Mustang Bio rare cancer treatment received FDA orphan drug nod
Photo | Courtesy Mustang Bio
Mustang Bio's building in Worcester
Worcester life sciences firm Mustang Bio reached a significant milestone for its new treatment for a rare type of non-Hodgkin's lymphoma, as the U.S. Food and Drug Administration granted its orphan drug designation for the project.
The designation is for Mustang Bio’s MB-106 drug for Waldenstrom macroglobulinemia, or WM, a type of non-Hodgkin’s lymphoma that originates in cancerous white blood cells, according to the Wednesday announcement from the company.
The FDA designation is reserved for drugs that treat rare diseases that affect fewer than 200,000 people in the U.S.
The Mustang Bio drug works through using chimeric antigen receptor (CAR) T cell therapy, which involves genetically modifying T cells, which the body produces to fight diseases, in a laboratory setting in order for them to fight cancerous cells. Mustang Bio collaborated with scientists at the Fred Hutchinson Cancer Research Center in Seattle to produce the drug.
With the FDA designation, the drug will begin to move into its first phase of clinical trials, with Phase ½ involving the dosing of its first patient to test safety and efficacy, before moving to the official first phase of the trial.
No approved CAR T cell therapy is available for WM, according to Mustang Bio. Mustang presented its data for its MB-106 drug earlier in the month at the 2022 European Hematology Association Hybrid Congress, which showed a strong response against WM, as well as other cancerous diseases such as follicular lymphoma and chronic lymphocytic leukemia.
“We are very pleased to receive orphan drug designation from the FDA,” said Manuel Litchman, the CEO of Mustang Bio, in a press release. “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.”
Headquartered in Worcester, Mustang Bio was founded in 2015.
WBJ Web Partners
Most Recent
Most Recent
0 Comments