Irish drug development firm Opsona Therapeutics has started a Phase I/II clinical trial of its lead drug candidate, OPN-305, in second-line lower (Low and intermediate-1) risk myelodysplastic syndrome (MDS) patients.

OPN-305 is a new humanised IgG4 monoclonal antibody (MAb) against the Toll-Like Receptor 2 (TLR2), a target within the innate immune system.

The company said that evaluation of OPN-305 in MDS will be the first of a range of oncology indications that it plans to explore and will be the first multiple dosing trial with OPN-305 in patients.

"We are continuing to develop and explore the potential of OPN-305 in bringing a much needed novel therapy option to MDS patients."

Currently, OPN-305 is being evaluated in a large multi-centre Phase II clinical trial as a treatment in the prevention of delayed graft function (DGF) following renal transplantation.

OPN-305 has also secured orphan status in the European Union and the US for solid organ transplantation.

The trial will be conducted at MD Anderson Cancer Centre by 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.

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Garcia Manero said: "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."

MDS are a complex group of bone marrow failure disorders characterised by ineffective hematopoiesis and poor prognosis.

Opsona Therapeutics Pharmaceutical Development and Operations vice-president Mary Reilly said: "We are privileged to be working with world class leaders from MD Anderson, one of the premier cancer centre’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."

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