This study is a Phase 1 dose-escalation and dose-confirmation study to evaluate the safety and antitumor activity of UB-VV111. The study will enroll patients with relapsed/refractory large B-cell lymphoma (LBCL) and chronic lymphocytic leukemia (CLL).

Start Date10 Mar 2025

Sponsor / Collaborator

Umoja Biopharma, Inc.

100 Clinical Results associated with UB-VV111

100 Translational Medicine associated with UB-VV111

100 Patents (Medical) associated with UB-VV111

Literatures (Medical) associated with UB-VV111

29 Aug 2024·BLOOD

In vivo CAR T-cell generation in nonhuman primates using lentiviral vectors displaying a multidomain fusion ligand

Article

Author: Umuhoza, Saluwa ; Scharenberg, Andrew M. ; Mangio, Richard S. ; Hernandez Lopez, Susana A. ; Qin, Jim ; Shin, Seungjin ; Gottschalk, Rebecca J. ; Michels, Kathryn R. ; Parrilla, Don ; Tang, Weiliang ; Kiem, Hans-Peter ; Park, Lisa Y. ; Cooper, Sara E. ; Parker, Maura H. ; McDonnell, Mollie M. ; Ulrich-Lewis, Justin T. ; Beitz, Laurie O. ; Ericson, Nolan G. ; Leung, Wai-Hang ; Nicolai, Christopher J. ; Ryu, Byoung Y. ; Brandes, Alissa H. ; Larson, Ryan P.

Abstract:

Chimeric antigen receptor (CAR) T-cell therapies have demonstrated transformative efficacy in treating B-cell malignancies. However, high costs and manufacturing complexities hinder their widespread use. To overcome these hurdles, we have developed the VivoVec platform, a lentiviral vector capable of generating CAR T cells in vivo. Here, we describe the incorporation of T-cell activation and costimulatory signals onto the surface of VivoVec particles (VVPs) in the form of a multidomain fusion protein and show enhanced in vivo transduction and improved CAR T-cell antitumor functionality. Furthermore, in the absence of lymphodepleting chemotherapy, administration of VVPs into nonhuman primates resulted in the robust generation of anti-CD20 CAR T cells and the complete depletion of B cells for >10 weeks. These data validate the VivoVec platform in a translationally relevant model and support its transition into human clinical testing, offering a paradigm shift in the field of CAR T-cell therapies.

News (Medical) associated with UB-VV111

28 Apr 2026

·www.biospace.com

Umoja Biopharma Announces Unveiling of UB-VV500 in Upcoming Poster Presentation at the American Society of Gene & Cell Therapy Annual Meeting

- Industry’s First Combination BCMA x GPRC5D In Vivo CAR T Cell Therapy for the Treatment of Multiple Myeloma - SEATTLE, April 27, 2026 (GLOBE NEWSWIRE) -- Umoja Biopharma, Inc. (Umoja), a clinical-stage biotechnology company committed to delivering innovative and potentially curative immunotherapies for patients with cancer and autoimmune diseases, today announced the acceptance of a poster presentation for UB-VV500, its dual-targeted BCMA x GPRC5D in vivo CAR T cell program for the treatment of multiple myeloma, at the upcoming American Society of Gene & Cell Therapy (ASGCT) Annual Meeting. Preclinical data for UB-VV500 will be presented in a scientific poster at the conference. “Development in multiple myeloma is moving beyond single-targeted approaches toward dual-targeting and combination strategies, particularly as patients progress through existing BCMA-directed therapies,” said Andrew Scharenberg, M.D., co-founder and Chief Executive Officer of Umoja Biopharma. “We believe the future of multiple myeloma immunotherapy will be shaped by combination products that are designed from the ground-up to more effectively address antigen escape and disease heterogeneity while aiming to deliver greater and more durable efficacy. UB-VV500 is designed to realize that vision through our in vivo CAR T cell approach.” Umoja expects to advance UB-VV500 into a Phase 1 clinical trial by the end of 2026. Initial clinical data disclosures across the company’s other clinical programs are expected to be reported at major medical meetings in the second half of 2026. “We are encouraged by our safety and early clinical results in our three ongoing Phase 1 programs—UB-VV111 for CD19 and UB-VV400/UB-VV410 for CD22—which use the same VivoVec TM in vivo platform that UB-VV500 is built upon,” Dr. Scharenberg added. “UB-VV500’s pre-clinical progress is exciting and we look forward to sharing more at ASGCT. Dual-targeting is the future of patient care for multiple myeloma, and we expect UB-VV500 to be at the forefront of that movement.” Details of the ASGCT poster presentation can be found below: Poster Presentation Title: Preclinical development of UB-VV500, an in vivo potency-enhanced CAR T cell product targeting BCMA and GPRC5D for multiple myeloma Presentation Date/Time: Wednesday, May 13, 2026, 5:00 – 6:30 p.m. ET Presenting Speaker: Christopher Nicolai, Ph.D. Publication Number: 2046 About Umoja Biopharma Umoja Biopharma, Inc. is a clinical-stage biotechnology company committed to delivering innovative and potentially curative immunotherapies for patients with cancer and autoimmune diseases. 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 umoja-biopharma.com. Investors Nate Hardy Chief Financial Officer nate.hardy@umoja-biopharma.com Media Matt Wright Real Chemistry mwright@realchemistry.com

