Promethera Biosciences said today it has acquired key assets of cell therapy developer Cytonet for an undisclosed amount of the buyer’s shares.
Promethera said the deal would create the global leader in cell therapy and regenerative medicine with a broader and more diversified pipeline to address a wide range of liver diseases—including fibrosis, nonalcoholic steatohepatitis (NASH), acute chronic liver failure, and hemophilia.
The combined company would offer Cytonet’s precommercialization-stage Heparesc® cellular therapy involving primary human hepatocytes, as well as Promethera’s HepaStem® and H2Stem® human liver-derived stem cell therapies for inborn liver metabolic diseases (ILMD) and acquired liver diseases with high unmet medical needs.
Heparesc was rejected last year by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for urea cycle disorders (UCD) in children from birth up to 3 years of age. CHMP cited concerns about the design and conduct of the studies, plus concerns about the clinical relevance of the results of the tests that measured the ability to produce urea.
More recently, Cytonet has pursued approval of Heparesc in Canada, with a narrower indication of neonatal onset UCD patients. Promethera said adding Heparesc to its portfolio will enable commercialization targeted for 2017 through the Canadian market approval process as well as through recognition by other countries.
Promethera said a team of seven Cytonet staffers from Germany—where the acquired company is headquartered in Weinheim and has facilities in Heidelberg—will be added to Promethera’s Belgian HQ in Wallonia to support a filing of a New Drug Submission (NDS) for Heparesc with Health Canada.
“We are delighted that this development will be taken forward by Promethera,” said Torsten Hombeck, Ph.D., managing director of Cytonet.
HepaStem has recently and successfully completed a Phase I/II study in UCD and Crigler-Najjar syndrome. The product has received orphan drug designations in both indications from both the European Medicines Agency (EMA) and FDA .
Promethera said it will evaluate additional options to target acute liver failure and liver graft dysfunction in the future, while continuing to target orphan indications, including UCD, ILMD, and α1-antitrypsin (A1AT) deficiency. The company said the potential existed for combining different cellular therapy approaches in its expanded portfolio to develop future liver-targeting robust treatments using Cytomet’s cell-encapsulation technologies, including the use of biological scaffolds.
Through the acquisition, Promethera will add to its holdings Cytonet’s facility in Durham, NC, staffed by 18 people specializing in organ and tissue processing, product manufacturing, and industrial-level liver sourcing through what the buyer said was the largest existing Organ Procurement Organizations network in the U.S. as a result, Promethera said. The deal also offered the company the prospect of near-term income generation potential both with tissue placement in the U.S. and supply of cryopreserved human liver cells to third parties
A spin-off of the Université Catholique de Louvain (UCL), Promethera was founded in 2009 by Prof. Etienne Sokal and UCL’s tech transfer office and has grown since then to 32 employees.
Cytonet’s leading shareholder, the Hopp family, will have up to 13% of the share capital after the deal is finalized, Promethera added.