Belgian cell therapy company Promethera Biosciences, has raised 23.6 million euros ($31.4 million) in Series B round of investment. Among the new investors are the venture arms of Boehringer Ingelheim and Shire, Japanese investment fund Mitsui Global Investment, US company ATMI and Belgian venture capital fund Sambrinvest.
Promethera Biosciences, the Belgian cell therapy company operating in the field of liver diseases, completed today an exceptional fundraising round that generated 23.6 million euros ($31.4 million), including 17 million euros in capital. Among the new investors are the venture arms of pharmaceutical industry leaders Boehringer Ingelheim and Shire, Japanese investment fund Mitsui Global Investment, US company ATMI and Belgian venture capital fund Sambrinvest. This Series-B fundraising has been successful thanks to the major achievements made by Promethera Biosciences since its Series-A fundraising in 2009. Most outstanding is the GMP accreditation following the successful transfer and scaling up of the production process developed at Université Catholique de Louvain (UCL) into a larger-scale pharmaceutical operation. Meanwhile, the company has been granted authorisations from the respective agencies to start its phase I/II clinical study in Belgium and the UK for its innovative cell therapeutic product HepaStem which may hold a cure for liver diseases and offer a breakthrough technology for repairing severe liver defects.
Belgian spin-off attracts foreign investors
A little over two years after its first fundraising initiative in October 2009, which raised EUR 5.3 million, Promethera continues to attract investors in this second round, securing a further capital increase of EUR 17 million. In addition, the Walloon region, which has backed the project since its inception, has granted a loan of EUR 6.6 million to support the clinical development of the HepaStem product. Five new investors have now acquired equity in Promethera: Boehringer Ingelheim Venture Fund, the venture capital fund of the pharmaceutical giant; Shire, a leading biopharmaceutical company; Mitsui Global Investment, the venture capital fund of Japanese industrial conglomerate Mitsui and Co Ltd.; ATMI, a global leader in semiconductors and innovative culture systems. In addition to these four groups of international scope and reputation is Sambrinvest, the investment fund of the Charleroi region in Wallonia. These five investors join the Belgian investors attracted in the first round: Vesalius Biocapital, the lead investor, SRIW, Vives-Louvain Technology Fund, Life Science Research Partners, NivelInvest, Financière Spin-off Luxembourgeoise, Sopartec (UCL’s technology transfer company), as well as several business angels.
“We are delighted at the trust our investors have placed in us and the opportunity to successfully complete this exceptional fundraising drive in the current economic context,” comments Eric Halioua, CEO of Promethera Biosciences. “Achieving all our objectives a year ahead of plan, the quality of the team, the attractiveness of the company’s business model and the proof of concept obtained in humans have been key factors in our investors’ decision.”
“We believe that Promethera(R) HepaStem has, even though early in development, significant potential to treat metabolic liver diseases and we are looking forward to working with the company now and in the future,” comments Doctor Ilka Wicke, director at the Boehringer Ingelheim Venture fund.
Successful technology transfer
In the wake of the first round of fundraising in October 2009, Promethera Biosciences has undergone a significant and fast growth. The successful transfer of technology from the UCL laboratory and from the tissue bank of Cliniques Universitaires St-Luc has enabled the company to develop from an academic towards an industrial pharmaceutical scale. In order to achieve this, premises in Mont-Saint-Guibert with more than 170 m² of clean rooms have been set up and received official GMP accreditation from the Belgian authorities (AFMPS). To date, 14 batches of its flagship product, HepaStem, have been produced at the new site. In just over two years, the company’s staff has grown from two to forty, headed by an experienced management team.
