According to a publication from BusinessWire, the Maryland-based pharmaceutical company OncoImmune, Inc. has announced successful phase 2 trial results for its acute graft versus host disease (GVHD) drug CD24Fc.
Graft Versus Host Disease
Acute graft versus host disease is a condition affecting somewhere between 35% and 50% of hematopoietic stem cell transplant recipients. Hematopoietic (related to the formation of blood) stem cell transplants are vital for people with damaged bone marrow or defective immune systems – it helps them maintain hematopoietic function and continue production of blood cells.
Acute GVHD affects several organs depending on how far it has progressed – the skin, the liver, and the gastrointestinal tract. One or several organs can be affected. The number of affected organs and the extent of their involvement contribute to the grading of GVHD cases between 0 and IV. Patients with grade III and grade IV GVHD have poor outlooks, and in serious cases it can be fatal.
Estimates predict that at the current rate of transplants, there will be 5,500 new GVHD patients every year.
CD24Fc is an experimental GVHD prophylaxis created by OncoImmune, Inc. that researchers hope will suppress GVHD reactions in hematopoietic stem cell recipients.
OncoImmune announced this month that it had completed a phase IIa trial for CD24Fc designed to determine the drug’s maximum tolerated dose – the largest possible dose that will produce the desired effect with no critical side effects.
CD24Fc hopes to target the CD24-Siglec pathway, a signaling pathway that plays an important role in controlling the body’s immune inflammation response. CD24Fc has received Orphan Drug designation in both the United States and Europe, meaning continued development of the drug will bring substantial benefits to OncoImmune, including tax credits, reimbursements, and famously, in the United States, a 7-year-long window of marketing exclusivity.
Yang Liu, OncoImmune’s CEO and co-founder, said the successful phase IIa trial made his researchers optimistic about their continued search for more effective GVHD prophylaxes. The company plans to proceed with phase III testing this year, Liu also said. Phase III tests are typically concerned with comparing the candidate’s effectiveness against other existing treatments. It’s worth noting that most drug candidates don’t reach this point of clinical testing. CD24Fc shows promise rounding second, but only more testing will prove if OncoImmune has a real score on their hands.
GVHD affects a significant number of hematopoietic stem cell recipients. What do you think about this exciting development? Are you cautious of celebrating too soon? Tell Patient Worthy why!