FDA Clears Umoja Biopharma's IND for UB-VV111 CAR T Therapy

Umoja Biopharma, Inc., a pioneering immunotherapy company based in Seattle, WA, announced on July 31, 2024, that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for UB-VV111. UB-VV111 is a groundbreaking gene therapy designed to generate CD19 chimeric antigen receptor (CAR) T-cells within the patient's body. This therapy targets hematologic malignancies, and the company plans to start a Phase 1 clinical trial and dose the first patient before the end of 2024. This marks the first clinical entry of a product from Umoja's VivoVec gene delivery platform.

Dr. Andrew Scharenberg, Co-Founder and CEO of Umoja, highlighted the significance of this development, stating that the FDA’s IND clearance is a pivotal step toward achieving their objective of creating off-the-shelf therapies that surpass the limitations of current ex vivo cellular immunotherapies. He emphasized that UB-VV111 aims to address various challenges posed by early-generation ex vivo CAR T-cell therapies, particularly their complex, time-consuming, and expensive manufacturing process, as well as their arduous administration protocols. According to Scharenberg, both physicians and patients have long awaited such advancements, and the initiation of the clinical trial is a momentous occasion for the company.

The upcoming Phase 1 study for UB-VV111 will involve dose escalation and confirmation phases to assess the safety, tolerability, and clinical antitumor activity of the therapy. The study will enroll patients with relapsed or refractory large-B-cell lymphoma (LBCL) and chronic lymphocytic leukemia (CLL), including those naïve to CAR T therapy and those who have previously undergone CAR T treatment.

Earlier in January 2024, Umoja Biopharma entered into two exclusive option and license agreements with AbbVie to develop multiple in situ generated CAR T-cell therapy candidates. These candidates are intended for oncology applications, with potential use in immunology. As part of this collaboration, AbbVie has secured an exclusive option to license Umoja’s CD19-directed in situ-generated CAR T-cell therapy candidates, including UB-VV111.

Umoja Biopharma, currently in the clinical stage, focuses on developing off-the-shelf therapeutics that enhance the reach, effectiveness, and accessibility of CAR T-cell therapies for both oncology and autoimmune diseases. The company’s innovative VivoVec in vivo gene delivery technology leverages a patient’s own immune system to combat disease effectively. This approach is supported by Umoja’s advanced lentiviral vector development and manufacturing facility located in Louisville, Colorado. Umoja believes that its methodologies can expand access to cutting-edge immunotherapies, ultimately enabling more patients to lead healthier, more fulfilling lives.

The VivoVec gene delivery platform combines third-generation lentiviral vector gene delivery with an innovative T cell targeting and activation surface complex. This technology allows T cells within the body to produce their own cancer-fighting CAR-T cells, potentially overcoming many of the obstacles associated with traditional ex vivo CAR-T approaches. These challenges include the need for collecting a patient's or donor's cells, which are modified outside the body and then readministered, as well as the associated time delays and manufacturing complexities.

UB-VV111, a lentiviral vector-based gene therapy from the VivoVec platform, features a surface-engineered viral envelope. It encodes a transgene for an anti-CD19 CAR and a Rapamycin Activated Cytokine Receptor (RACR), designed to enrich and expand UB-VV111 engineered CAR T cells in vivo. The therapy is currently being investigated for its efficacy in treating various B-cell malignancies, including Large B-Cell Lymphoma and Chronic Lymphocytic Leukemia.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!