Promethera Biosciences raises €25.33 million ($31.4 million) in Series C financial round
On November 2014, Promethera Biosciences raises €20.33 million in capital and €5 million in loans and subsidies from the Walloon region (Belgium). The success of the Series-C fundraising is the result of the completion of the HepaStem phase I/II study, following a Series B fundraising in March 2012 when €17 million in equity was raised. Promethera Biosciences has attracted two new investors in this new round, securing a third capital increase of €20.33 million. SFPI-FPIM, the Belgian Federal Holding and Investment Company, and SMS Investments, a Luxemburg based subsidiary office of the German SMS group, have now acquired equity in Promethera Biosciences. They join the company’s historical international investors: Vesalius Biocapital and Boehringer Ingelheim Venture Fund (the venture capital fund of the German pharmaceutical group) the lead investors; SRIW; Shire, a leading UK biopharmaceutical company; Mitsui Global Investment, the venture capital fund of Japanese industrial conglomerate Mitsui & Co Ltd. and Pall-ATMI LifeSciences; Vives-Louvain Technology Transfer Office Fund; as well as several business angels.
The new round supports the clinical development of HepaStem.
In addition, the Walloon region, which has backed the company since its inception, has granted loans and subsidies of €5 million to support the clinical development of HepaStem and the collaborative program with EMD-Millipore.
Promethera Biosciences receives approval in Belgium to enroll patients in the Phase 2B/3 (HEP002) clinical trial
On October 2014, the first agreement to start the phase 2b/3/HEP002 clinical trial was granted by Belgian authorities. It officially opens the start of the second clinical trial conducted by the company. Belgian patients will be recruited and treated in Cliniques Universitaires Saint-Luc in Brussels.
HEP002 is a prospective, open label, multicenter, efficacy and safety study with Promethera® HepaStem. The primary objective is to assess the efficacy of Promethera® HepaStem in patients with urea cycle deficiencies during the year following treatment. In the first clinical trial HEP001 Promethera® HepaStem demonstrated to be a safe treatment that can result in functional metabolic improvement in UCD patients.
Promethera Biosciences and EMD Millipore join forces to deliver a pre-clinical liver pharmaco-toxicological testing assay
Promethera Biosciences has identified a novel adult human hepatic progenitor cell population that can be maintained in vitro in two- and three-dimensional cell culture conditions providing new models for testing in vitro drug metabolism: H2Screen and H3screen. These cell-based models are derived from healthy human livers and might acquire a metabolic capacity within the range of primary hepatocytes. They have long-term stability in culture as well as potential for large-scale production and reproducibility across batches.
On March 2014, the collaboration between Promethera Biosciences and EMD Millipore allows to develop a ready-to-use microfluidic perfusion liver assay. This new product is designed to perform more robust studies in preclinical toxicity and drug metabolism. EMD Millipore is a global life science company with an extensive portfolio of cell analysis instruments, research reagents and assays, cell culture and sample preparation products, plus advanced microfluidic cell culture as well as drug discovery services.
EMD Millipore’s ‘Pearl’ microfluidic technology maintains hepatocyte functionality by mimicking the liver microenvironment. When liver cells are cultured in the ‘Pearl’ format they recover key metabolic functions and could display phenotypic profiles of the intact organ for over a month.
From Phase I/II to next clinical trial manufacturing: from open to a closed system using ATMI’s XP bioreactor technology
Promethera Biosciences is currently conducting a first multicentric phase I/II clinical trial (HEP001) for the treatment of Crigler-Najjar syndrome and Urea Cycle Disorders in a pediatric setting. Clinical batches were produced under aseptic conditions using cellbind-treated CellStacks.
To further upscale the process, minimize manual operations and related-risks, as well as to reduce overall costs, Promethera has developed a fully closed system for the next clinical trials. This new production process is based on ATMI’s Xpansion bioreactor technology. This multiplate bioreactor offers a similar surface treatment and area, allowing for an easy transfer from the existing multi-tray stacks process. But in addition, it offers a fully controlled environment via real-time monitoring of temperature, dissolved oxygen, pH and media flow rate, reducing in-process variations.
The Xpansion™ 2-D multiplate bioreactor offers a valuable technology for large-scale production. Using this single-use technology, Promethera Biosciences is able to increase the yield of its production process by 20-fold and reduce manpower by 50 %.
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