Mustang Bio, Inc. (NASDAQ: MBIO) saw its shares poke above breakeven Wednesday, on the announcement that the U.S. Food and Drug Administration (“FDA”) has granted Orphan Drug Designation to MB-106, Mustang’s CD20-targeted, autologous CAR T cell therapy for the treatment of Waldenstrom macroglobulinemia, a rare type of B-cell non-Hodgkin lymphoma.
MB-106 is being developed in a collaboration between Mustang and Fred Hutchinson Cancer Center to treat patients with relapsed or refractory B-NHLs and chronic lymphocytic leukemia.
The FDA grants Orphan Drug Designation to drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the U.S. Orphan Drug Designation provides certain incentives, such as tax credits toward the cost of clinical trials upon approval and prescription drug user fee waivers.
If a product receives Orphan Drug Status from the FDA, that product is entitled to seven years of market exclusivity for the disease in which it has Orphan Drug designation, which is independent from intellectual property protection.
CEO Manuel Litchman 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.
“We look forward to dosing the first patient in our multicenter Phase 1/2 clinical trial evaluating the safety and efficacy of MB-106 for relapsed or refractory B-NHL and CLL under Mustang’s IND shortly.”
MBIO shares began midweek Wednesday up .0064 cents, or 1%, to 63 cents.
