www.fdanews.com/articles/179034-opsona-therapeutics-achieves-orphan-designation-for-myelodysplastic-syndrome-with-opn-305
Opsona Therapeutics Achieves Orphan Designation for Myelodysplastic Syndrome with OPN-305
October 26, 2016
Dublin-based Opsona Therapeutics has received orphan drug designation from the US FDA for myelodysplastic syndromes.
OPN-305 is a novel proprietary humanized IgG4 monoclonal antibody against Toll-Like Receptor 2, a key target within the innate immune system.
A study in patients with lower-risk MDS who have failed hypomethylating agents is ongoing in collaboration with MD Anderson Cancer Center in Houston.