Opsona Therapeutics Ltd. initiates Phase I/II study in a First-in Class Monoclonal Antibody that blocks Toll-Like Receptor 2

Opsona Therapeutics Ltd. initiates a prospective open label Phase I/II study in second-line lower (Low and intermediate-1) risk myelodysplastic syndrome (MDS) with OPN-305, a First-in Class Monoclonal Antibody that blocks Toll-Like Receptor 2

Dublin – Opsona Therapeutics Ltd (‘Opsona’), the innate immune drug development company focused on novel therapeutic approaches to treat autoimmune, inflammatory diseases and oncology, announces that it has initiated a phase I/II clinical trial in second-line lower (Low and intermediate-1) risk myelodysplastic syndrome (MDS) patients with its lead drug candidate, OPN-305.

The lead principal investigator Professor Guillermo Garcia-Manero, who was closely involved in the preliminary work on the potential benefit of TLR2 antagonism in MDS, will conduct the trial at MD Anderson Cancer Center, Houston, USA, one of the premier cancer centres in the world.

Myelodysplastic syndromes (MDS) are a complex group of bone marrow failure disorders characterized by ineffective hematopoiesis, and poor prognosis. There is an urgent need for the development of novel therapies in the treatment of MDS which can delay progression, improve patient survival and which have fewer adverse effects.

OPN-305 is a novel proprietary humanized IgG4 monoclonal antibody (MAb) against the Toll-Like Receptor 2 (TLR2), a target within the innate immune system. Evaluation of OPN-305 in MDS will be the first of a range of oncology indications that the company plans to explore and this will be the first multiple dosing trial with OPN-305 in patients.

OPN-305 is also under development in a large multi-center phase II clinical trial as a treatment in the prevention of delayed graft function (DGF) following renal transplantation. OPN-305 has orphan status in the EU and USA for solid organ transplantation.

Opsona believes that OPN-305 has the potential to provide novel treatment options for a wide variety of autoimmune, inflammatory and oncology diseases.

Professor Guillermo Garcia Manero commented: “Data from our laboratory has indicated that TLR2 is commonly overexpressed in MDS and that alterations in innate immune signalling are a potential therapeutic target in MDS. We are very excited about using OPN-305 in patients with MDS.”

Commenting on today’s announcement, Mary Reilly, VP Pharmaceutical Development and Operations of Opsona Therapeutics said: “We are privileged to be working with world class leaders from MD Anderson, one of the premier cancer center‘s in the world. We are continuing to develop and explore the potential of OPN-305 in bringing a much needed novel therapy option to MDS patients”


For further information please contact:

Mary Reilly (VP Pharmaceutical Development and Operations) or Martin Welschof (CEO), telephone: + 353 16770223, e-mail: mreilly@opsona.com, mwelschof@opsona.com


For media enquiries, please contact:

Jim Devlin or Aoife Kelly at FTI Consulting, t. 01 6633600; e. jim.devlin@fticonsulting.com or aoife.kelly@fticonsulting.com


About Opsona Therapeutics

Opsona is a leading immunology drug development company, focused on novel therapeutic approaches to key targets of the innate immune system associated with a wide range of major human diseases, including autoimmune and inflammatory diseases, solid organ transplantation, cancer, diabetes, Alzheimer's disease and others. The company was founded in 2004 by three world-renowned immunologists at Trinity College in Dublin. Opsona have a strong international investor consortium including:

• Amgen Ventures (www.amgen.com/partners/amgen_ventures)

• Baxter Ventures (www.baxter.com/about_baxter/scientific_excellence/baxter_ventures)

• BB Biotech Ventures (www.bbbiotechventures.com)

• EMBL Ventures (www.embl-ventures.com)

• Enterprise Ireland (www.enterprise-ireland.com)

• Fountain Healthcare Partners (www.fh-partners.com)

• GenenFund (www.gene.com)

• Inventages Venture Capital (www.inventages.com)

• Novartis Venture Fund (www.venturefund.novartis.com)

• Omnes Capital (www.omnescapital.com)

• Roche Venture Fund (www.venturefund.roche.com)

• Seroba Kernel Life Sciences (www.seroba-kernel.com)

• Sunstone Capital (www.sunstone.eu)