© 2023 Cellaïon
Mont-Saint-Guibert, Belgium, 2023/06/20: Cellaïon is a biotechnology company based in Mont-St-Guibert, active in the field of liver regenerative advanced therapy, an area of excellence in the life sciences industry in Wallonia. Its flagship product HepaStem®, in advanced clinical development, targets severe liver diseases, and in particular acute-on chronic liver failure (ACLF)
Dr Walid Abi-Saab has joined the board of Cellaïon as Independent Director. Dr Abi-Saab has more than 20 years of experience in pharmaceutical R&D in medium and large size companies such as Pfizer, AbbVie, Novartis, Shire and was Chief Medical Officer at Galapagos.
“We are very proud to welcome Walid in our Board. The medical and scientific expertise of Walid’s and his broad knowledge and experience in drug development up to market is a key extension of our Board to successfully bring Cellaïon to the next stage of an international liver company” says Dr Philippe Pouletty, Chairman of the Board of Director.
Dr Walid Abi-Saab said “Cellaïon is a great company working to address a serious unmet medical need. I have been impressed by the great science and the quality of the medical and clinical development; I believe HepaStem® promises to be the first in class approved advanced therapy in liver regenerative medicine”.
Prof Etienne Sokal, Hepatologist, founder, CEO of Cellaïon and Vice-Chairman of the Board added “ I am very enthusiastic to work in close hands with Walid on the current strategy but also on the future plans for HepaStem®, as a platform therapy able to bring innovative solutions for a broad spectrum of inflammatory liver diseases”.
Cellaïon also announces the appointment of Griet Goddemaer as Vice President of Clinical Development. Following the completion of the ongoing phase IIB Proof of concept for which conditional approval is expected, Griet Goddemaer will prepare the company for the advanced clinical stage development including phase III and post marketing studies in EU and North and South America.
“It’s great to welcome Griet ! Griet will bring our already solid team her executive expertise from a large international organization to develop further HepaStem® following the completion of the ongoing Dheliver Phase IIB trial, and bring this life saving therapy to the market for patients in need“ says Prof Etienne Sokal.
“I am very excited to be part of the Cellaïon team in the development of HepaStem®, aspiring to provide a solution for patients with an unmet medical need. It is very inspiring to see the drive for quality, powered by science and passion!” says Griet Goddemaer, Vice President Clinical Development.
Cellaïon is also delighted to announce that following the randomization and completion of the study of the first fifty patients in the phase IIB clinical study Dheliver in acute on chronic liver failure (ACLF), the Data and Safety Monitoring Board (DSMB) has evaluated positively the safety of HepaStem® and gave Cellaïon the green light to pursue the clinical trial as designed. “The safety package of HepaStem® is becoming stronger and stronger, and we look forward to demonstrate with Dheliver the life saving benefit of HepaStem® in ACLF patients” says Etienne Sokal.
ACLF is an acute hepatic failure leading secondarily to multi-system failure (i.e., other organs such as kidneys, heart, brain, lungs). Mortality exceeds 50% in the short term. HepaStem® brings hope to counter this hyper-inflammatory condition and to significantly improve the survival of these patients. There is currently no therapeutic alternative, and emergency liver transplantation remains largely inaccessible for these patients.
Cellaïon is a Biotechnology company created in March 2021 and established in the Walloon biotechnological valley of cell therapy, in Mont-St-Guibert, Belgium.
Cellaïon develops cellular therapy using the anti-inflammatory and regenerative signaling properties of liver stem cells.
Its technology is protected by a wide range of patents resulting from academic research at UCLouvain (Louvain-La-Neuve, Belgium) and its own research and development.
The leading indication, namely multi-organ failures that complicate the loss of liver function – acute on chronic liver failure – ACLF – is a fatal disease for which no treatment is currently available.
HepaStem® acts directly on the cells making up the inflammatory reaction and on the signaling pathways of hepatic regeneration. By restoring liver function, secondary failures of other organs also recover their functional capacity.
The company is in advanced clinical development after successfully passing safety studies. More than one hundred patients have already received HepaStem®. Cellaïon has developed a manufacturing method allowing HepaStem® to be administered by a simple intravenous infusion with perfect tolerance.
The capital of Cellaïon is held by Fund+, Sofipôle, WE, Truffle Capital, Newton Biocapital, Brabant Walloon Invest, 6K Venture Capital as well as by Belgian and German private shareholders.
Contact informations : Cellaïon SA
Tel: +32 (0)10 39 43 00
QA ANALYST – GcP
Cellaïon SA is currently hiring a QA Analyst – GcP.
– Writing of general quality system procedures to support business objectives and comply with regulatory requirements for clinical, production, logistics, QA and QC activities.
– Review and evaluate production batch and QC files (batch records, certificates of analysis and compliance, etc.) prior to the release of clinical batches.
– Manage and update quality assurance system documents.
More Info? Please, download the Job description!
A new article on the Multi-Target Effect of HALPCs in the NASH STAM model has recently been published in Cells Journal. “Human Allogeneic Liver-Derived Progenitor Cells Significantly Improve NAFLD Activity Score and Fibrosis in Late-Stage NASH Animal Model”. Cells is an international, peer-reviewed, open access journal of cell biology, molecular biology, and biophysics This peer-reviewed publication recognizes HALPCs as part of the most recent advances in liver repair strategies. This article is the first to show the results of the in vitro and in vivo properties of HALPCs.
A phase II study of human allogeneic liver-derived progenitor cell therapy for acute-on-chronic liver failure and acute decompensation
Phase I/II Trial of Liver–derived Mesenchymal Stem Cells in Pediatric Liver–based Metabolic Disorders
The new Walloon company Cellaïon makes its first closing.
Cellaion SA announces a total fundraising of EUR 23 million in 2022.
Cellaion SA announces the arrival of Walid Abi-Saab in its Board of Directors, the hiring of Griet Goddemaer to lead clinical development and the green light from the DSMB for the continuation of ACLF- Dheliver Clinical trial.