Cellaïon News
10-May-2024
Cellaïon Announces Discontinuation of Phase 2b Clinical Trial in Acute on Chronic Liver Failure with HepaStem®
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• Appointment of James Neil Phillips as Chief Executive Officer of Cellaïon SA
• Nomination of Etienne Sokal as Chairman of the Scientific and Medical Advisory Board and Vice-Chairman of the Board of Directors
Mont-Saint-Guibert, Belgium, 2023/10/02: Cellaïon is a biotechnology company based in Mont-
St-Guibert, active in the field of liver regenerative advanced therapy, which is an area of excellence in the life sciences industry in Wallonia. Its flagship product, HepaStem®, is in advanced clinical development, and targets severe liver diseases, particularly Acute-on-Chronic Liver Failure (ACLF)1.
Dr James Neil Phillips has joined Cellaïon SA as Chief Executive Officer and member of the board of directors. Jim is a registered physician with an MBA from Bayes Business School in London. With over 25 years of experience in the pharmaceutical industry, Jim brings expertise in product development and commercialization. Previously, he was CEO of Païon AG, Managing Director of Imevax GmbH and for five years, CEO of Midatech Pharma. In Europe. He played a pivotal role as President of EUSA Pharma Europe during its key growth phase before its acquisition by Jazz Pharma in 2012. Jim was the CEO and founder of Talisker Pharma (established in 2004 and later acquired by EUSA Pharma in 2006). Additionally, he served as Chairman of Prosonix from 2007 to 2012, leading to its successful acquisition by Circassia. Prior to these roles, Dr. Phillips held senior executive positions at Johnson & Johnson and Novartis. In 2022 he founded the Sofiia Okunevska Foundation dedicated to providing medical aid and supplies to Ukraine. Jim Phillips takes over from the founder, Etienne Sokal, who has been serving as the CEO since the Company’s establishment in 2021.
“ I am honoured and humbled to be joining Cellaïon at this exciting time. The Company’s lead program to treat ACLF aims at demonstrating a meaningful clinical impact for patients. The promising Phase IIa clinical data generated with HepaStem® are encouraging for both its safety and potential clinical efficacy and I am convinced that the ongoing Phase IIb clinical trial could bring data to support the accelerated patient access for HepaStem®. I look forward to working with the talented team at Cellaïon and progressing the Company’s cellular therapy platform that has the potential to save patients’ lives in advanced liver diseases with high unmet medical needs .”
Prof Etienne Sokal, the founder, CEO and CMO of Cellaïon since its inception in 2021 will assume the role of Chairman of the Scientific and Medical Advisory Board and Vice-Chairman of the Board. Prof Etienne Sokal MD, PhD, is paediatric hepatologist at Cliniques Universitaires St Luc, and a Full Professor of Medicine at UCLouvain. In the 1980’s, he pioneered pediatric liver transplantation in Europe and made significant contributions to liver cell transplantation in 2000, providing innovative solutions for children with inborn errors of liver metabolism. His academic research at UCLouvain focused on liver cell and stem biology, leding to the discovery, alongside with Dr M Najimi, of liver derived stem cells (HepastemR) which were extensively characterised and translated into clinical applications as advanced therapy medicinal products.
Prof Sokal characterized the paracrine properties and immune-modulatory potency of HepastemR, conducting its clinical development in fibro inflammatory liver diseases through, a spinoff biotech company, Promethera Biosciences. In 2021, he founded Cellaïon based on transfer of HepaStemR assets from Promethera. He has led the company’s operations as CEO and Chief Medical Officer to its current advanced clinical and manufacturing stage of development. Etienne is also a member of the Royal Academy of Medicine and prominent scientific societies in the field of stem cells and hepatology. He has published more than 440 peer reviewed articles, boasting an impressive h-index of 82 and 26 000 citations.
“It has been a fantastic odyssey to bring Hepastem® from bench discovery to late clinical stage. I am extremely thankful to all the people – early-stage shareholders, investors, collaborators and investigators – who have supported the creation and development of Cellaïon. I am proud of what has been achieved with the team and to pass on the reins of an healthy and promising company. I trust the success of Cellaïon in its next phases of development. We will closely work with the board of director and with Jim to ensure the project’s future success”
“On behalf of the Board, I would like to warmly thank Etienne Sokal for his dedication and relentless commitment to leading Hepastem® up to this clinical stage. Etienne has built up Cellaïon and positioned the company as a leader in the field of cell therapy development for inflammatory liver diseases.
The evolution of the Company’s governance is an important step to accelerate its development. Jim has an outstanding track record as a global biopharma leader and his deep expertise in product development and commercialization will be invaluable in Cellaïon’s next stage of growth. The company’s lead drug candidate – HepaStem® is currently evaluated in a Phase IIb randomized trial to address the high unmet medical needs of patients with Acute on Chronic Liver Failure. Jim’s leadership and experience in strategy, regulatory, business development and commercial operations, provide a unique skillset to the team as we progress our lead program to the late-stage clinic and commercialization.
Cellaïon is in advanced stage clinical development and plans to file BLA for market authorizations by 2026 for this first indication, subject to positive clinical trial results and regulatory market approval.
Cellaïon Announces Discontinuation of Phase 2b Clinical Trial in Acute on Chronic Liver Failure with HepaStem®
Cellaïon SA appoints new Chief Executive Officer to drive Clinical & Commercial development
Cellaïon SA announces an additional closing of 5,5M Euros financing on June 13th 2023.
Cellaïon 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.
Cellaïon announces update to its Board of Directors:
Dr. Fouzia LAGHRISSI-THODE joins the biotech as Member of the Board