Umoja Bio Wins Fast Track for B-Cell Malignancies Drug

FDA has granted Umoja Biopharma a fast track designation for its investigational therapy UB-VV111 for treating relapsed or refractory Large B-cell Lymphoma and Chronic Lymphocytic Leukemia following two or more prior therapies. The company describes UB-VV111 as an off-the-shelf, in vivo CAR T cell therapy designed to generate CD19-directed CAR T cells directly inside patients. The approach aims to overcome several limitations of traditional autologous CAR T cell therapies, including high manufacturing costs, long wait times, complex treatment processes, and limited product availability, it says.

The therapy is currently being evaluated in a Phase 1 clinical trial (NCT06528301) for safety and antitumor activity in patients with CD19-positive B-cell malignancies. AbbVie retains an exclusive option to license Umoja’s CD19-directed in vivo CAR T cell therapy candidates, including UB-VV111, the company says.