Umoja Biopharma Announces FDA Clearance of IND Application for UB-VV111, a CD19 Directed in situ CAR T for Hematologic Malignancies
- UB-VV111 is potentially the first in situ generated CD19 chimeric antigen receptor (CAR)-T cell therapy to be evaluated in humans in the hematology setting -
- First patient expected to be dosed by end of 2024 –
/EIN News/ -- SEATTLE, July 31, 2024 (GLOBE NEWSWIRE) -- Umoja Biopharma, Inc. (Umoja), a transformative immunotherapy company creating off-the-shelf treatments that aim to extend the reach and effectiveness of CAR-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 CAR 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.
“The IND clearance for UB-VV111 is a significant milestone in Umoja’s mission to develop off-the-shelf therapies that overcome the limitations of current ex vivo cellular immunotherapies,” said Andrew Scharenberg, M.D., Co-Founder and Chief Executive Officer of Umoja. “We 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 CAR 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.”
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 CAR T naïve and CAR T treated patients.
In January 2024, Umoja Biopharma and AbbVie announced two exclusive option and license agreements to develop multiple in situ generated CAR 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’s CD19-directed in situ generated CAR T-cell therapy candidates, including UB-VV111.
About Umoja Biopharma
Umoja Biopharma, Inc. is a clinical-stage biotechnology company aiming to develop off-the-shelf therapeutics that improve the reach, effectiveness, and access of CART cell therapies in both oncology and autoimmunity. Umoja’s VivoVecTM 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/.
About VivoVecTM
Umoja’s 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 CAR-T cells in vivo. This has the potential to eliminate many challenges associated with traditional CAR-T approaches, including reliance on gathering a patient’s 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’s lymphodepletion.
About UB-VV111
UB-VV111 is a lentiviral vector-based gene therapy from Umoja’s VivoVec platform, comprising a surface-engineered viral envelope. UB-VV111 encodes a transgene for an anti-CD19 CAR and a Rapamycin Activated Cytokine Receptor (RACRTM), which is designed to enrich and expand UB-VV111 engineered CAR 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 Umoja Biopharma, Inc. (the “Company,” “we,” “us,” or “our”). 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’s 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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