Patent issued for the development of an antibody directed against Toll-like Receptor TLR-2

April 17th, 2012, Dublin, Ireland - Opsona Therapeutics, the innate immune drug development company, today announced that the European Patent Office has issued EP Patent 1,664,118 which covers an antibody directed against Toll-like Receptor-2 (TLR-2) and the use and development thereof.

TLR-2 plays an important role in the induction and progression of a number of non-pathogen associated inflammatory conditions including ischemia reperfusion injury (delayed graft function in renal transplantation, myocardial infarct), certain cancer, autoimmune diseases, diabetes, Alzheimer's disease and atherosclerosis.

TLR-2 is one of the key structures of the innate immune system and is part of the first line defense against microbial organisms. Upon stimulation it induces and propagates inflammation. TLR-2 is activated through so called external danger signals (microbial cell wall components) as well as through so called internal danger signals resulting from tissue injury.

This patent describes a cross reactive antibody which specifically blocks mammalian TLR-2 and further provides for a pharmaceutical composition for the treatment of various inflammatory conditions. The recently issued patent is assigned to the Technische Universitat Munchen (TUM) and Amgen Inc, and is exclusively licensed by Opsona Therapeutics.

Using the TUM/Amgen license, Opsona has developed a clinical anti-TLR-2 antibody candidate, termed ‘OPN-305'. OPN-305 is a humanised IgG4 monoclonal antibody (MAb) antagonizing TLR-2 and is under development as a treatment for the prevention of Delayed Graft Function (DGF) following renal transplantation, in addition to other therapeutic indications.

Opsona has successfully conducted a phase 1 clinical trial in healthy volunteers with its lead drug candidate OPN-305. This is the first-in-human study with OPN-305 and also represents the first clinical study for an anti-TLR-2 drug candidate.

Following successful completion of the phase 1 trial, the company plans to conduct a two-part multi-centered, double blinded and placebo controlled clinical study to evaluate the safety, tolerability and efficacy of OPN-305 in renal transplant patients at high risk of Delayed Graft Function (DGF) as the first clinical target indication for the development of OPN-305 to be initiated in 2012.

Commenting on today's announcement, Mary Reilly VP Pharmaceutical Development and Operations of Opsona Therapeutics said, "The issuance of this patent is an important milestone in the development of Opsona's TLR2 intellectual property portfolio and will facilitate market exclusivity for the use of OPN-305 in the ever expanding area of TLR2 mediated diseases."

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, transplant rejection, cancer, diabetes, Alzheimer's disease and atherosclerosis. The company was founded in 2004 by three world-renowned immunologists at Trinity College in Dublin. Opsona's lead product, a fully human monoclonal IgG4 antibody (OPN-305) targeting Toll-like-receptor-2 (TLR-2) has demonstrated activity in a number of animal models and was recently tested in a phase 1 clinical trial in healthy volunteers. Following successful completion of the phase 1 trial, the company plans to conduct a two-part multi-centered, double blinded and placebo controlled clinical study to evaluate the safety, tolerability and efficacy of OPN 305 in renal transplant patients at high risk of Delayed Graft Function (DGF) as the first clinical target indication for the development of OPN-305 to be initiated in 2012. In May 2009 the company announced the completion of a € 21.3 million equity funding with an international investor consortium including: Inventages Venture Capital, Novartis Venture Fund, Roche Venture Fund, Seroba Kernel Life Sciences, Fountain Healthcare Partners and Enterprise Ireland. Further information is available at http://www.opsona.com/.

For further information please contact:

Martin Welschof (CEO)
Telephone: + 35316770223
E-mail: mwelschof@opsona.com