Fate Therapeutics Inc.'s lead investigative product, ProTmune, has been granted Orphan Drug Designation by the U.S. Food and Drug Administration.
The therapy, currently in mid-stage clinical studies for cancer and immune disorders, is meant to prevent patients undergoing a kind of stem cell therapy from reacting poorly to the transplant.
Specifically, Fate is targeting patients who contract acute graft-versus-host disease (GvHD) during an allogeneic hematopoietic cell transplantation (HCT).
ProTmune is meant to reduce the incidence and severity of GvHD, a condition that occurs when a donor’s bone marrow or stem cells attack the patient receiving them.
“Graft-versus-host disease is a significant cause of morbidity and mortality in patients undergoing allogeneic HCT and there are no FDA-approved therapies to prevent its occurrence,” said Scott Wolchko, president and CEO of Fate Therapeutics, in a statement.
Fate’s new Orphan Drug Designation entitles the company to seven years of market exclusivity in the U.S. if the drug candidate reaches the market.
The designation is part of the Orphan Drug Act, which provides economic incentives to encourage the development of drugs for diseases affecting fewer than 200,000 people in the U.S. Extra incentives under the program include tax credits related to clinical trial expenses, and FDA assistance in clinical trial design.