Chengdu Ucelino's UC101 Becomes World’s First Umbilical Cord Blood-Derived Allogeneic CAR-T Therapy to Receive FDA IND Approval

Jan 13, 2025 07:21 CST Updated 07:21

Ucello

Developer and Manufacturer of Universal CAR-T Cell Therapy Drugs

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January 13, 2025

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Recently, UCELLO announced that its self-developed allogeneic universal CD19-targeted chimeric antigen receptor (CAR) T-cell injection (UC101) received approval from the U.S. Food and Drug Administration (FDA) for a new drug clinical trial application (IND) on January 11, 2025. This is also the first universal CAR-T product produced in China to pass the FDA's IND approval.

World's First Universal Cord Blood CAR-T

UC101 is the world's first umbilical cord blood-derived allogeneic universal CAR-T to receive FDA IND approval. T cells derived from umbilical cord blood are the youngest T cells, with the natural advantages of low immunogenicity and being in an early differentiation state. The low immunogenicity of umbilical cord blood T cells can reduce host-versus-graft (HvGR) reactions, allowing allogeneic universal CAR-T to expand more easily and effectively within the patient’s body, significantly increasing the median persistence time of allogeneic CAR-T cells in vivo. More importantly, 90% of umbilical cord blood T cells are naïve T cells, and after extensive in vitro expansion, 80% remain as Tscm and Tcm cells. Tscm and Tcm cells, which are in the early stages of differentiation, exhibit stronger in vivo expansion capacity and persistence, making the product more therapeutically effective.

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Exclusive Technical Highlights

UC101 is alsoThe World's First CAR-T Approved for IND Using a Stable Cell Line to Produce Lentiviral VectorsThe production of lentiviral vectors by stable transfection cell lines does not require plasmids as raw materials, making the production process simpler. Lentiviral vectors produced through this process have the advantages of high batch-to-batch consistency, high viral titer, low empty capsid rate, high transduction efficiency, and more controllable quality. Compared with lentiviral vectors produced by traditional transient transfection processes, this method significantly reduces costs while improving quality.

UC101 adopts a unique gene-editing combination, which can reduce immunogenicity, enhance efficacy, and better control adverse reactions at the same time.In this FDA IND application, the company successfully completed multiple large-scale production batches using imported umbilical cord blood from the U.S. in a GMP environment, with one batch being sufficient for use by more than 100 people., truly achieving a significant reduction in the price of CAR-T cell therapy and enhancing medical accessibility.

Ingeniously Developed, Benefiting Patients

UC101 is the first allogeneic universal CAR-T in China to receive FDA IND approval, marking the official entry of China's allogeneic universal CAR-T onto the international stage. The FDA IND approval of UC101 signifies that many innovative aspects of UCELLO's umbilical cord blood allogeneic universal CAR-T cell technology platform have been recognized by top international regulatory authorities. It also marks the completion of validation for the first product from the company’s technology platform, laying a solid industrial foundation for subsequent development of new indications and new target products based on this platform, and demonstrating the company’s immense potential in its global strategy.

UCELLO's early platform technology has demonstrated significant efficacy and good safety in the IIT clinical trial for acute B-cell lymphoblastic leukemia (B-ALL)., the latest platform technology has expanded IIT clinical trial research to multiple indications, including multiple myeloma (MM), systemic lupus erythematosus (SLE), and Sjögren's syndrome (SjD).In the IIT clinical trial targeting systemic lupus erythematosus, significant CAR-T cell expansion has been achieved in consecutive patients, and B-cell reconstitution has been completed., the autologous CAR-T cell therapy developed by UCELLO has shown that patients' self-reactive antibodies significantly decreased, with the hope of achieving drug-free remission. The effect is comparable to the international industry data of autologous CAR-T. It is believed that in the future, UCELLO will provide more cost-effective treatment options for a wider range of patient populations in China, improving their quality of life and restoring their confidence in life.

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