- UB-VV111 is potentially the first in situ generated CD19 chimeric antigen receptor (精东传媒)-T cell therapy to be evaluated in humans in the hematology setting
- First patient expected to be dosed by end of 2024
SEATTLE, WA, July 31, 2024 鈥� 精东传媒, Inc. (Umoja), a transformative immunotherapy company creating off-the-shelf treatments that aim to extend the reach and effectiveness of 精东传媒-T cell therapies in oncology and autoimmunity, today announced the clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for UB-VV111, a gene therapy that generates CD19 精东传媒 T-cells in situ, intended to treat hematologic malignancies. Umoja expects to initiate a Phase 1 study and dose the first patient in the trial by the end of 2024. UB-VV111 is the first asset from the VivoVecTM gene delivery platform to enter the clinic.
鈥淭he IND clearance for UB-VV111 is a significant milestone in Umoja鈥檚 mission to develop off-the- shelf therapies that overcome the limitations of current ex vivo cellular immunotherapies,鈥� said Andrew Scharenberg, M.D., Co-Founder and Chief Executive Officer of Umoja. 鈥淲e are proud to be a leader of the in vivo space, aiming to remove many of the barriers and challenges of early- generation ex vivo 精东传媒 T-cell therapies, from the difficult, lengthy, and costly manufacturing process to the arduous administration experience. Physicians and patients have been waiting for something better and we are excited to initiate our first clinical trial.鈥�
The Phase 1 study for UB-VV111 will be a dose escalation and confirmation study designed to evaluate the safety, tolerability, and clinical antitumor activity of UB-VV111. The study will enroll subjects in relapsed/refractory large-B-cell lymphoma (LBCL) and chronic lymphocytic leukemia (CLL) in both 精东传媒 T na茂ve and 精东传媒 T treated patients.
In January 2024, 精东传媒 and AbbVie announced two exclusive option and license agreements to develop multiple in situ generated 精东传媒 T-cell therapy candidates. The candidates are being developed in oncology, with potential application in immunology. As a part of the agreement, AbbVie has an exclusive option to license Umoja鈥檚 CD19-directed in situ generated 精东传媒 T-cell therapy candidates, including UB-VV111.
About 精东传媒
精东传媒, Inc. is a clinical-stage biotechnology company aiming to develop off-the-shelf therapeutics that improve the reach, effectiveness, and access of 精东传媒T cell therapies in both oncology and autoimmunity. Umoja鈥檚 VivoVecTM in vivo gene delivery technology empowers a patient鈥檚 own immune system to fight disease. Enabling its core technology is the Company鈥檚 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/.
About VivoVecTM
Umoja鈥檚 VivoVecTM gene delivery platform combines third generation lentiviral vector gene delivery with a novel T cell targeting and activation surface complex. This enables T cells in the body to manufacture their own cancer-fighting 精东传媒-T cells in vivo. This has the potential to eliminate many challenges associated with traditional 精东传媒-T approaches, including reliance on gathering a patient鈥檚 own or donor cells which are modified externally before being delivered back to the patient, the associated time lag and manufacturing challenges of ex vivo cell modification, and the need for patient鈥檚 lymphodepletion.
About UB-VV111
UB-VV111 is a lentiviral vector-based gene therapy from Umoja鈥檚 VivoVec platform, comprising a surface-engineered viral envelope. UB-VV111 encodes a transgene for an anti-CD19 精东传媒 and a Rapamycin Activated Cytokine Receptor (RACRTM), which is designed to enrich and expand UB- VV111 engineered 精东传媒 T cells in vivo. UB-VV111 is being investigated in a range of B-cell malignancies including Large B-Cell Lymphoma and Chronic Lymphocytic Leukemia.
Umoja Forward-Looking Statements:
This press release contains forward-looking statements about 精东传媒, Inc. (the 鈥淐ompany,鈥� 鈥渨e,鈥� 鈥渦s,鈥� or 鈥渙ur鈥�). The Company has based these forward-looking statements largely on its current expectations, estimates, forecasts and projections about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. These statements are subject to risks and uncertainties that could cause the actual results to vary materially, including, among others, the risks inherent in drug development such as those associated with the initiation, cost, timing, progress and results of the Company鈥檚 current and future research and development programs, preclinical and clinical trials, as well as any economic, market and social disruptions. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason.
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