Promethera Biosciences raises €23.6m series-B financing

28 March 2012

Mont-Saint-Guibert, Belgium.  Promethera Biosciences, a cell therapy company operating in the field of liver diseases, has completed a fundraising round that generated €23.6 million, including €17 million 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 €5.3 million, Promethera continues to attract investors in this second round, securing a further capital increase of €17 million.

In addition, the Walloon region, which has backed the project since its inception, has granted a loan of €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 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."

Major innovation

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 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.


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