Umoja Biopharma announces United States clinical trial initiation of industry’s first known CD22-targeted In Vivo CAR-T Therapy, developed in collaboration with IASO Bio

July 16, U.S. local time — Umoja Biopharma of the United States, a collaborator with IASO Bio, announced that the U.S. Food and Drug Administration (FDA) recently cleared its Investigational New Drug (IND) application for UB-VV400, a CD22-directed in vivo CAR T cell therapy candidate under development for adults with relapsed/refractory (R/R) B-cell malignancies. Under the terms of a collaboration with IASO Bio announced in January 2024, Umoja received exclusive rights to CAR cassettes for CD22 and a second undisclosed target for the advancement of two in vivo product candidates incorporating VivoVec™, Umoja’s proprietary lentiviral in vivo gene delivery technology. Umoja is responsible for product development, manufacturing, regulatory and commercialization in territories outside of Greater China, and IASO for the Greater China territory. 

Umoja plans to initiate an openlabel, dose-escalation and expansion Phase 1/2 clinical study, with the first patient anticipated to be dosed in the third quarter of 2026. Dr. Luke Walker, Chief Medical Officer of Umoja, stated: "UBVV400 is our second VivoVec™ -based in vivo CAR T cell program to advance to U.S. clinical trials. Generating CAR-T cells within a patient’s body would have the potential to transform clinical practice."

UB-VV400 is the industry's first known CD22-directed in vivo CAR-T cell therapy candidate. Unlike conventional CAR-T cell therapies, which require the ex vivo collection, genetic engineering and expansion of a patient's T cells prior to reinfusion, UB-VV400 leverages Umoja’s proprietary in vivo delivery platform to directly deliver the CD22 CAR transgene to the patient's own T lymphocytes. This enables CAR T cells to be generated directly within the patient's body, allowing them to specifically recognize and eliminate CD22-expressing B-cell malignancies.

About IASO Bio

Founded in 2017, IASO Bio is one of the few commercial-stage biopharmaceutical companies in the Advanced Therapy Medicinal Product (ATMP) sector bringing China’s breakthrough innovations to the global market. We specialize in developing cell therapies and biologics for hematological malignancies and autoimmune diseases. Our industry-leading, fully integrated platforms leverage cutting-edge technologies that span the entire product lifecycle—from discovery and development to manufacturing and commercialization.

We have established a robust and synergistic pipeline, reflecting our commitment to making transformative cell therapies broadly accessible to patients worldwide. Our current portfolio includes ten products and product candidates, anchored by our core product, Equecabtagene Autoleucel (Eque-cel). The CAR-T therapy Eque-cel has been approved in China for the treatment of relapsed or refractory multiple myeloma (r/r MM) in patients who have progressed after at least three prior lines of therapy. It is also being developed for use in earlier lines of r/r MM treatment and for autoimmune diseases, including myasthenia gravis (MG), multiple sclerosis (MS), and systemic lupus erythematosus (SLE)/lupus nephritis (LN). 

We collaborate with leading biotechnology and biopharmaceutical companies such as Innovent, Sana, Cabaletta, and Umoja, as well as top-tier academic institutions and hospitals, to strengthen our product development capabilities.

Leveraging our strong execution capability, an integrated and experienced management team in ATMPs, a robust pipeline, and advanced manufacturing and CMC capabilities, IASO Bio remains committed to making transformative cell therapies broadly accessible to patients worldwide.

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. 

Reference：

https://www.umoja-biopharma.com/news/umoja-biopharma-announces-fda-clearance-of-ind-application-for-ub-vv400-the-industrys-first-known-cd22-directed-in-vivo-car-t-cell-therapy-for-relapsed-refractory-b-cell-malignancies/