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    Home > Active Ingredient News > Blood System > Universal CD20 CAR-γδ T cell therapy has been granted Fast Track designation by the US FDA. What are the advantages of γδ T cells?

    Universal CD20 CAR-γδ T cell therapy has been granted Fast Track designation by the US FDA. What are the advantages of γδ T cells?

    • Last Update: 2022-06-12
    • Source: Internet
    • Author: User
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    April 21, 2022/eMedClub News/--On April 19, 2022, Adicet Bio announced that the U.
    S.
    FDA has granted its CD20-targeting allogeneic CAR-γδ T product candidate ADI-001 Fast Track designation, For the treatment of relapsed or refractory B-cell non-Hodgkin lymphoma (NHL)

    .

       ADI-001 is currently undergoing a dose-escalation Phase 1 clinical study to evaluate the safety and tolerability of ADI-001 for the potential treatment of NHL
    .

    Interim results of the study showed that 3 out of 4 evaluable patients achieved remission, including 2 complete remission (CR) and 1 partial remission (PR), no dose-limiting toxicity, graft-versus-host disease , Immune effector cell-associated neurotoxicity syndrome or grade 3 or higher cytokine release syndrome
    .

     ▲ ADI-001 interim data summary (Image source: Adicet official website) Chen Schor, President and CEO of Adicet Bio, said: "The fast track designation obtained this time represents an important milestone in the clinical development of
    ADI
    -001.
    Unique in that it is designed to target malignant B cells by exploiting naturally occurring innate and adaptive receptors on γδ T cells, with the added benefit of engineering an anti-CD20 CAR

    .

    We remain optimistic about the potential of this project and look forward to Report more data
    from the Phase 1 clinical trial of ADI-001 in the first half of 2022.

    ” Adicet: Focused on allogeneic γδ T cell therapy Adicet Bio is a clinical-stage biotechnology company focused on discovery and development for cancer Therapeutic allogeneic γδ T cell therapy
    .

    Adicet has developed a proprietary and powerful cell technology platform to activate, engineer and expand γδ T cells
    .

     ▲ Adicet’s γδ T cell-based cell therapy process (Image source: Adicet’s official website) In addition, Adicet has demonstrated that it can target by generating and validating high-affinity and high-specificity T cell receptor-like monoclonal antibodies (TCRLs) The intracellular proteome, these TCRLs against disease-specific antigens presented on the cell surface by MHC class I complexes, could be exploited to arm γδ T cells, as T cell linkers, and as ADCs
    .

    Adicet has also developed proprietary technology, Epitarget™, to identify and validate novel disease-specific peptide targets
    .

     Natural Killer γδ T Cells γδ T cells are a component of lymphocytes (leukocytes) that are present in all human beings and account for approximately 1-5% of peripheral blood lymphocytes
    .

    As part of the immune system's innate response, the natural properties make it a promising therapeutic candidate
    .

     Analysis of gene expression in 18,000 individual tumors from 39 different malignancies revealed that γδ T cells were the infiltrating immune cells most likely to be associated with a positive outcome
    .

    Researchers have shown that there are various types of γδ T cells, all with slightly different properties
    .

     Currently, a major goal in the field of adoptive immunotherapy is the generation of tumor-reactive αβ T cells for patients with a variety of cancers
    .

    To promote the rapid generation of tumor-reactive αβ T cells, it has been proposed to use αβ T cells that express tumor-specific αβ TCRs or CARs
    .

    However, its efficacy can be reduced following loss/downregulation of antigen expression by malignant cells, which often occurs in response to selective pressure on the therapy itself
    .

     Unlike αβ T cells, γδ T cells are not limited by this: once γδ T cells recognize alterations in physiological stress signals, they can respond very rapidly without the need for priming by antigen-presenting cells or clonal expansion in the lymphatic system
    .

    They can immediately kill transformed or infected cells, engage the conventional adaptive immune system or self-present antigens in order to initiate a fully developed systemic immune response
    .

     The advantages of γδ T as a carrier for cell therapy also include: Innate cytotoxicity through many different mechanisms, antigen presentation and cytokine/chemokine release to activate a broader immune response; Through sensing of stress signals specifically expressed by cancer cells , γδ TCR can distinguish cancer cells from healthy cells
    .

    Completely safe for healthy cells and will not kill them even when introduced in very high numbers; γδ TCRs are not MHC (histocompatibility complex) restricted
    .

    This means that if the donor's γδ T cells are transferred to the patient, the γδ T cells will not recognize the patient's body as foreign and will not cause GvHD (graft-versus-host disease)
    .

    This makes them ideal for allogeneic therapy - which can be harvested from healthy donors, scaled to very high quantities, stored and frozen, providing an easily accessible starting material for the manufacture of a wide variety of products
    .

     References: 1.
    https:// https://www .
    adicetbio.
    com/——List of recent popular activities——▼On April 22, the thermal stability evaluation of DSC technology in ADC drugs was reviewed.
    ▼On April 25, the quality control strategy of AAV gene therapy products and processes
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