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    Home > Active Ingredient News > Blood System > Allogene's universal BCMA CAR-T cells obtained the U.S. FDA fast-track designation medical Maimeng broke the news

    Allogene's universal BCMA CAR-T cells obtained the U.S. FDA fast-track designation medical Maimeng broke the news

    • Last Update: 2021-08-22
    • Source: Internet
    • Author: User
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    Recent popular reports from Yimaike ★ Invitation to the event2021 Oncolytic Virus Drug Development Forum is about to open in Shanghai ★ The financing has reached hundreds of millions in half a year, and the oncolytic virus has entered the fast laneYimai New Observation Click on the picture and register now July 2, 2021 /Healthcare News eMedClub News/--Recently, Allogene Therapeutics, which focuses on the development of allogeneic CAR-T (AlloCAR T™) therapy for cancer, announced that its universal CAR-T candidate product ALLO-605 has been granted a rapid Channel designation for the treatment of multiple myeloma (MM)
    .

    ALLO-605 is the first TurboCAR™ T cell therapy targeting BCMA developed by Allogene.
    TurboCAR technology can selectively transduce ligand-independent cytokine signals into CAR-T cells, which can enhance the proliferation and proliferation of AlloCAR T cells.
    Overcome the potential of T cell exhaustion
    .

    The results of preclinical studies show that ALLO-605 shows enhanced cytokine secretion, versatility, continuous killing activity in vitro and tumor eradication in animal models of myeloma
    .

    The FDA granted ALLO-605 a fast track designation based on the potential of ALLO-605 to address the unmet needs of patients who have failed other standard multiple myeloma treatments
    .

    The first phase of the dose escalation part of the IGNITE trial evaluating ALLO-605 will start in the second quarter of 2021
    .

    Rafael Amado, MD, Executive Vice President of R&D and Chief Medical Officer of Allogene, said: “We are very pleased to see the continued growth of our anti-BCMA combination for patients with multiple myeloma and look forward to the allogeneic CAR-T treatment for these patients.
    Potential options
    .

    Currently, research on ALLO-715 alone and in combination with γ-secretase inhibitors, as well as research on ALLO-605 as our next-generation CAR-T therapy, is taking an active three-pronged approach to explore AlloCART Unique attributes for treating patients with rapidly progressing diseases
    .

    "General BCMA CAR-T Allogene Therapeutics is a clinical-stage biotechnology company, leading the field in today's cancer allogeneic CAR-T (AlloCAR T) therapy, with a variety of allogene CAR-T cell pipelines
    .

    ▲ Allogene R&D The pipeline (picture source: Allogene official website) In addition to ALLO-605, Allogene also owns another BCMA CAR-T product, ALLO-715.
    ALLO-715 is Allogene's AlloCAR T therapy targeting BCMA, which treats MM and other BCMAs.
    A potential therapy for positive cancers
    .

    It uses Cellectis' TALEN gene editing technology to specifically destroy the T cell receptor α chain and CD52 locus.
    The modified cells have a lower risk of TCR-mediated graft versus host disease and antibodies to CD52 Resistance to alemtuzumab (clearing lymphocytes)
    .

    On June 4, 2019, Allogene announced that the U.
    S.
    FDA has approved a new drug research application (IND) for the universal BCMA CAR-T cell ALLO-715 to initiate the combined CD52 antibody ALLO-647 Clinical trials for relapsed/refractory multiple myeloma
    .

    In December 2020, ALLO-715 received another IND application approved by the US FDA for use in combination with γ-secretase inhibitor (GSI) Nirogacestat for relapsed or refractory Patients with multiple myeloma (R/R MM)
    .

    Recommended reading: FDA approves BCMA universal CAR-T combination therapy to enter the clinicalYimai Meng broke the news.
    In addition, Allogene also has universal CAR-T cells targeting CD19 (ALLO-501 and ALLO-501A), which will be held some time ago in 2021 At the annual meeting of the American Society of Clinical Oncology (ASCO), Allogene announced a number of clinical data on these two CAR-T cells
    .

    Recommended reading: ASCO 2021: Allogene announces the latest clinical data of two allogeneic CD19 CAR-T drug treatments Yimai Meng broke the news that BCMA: MM's popular target Multiple myeloma (MM) is a clonal plasma cell abnormality The proliferative malignant disease is also the second most common hematological malignancy after non-Hodgkin’s lymphoma.
    Approximately 160,000 patients worldwide are diagnosed with multiple myeloma each year
    .

    In this disease, clonal plasma cells in the bone marrow deteriorate and abnormally proliferate.
    Malignant plasma cells can replace normal blood cells in the body, leading to anemia and uncontrollable bleeding
    .

    It can also cause bone density and strength problems, and increase the risk of infection by reducing the body's immune response
    .

    The important feature of B cell maturation antigen (BCMA) is that it is highly expressed on MM cells and not expressed in other normal tissues (except plasma cells).
    Therefore, it has become a number of companies and research institutions to develop immunotherapy strategies for MM and other hematological malignancies.
    Popular target
    .

    Currently, targeted immune therapy for MM have to include monoclonal antibodies, antibody-drug conjugates (ADC), bispecific antibodies, CAR-T therapy, tumor vaccine
    .

    It is worth mentioning that in March this year, the US FDA has approved Abecma (idecabtagene vicleucel; ide-cel), the BCMA CAR-T cell therapy product of Bristol-Myers Squibb (BMS) and bluebird bio (bluebird), for treatment acceptance Adult patients with relapsed/refractory multiple myeloma (r/r MM) who have received more than four previous treatments
    .

    This is also the first approved BCMA CAR-T cell
    .

    Recommended reading: Heavy! The first BCMA CAR-T was approved for listing! Yimai Meng broke the news that it was only one step away from the EU’s listing, Bristol-Myers BCMA CAR-T received positive opinions from CHMP Yimai Meng broke the news that in the field of BCMA targeted CAR-T cell therapy, except for BMS/Bluebird’s Abecma , Legendary Bio/Janssen's cilta-cel is also in the lead.
    Both the FDA and EMA have accepted the accelerated application for the therapy BLA or MAA earlier this year; the FDA’s PDUFA date has been determined to be November 29, 2021 , Which means that cilta-cel is expected to be approved for listing in the United States this year
    .

    Domestically, BCMA CAR-T from companies such as Nanjing Reindeer, Keji Biology, Hengrun Dasheng, and Prekin have also successfully entered the clinical trial stage.
    In addition, Genxi Biology, Sibiman Biology, Yimiao Shenzhou, Boshengji, etc.
    The company has already had a similar pipeline layout (incomplete statistics)
    .

    Reference materials: 1.
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