Orbsen Therapeutics, a spin-out from NUI Galway’s Regenerative Medicine Institute (REMEDI), will partner with the University of Birmingham in the €6 million EU FP7 funded MERLIN project to develop a cell therapy inflammatory liver disease

Orbsen Therapeutics is Irelands leading Cell Therapy biotechnology company and is a spin-out from NUI Galways’ Regenerative Medicine Institute (REMEDI).  The EU FP7-funded project known by the acronym “MERLIN” (MEsynchymal stem cells to Reduce Liver INflammation) is led by Professor Phil Newsome, Clinical Director of the Birmingham University Stem Cell Centre. MERLIN will advance Orbsen’s proprietary cell therapy to a Phase 2a clinical trial in patients with inflammatory liver disease.

This MERLIN project will evaluate the Orbsen cell therapy in 4 different research laboratories across Europe and the project will culminate in a Phase 2a clinical trial of the therapy in the crippling inflammatory liver disease, Primary Sclerosing Cholangitis.

This is Orbsen’s fourth success in attracting FP7 funding (the EU’s Seventh Framework Programme for Research), making them one of Ireland’s most successful private companies in this funding programme and now connects Orbsen to 23 global collaborators. Other successful cell therapy projects for Orbsen include PURSTEM (completed), REDDSTAR (ongoing) and DeCIDE (ongoing).

Orbsen Therapeutics Ltd. is a privately-held company founded in 2006 as a spin-out from Ireland’s Regenerative Medicine Institute (REMEDI) in NUI Galway. As part of the PurStem EU FP7 program, Orbsen developed proprietary technologies that enable the prospective purification of highly defined and therapeutic (stromal) cells from several human tissues, including bone marrow, adipose tissue and umbilical cord.

Orbsen’s CEO Brian Molloy said, “Orbsen has secured substantial amounts of research funding in the last 18 months which will further validate our product and bring us through to a “first in man” clinical trial in 2015/16. Our model has always focused on putting the ‘science first’ and we have successfully used that approach to develop a technology that could potentially position us and indeed Ireland at the leading edge of European Cell Therapy development.”

Mr Molloy continued, “As a spin-out from the NUI Galway based REMEDI Institute we have focused the majority of our collaborations with an Irish research team. Our success in the MERLIN project now demonstrates that we are capable of playing a key role in collaborations led by researchers across Europe.”

The total research budget for the MERLIN project is close to €6 Million of which €1 Million will go directly to Orbsen Therapeutics over the 4-year period of the project.

Dr Stephen J Elliman, Head of Research for Orbsen Therapeutics added, “The EU projects, like MERLIN have enabled us to build a very strong research network of 23 invaluable collaborators across Europe, who are independently validating our technology and aiding our development toward the clinic and market. In addition, the FP7 program has helped us develop a research team of 14 over the past 18 months – these are all highly qualified researchers who are working within Orbsen to develop our cell therapy for conditions that are currently not adequately treated with existing medicines. MERLIN allows us to further expand our pipeline and to develop our understanding of how adult mesenchymal stromal cells can aid the treatment of a range of immunological and inflammatory conditions.”

The MERLIN project commenced in February 2014 and will run for 4-years culminating in a Phase 2a clinical trial in primary sclerosing cholangitis (an uncommon condition affecting the bile ducts and liver). The project is being co-ordinated by University of Birmingham and includes the NHSBT in the UK, Orbsen Therapeutics in Ireland, Erasmus Medical Centre in Rotterdam, Fondazione Humanities per la Ricerca in Italy and BioInvision Inc. in the US. Pintail Ltd are based in Dublin and are providing administration and co-ordination services to the MERLIN project.

The novel aspects of Orbsen’s technology place it at the leading edge of research, development and regulatory compliance of adult mesenchymal stromal (stem) cell therapies. The Orbsen cells can be purified from a single human donor, expanded and frozen to generate many doses of high-margin, allogeneic (“off-the-shelf”) therapeutic products for conditions with unmet need.

Orbsen’s proprietary ORB1-MSC (Orbsen developed mesenchymal stromal cells) therapy is being developed for several diseases, including inflammatory disease of the lungs and liver, diabetes, cardiovascular disorders, joint disease, kidney injury, organ graft rejection and wound repair.

For further information on Orbsen Therapeutics visit www.orbsentherapeutics.com  

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