Umoja Biopharma Announces that UB-VV111 Receives FDA Fast Track Designation for Relapsed/Refractory B-Cell Malignancies

SEATTLE, Sept. 30, 2025 (GLOBE NEWSWIRE) — Umoja Biopharma, the clinical-stage leader of in vivo cell therapies that aim to realize the full reach and promise of CAR T cells, 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 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 (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. As previously announced, 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. “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. This achievement is a testament to the dedication of our clinical trial sites and to the patients who inspire our mission every day.”

About 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. Umoja’s VivoVec™ in vivo gene delivery technology empowers a patient’s own immune system to fight disease. Enabling its core technology is the Company’s state-of-the-art lentiviral vector development and manufacturing facility in Louisville, Colorado. Umoja believes its approach can provide broader access and improved effectiveness of the most advanced immunotherapies, enabling more patients to live better, fuller lives. To learn more, connect with Umoja on LinkedIn and visit http://umoja-biopharma.com/.

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