ImmunotherapyCell Therapy

11 Dec 2025

·endpoints.news

Umoja delays first readout for in vivo CAR-T therapy

Umoja Biopharma, one of the most well-capitalized developers of in vivo CAR-T therapy, is delaying its first clinical readout from its China-based first trial. The startup told Endpoints News that it now expects to share initial data on its in vivo CAR-T therapy, known as UB-VV400, in the second half of next year. It was previously targeting the end of this year. “This reflects the natural cadence of enrollment and a desire to provide more significant clinical updates, even if on a less frequent basis,” Umoja wrote in a statement. “Looking ahead, we continue to advance our broader pipeline and expect to share additional updates on our overall progress in 2026.” Umoja said the delay wasn’t related to any safety or efficacy finding. Other in vivo CAR-T developers have already shared initial data on some patients from their programs, showing the early potential of the approach. Those include EsoBiotec, now part of AstraZeneca, China’s MagicRNA, and most recently, Kelonia Therapeutics . The delayed readout could also put pressure on Umoja’s current cash reserves. At the start of this year, Umoja announced a $100 million Series C, which it said would give it enough money to last until late 2026. It previously raised rounds of $210 million and $53 million. Typical CAR-T therapies have been transformative in the treatment of blood cancers, but are made from a patient’s own cells through a complex and costly process. The hope with in vivo CAR-Ts is to send instructions for making the cell therapy directly into a patient’s body through a simple infusion, or set of infusions. But the approach is still in its early days of development, and while it has garnered excitement, its ultimate safety and efficacy are unknown. Umoja said it still plans to ask the FDA in the first half of 2026 to start a clinical trial in the US. The Seattle and Colorado-based biotech is developing a CD22-targeted therapy for cancer and autoimmune disease. Its China-based investigator-initiated trial, or IIT, is looking at the experimental treatment in B cell cancers. That work is sponsored by its China partner IASO Biotechnology. The China trial could enroll up to about 70 patients, according to a federal clinical trials database . Umoja is also developing a CD19-targeted in vivo cell therapy called UB-VV111, which is partnered with AbbVie. AbbVie in June announced a $2.1 billion buyout of Capstan , another in vivo CAR-T developer using mRNA and lipid nanoparticles instead of viral vectors like Umoja. “Our partnership with AbbVie remains strong and ongoing for both UB-VV111 and the discovery programs. We’re continuing to accrue clinical data as guided. At this time, we’re not sharing timing or data disclosures for the program,” Umoja said.

Cell TherapyAcquisitionImmunotherapyClinical Study

02 Oct 2025

·www.globenewswire.com

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

Sept. 30, 2025 -- 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.” 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. The content above comes from the network. if any infringement, please contact us to modify.

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

ImmunotherapyCell TherapyFast TrackIND

100 Deals associated with UB-VV111

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
CD19 Expressing Malignancies	Phase 1	United States	Umoja Biopharma, Inc.	10 Mar 2025
CD19 Expressing Malignancies	Phase 1	Australia	Umoja Biopharma, Inc.	10 Mar 2025
Chronic Lymphocytic Leukemia	Phase 1	United States	Umoja Biopharma, Inc.	10 Mar 2025
Chronic Lymphocytic Leukemia	Phase 1	Australia	Umoja Biopharma, Inc.	10 Mar 2025
Diffuse Large B-Cell Lymphoma	Phase 1	United States	Umoja Biopharma, Inc.	10 Mar 2025
Diffuse Large B-Cell Lymphoma	Phase 1	Australia	Umoja Biopharma, Inc.	10 Mar 2025

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