HepaStem: phase I/II clinical study authorisations
Since the discovery of HHALPC (Heterologous Human Adult Liver Progenitor Cells, forming the basis for Promethera HepaStem product) by Professor Sokal and Doctor Najimi at the UCL laboratories in 2005, Promethera Biosciences has made considerable scientific advances. The patent protecting the HHALPC cell and all of its applications has been officially awarded in Europe. The proof of concept for the therapeutic use of the cells has been demonstrated in three different animal models. Between 2009 and 2011, injections of HHALPC were safely administered to three patients – a world first – at Cliniques Universitaires St Luc by Professor Sokal and his team. These various achievements have enabled Promethera Biosciences to obtain the first authorisations from the British (MHRA) and Belgian (AFMPS) regulatory authorities to begin the phase I/II clinical study of HepaStem. As part of the clinical study, the cell therapeutic product is assessed in a paediatric setting involving children suffering from Crigler-Najjar syndrome or urea cycle disorders. Most young patients have only limited other therapeutic options and may die at an early age.
“There is a real need for medical innovation to treat metabolic diseases in children; too many diseases are still intractable,” notes Professor Etienne Sokal, founder and chief scientific officer at Promethera Biosciences, paediatric hepatologist at Cliniques Universitaires St Luc and director of UCL’s cell therapy research lab. “The first HepaStem studies represent a major step towards, we hope, eventually transforming the prognosis of these diseases.”
The major innovation of Promethera HepaStem resides in the simplicity of the treatment – a simple injection into the vein leading to the liver – which may make it possible to avoid radical and invasive surgery such as a liver transplant. Promethera HepaStem could be used to treat a wide variety of liver pathologies. Thanks to the industrial development, if this therapy proves to be safe and effective, as many as a hundred patients could be treated from a single liver, thus largely overcoming the organ shortage problem. In parallel, Promethera(R) Biosciences is developing HepaScreen, a cell model designed to mimic and reproduce the metabolism and stimulate the detoxification of new drugs by the human liver.
About Promethera Biosciences:
Promethera Biosciences is a pharmaceutical company that develops innovative therapies for the treatment of liver disease. It is currently developing two products based on a newly discovered and patented cell, the Heterologous Human Adult Liver Progenitor Cells (HHALPC):
Promethera(R) HepaStem is a cell therapy product based on the use of allogeneic stem cells isolated from healthy adult human livers (Heterologous Human Adult Liver Progenitor Cells, HHALPC). These cells can be used to treat a wide variety of liver diseases, from rare inborn metabolic diseases (which can be classified as “orphan diseases” and mainly affect children), to acquired deficiencies affecting adults, such as fulminant hepatitis or liver fibrosis. This treatment has already received the orphan drug designation from the European Medicines Agency for the treatment of two very debilitating paediatric pathologies and from the Food and Drug Administration (USA) for one indication.
Promethera(R) HepaScreen (http://www.promethera.com/vpage.php?id=25&lg=2) is a different, non-therapeutic product that uses the same adult human liver-derived stem cells as a biotechnology tool designed for evaluation of new chemical entities. This product meets a real need in the market, which currently lacks sufficiently predictive models to assess the hepatic metabolism of chemical compounds in the body. This unique cell model will be made available to the pharmaceutical industry to evaluate the metabolism and toxicity of new drugs in humans in a more reliable way than animal experimentation, thereby reducing the need and number of animals for such experiments.
Promethera Biosciences is a spin-off of the Université Catholique de Louvain (UCL), founded in 2009 by Sopartec S.A., UCL’s technology transfer company, and Professor Etienne Sokal, a leading expert in paediatric liver disease and cell therapy. The company, under the direction of Eric Halioua, CEO, is located in Mont-Saint-Guibert.
ATMI, Inc. provides specialty semiconductor materials, leading-edge materials development science, and high-purity materials handling and delivery solutions designed to increase process efficiencies for the worldwide semiconductor, flat panel and life sciences industries.
