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    Focused on rapidly developing cell therapies


    Our global R&D network allows us to increase speed of clinical development
    Image of light streams
    hexagons

    Legend Biotech remains fearless in our research

    To accelerate the science and bring innovative therapies to patients, we will:


    Icon of extended lines to show pipeline advancement
    Enrich our pipeline
    Icon of test tubes to represent technology platforms
    Advance our
    technology platforms

    Program areas of development

    Legend Biotech is utilizing the extensive cell therapy experience of our leadership and R&D staff, global clinical partners, and expanding research facilities to realize the potential of cell therapy to treat diseases that are thought to be incurable, such as hematologic malignancies, solid tumors, infectious diseases, and autoimmune diseases.

    ?
    Infectious Diseases Solid Tumors Preclinical Phase 1 Phase 2 Phase 3 LCAR-B38M / JNJ-4528 Autologous TCL (CD4) NHL-DLBCL (CD19 x CD22) AML (CD33 x CLL-1) R/R MM (BCMA) Allogeneic NHL-DLBCL, FL, MCL, SLL (CD20) HIV LB1901 LB1909 LB1910 LB1905 LB1903 Pancreatic Cancer (Claudin 18.2) LB1904 Gastric Cancer (Claudin 18.2) LB1904 Ovarian Cancer LB1902 Hematologic Malignancies US / RoW US / China China “AML=acute myeloid leukemia, BCMA=B-cell maturation antigen, DLBCL=diffuse large B-cell lymphoma, FL=follicular lymphoma, HIV= human immunodeficiency virus,?MCL=mantle cell lymphoma, NHL=non -Hodgkin lymphomas, R/R MM=relapsed or refractory multiple myeloma, RoW=Rest of World, SLL=small lymphocytic lymphoma,?TCL=T-cell lymphoma LEGEND-2 CARTITUDE-4 CARTITUDE-1 CARTIFAN-1 CARTITUDE-2

    Rapid progress

    Our milestones show our acceleration in product and infrastructure development


    TIMELINE
    2019

    May: Additional data from LEGEND-2 published in the Proceedings of the National Academy of Sciences of the United States of America

    April: JNJ-4528 was granted the PRIME designation in the treatment of relapsed or refractory multiple myeloma

    February: Joined other corporate industry leaders in the ASTCT Corporate Council

    2018

    December: Data from LEGEND-2 published in the Journal of Hematology & Oncology

    December: Updated data from Phase 1/2 open-label study of LCAR-B38M (LEGEND-2) presented at ASH 2018

    May: Phase 1b/2 IND for JNJ-4528 cleared by the FDA

    March: Phase 2 IND for LCAR-B38M cleared by NMPA

    2017

    December: Worldwide collaboration and licensing agreement with Janssen signed in December

    June: Results from an ongoing, early-phase clinical trial with LCAR-B38M presented at ASCO

    2016

    March: First RRMM patient treated with LCAR-B38M in China

    2014

    Legend Biotech business entity created



    RRMM=relapsed or refractory multiple myeloma

    The safety and efficacy of the agents and/or uses under investigation have not been established. There is no guarantee that the agents will receive health authority approval or become commercially available in any country for the uses being investigated.

    *LCAR-B38M identifies the investigational product being studied in China and Janssen Biotech, Inc.'s JNJ-68284528 (also referenced as JNJ-4528) identifies the investigational product being studied in the United States, both of which are representative of the same CAR-T cell therapy.

