Seattle, Washington — September 30, 2025 — Leads & Copy — Umoja Biopharma announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to UB-VV111 for the treatment of relapsed/refractory Large B-cell Lymphoma and relapsed/refractory Chronic Lymphocytic Leukemia.
UB-VV111 is an investigational drug product that generates CD19-directed CAR T cells in vivo. An ongoing Phase 1 clinical trial is evaluating the safety and antitumor activity of UB-VV111 in CD19+ B-cell malignancies (NCT06528301). In 2024, UB-VV111 became the first in vivo CAR T cell therapy to receive clearance of its Investigational New Drug application by the FDA. AbbVie retains an exclusive option to license Umoja’s CD19-directed in vivo CAR T cell therapy candidates, including UB-VV111.
“This Fast Track Designation marks a key milestone in the advancement of in vivo CAR T cell therapies,” said Luke Walker, M.D., Chief Medical Officer of Umoja Biopharma.
Umoja Biopharma, Inc. is a clinical-stage biotechnology company aiming to develop in vivo cell therapies that improve the reach, effectiveness, and access of CAR T cell therapies in both oncology and autoimmunity.
Contact:
Tonya Swick
tonya.swick@umoja-biopharma.com
Source: Umoja Biopharma
