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Phase I/II clinical trial in second-line lower risk myelodysplastic syndrome with OPN-305 initiated

, the innate immune drug development company focused on novel therapeutic approaches to treat autoimmune, inflammatory diseases and oncology, announces that it has initiated a phase I/II clinical trial in second-line lower (Low and intermediate-1) risk myelodysplastic syndrome (MDS) patients with its lead drug candidate, OPN-305.

The lead principal investigator Professor , who was closely involved in the preliminary work on the potential benefit of TLR2 antagonism in MDS, will conduct the trial at , Houston, USA, one of the premier cancer centres in the world.

(MDS) are a complex group of bone marrow failure disorders characterized by ineffective hematopoiesis, and poor prognosis. There is an urgent need for the development of novel therapies in the treatment of MDS which can delay progression, improve patient survival and which have fewer adverse effects.

OPN-305 is a novel proprietary 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 this will be the first multiple dosing trial with OPN-305 in patients.

OPN-305 is also under development in a large multi-center phase II clinical trial as a treatment in the prevention of delayed graft function (DGF) following renal transplantation. OPN-305 has orphan status in the EU and USA for solid organ transplantation.

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

commented: “Data from our laboratory has indicated that TLR2 is commonly overexpressed in MDS and that alteration in innate immune signalling are a potential therapeutic target in MDS. We are very excited about using OPN-305 in patients with MDS.”

Commenting on today’s announcement, Mary Reilly, VP Pharmaceutical Development and Operations of said: “We are privileged to be working with world class leaders from MD Anderson, one of the premier cancer center’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”.


Source: Opsona Therapeutics