatory and anti-fibrotic properties.

We are a team of international experts operating out of R&D and GMP facilities in Mont-Saint-Guibert, Belgium, and Durham, NC, USA. 

Science & Technology or Services

Promethera is pioneering the development of novel cell-based medicines for the treatment of a broad variety of liver diseases. The Company’s platforms have the potential to deliver novel therapeutic solutions for inherited disorders including hemophilia as well as acquired acute liver diseases such as Acute-on-Chronic-Liver Failure (ACLF) and Non-Alcoholic Steatohepatits (NASH) and fibrosis. 

Promethera’s lead clinical program is derived from a patented allogenic liver cell platform called HepaStem. Currently in an open-label Phase 2 clinical trial to treat patients with Acute-on-Chronic-Liver Failure (ACLF), the program is expected to enter clinical development in Non-Alcoholic Steatohepatits (NASH) in the second half of 2017

Product description

HepaStem
HepaStem is a human liver derived mesenchymal stem cell with the potential to differentiate into hepatocyte like cells and displaying anti-inflammatory and anti-fibrotic properties. HepaStem is today developed in ACLF and NASH/Fibrosis. Promethera Biosciences has started a phase IIa trial in ACLF to establish the safety of the peripheral intravenous infusion of HepaStem as a primary endpoint and explore clinical and biological parameters as secondary endpoints.

The Company is also exploring the possibility to use HepaStem as a distinct cell-based gene therapy platform after genetic modification of this cell. Currently this approach is using the Hemophilia B indication for a general proof of concept before designing tailored cells for its core programs. HepaStem will be administered intravenously, a customary injection method in stem-cell based medicines.

H2Stem
H2Stem is a human liver derived progenitor cell line that has the potential to differentiate towards the hepatocyte lineage. The Company is currently advancing the platform towards the clinic by improving the manufacturing process and further characterization of the cell type’s therapeutic potential.

H2Stem technology platform

H2stem are liver derived progenitor cells characterized by the expression of biliary, endoderm, hepatocytic and mesenchymal markers. In addition, they retain the capability of differentiating in vitro into hepatocyte-like cells and show a high capacity to home and repopulate the liver of FRG mice, an established model for human xenografts, with mature functional hepatocytes. These results suggest a liver stem cells role of H2stem.

H2stem can be differentiated in vitro towards hepatocyte lineage and differentiated cells are characterized by the expression and secretion of albumin and alpha 1-antitrypsin.

Heparesc

Heparesc is Promethera’s most advanced pre-commercial product. Two clinical studies have successfully been completed.  Promethera is preparing a New Drug Submission (NDS) with Health Canada planned for early 2017. 

Heparesc (Human Heterologous Liver Cells [HHLivC]) is a cell therapy product of allogenic source that has been developed for the treatment of patients with urea cycle disorders (UCDs).  The product consists of a cryopreserved suspension of liver cells, which are isolated from non-transplantable donor organs and prepared in a standardized manufacturing process under Good Manufacturing Practice (GMP) conditions. Thus, the cell technology is comprised of liver-derived primary, mature hepatocytes.

Alliances

Promethera has developed a series of research and development as well as collaborative partnerships. These agreements are signed with both academic and industrial partners, designed to help Promethera broaden and accelerate its clinical development.

Industrial partnerships

Early 2017 Promethera signed a strategic alliance with LifeLiver to develop liver disease therapeutics in South Korea.

Promethera is collaborating with PALL to develop innovative manufacturing processes.

Academic Partners

Université Catholique de Louvain and the Pediatric Hepatology and Cell Therapy Laboratory

Promethera Biosciences has an ongoing collaboration agreement with Université Catholique de Louvain and the Pediatric Hepatology and Cell Therapy Laboratory.

ULB (Université Libre de Bruxelles)

Promethera Biosciences has an agreement for its histology studies and bio-marker research with the CMMI department of the ULB.

University College of London

Early 2015 Promethera entered into a collaborative partnership with University College of London.  The partnership includes the possibility of developing 3D engineered tissues by combining human liver biological scaffolds and human liver-derived stem cells.

Collaborative Projects

Promethera Biosciences received funding from:

The Walloon Region, Belgium (DGO6) and the EU have granted conditional loans and subsidies for Promethera to develop its cell therapy products and conduct clinical studies for targeted indications for a total amount of 22.78 million euros.

  • The amount granted in RCA’s is 20.2 million euros
  • 1.8 million euros in subsidies
  • 0.78 million euros from FEDER funds (European Fund for Economic and Regional Development)

L'agence Wallonne de l'Exportation (AWEX), Belgium supports the international development of Promethera Biosciences. 

CER groupe

In 2011, Promethera entered into a collaboration with the CER groupe in order to conduct in-vivo pre-clinical studies for its cell-therapy products. In addition, in January 2016 both companies started to collaborate on a new CWALity project, partially funded by the Walloon region.

More info

Address: Watson & Crick Hill
Rue Granbonpré 11
1435 Mont-Saint-Guibert
Belgium

Route: Via Google Maps
Website: http://www.promethera.com

Phone: +32 10 39 43 00
Fax: +32 10 39 43 01
Foundation date: 2/2009
Email: info@promethera.com

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