    We are rapidly advancing our 3 core cell therapy platforms:



    CHIMERIC ANTIGEN RECEPTOR
    T-CELL THERAPY (CAR-T)

    LCAR-B38M/JNJ-4528*

    Our first product candidate, LCAR-B38M/JNJ-4528, is a B cell maturation antigen (BCMA)-directed CAR-T cell therapy. BCMA is highly expressed on myeloma cells and plasma cells.1,2 Proof of concept has been achieved in an investigator-initiated, first-in-human study (LEGEND-2) conducted in 74 patients with RRMM in China.1,3 Globally, Legend Biotech, together with Janssen Biotech, Inc., is advancing the Phase 1b/2 trial (CARTITUDE-1, NCT03548207) with JNJ-4528 to evaluate its efficacy and safety in adults with RRMM. The study is currently enrolling patients following US Food and Drug Administration clearance of an Investigational New Drug application as announced in May 2018.

    A Phase 2 confirmatory trial (CARTIFAN-1, CTR20181007, NCT03758417) registered with the Center for Drug Evaluation is currently enrolling patients in China to further evaluate LCAR-B38M in patients with advanced RRMM.


    Image of Legend Biotech CAR-T cell therapy LCAR-B38M/JNJ4528

    Other CARs typically have a single binding domain. However, LCAR-B38M/JNJ-4528 CAR-T cells contain 2 single-domain antibodies that target BCMA.

    Spacer/hinge and
    transmembrane domains

    Influences the length and flexibility of the CAR, which may affect tumor recognition, CAR expression, and T-cell activation.4

    Costimulatory domain (4-1BB)

    Transmits costimulatory signals for T-cell proliferation and enhanced persistence of LCAR-B38M/JNJ-4528.

    T-cell activation domain (CD3ζ)

    Provides the primary signal for T-cell activation.

    LCAR-B38M/JNJ-4528 — a structurally differentiated CAR-T cell therapy containing a 4-1BB co-stimulatory domain and two BCMA-targeting single-domain antibodies designed to confer avidity


    RRMM=relapsed or refractory multiple myeloma

    T-CELL RECEPTOR
    T-CELL THERAPY (TCR-T)

    TCR-T

    Legend Biotech recognizes that T-cell receptors (TCRs) isolated from tumor-specific T cells can be another effective approach to target tumors; in particular, solid tumors. Unlike CARs, TCRs can bind to polypeptides (antigens) derived from intracellular proteins.

    Mutations with altered protein sequences occur frequently in many cancers. The mutated proteins are cleaved inside the cell and presented on the cell surface as polypeptides (epitopes) by the major histocompatibility complex (MHC). Neoepitopes are polypeptides derived from mutated genes/proteins presented only on tumors but not normal cells, which can be highly immunogenic and induce potent anti-tumor T-cell responses. TCRs isolated from neoepitope-specific T cells can then be engineered to TCR-T for clinical use.

    At Legend Biotech, we are addressing the challenges of treating solid tumors by identifying novel TCRs to build TCR-T based on a foundation of studying with the leaders in the field, and further improving TCR-T as therapeutics by overcoming the immunosuppressive tumor microenvironment.

    ALLOGENEIC CELL THERAPY

    Allogeneic

    Legend Biotech sees the promise of allogeneic cell therapy and its potential benefits. We are exploring a range of versatile tools and cell types in pursuit of a truly "off-the-shelf" cell therapy.

    LCAR-B38M/JNJ-4528*

    Our first product candidate, LCAR-B38M/JNJ-4528, is a B cell maturation antigen (BCMA)-directed CAR-T cell therapy. BCMA is highly expressed on myeloma cells and plasma cells.1,2 Proof of concept has been achieved in an investigator-initiated, first-in-human study (LEGEND-2) conducted in 74 patients with RRMM in China.1,3 Globally, Legend Biotech, together with Janssen Biotech, Inc., is advancing the Phase 1b/2 trial (CARTITUDE-1, NCT03548207) with JNJ-4528 to evaluate its efficacy and safety in adults with RRMM. The study is currently enrolling patients following US Food and Drug Administration clearance of an Investigational New Drug application as announced in May 2018.

    A Phase 2 confirmatory trial (CARTIFAN-1, CTR20181007, NCT03758417) registered with the Center for Drug Evaluation is currently enrolling patients in China to further evaluate LCAR-B38M in patients with advanced RRMM.


