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news.Opsona Therapeutics has commenced 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.
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OPN-305 is a new humanized IgG4 monoclonal antibody (MAb) against the Toll-Like Receptor 2 (TLR2), a target within the innate immune system.
Evaluation of OPN-305 in MDS will be the first of a range of oncology indications that the company plans to explore and will be the first multiple dosing trial of OPN-305.
The trial will be conducted at MD Anderson Cancer Center 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.
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."
At present, OPN-305 is being assessed in a large multi-center Phase II clinical trial as a treatment in the prevention of delayed graft function (DGF) following renal transplantation.
The company has also received orphan status for OPN-305 in the European Union (EU) and the US for solid organ transplantation.
According to the company, OPN-305 has the potential to provide new treatment options for a variety of autoimmune, inflammatory and oncology diseases.