Opsona Therapeutics won a €5.9 million (about $8.8 million) European Commission grant to fund clinical development of its lead candidate OPN-305 in solid organ transplantation. The Framework 7 award will involve establishing a European consortium of research and clinical groups known as MABSOT (monoclonal antibody solid organ transplantation).
The initial clinical trial, due to start this year, will evaluate OPN-305 in preventing delayed graft function in renal transplant patients. Pending results from the Phase I trial, a prospective placebo-controlled Phase II study in the prevention of delayed graft function could begin during 2012, Opsona says.
OPN-305 is a fully humanized anti-TLR antibody designed to reduce pro-inflammatory cytokine production associated with heart and kidney diseases. The firm claims positive preclinical data has already been generated in multiple models of diseases including cardiac and kidney ischemia/reperfusion injuries, sepsis, as well as ex vivo models of human rheumatoid arthritis.
Opsona is developing a platform of small molecules, monoclonal antibodies, and biologics that target immune system activity. The firm’s preclinical programs include an inflammasome project focused on the development of inhibitors of 1L-1β production.
Its OpsoVac™ TLR platform, originally licensed from Trinity College, Dublin aims to boost the effectiveness of TLR agonist therapy by co-administering molecules that inhibit T-regulatory cells. The firm claims research at Trinity College has demonstrated that contrary to current dogma, TLR ligands promote the induction of regulatory T cells and anti-inflammatory mediators such as IL-10, TGF-β, and PGE2, which can exacerbate immunosuppressive conditions in patients with cancer or chronic infections and thus effectively counteract the benefits of TLR-based therapy. Opsona aims to develop the OpsoVac platform through partnerships and is already working with CSL on a collaboration focused on identifying novel vaccine adjuvant formulations.