    Image of Legend Biotech CAR-T cell therapy LCAR-B38M/JNJ-4528
    Binding domains

    Other CARs typically have a single binding domain. However, LCAR-B38M/JNJ-4528 CAR-T cells contain 2 single-domain antibodies that target BCMA.

    Spacer/hinge and
    transmembrane domains

    Influences the length and flexibility of the CAR, which may affect tumor recognition, CAR expression, and T-cell activation.4

    Costimulatory domain (4-1BB)

    Transmits costimulatory signals for T-cell proliferation and enhanced persistence of LCAR-B38M/JNJ-4528.

    T-cell activation domain (CD3ζ)

    Provides the primary signal for T-cell activation.

    LCAR-B38M/JNJ-4528 — a structurally differentiated CAR-T cell therapy containing a 4-1BB co-stimulatory domain and two BCMA-targeting single-domain antibodies designed to confer avidity


    RRMM=relapsed or refractory multiple myeloma

    TCR-T

    Legend Biotech recognizes that T-cell receptors (TCRs) isolated from tumor-specific T cells can be another effective approach to target tumors; in particular, solid tumors. Unlike CARs, TCRs can bind to polypeptides (antigens) derived from intracellular proteins.

    Mutations with altered protein sequences occur frequently in many cancers. The mutated proteins are cleaved inside the cell and presented on the cell surface as polypeptides (epitopes) by the major histocompatibility complex (MHC). Neoepitopes are polypeptides derived from mutated genes/proteins presented only on tumors but not normal cells, which can be highly immunogenic and induce potent anti-tumor T-cell responses. TCRs isolated from neoepitope-specific T cells can then be engineered to TCR-T for clinical use.

    At Legend Biotech, we are addressing the challenges of treating solid tumors by identifying novel TCRs to build TCR-T based on a foundation of studying with the leaders in the field, and further improving TCR-T as therapeutics by overcoming the immunosuppressive tumor microenvironment.

    Allogeneic

    Legend Biotech sees the promise of allogeneic cell therapy and its potential benefits. We are exploring a range of versatile tools and cell types in pursuit of a truly "off-the-shelf" cell therapy.

    References: 1. Zhao WH, Liu J, Wang BY, et al. A phase 1, open-label study of LCAR-B38M, a chimeric antigen receptor T cell therapy directed against B cell maturation antigen, in patients with relapsed or refractory multiple myeloma. J Hematol Oncol. 2018;11(1):141. 2. Carpenter RO, Evbuomwan MO, Pittaluga S, et al. B-cell maturation antigen is a promising target for adoptive T-cell therapy of multiple myeloma. Clin Cancer Res. 2013;19(8):2048-2060. 3. Xu J, Chen LJ, Yang SS, et al. Exploratory trial of a biepitopic CAR T-targeting B cell maturation antigen in relapsed/refractory multiple myeloma. Proc Natl Acad Sci USA. 2019;doi: 10.1073/pnas.1819745116. 4. Guedan S, Calderon H, Posey AD Jr, Maus MV. Engineering and design of chimeric antigen receptors. Mol Ther Methods Clin Dev. 2018;12:145-156. 5. Efremova M, Finotello F, Rieder D, Trajanoski Z. Neoantigens generated by individual mutations and their role in cancer immunity and immunotherapy. Front Immunol. 2017;8:1679. 6. Data on file. Piscataway, NJ: Legend Biotech USA Inc.



    The safety and efficacy of the agents and/or uses under investigation have not been established. There is no guarantee that the agents will receive health authority approval or become commercially available in any country for the uses being investigated.

    *LCAR-B38M identifies the investigational product being studied in China and Janssen Biotech, Inc.'s JNJ-68284528 (also referenced as JNJ-4528) identifies the investigational product being studied in the United States, both of which are representative of the same CAR-T cell therapy.

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