About ATMI LifeSciences
ATMI LifeSciences is a leader in single-use technologies, products and systems for mixing, storage, bioreactors, cell culture technology, fluoropolymer-based products, and custom-engineered, flexible packaging solutions. The company’s cleanroom manufacturing experience, combined with its fundamental knowledge of bioproduction – especially within cell culture – help drive development of specific single-use technologies that are well-adapted to process operations. All products comply with internal, industry and regulatory standards and many of their products are completely animal derived components free (ADCF). All ATMI manufacturing facilities house ISO Class 5 cleanroom conditions, follow European current Good Manufacturing Practices (cGMP) and are ISO9001/2008 certified.
About Boehringer Ingelheim
The Boehringer Ingelheim Venture Fund was formed in March 2010 to invest in biotechnology and start-up companies to help drive innovation in medical science. These may include – but are not limited to – novel technologies to address so far undrugable targets, new generation vaccines and new biological entities, such as antibody-dependent oncolysis. Novel therapeutic targets and disease-related biomarkers, as well as new approaches in regenerative medicine, are an additional focus.
About Mitsui Global Investment
Mitsui Global Investment (MGI) is a subsidiary of Mitsui & Co. Ltd. which invests in opportunities that have potential for growth. Headquartered in Tokyo, the company has offices in Silicon Valley, New York, Shanghai, Beijing, Mumbai and London (Alliance Team office) and its investments reach beyond these geographical barriers, reflecting a diversified global portfolio.
Sambrinvest is an actor in risk capital in the region of Charleroi in Belgium, based in the aeropole of Gosselies, with the objective to support the development of SMEs. Thanks to its expertise, it advises entrepreneurs at every development stage of their projects whilst respecting their management autonomy.
Shire’s strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit hyperactivity disorder, human genetic therapies, gastrointestinal diseases and regenerative medicine as well as opportunities in other therapeutic areas to the extent they arise through acquisitions. Shire’s in-licensing, merger and acquisition efforts are focused on products in specialist markets with strong intellectual property protection and global rights. Shire believes that a carefully selected and balanced portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results.
About Sopartec & Vives-Louvain Technology Fund
Vives-Louvain Technology Fund is a multi-sectorial technology investment fund that invests in UCL spin-offs and start-ups in both in Belgium and neighbouring countries. The objective of the fund is to invest in the development of start-ups from technological validation through to commercial maturity. The funds (Vives One of EUR 15 million and Vives Two of EUR 43 million) are managed by Sopartec, the technology transfer company of the Université Catholique de Louvain (UCL). Sopartec, a member of the Louvain Technology Transfer Office (LTTO), together with the university’s Research Administration (ADRE) are in charge of the overall technology transfer process. This covers the financing of research contracts, the identification of inventions within the laboratories, the protection and management of intellectual property as well as the technological maturation. More specifically, Sopartec coordinates the management of licensing agreements and the technological maturation of UCL spin-offs. More than 50 spin-offs, which today generate more than 3,000 jobs, have been created in whole or part from the results of research conducted at the UCL. These include Ion Beam Application (IBA), I.R.I.S. Group, IbT, Telemis, Alterface, Cissoid, Viridaxis, Promethera, etc.
SRIW (Société Régionale d’Investissement de Wallonie/the Wallonia Regional Investment Company) provides finance within and outside Belgium for businesses undertaking industrial projects or providing services that generate added value. For the last 30 years, the company has in this way been facilitating the Walloon region of Belgium’s economic development, contributing effectively and in real terms to the modernisation, growth and restructuring of the businesses that make up our industrial fabric.
Vesalius Biocapital invests in companies active in human health through venture capital funds raised since 2007. It has contributed to developing twelve companies since inception, one of which was acquired through a trade sale. With over EUR 120 million under management in two funds, Vesalius Biocapital Partners plays the role of lead investor in the large majority of its financing rounds. Vesalius Biocapital companies are based in Europe allowing easy interaction with management. Investments are in all stages of development and do not shy away from relatively early-stage projects with a sound proprietary technology and corresponding IP, unique team skills and a clear competitive edge based on solid data. The investment strategy is focused on four areas: therapeutics, medical devices, diagnostics and novel food applications.