Opsona Therapeutics Ltd. Patent issued in US and EU covering the Opsona-developed antibody OPN-305, which is directed against Toll-like Receptor-2 (TLR-2) and the use and development thereof

18th February 2015, Dublin, Ireland – Opsona Therapeutics Ltd (‘Opsona’), the innate immune drug development company focused on novel therapeutic approaches to treat autoimmune, inflammatory diseases and oncology, today announced the issuances of US Patent 8,734,794 and European Patent, EP2,451,842, which cover the Opsona developed antibody OPN-305, which is 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 ischaemia 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.

OPN-305, which has been developed by Opsona, is a humanised IgG4 monoclonal antibody (mAb) antagonizing TLR-2 and is under development as a treatment for the prevention of Early Graft Dysfunction following renal transplantation, second–line lower risk Myelodysplastic Syndrome (MDS) in addition to other therapeutic indications.

These patents describe OPN-305, which is 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 patents are exclusively owned by Opsona Therapeutics.
Opsona has successfully conducted a Phase I clinical trial in healthy volunteers with its lead drug candidate OPN-305. This was the first-in-human study with OPN-305 and also represents the first clinical study for an anti-TLR-2 drug candidate.

A three-part multi-center, double blinded and placebo controlled Phase II clinical study to evaluate the safety, tolerability and efficacy of OPN-305 in renal transplant patients at high risk of Early Graft Dysfunction as the first clinical target indication for the development of OPN-305 was initiated in April 2013 and is currently ongoing.

An open label Phase I/II study to assess the safety and efficacy of cycles of intravenously infused doses of OPN-305 in second-line lower (low and intermediate-1) risk MDS, a form of blood cancer, as the second clinical target indication for OPN-305 was initiated in January 2015.

Commenting on today's announcement, Mary Reilly VP Pharmaceutical Development and Operations of Opsona Therapeutics said, "The issuance of these patents 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."

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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

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.nvfund.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)