The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Mustang Bio’s (NASDAQ:MBIO) lead drug MB-106 for the treatment of Waldenstrom macroglobulinemia (WM), a rare type of B-cell non-Hodgkin lymphoma (B-NHL).
MB-106 is being developed in a collaboration between Mustang and Fred Hutchinson Cancer Center for patients suffering from relapsed or refractory B-NHLs and chronic lymphocytic leukemia (CLL).
The company is planning to begin patient enrolment in its multicenter Phase 1/2 clinical trial evaluating the safety and efficacy of MB-106 for relapsed or refractory B-NHL and CLL.
Manuel Litchman, M.D., President and Chief Executive Officer, said, "We are very pleased to receive Orphan Drug Designation from the FDA, as it is an important regulatory milestone for Mustang's MB-106 program for the treatment of Waldenstrom macroglobulinemia, a rare B-NHL with a significant unmet medical need.”
Recently, MB-106 data was presented at the European Hematology Association 2022 Hybrid Congress continue to demonstrate high efficacy and a very favorable safety profile across all five dose levels.
FDA grants orphan status to support development of medicines for the treatment of rare diseases that affect fewer than 200,000 people in the United States. It also provides benefits of seven-year period of market exclusivity if the drug is approved, tax credits for qualified clinical trials and an exemption from FDA application fees.
Mustang Bio shares are trading up 3 percent at $0.64 in the pre-market session.
