The European Patent Office has recently issued an EP Patent covering an antibody-technology directed against Toll-like Receptor TLR2, which was developed at the Technische Universität München (TUM) and Amgen. The issuance of the patent, which has been licensed exclusively to the drug development company Opsona Therapeutics, has triggered a milestone payment for the university, Amgen and the inventors. This is the 3rd payment generated by the technology, which is aimed at treating inflammatory diseases. The Bayerische Patentallianz GmbH, the patent and marketing agency for 28 Bavarian universities, represented TUM in the licensing negotiations.
TLR2 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. TLR2 is one of the key structures of the innate immune system. It is part of the first line defense against microbial organisms. Upon stimulation it induces and propagates inflammation. TLR2 gets 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 (EP 1 664 118 B1) describes a cross reactive antibody which specifically blocks mammalian TLR2 and further provides for a pharmaceutical composition for the treatment of various inflammatory conditions. The recently issued patent is assigned to TUM and Amgen and is exclusively licensed by Opsona Therapeutics. Using the TUM/Amgen license Opsona has developed a clinical anti-TLR2 antibody candidate, termed ‘OPN-305’. OPN-305 is a humanised IgG4 monoclonal antibody (MAb) antagonizing TLR2 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-TLR2 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.”