Umoja Biopharma’s In Vivo CAR T Therapy Receives FDA Fast Track Designation

SEATTLE, WA– September 30, 2025 – Umoja Biopharma, a clinical-stage biotechnology company specializing in in vivo cell therapies, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead candidate, UB-VV111.

The designation applies to UB-VV111 for the treatment of relapsed/refractory Large B-cell Lymphoma (LBCL) and relapsed/refractory Chronic Lymphocytic Leukemia (CLL), both following two or more lines of prior therapy.

Pioneering the In Vivo CAR T Approach

UB-VV111 is an investigational, off-the-shelf drug designed to generate CD19-directed CAR T cells directly in vivo (inside the patient’s body). This approach is intended to overcome significant limitations of traditional ex vivo (manufactured outside the body) autologous CAR T cell therapies, which restrict broad patient access due to high manufacturing costs, long wait times, and burdensome treatment processes.

UB-VV111 is currently being evaluated in an ongoing Phase 1 clinical trial (NCT06528301) for its safety and anti-tumor activity in CD19+ B-cell malignancies.

The therapy has already marked a pioneering milestone, becoming the first in vivo CAR T cell therapy to receive FDA clearance of its Investigational New Drug (IND) application in 2024. AbbVie retains an exclusive option to license Umoja’s CD19-directed in vivo CAR T cell therapy candidates, including UB-VV111.

Accelerating Development for B-cell Malignancies

The FDA’s Fast Track designation is intended to facilitate the development and expedite the review of drugs that treat serious conditions and have the potential to address an unmet medical need.

“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. “UB-VV111 continues to lead the in vivo CAR T cell field in the U.S., and today’s announcement further reinforces its potential to address unmet needs in the treatment of those living with relapsed/refractory B-cell malignancies.”