Symphogen’s lead product candidate, Sym001 (anti-Rhesus D), is a recombinant polyclonal antibody consisting of 25 unique anti-Rhesus D (RhD). Sym001 is being developed as an alternative to existing anti-RhD hyperimmune immunoglobulins for the treatment of Idiopathic Thrombocytopenic Purpura (ITP) and the prevention of Hemolytic Disease of Newborns (HDN). Sym001 is being co-developed with Biovitrum AB.
Idiopathic Thrombocytopenic Purpura is an autoimmune bleeding disorder caused by abnormally low platelet levels, making it difficult for the blood to clot normally. Hemolytic Disease in Newborns is a Rhesus D-negative woman becoming sensitive to RhD during the pregnancy with or delivery of a Rhesus D-positive child. This immune reaction may trigger a maternal antibody response in subsequent RhD-positive pregnancies, causing the breakdown of fetal red blood cells.
Markets The development of RhD diagnostic tests and anti-RhD antibody regimens has significantly reduced the risk of serious complications from ITP and HDN. However, the immunoglobulins currently used are isolated from the blood of donors, and therefore are subject to safety issues due to the risk of disease transmission, as well as to supply shortages caused by dependence on donor blood availability. Symphogen’s polyclonal antibodies are recombinant, so they can be produced in unlimited supply, and they carry no risk of viral or prion transmission, qualities that may make them a more attractive therapeutic option for HDN and ITP.
Status In In March 2007, Sym001 entered Phase 1 clinical trials, making it the first ever recombinant polyclonal antibody to enter clinical evaluation. The results from the dose-escalation, placebo-controlled study was available in February 2008 and showed that Sym001 is safe and well tolerated. In April Sym001 announced the initiation of a clinical proof of mechanism study for ADP to demonstrate the ability of Sym001 to clear RhD-positive red blood cells from the circulation of RhD-negative healthy volunteers. A phase 2 clinical trial in ITP was initiated in H1 2008.
