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    Home > Active Ingredient News > Antitumor Therapy > Express targets a variety of solid tumors, and clinical trials of allogeneic CAR-T therapy have been approved by the FDA

    Express targets a variety of solid tumors, and clinical trials of allogeneic CAR-T therapy have been approved by the FDA

    • Last Update: 2021-12-28
    • Source: Internet
    • Author: User
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    ▎ WuXi AppTec content team editor today, Poseida Therapeutics announced that the US FDA has approved a new drug clinical trial application (IND) for the allogeneic CAR-T cell therapy P-MUC1C-ALLO1 to treat multiple solid tumor indications
    .

     Poseida's platform technology focuses on stem memory T cells (TSCM)
    .

    Such cells have the characteristics of long life, self-renewal and pluripotency, and can reconstruct the entire lineage of T cell subsets including effector T cells
    .

    Clinical trials have shown that they may survive for several years after treatment, providing the possibility of long-term efficacy
    .

    P-MUC1C-ALLO1, developed based on this type of platform technology, is the second completely allogeneic CAR-T candidate product approved by Poseida in 2021 and has the potential to treat a variety of epithelial cell-derived solid tumors, such as breasts.
    Cancer, colorectal cancer, lung cancer, ovarian cancer, pancreatic cancer, and kidney cancer, as well as other cancers that express the cancer-specific form of mucin 1 protein (MUC1C)
    .

    P-MUC1C-ALLO1 is designed to be completely allogeneic, eliminating or reducing the reaction between the host and the graft through gene editing
    .

    Poseida has demonstrated in preclinical models that P-MUC1C-ALLO1 can eliminate triple-negative breast and ovarian cancer tumor cells to undetectable levels
    .

    ▲Part of Poseida’s R&D pipeline (picture source: Poseida’s official website) The therapy will be evaluated in a multi-center, open-label, dose-escalation phase 1 clinical trial.
    The research object will be locally advanced or refractory to current standard treatments.
    Adult patients with metastatic epithelial solid tumors, or such patients who are considered unsuitable/rejected by another existing treatment option
    .

    The trial will evaluate the safety, tolerability and preliminary efficacy of P-MUC1C-ALLO1, and follow the 3+3 design of the dose-escalation cohort
    .

    After the subjects are enrolled, they will be given P-MUC1C-ALLO1 allogeneic CAR-T cells in accordance with the pretreatment regimen based on standard chemotherapy
    .

    In addition, the research protocol allows for the exploration of other dosing options, including re-dosing after the initial safety has been determined
    .

    Dr.
    Eric Ostertag, CEO of Poseida, said: “We are pleased to initiate a clinical trial evaluating the allogeneic CAR-T candidate product P-MUC1C-ALLO1
    .

    It is expected to treat a wide range of solid tumors, including breast, ovarian and other cancers
    .

    P- The gene editing in MUC1C-ALLO1 has been shown to reduce or completely eliminate alloreactivity
    .

    Our proprietary production process, including our booster molecule, has the potential to treat many patients with one production
    .

    We We look forward to starting this trial in 2022 and providing preliminary clinical data
    .

    "Reference: [1] Poseida Therapeutics Announces FDA Clearance of Investigational New Drug Application for P-MUC1C-ALLO1, a Fully Allogeneic CAR-T Targeting Multiple Solid Tumors.
    Retrieved December 20, 2021, from https://investors.
    poseida.
    com/news-releases/news-release-details/poseida-therapeutics-announces-fda-clearance-investigational-0 Disclaimer: WuXi AppTec's content team focuses on introducing global biomedical health research progress
    .

    This article is for information exchange only.
    The opinions
    in
    this article do not represent the position of WuXi AppTec, nor does it mean that WuXi AppTec supports or opposes the views in the article .
    This article is not a treatment plan recommendation
    .

    If you need treatment plan guidance, please go to a regular hospital
    .

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