The European Medicines Agency granted Mustang Bio’s (NASDAQ:MBIO) MB-107 with advanced therapy medicinal product classification for the treatment of X-linked severe combined immunodeficiency.
Patients with X-linked severe combined immunodeficiency produce very few T-cells and natural killer cells. MB-107 is a lentiviral gene therapy that is currently being assessed in these patients two Phase 1/2 clinical trials.
“We are extremely encouraged that the EMA has granted MB-107 with advanced therapy medicinal productclassification, an important step in establishing our path to market approval and commercialization in Europe,” Dr. Manuel Litchman, president and CEO of Mustang, said in a statement.
“This classification complements the regenerative medicine advanced therapy designation we received last year from the FDA and brings us closer to realizing our goal of commercializing MB-107 for X-linked severe combined immunodeficiency patients, as these patients are in desperate need of innovative and potentially curative treatment options,” he added.
