Umoja gets fast track for in vivo CAR-T in lymphoma

The U.S. FDA has granted fast track designation to Umoja Biopharma’s in vivo CAR-T cell therapy for the treatment of relapsed/refractory large B-cell lymphoma following two or more lines of prior therapy and relapsed/refractory chronic lymphocytic leukemia following two or more lines of prior therapy.

UB-VV111 is an investigational, off-the-shelf drug product that generates CD19-directed CAR-T cells in vivo, potentially addressing a range of shortcomings posed by traditional ex vivo autologous CAR-T cell therapies which limit broad patient access, including high manufacturing costs, long wait times, burdensome treatment processes, and limited product availability.

An ongoing phase 1 clinical trial is evaluating the safety and antitumor activity of UB-VV111 in CD19+ B-cell malignancies. In 2024, UB-VV111 became the first in vivo CAR-T cell therapy to receive clearance of its IND application by the FDA.

Through a deal inked in 2024, AbbVie retains an exclusive option to license Umoja’s CD19-directed in vivo CAR-T cell therapy candidates, including UB-VV111.